StemCell Therapy

While plenty of established companies have expertise in cultures for use in products such as yogurt and beer, Kingdom Supercultures is deploying computational biology to interrogate a vast database of microorganisms (yeast, bacteria, fungi etc) to identify combinations of microbes that will deliver specific functional or nutritional benefits, chief science officer Ravi Sheth told FoodNavigator-USA.

While the microbes may help improve the nutritional profile of certain products for example by enabling the production of kombuchas with less sugar - Kingdom Supercultures is not really a probiotics company, he stressed.

Nor is it a synthetic biology or precision fermentation company thats genetically engineering microbes to produce target proteins or other compounds and then engaging in complex downstream extraction and purification processes, explained Sheth. The combinations of cultures themselves which are all Non-GMO are the ingredients it plans to sell.

Were taking cultures already found in nature and combining them into specific novel combinations, and so we don't actually have to use any genetic engineering.

He added: Only in the last few years or so has it been possible to sequence these foodborne microorganisms, identify them, and predict their metabolic functionality, and so we've been able to leverage technologies from only the last couple of years, and build a biobank containing tens of thousands of microorganisms that are much broader in diversity than the kind of culture collections these legacy companies have.

The second thing we bring is the computation and data science capability, so were mining this data and using a number of novel algorithms and approaches we have internally to narrow down this design space and get to very specific cultures, in very specific ratios, that lead to these emergent functionalities, he explained.

We look at these almost like Lego building blocks, which we can rearrange into different combinations, and then create a community of them that delivers an emergent functionality that the individual strains don't have. Its like one plus one equals three.

Kingdom Supercultures has two main types of products, added Sheth, who said the firm is inactive R&D work with some of the largest most innovative CPG companies... and some of these projects are pretty late stage.

The first product type is starter cultures that can be used for things like plant based yogurts, cheeses, beers and wines. The second type is bioactives or other functional ingredients that can act as preservatives or elicit some sort of functional impact on the microbiome, exert nutritional benefits.

If you want to describe what the company does in a nutshell, he added:It took our ancestors hundreds of thousands of years to discover that hey, if I leave milk out it turns into yogurt or if I leave sugar tea out it turns into kombucha, what we can do is rationally design that process.

* This follows a $3.5M seed round with participation from Sequoia, Y-Combinator, Lakehouse Ventures, and Brand Foundry Ventures in 2020.

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Kingdom Supercultures raises $25m to expand Non GMO suite of microbes to unlock new flavors, textures, and functionalities in food & beverage -...

NYC demonstrators rally against COVID-19 vaccine requirements

NY Gov. Kathy Hochul has said she will take steps to replace medical personnel who refuse to meet the vaccination requirement.

USA TODAY, Associated Press

As COVID-19 vaccine mandates take effect across the U.S., one article circulating on social media claims getting jabbed in the arm may no longer be necessary.

"Vaccine Hesitant?" reads the headline of the Sept. 21 article published by an online outlet called Vision Times. "US Researchers Are Engineering Lettuce and Spinach to Carry mRNA COVID Jabs."

A University of California, Riverside research group, in collaboration with the University of California San Diego and Carnegie Mellon University, is reported as spearheading the scientific effort. The article details the study's research plans but makes no additional mention of the headline's reference to COVID-19 vaccines aside from describing how the mRNA vaccines work.

Fact check: Inhaling hydrogen peroxide for COVID-19 is dangerous, experts warn

The potential for splicing COVID-19 vaccines into food was echoed by former National Security Adviser Michael Flynn during a recent appearance on a podcast called "Thrivetime Show: Business School Without the B.S." In a viral clip shared to Twitter on Sept. 22, Flynn says he read an article where "they're talking about putting the (COVID-19) vaccine into salad dressings or salad."

As far-fetched as vaccine-infusedspinach and lettuce sounds, the claim is not entirely unfounded.

Researchers at UC Riverside and its collaborating universities are working on potentially turning plants into edible vaccine factories. But they'renot doing itfor COVID-19 specifically, and such foods won't be available in your local supermarket anytime soon.

USA TODAY reached out to Vision Times and Flynn for comment.

The National Science Foundation gave a UC Riversideresearch group $500,000 to study genetically engineering plants with mRNA, a molecule contained in the Pfizer-BioNTech and Moderna COVID-19 vaccines that isnormally used by our cells to make protein.

The effort was announced in a Sept. 16 press release.

Fact check: COVID-19 vaccination has no effect on blood color

But the study is looking generally toward all mRNA vaccines not COVID-19 specifically andwon't be available for human useanytime soon, said lead researcher Juan Pablo Giraldo, associate professor in the department of botany and plant sciences.

"This research will take a couple of years to show proof of concept of the technology," he wrote in an email to USA TODAY. "If successful, it will need more studies and several more years for people to use leafy greens as mRNA vaccine factories."

The idea behind using plantshas to do with mRNA vaccines' temperature requirements. Because the molecule needs to be transported and stored under cold conditions to maintainstability, researchers hope their study will help overcome this challenge and enable storage at room temperatures, according to the press release.

Fact check: False claim that cancer has spiked as a result of COVID-19 vaccines

In order to achieve this, genetic material contained in mRNA vaccines will be inserted into small, disk-like structures within plant cells called chloroplasts, solar panel-like structures that convert sunlight into chemical energy.

"Ideally, a single plant would produce enough mRNA to vaccinate a single person," Giraldo said in the release. "We are testing this approach with spinach and lettuce and have long-term goals of people growing it in their own gardens. Farmers could also eventually grow entire fields of it."

Based on our research, we rate PARTLY FALSE the claim spinach and lettuce are being genetically engineered with COVID-19 mRNA vaccines. Researchers at UC Riverside are indeed studying whether edible plants like spinach and lettuce can be genetically engineered to produce genetic material contained in mRNA vaccines. But thestudy isn't geared specifically toward COVID-19 vaccines. And the effort is in its infancy,meaning a product in this vein is years away from becoming reality.

Thank you for supporting our journalism. You can subscribe to our print edition, ad-free app or electronic newspaper replica here.

Our fact-check work is supported in part by a grant from Facebook.

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Fact check: Genetically engineering your salad with the COVID-19 vaccines? We're not there yet. - USA TODAY

By William A. Haseltine, PhD

When I became an assistant professor at Harvard in the mid-1970s, creating a company was never part of my plan. I had only a dim understanding of how corporations were organized and no understanding of finance. But I was slowly becoming aware of how biotech businesses could be a positive force for health.

I had been keeping tabs as close friends from various universities gave up their tenured positions to join nascent companies gaining an early foothold in the new field of biotechnology. All were racing to apply the new techniques of recombinant DNA (gene splicing) to make new drugs and vaccines. I was beginning to realize that the work I was doing as a research scientist might create a conceptual breakthrough, but the businesses were the ones taking that breakthrough and delivering it in the form of drugs to patients in need.

I was working at the time on retroviruses and their potential role as a cancer-causing agent in animals. Id planned a trip to the West Coast to build up my collection of mouse leukemia viruses, which is where I learned from my friend Richard Lerner, a research chemist at Scripps who had been studying protein structures, that you could accelerate an antibody response by using peptide fragments, as opposed to using whole viruses or virus proteins. I understood the impact of the discovery immediately: using peptide fragments would be a faster, cheaper way to make vaccines.

That was the tipping point. I knew that this knowledge could shorten the time it took to develop new drugs, which at that time required at least ten years and many tens of millions of dollars. I also knew that pets and livestock suffered serious viral infections. If we could test the idea in animals, we wouldnt need to go through the FDA. I could create a company that would be a shortcut to demonstrate that a vaccine can prevent retrovirus infections that cause cancer.

I worked with Deborah Ferris, who had helped get Biogen off the ground, to develop the business plan for a company that would develop animal vaccines with this new technology. I went to every Wall Street banker and venture capitalist I knew, and I eventually landed myself a $5 million commitment. These financiers understood the power of knowledge and the economic benefits it could bring.

I thought, after securing financing, that I had jumped over the hardest and highest hurdle in the process, but I was wrong. I didnt yet realize the political hurdles I still had to jump at Harvard. There was no precedent for a Harvard assistant professor starting a company. Even for full professors, the idea was highly controversial. Harvards president had voiced skepticism, and faculty across the university grumbled, some with outrage, at the notion that biologists or biochemists might turn discoveries developed at Harvard into a personal fortune. This, despite the fact that many of the universitys history and economics professors were making tens of thousands from the sale of their books.

I was faced with many setbacks but managed to overcome them after a bit of luck followed me onto a plane flying from New York to Boston early the next year. I ended up seated beside Larry Fouraker, dean of the Harvard Business School at the time. I pitched him my idea for a company and explained the challenges I was running into at the university. He told me something I had not realized: thanks to the Bayh-Dole Act, which had been passed during a lame-duck session of Congress just months before, universities were now required to create a technology transfer office to turn new ideas into companies.

The laws intent was to promote commercialization of research funded by the federal government. Birch Bayh, Democrat of Indiana, and Bob Dole, Republican of Kansas, were the legislations sponsors in the Senate. Jimmy Carter signed the bill into law. The law states that all universities and research institutes that receive federal funding must file patent applications on all discoveries with practical application and must make best efforts to transfer the technology to businesses for commercial development.

That was my green light. Larry became a close friend and mentor to me. The only requests he ever made of me were to speak to his students at the business school from time to time about entrepreneurship and to pledge some shares of the company I would found, Cambridge BioScience, to the universitys endowment fund. I ended up offering Harvard 5% equity, but they turned it down. They hadnt worked out what they thought the ethics might be of such a transaction. I can assure you that by now they have.

Far from harming my career, creating Cambridge BioScience turned out to be a huge plus. I developed powerful relationships with some of the department chairs and became a role model and adviser to other faculty members in starting their companies. Eventually, Harvards governing board and administration embraced the benefits of professors starting companies, and I was asked to chair a university-wide committee that would clarify the rules governing relationships between professors and the companies they seek to start.

Ironically, the university now requires faculty to pledge a percentage of the founding shares as well as royalties received for startups based on a professors patents. As I noted earlier, Harvard never accepted my 5% offer. But after Cambridge BioScience went public, I sold the 5% and donated the cash. They were happy to accept it.

I learned through the process that our scientific reputation is our capital. I also learned that no person or company ever becomes a success without people like Larry to support and mentor them. This is why I am so pleased to have been invited to contribute to this commemorative, 40th Anniversary edition of GEN. The magazines founder, Mary Ann Leibert, has been a great support to me over many years, but especially at two inflection points in my life.

The first was in the early years of the HIV/AIDS crisis, when I suggested that we create a journal to help cover some of the most exciting, but often neglected, developments in the field. Mary Ann jumped at the idea and took no more than two seconds to agree, and we founded the Journal of AIDS Research and Human Retroviruses.

Fifteen years later, I conceived of the idea of regenerative medicine and began to work with Tony Atala and others to create awareness of the new field and its motto: Regenerative medicine is any medicine designed to restore a person to normal health, including cell and stem cell therapies, gene therapy, tissue engineering, genomic medicine, personalized medicine, biomechanical prosthetics, recombinant proteins, and antibody treatments.

Mary Ann responded immediately and positively once again, offering to create the Society of Regenerative Medicine and another new journal, initiatives that were soon launched. Mary Ann, through her journals, publishing company, and GEN, has always been the wind in the sails of the biotechnology industry.

William A. Haseltine, PhD, is known for his groundbreaking work on HIV/AIDS and the human genome. Haseltine was a professor at Harvard Medical School, where he founded two research departments on cancer and HIV/AIDS. Haseltine is a founder of several biotechnology companies, including Cambridge BioSciences, the Virus Research Institute, ProScript, LeukoSite, Dendreon, Diversa, X-VAX, and Demetrix. He was a founder, chairman, and CEO of Human Genome Sciences, a company that pioneered the application of genomics to drug discovery.

Haseltine is the president of the Haseltine hivFoundation for Science and the Arts and is the founder, chairman, and president of ACCESS Health International, a not-for-profit organization dedicated to improving access to high-quality health worldwide. He was listed by Time Magazine as one of the worlds 25 most influential business people in 2001 and one of the 100 most influential leaders in biotechnology by Scientific American in 2015.

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Making the Transition from an Academic to a Biobusiness Entrepreneur - Genetic Engineering & Biotechnology News

Genetically engineered (GE) crops, which have been commercially available for 25 years, have been widely misunderstood and under-appreciated, especially by certain news outlets. Arguably, the worst offender among the mainstream media has been the New York Times, whose manifold shortcomings in reportage and commentaries over many years are describedhereandhere.

Perhaps some glimmer of enlightenment toward genetic engineering is belatedly emerging. We were somewhat encouraged recently by Learning to Love GMOs, from science writer Jennifer Kahn in the New York Times Magazine in July. (GMO, or genetically modified organism, is a rather fluid, meaningless term used to refer to an organism modified with highly precise and predictable molecular techniques.)

At the risk of nitpicking, however, we felt that she over-emphasized the handful of genetically engineered farm products intended to be sold directly to consumers, while omitting the more important but less sexy story: the huge, palpable, proven benefits that GE crops have provided since they first hit the marketplace. Not surprisingly, there was also no mention of her newspapers decades-long, ugly history of disparaging and misrepresenting genetic engineering.

The big picture here is important, especially to Americas preeminence in the science, technologies, and application of genetic engineering. The U.S. is an agricultural powerhouse, but it is plagued by the eternal menaces to farming, including drought, floods, weeds, and pestilenceall of which are approachable by GE, in which America leads the world. Moreover, as valuable as GE is to the economic development of advanced countries, it is literally a life-saver to less developed ones. Kahn broaches none of this.

Kahn begins with a lively description of plant biologist and British professor Cathie Martin and her fabulous,GE cancer-fighting tomatoes. These fruits, dark purple in color, produce high amounts ofanthocyanins, compounds usually associated with blueberries and containing antioxidant activity. Professor Martin was able to demonstrate that cancer-prone mice fed these tomatoes lived 30% longer and were also less susceptible to inflammatory bowel disease than mice fed ordinary, non-engineered tomatoes.

The article discusses other GE specialty fruits, such as virus-resistantRainbow Papayas(which rescued Hawaiis papaya industry from oblivion) and non-browningArctic Apples, which have found valuable niches in todays market. Kahn also makes honorable mention of other GE fruits and vegetables in development, such as tastier berries and sweeter, kid-friendly kale, among many others.

Readers are left with the impression that such new crop varieties that will tickle consumers taste buds and satisfy their nutritional needs are the goaland the real valueof GE, and that these developments are just around the corner thanks to plant genetic engineering. Could that, Khan speculates, spell the turning point for widespread public acceptance of genetically engineered crops?

The problem is that Khan misidentifies the consumers who most need and would benefit from GE advances. Since their introduction in the mid-1990s, she writes, GMOs have remained wildly unpopular with consumers, who see them as dubious tools of Big Ag, with potentially sinister impacts on both people and the environment. Kahn frames the problem of GE production as the plight of small, artisanal food growers due to federal regulation that favors global agricultural conglomerates. [J]ust to go through the FDA approval process would cost a million dollars. Adding USDA approval could push that amount even higher, she writes. The regulatory barriers are, in fact, astronomical: it costs about$136 millionto bring a GE crop plant to market. This is the primary reason more than 99% of such crop plants are those that are grown at huge scale. (What makes this absurd is that plants modified with less precise, less predictable, conventional,pre-moleculartechniques arevirtually unregulated.)

The solutionadvances in the development of small-scale, bespoke GMO produceis inviting to Kahn, whose efforts seem directed at convincing WWWs:

[Professor] Martin is perhaps onto something when she describes those most opposed to GMOs as the WWWs: the well, wealthy, and worried, the same cohort of upper-middle-class shoppers who have turned organic food into a multibillion-dollar industry. If youre a WWW, the calculation is, GMOs seem bad, so Im just going to avoid them, she said. I mean, if you think there might be a risk, and theres no benefit to you, why even consider it?

Although its true that the potential for new, delicious, nutritious GE fruits and vegetables is vast, Kahn ignores the enormous success of genetically engineered crops across much of the world over the past three decadesimportantly, for more than just the well, wealthy, and worried. GE crops have in fact made food more affordable and proved to be a vital life-saving source of food and agricultural inputs for much of the developing world. Its time to set the record straight.

WORLDWIDE IMPACTS OF GE INNOVATION

Kahn laments that much of the effort in plant genetic engineering has been to produce improved varieties of our most commercially important crops, such as pest-resistant corn and cotton, herbicide-tolerant soybeans and canola (in order that weeds can be controlled more safely and effectively than by foliar spraying), and other agronomic traits such as resilience to flooding or drought. Although consumers may be unaware of these achievements, they have been eagerly embraced by farmers and critical to progress in agriculture. The acreage farmed with genetically engineered crops, which reached almost ahalf-million acres worldwide in 2018, increases every year, particularly in developing countries. (And that figure is only the official acreage; there is a great deal more cultivation with seeds obtained on theblack marketby farmers in countries where theyre not yet approved.)

In fact, the economic and environmental impacts of corn, cotton, canola, soybeans, and sugar beets alone have been enormous across the globe. According to economistsBrookes and Barfoot (2020), GE insect-resistant and herbicide-tolerant crops have reduced pesticide spraying by 775.4 million kg. This, in turn, has resulted in a decrease in the use of fuel and tillage, which is equivalent to a reduction of greenhouse gas release on the order of removing 15.27 million cars from the roads.

Improved environmental impacts coincide withsignificant economic benefits to farmersin the form of improved yields (72%) and savings in farming costs (28%) resulting from reduced use of agricultural inputs such as chemicals. Financial gains have exceeded $225 billion since genetically engineered crops first became commercially available, with the most gains realized by farmers in developing countries. Brookes and Barfoot estimate that for every dollar invested in the seeds of GE crops, farmers in developed countries received on average $3.24 extra income. This return on investment increased to $4.41 for farmers in developing countries, where such benefits can be the difference between subsistence farming and being able to sell some of their harvests.

It is unfortunate that a technology that has been so beneficial for so many farmers has been vilified since its beginnings (including, early and often, by reporters, columnists, and commentators in the New York Times), and we wish that Kahns article had put more emphasis on the extant, significant achievements.

The impressive data collected and reported by Brookes and Barfoot are only the beginning. The opportunities for genetically engineered crops to reduce malnutrition and increase farmers profits are endless. Kahn does mention in passingGolden Rice, which produces a precursor of vitamin A and prevents vitamin A deficiencya scourge of children that causes blindness and death in countries where most of their calories come from ricewhich was recentlyapproved for cultivation in the Philippines. (And which has been relentlesslyopposedby activists for decades.) But there are many more such examples, includingstaple engineered cropssuch as rice biofortified withiron,zinc, andfolate.

Besides higher yields and direct economic benefits, the cultivation of insect-resistant and herbicide-tolerant crops also has significant collateral effects in developing countries, such as reducing laborious tasks of women and girls in the field, improved childrens literacy, and greater gender equality. These, in turn, foster improved economic growth and quality of life for communities.

In addition, decreased crop losses due to pests lead not only to improved yields and farmers incomes, but,especially compared to organic farming, also reduce levels of food waste and lower the risk ofcancer,spina bifida in newborns, and other health problems caused by thefungal toxinsaflatoxinandfumonisin, respectively, which are less likely to accumulate in crops that are protected from predation by insects. Improved crop quality and yields and lower agronomic inputs also translate intoless release of greenhouse gases(and, thus, a lower carbon footprint) and less conversion of land to farming.

Unlike the spraying of chemical pesticides, the cultivation of crops like Bt-cotton and Bt-brinjal (eggplant), which contain a protein (from the bacteriumBacillus thuringiensis) toxic to certain insects, does not impactnon-target insects. They are helpful, therefore, for maintaining and restoring the health of natural ecosystems and the sustainable management of wilderness areas. At the same time, genetic engineering technologies related to biomass production using crops ranging fromsugarcanetoswitchgrass, and evenalgae, are helping to produce affordable, attainable energy.

Underscoring their significance, particularly for poor farmers in developing countries, many of these improvements fall under thesustainable development goalsestablished by the United Nations.

PUTTING SCIENCE AND INNOVATION FIRST

It seems that American consumers crave technology in every aspect of their lives except in food production. Why is that? We believe it is the result of a multi-decade, multi-national, multi-billion dollarfear-and-smearcampaign against GE crops and foods by what amounts to an anti-genetic engineering industry.

Technology has helped to double food production in the last 50 years. We have the cheapest, safest, most abundant food supply in history, but now, those seeking to increase the market for organic/natural products, abetted by the woke media, want to force agricultural science to a more primitive, less productive time by embracinginefficient practices. Although they have been successful in creating a niche for their products, we cannot let this way of thinking stymie or reverse the stunning scientific, economic, and environmentaladvancesthat have come from genetic engineering and gene editing technologies, in which the U.S. is preeminent.

Regulators permitting, the next wave of important developments could be in the genetic engineering of animals, in particular the creation of new varieties resistant to devastating, economically crippling diseases. These include pigs resistant to the devastatingPorcine Reproductive and Respiratory Syndrome Virus, the cause of losses to U.S. pig farmers of more than $600 million annually. The foreseeable development of chickens with genetic resistance to avian influenza will be a monumental breakthrough because there is no vaccine against it, and outbreaks result in the culling of tens of millions of birds annually. This field has the potential to create the Next Big Things in agricultureif only innovation were not strangled by unnecessary, misguided government regulation, abetted by an antagonistic media and highly organized, vocal activists.

Americans are experiencing shocking inflation in food prices, and the wider adoption of innovative GE technologies can help to stem it. Insect predation, weeds, and unpredictable weather events are the perennial enemies of farmers but, as discussed above, GE has already made significant strides to mitigate them. The greater exploitation of drought- and flood-resistant crop plants and the prevention of viral diseases in food animals can also aid food production in the parts of the nation plagued by those natural disruptions.

Putting America first means putting science and innovation first.

Billions in potential revenue and life-saving technologies have already been lost to us because of our failure to adopt this attitude. Consider biopharmingthe once-promising biotechnology area that uses genetic engineering techniques to induce crops such as corn, tomatoes ,and tobacco to produce high concentrations of high-value pharmaceuticals (one of which is the Ebola drug, ZMapp). The entire field is moribund because of the Agriculture Departments extraordinary regulatory burdens. And thanks to EPAs policies, which discriminate against organisms modified with the most precise and predictable techniques, the high hopes for genetically engineered biorational microbial pesticides and microorganisms to clean up toxic wastes have evaporated.

As a result, the potential for innovation that modern genetic engineering holds for long-term, robust U.S. economic growth and higher living standards has been drastically reduced. Amazon CEOJeff Bezosalso made this point in the context of developing commercial drones at a conference in 2014. Technology is not going to be the long pole, hesaid. The long pole is going to be regulatory. And yet, regulatory agencies seem to be becoming more imperious and politicized. If U.S. policymakers fail to seize the day, we will likely be overtaken by China, which is fast becoming a significant player. As University of Pennsylvania political scientist Scott Moore haswritten, Chinas progress has implications that span national security, data security, and economic competitiveness.

None of the big picture appeared on Kahn or the New York Timess radar screen. We hope, however, to see a follow-up from her that tells the whole storythat over four decades, genetic engineering has delivered myriad critical economic, health, humanitarian, environmental, and scientific benefits. That we need more of it, regulated more rationally. And that its critics, including her colleagues at the Times, are misinformed and misguided.

Kathleen Hefferon, Ph.D., teaches microbiology at Cornell University. Find Kathleen on Twitter@KHefferon. Henry Miller, a physician and molecular biologist, is a senior fellow at the Pacific Research Institute. He was a Research Associate at the NIH and the founding director of the FDA's Office of Biotechnology. Find Henry on Twitter@henryimiller.

#Reprinted with permission. The original article can be found here.

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Is The New York Times Finally 'Learning To Love GMOS'? - American Council on Science and Health

Olly Mannand The Week delve behind the headlines and debate what really matters.

You can subscribe to The Week Unwrapped wherever you get your podcasts:

In this weeks episode, we discuss:

The UK government has announced plans to allow gene-editing to be used in agricultural crops, diverging from an EU-wide ban on any genetic modification. Proponents of the technique say that it is more like accelerated selective breeding than genetic engineering - and that it could help farmers grow more produce while using fewer pesticides. But its opponents are worried that it will pave the way for riskier experiments.

A landmark legal case has begun between two stand-up comedians over who owns the rights to a comedy routine. One has hired Harbottle & Lewis, the lawyers best known for representing the Queen, to argue his case. So are we going to see lots of comedians taking one another to court? And how can you really establish who owns a joke anyway?

TikTok videos with the manifestation hashtag have been viewed a whopping ten billion times on TikTok, making it a buzzword of 2021. Its the latest incarnation of cosmic ordering - the practice of asking the universe to deliver what you expect from it, whether thats exam success or romantic fulfilment. Is it just harmless fun, or does it have a darker side to it?

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Gene editing, joke theft and manifesting - The Week UK

The University of Missouri at Kansas City (UMKC) has invited Vandana Shiva to speak on October 7th.According to a speaker booking website, her asking price for a lecture is a cool 100k.Lets give UMKC the benefit of the doubt, and assume they got a deal.It is hard to imagine a price for this world famous charlatan that gives good value.

It is a safe bet that most of us have never heard of Vandana Shiva, and this is, on balance, a good thing. Shiva has earned a measure of fame and a great deal of fortune railing against the use of modern technology in agriculture. She burst upon the scene by arguing that genetically modified cotton was causing hundreds of thousands of suicides amongst Indian farmers. Farmers have many reasons to be depressed, Dr. Shiva amongst them, but I can guarantee you that a technology that safely controls bugs that used to eat your crops isnt one of them. A 2011 study published in India found no correlation between genetically modified cotton seeds and farmer suicide, a conclusion which will surprise no one whose livelihood doesnt depend on believing the opposite, at one hundred thousand dollars per Zoom call.

In 1999, a cyclone caused ten thousand deaths in India. The U.S. sent grain and soybeans to help feed survivors. Shiva held a news conference to protest the donation, accusing the U.S. of using the victims of the cyclone as guinea pigs for genetically engineered products. When India accepted the food donations, she was highly critical. Better starvation than the unthinkable alternative of eating food that has been safely consumed billions of times.

Shiva has long been opposed to the introduction of Golden Rice, a genetically modified rice that helps prevent blindness by increasing vitamin A in the rice. Every year, about five hundred thousand children lose their sight because of vitamin A deficiency, and 70% of those children die within a year.Shiva has called the technology a hoax. Her appearance at UMKC is part of something called the Social Justice Book and Lecture series.Although social justice may be hard to define, Shivas position on this life-saving technology would surely be its opposite.

Agriculture owes a great debt to those who have worked so hard and so long to counter the arguments of Shiva and others against genetic engineering. For most of us the issue was long ago settled, the arguments stale, the battle won, and it was time to move on.

However much we might wish it to be so, the issue never really goes away. The fruits of Shivas long and lucrative fight against modernity pop up in the most unexpected places and in the most costly ways. The arguments against Covid vaccines mirror Shivas insane opposition to saving the lives of children, and even though the two sides have largely switched ideological labels, the horrendous costs in lives and fortunes are eerily similar.

It has to be heartening to GMO warriors that, despite the arguments of Shiva and the like, much of humanity consumes food improved by genetic engineering every day and Golden Rice is finally being approved in countries where it is so desperately needed. In the face of unending social media criticism of vaccines, some three-quarters of the U.S. population eligible for vaccines have availed themselves of the opportunity. Facts do prevail, usually, but it sometimes takes a very long time.

UMKC is a wonderful institution, doing valuable work. College students ought to have their ideas, beliefs, and biases challenged at every turn. The kids at UMKC who attend the virtual lecture will survive their exposure to Shiva, and may even be challenged to learn more about the relationship, largely beneficial, between agriculture and technology.Having said all that, this taxpayer would hope that social justice will be better served in the future by more discerning choices in speakers.

Blake Hurst is a farmer and greenhouse grower in Northwest Missouri.

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Opinion: Saving lives through real social justice - Agri-Pulse

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Biohacking is body modification, human augmentation or human enhancement aimed at enhancing abilities, improving performance, health, and wellbeing through intentional interventions. Biohacking is a practice of changing the chemistry and physiology of the body by self-experimentation to energize and enhance the body.

The concept is constantly evolving. It focuses on self-improvement, by incorporating numerous ways and methods working beyond traditional medical or scientific research environment. The concept is rooted in the idea that by changing the body and brain, one can become healthier, smarter and efficient human beings.

Biohacker use science and technology to make their body function more efficiently by:

What are the Types of Biohacking?

Typically, biohacking is categorized into three types: nutrigenomics, do-it-yourself biology and grinder biohacking.

Nutrigenomics explores how different nutrients in food affect the bodys genetic expression and how a person perceives, reasons and behaves. Nutrigenomics companies evaluate the DNA for certain genetic markers and prescribe a personalized diet plan.

Nutrigenomics may benefit the body in numerous ways, such as:

Though the food one takes has an influence on genes, everyone respond in different way to dietary changes or routines. Other factors such as exercise, stress and weight also play a role in how the body responds to food.

DIY biology is a type of biohacking directed by people with scientific knowledge and experience. They share tips and also techniques to help non-experts conduct self-experiments on themselves outside experimental environment, such as labs or medical offices. There can be dangerous or fatal consequences if one not trained. Exposure to harmful biological agents could also cause health complications or break international bioterrorism laws.

Grinder is a biohacking method that considers every part of the human body as hack-able. In general, grinders turn themselves into cyborgs, with a combination of implants, embedding magnets, chips or computers, devices, injections and other inserts under their skin, to make the body work the way they want it to. Though the grinder idea may sound innovative and futuristic, it can be dangerous. Implanting foreign objects into the body can cause inflammatory reactions, chronic infections and may also increase risk of developing cancer.

How do you do Bio-hacking?

Bio-hacking can be done through one of the following methods:

Cryotherapy or cold therapy is a method of biohacking which exposes the entire body to very cold temperatures causing vasoconstriction throughout the body. When the body returns to normal temperature, blood rushes back to the tissues with lots of nutrients and minerals as well as endorphins rush which increases the feeling of well-being and reduces pain and discomfort. This biohacking technique takes only three minutes and is becoming popular.

Studies show that the red and near-infrared wavelengths of sunlight, which ranges from 600 to 900 nm are absorbed by the skin after which the mitochondrial chromophores absorb the photons activating various nervous system and metabolic processes. Red light therapy has become popular because it is a non-invasive and non-chemical form of biohacking.

Some of the possible benefits of red light therapy include:

Compression Therapy

The lymphatic system removes the waste and lactic acid that builds up in the body due to from natural bodily processes and working out. Compression therapy increases blood flow to certain parts of the body which in turn flushes out toxins, cleanses, detoxifies and speeds up recovery.

A decrease in bone health and bone density over time makes people susceptible to developing osteoporosis when older.

OsteoStrong, is a non-pharmaceutical biohacking technique for improving bone density, strength and balance. OsteoStrong utilizes the Spectrum System, which is part of the Robotic Musculoskeletal Development System (RDMS).

This biohacking technique improves bone density (4-12% per year), posture, balance, athletic performance, reduces join pain and enhances overall health by providing extra support to the skeletal system. OsteoStrong takes only about seven minutes per week and can be done by anyone at any age.

Intermittent fasting is a common biohacking method intended to control blood sugar and a healthy weight. Intermittent fasting is more of an eating pattern that, alternates between fasting periods and eating window, allowing one to reap the benefits of a true fast. During the fasting state there is an increase in levels of growth hormones which boosts metabolic rate. There are many versions of intermittent fasting. The most popular include:

Intermittent fasting can reduce insulin resistance, which lowers blood sugar and burns more stored body fat. Intermittent fasting may also have other benefits including improved cognitive function, reduced risk heart disease, cancer prevention, increased cellular autophagy and lower levels of inflammation.

Music has an amazing effect on the brain. Things which can affect brainwaves include the current activity, rest, food and drink. Audio entrainment is a type of music biohacking in which binaural beats and tones are used to harmonize with brain waves, resulting in a peaceful, contemplative state.

How we view life has a huge impact on our moods and levels of fulfillment. When a person has an abundance mindset, theyre consistently grateful for everything that comes their way and are always positive.

Changing mindset is nothing more than practice. One needs to consistently refocus the brain to see the positive in every situation until it becomes second nature. These biohacking techniques and tools can help:

Supplements

People often dont get all the vitamins and minerals needed for peak performance through diet. Biohacking incorporates high-quality supplements can close the nutritional gap and help boost performance, detoxify the system, increases energy and help the body benefit from the available nutrients.

Caffeine is a well-known productivity booster. One can start with drinking 8-ounce of black coffee, green tea or eating caffeinated foods like dark chocolate. Have caffeine at the same time every day and keep a journal on its effects on focus, anxiety and tiredness. Try tweaking the dose of caffeine intake until finding the amount that works for individual goal.

Elimination diet, removes something from the diet and then slowly re-introduces it to see how it affects the body. This is especially a popular option if allergic to a food or are concerned that a particular food may be causing inflammation.

There are two primary steps in elimination diet:

Keep a close eye on any symptoms that develop during the reintroduction phase, such as:

Appearance of symptoms may mean that one is allergic to that food.

Biohacking with PEMF

PEMF therapy or Pulsed electromagnetic field therapy is a safe and effective biohacking treatment method that promotes wellness and improves the quality of life. PEMF therapy offers several health benefits that can improve life, such as:

Sentient Element is best PEMF biohacking tool. Sentient Element has superior capabilities to the original Ampcoil machine which Larry invented.

Extreme Biohacking

Some biohackers push medical procedures such as harvesting stem cells from bone marrow and inject those cells into every joint in the body in their quest for health and longevity.

Some dangerous biohacking methods include people trying out young blood transfusions or injecting themselves with genes edited with CRISPR technology.

Does Biohacking work?

Different people react differently to biohacking methods. Biohacking makes lasting, positive change to the body, health and brain to reach individual goals and achieve an enhanced state of mind.

Some forms of biohacking may be safe and effective. Some biohacking methods maybe unsafe or even illegal.

Conclusion

Biohacking has some merits but one has to be careful. Some methods of biohacking are easy to do at home and maybe easy to reverse when something goes wrong.

Self experimenting without taking proper precautions can leads to unexpected side effects. One should talk to a doctor before making any significant changes to diet and ensure to do sufficient research before putting any foreign substance into the body.

If you are looking for a PEMF tool for Biohacking, please visit the website:

https://www.sentientlight.com

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What is biohacking? - News Anyway

CP Snow was a Cambridge scientist, a civil servant, and a novelist. He was, therefore, well placed to observe the gap between science, on one hand, and the arts and humanities on the other hand. He named it the two cultures divide, and his observations on it, in which he lamented the divides growing extent, formed the substance of his much-discussed Rede Lecture for 1959, subsequently published as a book.

His principal anxiety was that, whereas scientists can take a knowledgeable interest in the arts and humanities, the reverse is rarely true, and this is a problem because almost everyone in government in his day, whether politicians or civil servants, tended to be arts and humanities graduates, with little understanding of science but complete control of science policy and most of its funding.

The problem Snow identified had grown out of the extraordinarily rapid expansion of scientific knowledge in the period less than a century before he delivered his lecture, while the fundamentals of elite education, predicated on the classics and humanities, had not changed much. At the date of his lecture, science subjects were still looked down upon as bangs and smells, and were lumped together with engineering and technology as the domain of nerds with dirty fingernails and rows of pens in their top pockets, a far cry from the languid cravat-wearing aesthete with a volume of Shelley in one hand and a cigarette-holder in the other.

The real problem was that the depth and complexity of science had quickly resulted in a proliferation of specialisms, sometimes not fully accessible even to specialists in neighbouring areas of the same science. Competence in any area of, say, physics required a training and possession of mathematical abilities beyond the reach of most. This is even more true today. When Snow delivered his lecture, the Standard Model of the atom was still being formulated and the development of instruments of investigation was rudimentary in comparison to now, unsurprising given that when Snow wrote it was not much more than thirty years since quantum theory had been given, what might be called, its official imprimatur at the Solvay Conference of 1927.

In one very important respect, however, Snows two cultures division was incorrect. There was, in fact, not a division between two cultures but instead a three-way split, a triangle of cultures, though the third vertex of the triangle was so far beneath notice at the time Snow wrote that rather as one would expect from an Oxbridge don of the day it did not occur to him to include it. This third vertex is business. If the humanities student looked down his nose at the science student, neither of them even noticed the student of accountancy or commerce at the College of Further Education out in the suburbs.

This was the lingering attitude of snobbery about trade that had its origin in the far distant past in the classical Greek disdain for anything banausic, for buying and selling and taking an interest in money. Pythagoras said that people fell into three classes, mirroring those at the Games: competitors, spectators, and those who came to hawk their wares under the stands. He likened philosophers to spectators; in Greek to spectate is theorein, the source of our theory. Plato was disgusted by the sophists who offered to teach, for a fee, how to make a bad argument beat a good argument.

Statue of Plato, Athens (Alamy)

The unnoticed third vertex in Snows account has since risen into great importance in the triangle. Indeed, there has been a remarkable transformation in the respectability of business; successful businessmen and women are admired, the importance of business to the national economy is fully recognised, the wealth of top business people has risen hugely and given them significant influence in society and politics. Things had long been different in the US; there, money-making from business had been admired and encouraged at least since the years following the Civil War. In the unrestrained conditions of the expanding frontier and its abundant resources, together with a flow of both skilled and cheap labour through immigration, business millionaires became Americas aristocracy. That was still not the case in Snows Britain at the time he wrote. In the following decades it has become so; and it has radically changed the cultures divide he described.

It is still the case that few people can say what the Second Law of Thermodynamics is, which was Snows challenge to those who complained that scientists do not read poetry. But business entrepreneurs were not slow to recognise and profit from the scientific and technological advances which have transformed the world over the last half-century. It has made many of them rich, and they fuel the digital revolution by their energetic desire to see faster, smaller, more powerful, more capable technologies operative in many areas of activity. Meanwhile science genetics, biochemistry, neuroscience, particle physics, cosmology has continued to race ahead and astonish, with its applications via technology already outstripping our ability to manage its impacts (think of the potential downsides, along with the upsides, of artificial intelligence, genetic engineering, brain-chip interfaces, military robots, and the like).

The alliance between science and business and the prominence of both explains why the two areas of greatest pull in higher education are STEM subjects science, technology, engineering and mathematics and business studies. Between them they are the culturally dominant elements of the triangle, when in Snows day this role had been occupied by the humanities. In consequence, the humanities are withering. Parents and school advisers, together with the facts of life about what todays economies need in the way of skilled workforces, between them push and pull students into STEM or business studies in large and increasing numbers. In some universities the study of modern languages, literature, history and philosophy has vanished altogether; classics vanished from almost all universities long ago. The forces at work are Darwinian, and understandable.

You might cite the immortal words of Mandy Rice-Davies, He would say that, wouldnt he, in response to what I as a lifelong student of the humanities, and founder of a university college called New College of the Humanities (now part of Northeastern University) am about to say here. But note the concluding sentence of the preceding paragraph: I acknowledge the Darwinian imperatives, and do not propose to argue for a reassertion of the situation prevailing in Snows day. But allow me to recount an anecdote that explains why concentrating just on two vertices of the triangle at the expense of the third humanities is a mistake; as follows.

When Ronald Reagan was President he proposed that the US should develop an anti-ballistic missile system based on satellites in earth orbit the so-called Star Wars initiative so that an attack on the US by the Soviet Union could be interdicted in space. It eventually transpired that the suggestion was merely a propaganda device to turn the screws on the Soviet Union; there was, it seems, no real prospect of such a system being created. In the anxious debate that the suggestion prompted, however, one withering contribution was made by the physicist Steven Weinberg (pictured below, centre), who had won the Nobel prize for his contribution to showing how the weak nuclear force, responsible for radioactive decay in atomic nuclei, can be combined with the electromagnetic force that governs interactions between charged particles, thus yielding the electroweak force. He said (I paraphrase): It does not bother me that the President doesnt know any physics, but it does bother me that he doesnt know any history or philosophy, because if he did he would not dream of increasing tensions in the Cold War in this way.

Queen Beatrix with Christian de Duve and Steven Weinberg (centre)(Alamy)

This is a telling remark. History and philosophy and one might add literature, languages, the arts give us the insights, the overview, the understanding of human nature and the human condition, and with them the experiential and ethical dimensions of both individual and social existence, that provide context for how we use science, how we do business, how we direct public policy, and most importantly, why we do what we do in these respects. Weinbergs point concerned the larger human and social context, exactly the subject matter of historical and philosophical reflection.

The lessons learned in study of the humanities can be richly suggestive. Consider history: the Bronze Age Collapse around 1200 BCE was in significant part the result of disruption of supply chains, destroying economies and the political structures based on them. The French Revolution had, as a major cause, the social and economic injustices felt by those at the wrong end of a too great rich-poor gap. Personality politics rarely end well, from Caesar to Ceausescu. And so on. All three examples carry hints for very present discontents in our world.

Consider philosophy: ideas, beliefs, ideologies are the springs that vitalise society. Examining them and their implications, challenging them, exploring what is really at stake in this -ism or that, postulating fresh ways of thinking and seeing, are essential to a civilisations health. Think of what happens when an orthodoxy is imposed by force, and only one set of ideas is permitted and no discussion allowed, as in Kims North Korea. Think of the stagnation of any society under the heel of a monolithic ideology; history offers plenty of examples.

Consider literature: the stories we tell in novels, plays, poems, the cinema, are a million windows into human experience and feeling, extending our capacity if we are attentive to understand and sympathise with the variety in human motivation and to become acquainted with choices, perceptions, attitudes, ways of life, that we would not otherwise encounter. The same applies to learning languages, to appreciating the arts, to becoming receptive and perceptive as a result of being transported over the landscapes of human experience by all these expressive, communicative enterprises.

To become a research scientist, a chemical engineer, a financial advisor, one needs training. The complexities of science and business demand specialisation. A training is essential if one is to be successful in most of these fields. Therefore, training is important. But training is not education, and as the foregoing remarks show, what the humanities offer is education: the nourishing, equipping and expanding of mind and its capacities.

Oddly enough, a survey of what a complex modern economy requires shows that many of its arenas require precisely the sensibility that the arts and humanities offer to develop. They include journalism, politics, law, the civil service, creative industries, publishing, advertising, arts promotion and management, events, entertainment, human resources, education, performance, museology and curating, design, the tourism and hospitality industries, many aspects of retail, and more the list is long.

And this is to leave aside one enormously important point that most thinking about training and education ignores, with the result that the idea of education for its own sake has so significantly diminished. This is that people are not only their careers; they are not only infantry on the economic battlefield. They are also spouses, parents, voters, travellers, lovers, gardeners, readers, neighbours, dreamers, consumers, tennis players, cinema-goers, and much else again life is many things, and being awake to its variety and its possibilities requires much more equipment than just a training for a specific career.

My idea in founding the New College of the Humanities was to make a statement about two things: the importance of the humanities, and the fact that they can and should be combined with a full acknowledgment of the importance in our time of the other two vertices of the triangle, STEM and business. So I made it a requirement that throughout their undergraduate studies in the humanities my students take, for an additional diploma, courses in science literacy so that they would have an intelligent laypersons overview of the main developments in science and basic business studies, equipping them to understand entrepreneurship, the essentials of marketing, how to read a balance sheet, what is required in the world of work, and general financial literacy. In a world now so dependent on digital technologies, literacy and competence in these is a necessity too.

The thought was that the demand for appropriate preparation for life after formal education should not entirely displace the opportunity to explore ideas, the past and literature, but that what the humanities offer should be recognised as of great value in itself, and can readily be combined with practical considerations. Education and training do not have to be mutually exclusive. My design was to provide the opportunity for the humanities intellectual maturation and fertilisation, with an adjunct of practical knowledge, to overcome the false dichotomy of the two.

It is a principle of education viewed as the cultivation of a well-furnished and highly able mind that the beneficiary of it should develop a rich sense of context and connection. Someone interested in, say, medieval monasticism or Presocratic philosophy might relish the study of it for its own sake and find it absorbingly interesting, but might also see surprising relevances to his own life and times. This explains how, in the 18th and 19th centuries, Britain governed an empire by teaching Greek and Latin classics to those sent out to run it. For when you read and discuss the classics you read history, philosophy and literature, and through them you read about and discuss government, military affairs, ideas of justice and morality, statesmen and the way they handled problems, successes and disasters and what prompted either, subtleties of human nature, celebrations of virtue and condemnations of vice, poems of love and of mourning, the absurdity of certain beliefs, the nobility of certain ambitions and much besides of relevance to both the social and individual scales of life.

Of course, much of this might have gone over most of the heads of lazy and self-interested boys at their public schools we see an example of this vividly in our own day, alas but enough stuck so that the administration of empire was not always and everywhere a prejudiced and exploitative disaster. In any case, the point is that the aim of imparting the benefits of an education in the humanities might succeed often enough that the candles of civilisation will continue be carried, alight, over the floodwaters of time. Even if almost every educational institution should shed its commitment to the humanities, salvation would reside in that almost.

There might be another spin of the triangles orientation which changes which vertex is uppermost. Suppose most productive activity is taken over by artificial intelligence systems, with the result that more than enough wealth is generated to allow most of the population a comfortable national wage without having to work for a living. Then the arts and humanities will be at a premium, the practice and study of them the main avocation of many, the value of intellectual and educational attainment as great as the value of money-wealth is now. It is far from an impossibility that this might happen. It would be good if a flourishing tradition of the humanities were to survive into such a time.

CP Snow wished to see the two cultures divide closed, or at least narrowed. I say that that the three vertices of the triangle should be kept connected, because to lose the perspectives offered by the humanities would render our society technocratic and banausic merely, a fate it is already not far from. Snows anxiety was that science would be mishandled by uncomprehending humanists, whereas today the anxiety is very different; it is that technology and the imperatives of bottom lines will determine all our choices for us.

Perhaps one can sum up the matter by saying that whereas science and technology is about capability, and business is about profit and cost, the humanities are about value. That is a vertex of the triangle we cannot afford to lose.

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Science, business and the humanities: CP Snow's 'Two Cultures' sixty years on - TheArticle

Researchers have genetically engineered a probiotic yeast to produce beta-carotene in the guts of laboratory mice. The advance demonstrates the utility of work the researchers have done to detail how a suite of genetic engineering tools can be used to modify the yeast.

"There are clear advantages to being able to engineer probiotics so that they produce the desired molecules right where they are needed," says Nathan Crook, corresponding author of the study and an assistant professor of chemical and biomolecular engineering at North Carolina State University. "You're not just delivering drugs or nutrients; you are effectively manufacturing the drugs or nutrients on site."

The study focused on a probiotic yeast called Saccharomyces boulardii. It is considered probiotic because it can survive and thrive in the gut, whereas most other yeast species either can't tolerate the heat or are broken down by stomach acid. It also can inhibit certain gut infections.

Previous research had shown that it was possible to modify S. boulardii to produce a specific protein in the mouse gut. And there are many well-established tools for genetically engineering baker's yeast, S. cerevisiae - which is used in a wide variety of biomanufacturing applications. Crook and his collaborators wanted to get a better understanding of which genetic engineering tools would work in S. boulardii.

Specifically, the researchers looked at two tools that are widely used for gene editing with the CRISPR system and dozens of tools that were developed specifically for modifying S. cerevisiae.

"We were a little surprised to learn that most of the S. cerevisiae tools worked really well in S. boulardii," Crook says. "Honestly, we were relieved because, while they are genetically similar, the differences between the two species are what make S. boulardii so interesting, from a therapeutic perspective."

Once they had established the viability of the toolkit, researchers chose to demonstrate its functionality modifying S. boulardii to produce beta-carotene. Their rationale was both prosaic and ambitious.

"On the one hand, beta-carotene is orange - so we could tell how well we were doing just by looking at the colonies of yeast on a petri dish: they literally changed color," Crook says. "On a more ambitious level, we knew that beta-carotene is a major provitamin A carotenoid, which means that it can be converted into vitamin A by the body - and we knew that vitamin A deficiency is a major public health problem in many parts of the world. So why not try to develop something that has the potential to be useful?"

Researchers tested the modified S. boulardii in a mouse model and found that the yeast cells successfully created beta-carotene in the guts of mice.

"This is a proof of concept, so there are a lot of outstanding questions," Crook says. "How much of this beta-carotene is getting absorbed by the mice? Are these biologically relevant amounts of beta-carotene? Would it work in humans? All of those are questions we'll have to address in future work. But we're excited to see what happens. And we're excited that these tools are now publicly available for use by others in the research community."

Reference:Durmusoglu D, AlAbri IS, Collins SP, et al. In situ biomanufacturing of small molecules in the mammalian gut by probiotic Saccharomyces boulardii. ACS Synth Biol. 2021. doi:10.1021/acssynbio.0c00562

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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Probiotic Yeast Engineered To Produce Beta-Carotene - Technology Networks

This spring, the biotechnology company Oxitec plans to release genetically modified (GM) mosquitoes in the Florida Keys. Oxitec says its technology will combat dengue fever, a potentially life-threatening disease, and other mosquito-borne viruses such as Zika mainly transmitted by the Aedes aegypti mosquito.

While there have been more than 7,300 dengue cases reported in the United States between 2010 and 2020, a majority are contracted in Asia and the Caribbean, according to the US Centres for Disease Control and Prevention. In Florida, however, there were 41 travel-related cases in 2020, compared with 71 cases that were transmitted locally.

Native mosquitoes in Florida are increasingly resistant to the most common form of control insecticide and scientists say they need new and better techniques to control the insects and the diseases they carry. There arent any other tools that we have. Mosquito nets dont work. Vaccines are under development but need to be fully efficacious, says Michael Bonsall, a mathematical biologist at the University of Oxford, who is not affiliated with Oxitec but has collaborated with the company in the past, and who worked with the WHO to produce a GM mosquito-testing framework.

Bonsall and other scientists think a combination of approaches is essential to reducing the burden of diseases and that, maybe, newer ideas like GM mosquitoes should be added to the mix. Oxitecs mosquitoes, for instance, are genetically altered to pass what the company calls self-limiting genes to their offspring; when released GM males breed with wild female mosquitoes, the resulting generation does not survive into adulthood, reducing the overall population.

But Oxitec has been proposing to experimentally release GM mosquitos in the Keys since 2011, and the plan has long been met with suspicion among locals and debate among scientists. Some locals say they fear being guinea pigs. Critics say they are concerned about the possible effects GM mosquitoes could have on human health and the environment. In 2012, the Key West City Commissionobjected to Oxitecs plan; in a non-binding referendum four years later, residents of Key Haven where the mosquitoes would have been released rejected it, while residents in the surrounding county voted in support of the release. With the decision left up to the Florida Keys Mosquito Control District, officials approved the trial to be conducted elsewhere in the Keys.

According to Oxitec, the release was delayed due to a transfer of jurisdiction over the project from the U.S. Food and Drug Administration to the Environmental Protection Agency.

The company reapplied for approval to release a new version of the mosquitoes, called OX5034, in the Keys. In May, the EPA granted a two-year experimental use permit, which the agency can cancel at any time. State and local sign-off soon followed finally giving the project the greenlight.

Oxitecs OX5034 mosquitoes are the first GM mosquitoes approved for release in the US. The company has already conducted a trial with the OX5034 mosquitoes in Brazil and released more than a billion of a previous version, called OX513A, there and in other locations over the years including the Cayman Islands. The company says it is confident in the effectiveness and safety of the technology.

But some scientists want to hit pause on Oxitecs Florida trial, to find what they say is a fairer process in deciding to release the mosquitoes. Others want to see clearer proof that this technology is even necessary, claiming that the company has only released its most positive data with the public and has kept other key data, including whether the mosquitoes curb disease transmission, private. And if the release actually launches as planned, some Keys residents say they aim to interfere.

Critics also say that Oxitec failed to engage with local communities in Florida and get their consent to release the mosquitoes. Whats the most upsetting is that the very people that are going to be most impacted, both by the benefits or the risks of such a decision, have like the smallest voice in how these choices are made. I think thats a really big issue, says Natalie Kofler, a molecular biologist and bioethicist who founded Editing Nature, a platform that advocates for inclusive decision-making processes to steer the use of genetic technology. If Oxitec doesnt do this right, she adds, we could have a huge impact on delaying the use of other beneficial technologies like that in the future.

Oxitecs OX5034 mosquitoes are programmed to combat the transmission of mosquito-borne illnesses by suppressing local Aedes aegypti populations. Oxitec which is US-owned and based in the United Kingdom describes their mosquitoes as friendly because they will only release males, which, unlike females, do not bite humans or transmit disease.

Also read: Clever Approach: Scientists Create GM-Free Organisms Using Genetic Engineering

At Oxitecs laboratory in the UK, the company genetically engineers the mosquitoes, giving the insects the self-limiting gene that makes the females dependent on the antibiotic tetracycline. Without the drug, they will die. Eggs from these genetically-altered mosquitoes which will hatch both male and female insects will be shipped to the Keys. Mosquitoes require water to mature from an egg to an adult; when Oxitecs team adds water to the boxes the mosquitoes will be deployed in, both GM males and GM females will hatch. With no tetracycline present in the box, the GM females are expected to die in early larval stages.

The male mosquitoes will survive and carry the gene. When they leave the boxes, the insects will, hypothetically, fly away to mate with wild females to pass the gene to the next wild generation, according to Nathan Rose, head of regulatory affairs at Oxitec. Kevin Gorman, the companys chief development officer, says the local female mosquito population will be increasingly reduced which will also reduce the number of wild male mosquitoes in the treatment areas.

Gorman emphasised to Undark that the EPA and other regulators found no risk in using tetracycline in breeding their genetically-altered mosquitoes. But some scientists think the presence of this antibiotic in the environment does pose a risk. According to Jennifer Kuzma, co-founder and co-director of the Genetic Engineering and Society Centre at North Carolina State University, tetracyline is commonly used in Florida to prevent bacterial diseases in agriculture particularly in citrus groves and to treat bacteria in sewage plants.

The use of the antibiotic for these purposes may mean that it will remain in the environment, especially in water where the mosquitoes breed, which could allow Oxitecs female mosquitoes to survive. While the company does not plan to release the mosquitos near areas where the antibiotic is used, Kuzma says the EPAs risk assessment did not include testing of any standing water for tetracycline something, she adds, would have been easy enough to do for good due diligence.

Skeptics of Oxitecs GM mosquitoes include local residents, physicians, scientists and environmental activists. Many of these opponents say they arent anti-GMO, but disagree with how the approval process has been handled. One group has even kept a running list of what it sees as Oxitecs wrongdoings since it first began experimental releases. The list includes Oxitecs lack of disease monitoring in the countries where it has released mosquitoes; the unknown price of its technology; and complaints that the company has overstated the success of some of it its trials.

I cannot trust this company. I cannot trust this technology, says Mara Daly, a resident of Key Largo who says shes been following Oxitecs plans for nine years.

This is not a traditional pesticide, she adds. This is not a chemical that you can trace. This is something completely different, new emerging technology, and we need better regulation.

Phil Goodman, chairman of the Florida Keys Mosquito Control District (FKMCD), an independently-elected commission carrying out mosquito control within Monroe County, says that many of those who discredit Oxitecs evidence do not understand the technology. Theyre fear-mongering, he says.

They have very little credibility here in the Florida Keys as far as Im concerned, he adds.

But people like Daly and Barry Wray, executive director of the Florida Keys Environmental Coalition, disagree. We want to know its safe, says Wray, who notes that his group more generally supports GM technology. We dont have another Florida Keys ecosystem. We dont have another Florida Keys community. We have this one.

Daly, Wray, and others point to what they perceive as the FKMCDs disrespect for public opinion. They argue that the community wasnt given a chance to consent before the EPA approval. There was a 30-day public forum in September 2019 about Oxitecs technology application, with 31,174 comments opposing release and 56 in support. A statement emailed to Undark by Melissa Sullivan, an EPA spokesperson, noted that the agency considered these comments during the review, but critics think it happened too quickly to be of real use.

In June, Kofler and Kuzma wrote an opinion piece in The Boston Globe about the EPA approval, critiquing the agencys regulatory system and calling for a better process for evaluating new biotechnologies. The researchers expressed concern that the EPA did not convene an independent, external scientific advisory panel to review Oxitecs claims about its mosquito strategy and that the agency only publicly released its risk assessment after approving the technology. The American public, Kofler and Kuzma wrote, needs to be assured that these decisions are made free of conflicts of interest. The statement from the EPAs Sullivan noted that the agency conducted anextensive risk assessment based on the best available science.

Some critics also wanted there to be more public engagement. Kofler and Kuzma say they offered to provide their expertise, along with other outside experts, to the mosquito control district to allow more discussion about the GM mosquitoes with the Keys community. But Kofler says the district wasnt responsive. Oxitec itself launched webinars about their new product, but not until after the EPA approval. Here we are, like in the final hour, having these conversations that needed to be happening a year ago, says Kofler.

Without public trust and enthusiasm, it doesnt matter whether Oxitecs mosquito technique works, says Guy Reeves, a genetic researcher at the Max Planck Institute for Evolutionary Biology in Germany, who stresses that he doesnt think the companys approach is unsafe. If the population in Florida Keys becomes so sensitised to this issue that they can no longer cooperate with each other thats good for the mosquitoes, not good for the people, he adds.

Based on their first generation mosquito OX513A, Oxitec says it has shown that the approach reduces a targeted mosquito population in trials in both Brazil and the Cayman Islands. But theres no evidence that this new OX5034 mosquito release will actually be worth it for mosquito suppression, says Reeves. Oxitec also hasnt explained how their new mosquito will directly curb human diseases, such as dengue. Reducing disease transmission and burden should be measures of efficacy for this technology, says Kofler.

According to Gorman, independent disease suppression data has only been collected by municipalities in Brazil because thats where most of the companys trials have been released in larger scales. These municipalities have shown that Oxitec mosquitoes have reduced dengue cases in areas of release, Gorman says. In order for Oxitec to collect additional data, he adds, the company needs to release and test large areas over sustained periods of time. Gorman maintains that the company is not required to report formal health impact studies.

Reeves adds that Oxitec also hasnt explained what resources are needed to sustain this product, how long it could take to be effective, or the cost. When asked about the cost of the Florida Keys project, Oxitec responded to Undark by email: Oxitec is a pre-commercial, pre-profit company. We will not profit from this pilot project in Florida. We are paying for it ourselves.

Oxitec has released more than a billion of their OX513A mosquitoes over the past 10 years. According to independent scientists, some of those experiments did not go well.

For example, researchers at Yale University and collaborators from Brazil analysed Oxitecs 2015 release of OX513A in Brazil. The scientists confirmed that some offspring of the genetically modified mosquitoes which were supposed to die and not pass new genes to the wild population survived to adulthood and mated with their native counterparts. Between 10 and 60 percent of the native mosquitoes contained genes from Oxitec, according to the Yale study, which published in Nature in 2019. The papers authors concluded they do not know what impacts these mixed mosquitoes have on disease control or transmission, but added that their findings underscore the importance of monitoring the genetics of the insects.

Oxitec disagreed with the findings and responded on the journals website. Oxitec told Gizmodo that Yales study includes numerous false, speculative, and unsubstantiated claims and statements about Oxitecs mosquito technology. And when Kofler and three other scientists wrote about Oxitecs Brazil trial in The Conversation, Oxitec pushed to have the article retracted, says Kofler.

For this coming release, some Key Largo locals are willing to act on their anger. Daly, for instance, says that if the mosquitoes are deployed in her neighbourhood, shell try to put insecticide in any box she finds or send it to an expert to test even if it means getting in trouble with the federal authorities. I already have my arresting officer and she said shes gonna clean her handcuffs for me, she says. I dont care.

Ideally, Daly says, it wont have to come to that. She and other locals hope to stop Oxitec before the latest mosquitos are delivered. Daly says she has been busy organising protests like one that happened recently in Key Largo and giving out yard signs to residents who dont want their property used in the trial. Locals are pissed off. So I have been busy getting the press to cover the local opposition, Daly wrote in an email to Undark.

The first flying insect or animal that can actually use our human blood for a friggin trial for a product to come to market without my consent, Daly says.

Thats my blood, she adds. Thats my sons blood. Thats my dogs blood.

Taylor White is a freelance journalist based in Cape Cod, MA and a graduate of the Science, Health & Environmental Reporting Program at the NYU school of journalism. Her work has appeared in NOVA GBH, Dana-Farber Cancer Institute, the American Association for the Advancement of Science, GenomeWeb, Spectrum and Science Vs.

This article was originally published on Undark. Read the original article.

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In the US, Imminent Release of Genetically Modified Mosquitoes To Fight Dengue - The Wire Science

Over the past decade, the CRISPR-Cas9 gene editing system has revolutionized genetic engineering, allowing scientists to make targeted changes to organisms DNA. While the system could potentially be useful in treating a variety of diseases, CRISPR-Cas9 editing involves cutting DNA strands, leading to permanent changes to the cells genetic material.

Now, in a paper published online in Cell on April 9, researchers describe a new gene editing technology called CRISPRoff that allows researchers to control gene expression with high specificity while leaving the sequence of the DNA unchanged. Designed by Whitehead Institute Member Jonathan Weissman, University of California San Francisco assistant professor Luke Gilbert, Weissman lab postdoc James Nuez and collaborators, the method is stable enough to be inherited through hundreds of cell divisions, and is also fully reversible.

The big story here is we now have a simple tool that can silence the vast majority of genes, says Weissman, who is also a professor of biology at MIT and an investigator with the Howard Hughes Medical Institute. We can do this for multiple genes at the same time without any DNA damage, with great deal of homogeneity, and in a way that can be reversed. It's a great tool for controlling gene expression.

The project was partially funded by a 2017 grant from the Defense Advanced Research Projects Agency to create a reversible gene editor. Fast forward four years [from the initial grant], and CRISPRoff finally works as envisioned in a science fiction way, says co-senior author Gilbert. It's exciting to see it work so well in practice.

Because these methods alter the underlying DNA sequence, they are permanent. Plus, their reliance on in-house cellular repair mechanisms means it is hard to limit the outcome to a single desired change. As beautiful as CRISPR-Cas9 is, it hands off the repair to natural cellular processes, which are complex and multifaceted, Weissman says. It's very hard to control the outcomes.

Thats where the researchers saw an opportunity for a different kind of gene editor one that didnt alter the DNA sequences themselves, but changed the way they were read in the cell.

This sort of modification is what scientists call epigenetic genes may be silenced or activated based on chemical changes to the DNA strand. Problems with a cells epigenetics are responsible for many human diseases such as Fragile X syndrome and various cancers, and can be passed down through generations.

Epigenetic gene silencing often works through methylation the addition of chemical tags to to certain places in the DNA strand which causes the DNA to become inaccessible to RNA polymerase, the enzyme which reads the genetic information in the DNA sequence into messenger RNA transcripts, which can ultimately be the blueprints for proteins.

Weissman and collaborators had previously created two other epigenetic editors called CRISPRi and CRISPRa but both of these came with a caveat. In order for them to work in cells, the cells had to be continually expressing artificial proteins to maintain the changes.

With this new CRISPRoff technology, you can [express a protein briefly] to write a program that's remembered and carried out indefinitely by the cell, says Gilbert. It changes the game so now you're basically writing a change that is passed down through cell divisions in some ways we can learn to create a version 2.0 of CRISPR-Cas9 that is safer and just as effective, and can do all these other things as well.

Because the method does not alter the sequence of the DNA strand, the researchers can reverse the silencing effect using enzymes that remove methyl groups, a method they called CRISPRon.

As they tested CRISPRoff in different conditions, the researchers discovered a few interesting features of the new system. For one thing, they could target the method to the vast majority of genes in the human genome and it worked not just for the genes themselves, but also for other regions of DNA that control gene expression but do not code for proteins. That was a huge shock even for us, because we thought it was only going to be applicable for a subset of genes, says first author Nuez.

Also, surprisingly to the researchers, CRISPRoff was even able to silence genes that did not have large methylated regions called CpG islands, which had previously been thought necessary to any DNA methylation mechanism.

What was thought before this work was that the 30 percent of genes that do not have a CpG island were not controlled by DNA methylation, Gilbert says. But our work clearly shows that you don't require a CpG island to turn genes off by methylation. That, to me, was a major surprise.

The researchers chose a gene to silence in the stem cells, and then induced them to turn into nerve cells called neurons. When they looked for the same gene in the neurons, they discovered that it had remained silenced in 90 percent of the cells, revealing that cells retain a memory of epigenetic modifications made by the CRISPRoff system even as they change cell type.

They also selected one gene to use as an example of how CRISPRoff might be applied to therapeutics: the gene that codes for Tau protein, which is implicated in Alzheimers disease. After testing the method in neurons, they were able to show that using CRISPRoff could be used to turn Tau expression down, although not entirely off. What we showed is that this is a viable strategy for silencing Tau and preventing that protein from being expressed, Weissman says. The question is, then, how do you deliver this to an adult? And would it really be enough to impact Alzheimer's? Those are big open questions, especially the latter.

Even if CRISPRoff does not lead to Alzheimers therapies, there are many other conditions it could potentially be applied to. And while delivery to specific tissues remains a challenge for gene editing technologies such as CRISPRoff, we showed that you can deliver it transiently as a DNA or as an RNA, the same technology that's the basis of the Moderna and BioNTech coronavirus vaccine, Weissman says.

Weissman, Gilbert, and collaborators are enthusiastic about the potential of CRISPRoff for research as well. Since we now can sort of silence any part of the genome that we want, it's a great tool for exploring the function of the genome, Weissman says.

Plus, having a reliable system to alter a cells epigenetics could help researchers learn the mechanisms by which epigenetic modifications are passed down through cell divisions. I think our tool really allows us to begin to study the mechanism of heritability, especially epigenetic heritability, which is a huge question in the biomedical sciences, Nuez says.Reference:Nuez JK, Chen J, Pommier GC, et al. Genome-wide programmable transcriptional memory by CRISPR-based epigenome editing. Cell. 2021;0(0). doi:10.1016/j.cell.2021.03.025

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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CRISPRoff: A New Addition to the CRISPR Toolbox - Technology Networks

When it comes to Alzheimers versus science, science is on the losing side.

Alzheimers is cruel in the most insidious way. The disorder creeps up in some aging brains, gradually eating away at their ability to think and reason, whittling down their grasp on memories and reality. As the worlds population ages, Alzheimers is rearing its ugly head at a shocking rate. And despite decades of research, we have no treatmentnot to mention a cure.

Too much of a downer? The National Institutes of Health (NIH) agrees. In one of the most ambitious projects in biology, the NIH is corralling Alzheimers and stem cell researchers to come together in the largest genome editing project ever conceived.

The idea is simple: decades of research have found certain genes that seem to increase the chance of Alzheimers and other dementias. The numbers range over hundreds. Figuring out how each connects or influences anotherif at alltakes years of research in individual labs. What if scientists unite, tap into a shared resource, and collectively solve the case of why Alzheimers occurs in the first place?

The initiatives secret weapon is induced pluripotent stem cells, or iPSCs. Similar to most stem cells, they have the ability to transform into anythinga cellular Genie, if you will. iPSCs are reborn from regular adult cells, such as skin cells. When transformed into a brain cell, however, they carry the original genes of their donor, meaning that they harbor the original persons genetic legacyfor example, his or her chance of developing Alzheimers in the first place. What if we introduce Alzheimers-related genes into these reborn stem cells, and watch how they behave?

By studying these iPSCs, we might be able to follow clues that lead to the genetic causes of Alzheimers and other dementiaspaving the road for gene therapies to nip them in the bud.

The iPSC Neurodegenerative Disease Initiative (iNDI) is set to do just that. The project aims to stimulate, accelerate, and support research that will lead to the development of improved treatments and preventions for these diseases, the NIH said. All resulting datasets will be openly shared online, for anyone to mine and interpret.

In plain language? Lets throw all of our new biotech superstarswith CRISPR at the forefrontinto a concerted effort against Alzheimers, to finally gain the upper hand. Its an Avengers, assemble moment towards one of our toughest foesone that seeks to destroy our own minds from within.

Alzheimers disease was first recognized in the early 1900s. Ever since, scientists have strived to find the cause that makes a brain waste away.

The most prominent idea today is the amyloid hypothesis. Imagine a horror movie inside a haunted house with ghosts that gradually intensify in their haunting. Thats the amyloid horrora protein that gradually but silently builds up inside a neuron, the house, eventually stripping it of its normal function and leading to the death of anything inside. Subsequent studies also found other toxic proteins that hang around outside the neuron house that gradually poison the molecular tenants within.

For decades scientists have thought that the best approach to beat these ghosts was an exorcismthat is, to get rid of these toxic proteins. Yet in trial after trial, they failed. The failure rate for Alzheimers treatmentso far, 100 percenthas led some to call treatment efforts a graveyard of dreams.

Its pretty obvious we need new ideas.

A few years ago, two hotshots strolled into town. One is CRISPR, the wunderkind genetic sharpshooter that can snip way, insert, or swap out a gene or two (or more). The other is iPSCs, induced pluripotent stem cells, which are reborn from adult cells through a chemical bath.

The two together can emulate Dementia 2.0 in a dish.

For example, using CRISPR, scientists can easily insert genes related to Alzheimers, or its protection, into an iPSCeither that from a healthy donor, or someone with a high risk of dementia, and observe what happens. A brain cell is like a humming metropolitan area, with proteins and other molecules whizzing around. Adding in a dose of pro-Alzheimers genes, for example, could block up traffic with gunk, leading scientists to figure out how those genes fit into the larger Alzheimers picture. For the movie buffs out there, its like adding into a cell a gene for Godzilla and another for King Kong. You know both could mess things up, but only by watching what happens in a cell can you know for sure.

Individual labs have tried the approach since iPSCs were invented, but theres a problem. Because iPSCs inherit the genetic baseline of a person, it makes it really difficult for scientists in different labs to evaluate whether a gene is causing Alzheimers, or if it was just a fluke because of the donors particular genetic makeup.

The new iNDI plan looks to standardize everything. Using CRISPR, theyll add in more than 100 genes linked to Alzheimers and related dementias into iPSCs from a wide variety of ethnically diverse healthy donors. The result is a huge genome engineering project, leading to an entire library of cloned cells that carry mutations that could lead to Alzheimers.

In other words, rather than studying cells from people with Alzheimers, lets try to give normal, healthy brain cells Alzheimers by injecting them with genes that could contribute to the disorder. If you view genes as software code, then its possible to insert code that potentially drives Alzheimers into those cells through gene editing. Execute the program, and youll be able to observe how the neurons behave.

The project comes in two phases. The first focuses on mass-engineering cells edited with CRISPR. The second is thoroughly analyzing these resulting cells: for example, their genetics, how their genes activate, what sorts of proteins they carry, how those proteins interact, and so on.

By engineering disease-causing mutations in a set of well-characterized, genetically diverse iPSCs, the project is designed to ensure reproducibility of data across laboratories and to explore the effect of natural variation in dementia, said Dr. Bill Skarnes, director of cellular engineering at the Jackson Laboratory, and a leader of the project.

iNDI is the kind of initiative thats only possible with our recent biotech boost. Engineering hundreds of cells related to Alzheimersand to share with scientists globallywas a pipe dream just two decades ago.

To be clear, the project doesnt just generate individual cells. It uses CRISPR to make cell lines, or entire lineages of cells with the Alzheimers gene that can pass on to the next generation. And thats their power: they can be shared with labs around the world, to further hone in on genes that could make the largest impact on the disorder. Phase two of iNDI is even more powerful, in that it digs into the inner workings of these cells to generate a cheat codea sheet of how their genes and proteins behave.

Together, the project does the hard work of building a universe of Alzheimers-related cells, each outfitted with a gene that could make an impact on dementia. These types of integrative analyses are likely to lead to interesting and actionable discoveries that no one approach would be able to learn in isolation, the authors wrote. It provides the best chance at truly understanding Alzheimers and related diseases, and promising treatment possibilities.

Image Credit: Gerd Altmann from Pixabay

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A Massive New Gene Editing Project Is Out to Crush Alzheimer's - Singularity Hub

The human genome has long been a difficult book to read. Modern technological advances have recently opened doors for researchers to begin asking a big question: What parts of our DNA sequences might influence disease? Mary Lauren Benton, Ph.D., recently joined the Baylor Engineering and Computer Science faculty as an assistant professor of bioinformatics, and she is working to answer that question.

Mary Lauren Benton, Ph.D.

If you think of the genome like an instruction manual, Im interested in the grammar, Benton said. Im interested in understanding how short DNA sequences turn genes on and off in different cells and allow for many different outcomes. If we know how a particular sequence influences risk of heart disease, for example, we can use that information to help us guide clinical decisions, whether thats applying different treatments, prescribing different medications or scheduling more preventative care. All of these things can help clinicians to better prioritize and care for patients.

Benton uses computer modeling to look through large data sets of genetic information. Bioinformatics allows for processing of these large data in ways not possible previously, giving room for biological researchers to find patterns and solutions using methods and tools from computer science.

I think of bioinformatics as the intersection of computer science and biology, Benton said. I take tools and methods from computer science, and I apply them to solve fundamental biological questions. We have a lot of really big data sets in biology. The human genome is 3 billion base pairs long, which we cant analyze by hand. The tools from computer science and statistics give us a way to ask questions that we wouldnt be able to otherwise. They open the doors to analyses that would have been impossible even 10 or 20 years ago.

Benton most recently authored The Influence of Evolutionary History on Human Health and Disease, which was published in the Nature Reviews Genetic Journal and takes a look at the evolutionary origins of disease. Being diagnosed with a disease or health problem may feel like a present problem; however, Benton explained that looking at the foundations of a disease is important to understanding how to move forward with treatment.

The foundations and the systems that are involved in disease have really deep evolutionary origins, she said. Cancer might be something that youre diagnosed with today, but the foundation of cancer can be traced back to the idea that we have cells that are able to grow and divide, which also provides the opportunity for tumors to grow.

Benton explained that its important to consider the history of the disease and the systems involved alongside any variants or environmental factors that help to cause the disease. A holistic understanding of disease can influence how patients are treated as well as provide information about how their diseases came to be.

Its not enough to understand whats happening in a person right now or in the last five years, Benton said. Understanding the million-year history of how people got here is equally important to make advances in personalizing medicine, especially genomic medicine. Having that long lens is something that is often lost in the day-to-day operations of a doctors office.

Benton is excited to be evaluating the way that researchers think about decoding genetic information. While a common approach is to think of genes as being able to be turned off or on with a simple switch, that may not be the most accurate approach.

We study these sets of genetic switches and how they turn genes on and off at the right times. Often, we think about these switches working one-at-a-time; the gene is either on or its off, Benton said. But it is much more complicated than that. There are often multiple switches that act more like a dashboard of knobs and dials that all work together to properly tune the output of the genome.

Bentons research is moving toward the development of new models and ways of thinking about how known individual elements are combined and factored into this much larger, more accurate dashboard. Differences based on demographic histories, environmental variables and evolutionary processes all influence the risk of disease in different ways. A better understanding of genomes and how genetic variants relate to disease has major implications for precision medicine.

Its really vital for precision medicine to take into account the full diversity of the human experience. We cant focus on one particular kind of person or one population. People of European ancestry are over-represented in genetic studies, Benton said. Improving diversity and representation in our genomic studies is vital to understanding how the genome relates to disease and to learning how to appropriately treat all of the patients that might walk through the doors of a clinic.

Precision medicine, in some ways, seems futuristic and far-off. But, in other ways, precision medicine is already being used to protect at-risk individuals from diseases like cancer. While widespread precision medicine may not be seen for a long time, research like Bentons plays a role in better understanding disease risk broadly and providing context for clinical solutions moving forward.

Precision medicine is both happening right now and is something that well probably always be working toward, Benton said. There are things that we understand right now about specific genetic variants that might predispose you to a certain kind of breast cancer, for example. We already have diseases that we can test for or treat differently based on someones genotype. But, because the genome is such a complicated thing, walking into the clinic and handing your DNA sequence to the doctor, who would then read it and prescribe the right treatments on the spot, is a goal that well always be working toward. Still, I expect well see big changes in the next five to 10 years given the current rate of progress.

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Grammar of the Genome: Reading the Influence of DNA on Disease - Baylor University

The information and biotechnology revolutions have changed our world and will heavily inform the future of society. Whoever controls these technologies controls the future, and whoever controls their standardization controls the technologies. China understands this well. For two decades, it has been working to take over international standardization rulemaking bodies to serve the goals advanced in Made in China 2025 that is, to dominate world manufacturing and then transition to become the center of the worlds technological innovation

The dangers to the United States are already present, and in forms that are not obvious. These include, first, direct-to-consumer genetic testing. China may be using such testing to gain genetic information that permits the identification and tracking of Americans, including U.S. military and intelligence community personnel or their relatives. Second, health monitoring apps are able to provide geolocation data to Chinese entities, which means to the Chinese Communist Party (CCP) and its security services. This provides location data that is valuable on its own and might be compared with data from other sources to reveal key information about Americans. Third, the CCP, in cooperation with Chinese industrial entities on international bodies, are developing and setting international standards for emerging technologies. Chinas influence has grown over the past two decades, and Beijing now possesses leadership roles in standards-drafting technical committees, which means it could shape outcomes to its benefit.

China has formulated a four-step strategy to seek dominance in this area: plan, track, participate and take over. Beijing has boasted that it completed the first three steps and is on the last, which is to develop indigenous standards and to lead international standardization. This means China may be replacing international standards with its own standards, in order to control technologies and the market. In 2017, China revised its standardization law, almost 30 years after its adoption in 1989. It also set up the Standardization Administration of China to implement its strategy in the early 2000s. Chinas standardization strategy also has been incorporated into the Belt and Road Initiative so that, as countries are weaved into this network, they adopt Chinas standards.

Beijing essentially has had the three primary standard-setting international organizations the International Organization for Standardization (ISO), the International Telecommunication Union (ITU) and the International Electrotechnical Commission (IEC) under its influence. Two Chinese government officials currently serve as president of ITU and IEC, and placed Chinas proxy as the head of the ISO after the organization was led by a Chinese official for many years. Meanwhile, Beijing has taken leadership or other influential positions in the International Accreditation Forum (IAF), United Nations Industrial Development Organization (UNIDO), International Civil Aviation Organization (ICAO), American Society for Quality (ASQ) and perhaps others.

Chinas strategy to determine the worlds standards appears to be working. In 2019 alone, China submitted 830 standards proposals to the ITU. According to Zhang Xiaogang, former president of the ISO, China planned to initiate 395 international standards by 2020 but, in actuality, it set 495. Zhang claims that China has made the greatest contribution in the field of international standardization in the past five years. Indeed, China has dominated 5G standard-setting, for example, in the 3rd Generation Partnership Project (3GPP), an organization to develop mobile broadband standards, and 90 percent of standard proposals in the 5G super uplink field is done by China Telecom.

Unfortunately, Western countries fail to see the importance of Chinas strategic move. Zhang states, Whoever leads in standard-setting will be the leader of the technology and the controller of the market. Chinas dominance in 5G standards-setting enables it to avoid the Wests sanctions against its tech giants such as Huawei, continue to expand globally, and to dominate the market. This could be a paramount communication-security problem for the U.S.

Of particular importance is Chinas standardization strategy as identified in China Standards 2035 on international bodies engaged in developing and setting standards for select emerging technologies. These include advanced communication technologies and cloud computing and cloud services. The United States and its allies must ensure that international standards for emerging technologies are not being designed to promote the interests of China. If China is successful, it would lead to the exclusion of other participants; China would be the architect, builder and maintainer of the 21st centurys information technology infrastructure.

Washington must take steps to bolster U.S. public- and private-sector participation in international standards-setting bodies. The U.S. must underscore the dangers of interacting with Chinese firms. The government, particularly the Department of Homeland Security, has called attention to this, but there is little recognition that U.S. firms understand the risks associated. There must be greater awareness of smartphone apps, which should be graded on user privacy and their security from Chinese penetration. And U.S. entities that permit Chinese entities to exploit data should be subject to possible legal action.

A key question of the 21st century is a holdover from the previous century: Which state will control scientific knowledge and its standards? The answer is not yet clear. Thankfully, in the 20th century, the U.S. surpassed Nazi Germany to dominate physics and related sciences and industries, and generated the centurys most fearsome weapon the atomic bomb and its progeny, the hydrogen bomb.

If these revolutionary advances occur within the framework of the U.S.-led liberal international order, we are assured improvements to the well-being of people. But if China leads the scientific and technological revolution, these advances will serve the CCPs inherently malign interests. China will aggressively seize opportunities, particularly in nascent areas where standards are not developed including biotechnology, genetic engineering, energy production and distribution technologies, aerospace, 5G and artificial intelligence.

If China has its way in standards-setting, the communist regime will control these critical technologies and the global supply chain. That means it would dominate the future of the free worlds economy, media and politics. The United States no longer can afford complacency.

Bradley A. Thayer is the co-author of How China Sees the World: Han-Centrism and the Balance of Power in International Politics.

Lianchao Han is vice president of Citizen Power Initiatives for China. After the Tiananmen Square massacre in 1989, he was one of the founders of the Independent Federation of Chinese Students and Scholars. He worked in the U.S. Senate for 12 years, as legislative counsel and policy director for three senators.

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We cannot let China set the standards for 21st century technologies | TheHill - The Hill

This spring, the biotechnology company Oxitec plans to release genetically modified (GM) mosquitoes in the Florida Keys. Oxitec says its technology will combat dengue fever, a potentially life-threatening disease, and other mosquito-borne virusessuch as Zika mainly transmitted by the Aedes aegypti mosquito.

While there have been more than 7,300 dengue cases reported in the United States between 2010 and 2020, a majority are contracted in Asia and the Caribbean, according to the U.S. Centers for Disease Control and Prevention. In Florida, however, there were 41 travel-related cases in 2020, compared with 71 cases that were transmitted locally.

Native mosquitoes in Florida are increasingly resistant to the most common form of control insecticideand scientists say they need new and better techniques to control the insects and the diseases they carry. There arent any other tools that we have. Mosquito nets dont work. Vaccines are under development but need to be fully efficacious, says Michael Bonsall, a mathematical biologist at the University of Oxford, who is not affiliated with Oxitec but has collaborated with the company in the past, and who worked with the World Health Organization to produce a GM mosquito-testing framework.

Bonsall and other scientists think a combination of approaches is essential to reducing the burden of diseasesand that, maybe, newer ideas like GM mosquitoes should be added to the mix. Oxitecs mosquitoes, for instance, are genetically altered to pass what the company calls self-limiting genes to their offspring; when released GM males breed with wild female mosquitoes, the resulting generation does not survive into adulthood, reducing the overall population.

But Oxitec has been proposing to experimentally release GM mosquitos in the Keys since 2011, and the plan has long been met with suspicion among locals and debate among scientists. Some locals say they fear being guinea pigs. Critics say they are concerned about the possible effects GM mosquitoes could have on human health and the environment. In 2012, the Key West City Commissionobjected to Oxitecs plan; in a non-binding referendum four years later, residents of Key Havenwhere the mosquitoes would have been releasedrejected it, while residents in the surrounding county voted in support of the release. With the decision left up to the Florida Keys Mosquito Control District, officials approved the trial to be conducted elsewhere in the Keys.

According to Oxitec, the release was delayed due to a transfer of jurisdiction over the project from the U.S. Food and Drug Administration to the Environmental Protection Agency.

The company reapplied for approval to release a new version of the mosquitoes, called OX5034, in the Keys. In May, the EPA granted a two-year experimental use permit, which the agency can cancel at any time. State and local sign-off soon followedfinally giving the project the greenlight.

Oxitecs OX5034 mosquitoes are the first GM mosquitoes approved for release in the US. The company has already conducted a trial with the OX5034 mosquitoes in Brazil and released more than a billion of a previous version, called OX513A, there and in other locations over the yearsincluding the Cayman Islands. The company says it is confident in the effectiveness and safety of the technology.

But some scientists want to hit pause on Oxitecs Florida trial, to find what they say is a fairer process in deciding to release the mosquitoes. Others want to see clearer proof that this technology is even necessary, claiming that the company has only released its most positive data with the public and has kept other key data, including whether the mosquitoes curb disease transmission, private. And if the release actually launches as planned, some Keys residents say they aim to interfere.

Critics also say that Oxitec failed to engage with local communities in Florida and get their consent to release the mosquitoes. Whats the most upsetting is that the very people that are going to be most impacted, both by the benefits or the risks of such a decision, have like the smallest voice in how these choices are made. I think thats a really big issue, says Natalie Kofler, a molecular biologist and bioethicist who founded Editing Nature, a platform that advocates for inclusive decision-making processes to steer the use of genetic technology. If Oxitec doesnt do this right, she adds, we could have huge impact on delaying the use of other beneficial technologies like that in the future.

Oxitecs OX5034 mosquitoes are programmed to combat the transmission of mosquito-borne illnesses by suppressing local Aedes aegypti populations. Oxitecwhich is US-owned and based in the United Kingdomdescribes their mosquitoes as friendly because they will only release males, which, unlike females, do not bite humans or transmit disease.

At Oxitecs laboratory in the UK, the company genetically engineers the mosquitoes, giving the insects the self-limiting gene that makes the females dependent on the antibiotic tetracycline. Without the drug, they will die. Eggs from these genetically-altered mosquitoeswhich will hatch both male and female insectswill be shipped to the Keys. Mosquitoes require water to mature from an egg to an adult; when Oxitecs team adds water to the boxes the mosquitoes will be deployed in, both GM males and GM females will hatch. With no tetracycline present in the box, the GM females are expected to die in early larval stages.

The male mosquitoes will survive and carry the gene. When they leave the boxes, the insects will, hypothetically, fly away to mate with wild females to pass the gene to the next wild generation, according to Nathan Rose, head of regulatory affairs at Oxitec. Kevin Gorman, the companys chief development officer, says the local female mosquito population will be increasingly reducedwhich will also reduce the number of wild male mosquitoes in the treatment areas.

Gorman emphasized to Undark that the EPA and other regulators found no risk in using tetracycline in breeding their genetically-altered mosquitoes. But some scientists think the presence of this antibiotic in the environment does pose a risk. According to Jennifer Kuzma, co-founder and co-director of the Genetic Engineering and Society Center at North Carolina State University, tetracyline is commonly used in Florida to prevent bacterial diseases in agricultureparticularly in citrus grovesand to treat bacteria in sewage plants. The use of the antibiotic for these purposes may mean that it will remain in the environment, especially in water where the mosquitoes breed, which could allow Oxitecs female mosquitoes to survive. While the company does not plan to release the mosquitos near areas where the antibiotic is used, Kuzma says the EPAs risk assessment did not include testing of any standing water for tetracyclinesomething, she adds, would have been easy enough to do for good due diligence.

Skeptics of Oxitecs GM mosquitoes include local residents, physicians, scientists, and environmental activists. Many of these opponents say they arent anti-GMO, but disagree with how the approval process has been handled. One group has even kept a running list of what it sees as Oxitecs wrongdoings since it first began experimental releases. The list includes Oxitecs lack of disease monitoring in the countries where it has released mosquitoes; the unknown price of its technology; and complaints that the company has overstated the success of some of it its trials.

I cannot trust this company. I cannot trust this technology, says Mara Daly, a resident of Key Largo who says shes been following Oxitecs plans for nine years.

This is not a traditional pesticide, she adds. This is not a chemical that you can trace. This is something completely different, new emerging technology and we need better regulation.

Phil Goodman, chairman of the Florida Keys Mosquito Control District (FKMCD), an independently-elected commission carrying out mosquito control within Monroe County, says that many of those who discredit Oxitecs evidence do not understand the technology. Theyre fearmongering, he says.

They have very little credibility here in the Florida Keys as far as Im concerned, he adds.

But people like Daly and Barry Wray, executive director of the Florida Keys Environmental Coalition, disagree. We want to know its safe, says Wray, who notes that his group more generally supports GM technology. We dont have another Florida Keys ecosystem. We dont have another Florida Keys community. We have this one.

Daly, Wray, and others point to what they perceive as the FKMCDs disrespect for public opinion. They argue that the community wasnt given a chance to consent before the EPA approval. There was a 30-day public forum in September 2019 about Oxitecs technology application, with 31,174 comments opposing release and 56 in support. A statement emailed to Undark by Melissa Sullivan, an EPA spokesperson, noted that the agency considered these comments during the review, but critics think it happened too quickly to be of real use.

In June, Kofler and Kuzma wrote an opinion piece in The Boston Globe about the EPA approval, critiquing the agencys regulatory system and calling for a better process for evaluating new biotechnologies. The researchers expressed concern that the EPA did not convene an independent, external scientific advisory panel to review Oxitecs claims about its mosquito strategy and that the agency only publicly released its risk assessment after approving the technology. The American public, Kofler and Kuzma wrote, needs to be assured that these decisions are made free of conflicts of interest. The statement from the EPAs Sullivan noted that the agency conducted anextensive risk assessmentbased on the best available science.

Some critics also wanted there to be more public engagement. Kofler and Kuzma say they offered to provide their expertise, along with other outside experts, to the mosquito control district to allow more discussion about the GM mosquitoes with the Keys community. But Kofler says the district wasnt responsive. Oxitec itself launched webinars about their new product, but not until after the EPA approval. Here we are, like in the final hour, having these conversations that needed to be happening a year ago, says Kofler.

Without public trust and enthusiasm, it doesnt matter whether Oxitecs mosquito technique works, says Guy Reeves, a genetic researcher at the Max Planck Institute for Evolutionary Biology in Germany, who stresses that he doesnt think the companys approach is unsafe. If the population in Florida Keys becomes so sensitized to this issuethat they can no longer cooperate with each otherthats good for the mosquitoes, not good for the people, he adds.

Based on their first generation mosquito OX513A, Oxitec says it has shown that the approach reduces a targeted mosquito population in trials in both Brazil and the Cayman Islands. But theres no evidence that this new OX5034 mosquito release will actually be worth it for mosquito suppression, says Reeves. Oxitec also hasnt explained how their new mosquito will directly curb human diseases, such as dengue. Reducing disease transmission and burden should be measures of efficacy for this technology, says Kofler.

According to Gorman, independent disease suppression data has only been collected by municipalities in Brazil because thats where most of the companys trials have been released in larger scales. These municipalities have shown that Oxitec mosquitoes have reduced dengue cases in areas of release, Gorman says. In order for Oxitec to collect additional data, he adds, the company needs to release and test large areas over sustained periods of time. Gorman maintains that the company is not required to report formal health impact studies.

Reeves adds that Oxitec also hasnt explained what resources are needed to sustain this product, how long it could take to be effective, or the cost. When asked about the cost of the Florida Keys project, Oxitec responded to Undark by email: Oxitec is a pre-commercial, pre-profit company. We will not profit from this pilot project in Florida.We are paying for it ourselves.

Oxitec has released more than a billion of their OX513A mosquitoes over the past 10 years. According to independent scientists, some of those experiments did not go well.

For example, researchers at Yale University and collaborators from Brazil analyzed Oxitecs 2015 release of OX513A in Brazil. The scientists confirmed that some offspring of the genetically modified mosquitoeswhich were supposed to die and not pass new genes to the wild populationsurvived to adulthood and mated with their native counterparts. Between 10 and 60 percent of the native mosquitoes contained genes from Oxitec, according to the Yale study, which published in Nature in 2019. The papers authors concluded they do not know what impacts these mixed mosquitoes have on disease control or transmission, but added that their findings underscore the importance of monitoring the genetics of the insects.

Oxitec disagreed with the findings and responded on the journals website. Oxitec told Gizmodo that Yales study includes numerous false, speculative, and unsubstantiated claims and statements about Oxitecs mosquito technology. And when Kofler and three other scientists wrote about Oxitecs Brazil trial in The Conversation, Oxitec pushed to have the article retracted, says Kofler.

For this coming release, some Key Largo locals are willing to act on their anger. Daly, for instance, says that if the mosquitoes are deployed in her neighborhood, shell try to put insecticide in any box she finds or send it to an expert to testeven if it means getting in trouble with the federal authorities. I already have my arresting officer and she said shes gonna clean her handcuffs for me, she says. I dont care.

Ideally, Daly says, it wont have to come to that. She and other locals hope to stop Oxitec before the latest mosquitos are delivered. Daly says she has been busy organizing protests like one that happened recently in Key Largoand giving out yard signs to residents who dont want their property used in the trial. Locals are pissed off. So I have been busy getting the press to cover the local opposition, Daly wrote in an email to Undark.

The first flying insect or animal that can actually use our human blood for a friggin trial for a product to come to market without my consent, Daly says.

Thats my blood, she adds. Thats my sons blood. Thats my dogs blood.

This article was originally published on Undark. Read the original article.

Image Credit: Frauke Feind from Pixabay

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First GMO Mosquitoes to Be Released in the Florida Keys - Singularity Hub

GAITHERSBURG, Md., April 14, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced its participation in a newly expanded investigator-initiated Phase 2 clinical trial called Comparing COVID-19 Vaccine Schedule Combinations Stage 2(Com-COV2), to be conducted by the University of Oxford and supported by the UK Vaccines Taskforce. Novavax' recombinant protein vaccine candidate, NVX-CoV2373, is one of four COVID-19 vaccines that will be studied to evaluate the potential for combined regimens that mix vaccines from different manufacturers to achieve immune protection against COVID-19.

"Novavax' addition to this important study reflects the urgency of finding innovative ways to protect as many people as possible in a dynamic pandemic landscape," said Filip Dubovsky, M.D., Executive Vice President, Chief Medical Officer, Novavax. "The potential utility of pooling public health resources, including all available vaccines, could help us get ahead of an evolving virus."

Com-COV2 will include 1050 adults 50 years of age or older who received their first vaccination during the prior 8-12 weeks. Volunteer study participants will receive one of four different vaccines as a second dose, 350 of whom will be administered NVX-CoV2373. The research will compare the immune system responses from those who receive a heterologous regimen to those who receive a homologous regimen.

"The focus of these studies is to explore whether multiple COVID-19 vaccines can be used more flexibly, with different vaccines being used for the first and second doses," said Matthew Snape, Associate Professor in Paediatrics and Vaccinology at the University of Oxford, and Chief Investigator on the trial. "If we can show that these mixed schedules generate an immune response that is as good as the standard schedules, this could potentially allow more people to complete their COVID-19 immunization course more rapidly."

Under the protocol, which is a designed as a non-inferiority study, participants will be followed for reactogenicity (safety) and immune responses. The UK Medicines and Healthcare products Regulatory Agency (MHRA) and Joint Committee on Vaccination and Immunisation (JCVI) will formally assess the safety and efficacy of any new vaccination regimen before it is made available to the public.

About NVX-CoV2373NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax' patented saponin-based Matrix-M to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that blocked the binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response in Phase 1/2 clinical testing.

NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials, a trial in the U.K that demonstrated efficacy of 96.4% against the original virus strain and 89.7% overall, and the PREVENT-19 trial in the U.S. and Mexico that began in December 2020. It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 48.6% efficacy against a newly emerging escape variant, and a Phase 1/2 continuation in the U.S. and Australia.

NVX-CoV2373 is stored and stable at 2- 8C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.

About Matrix-MNovavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About NovavaxNovavax, Inc.(Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavaxis conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

For more information, visit http://www.novavax.com and connect with us on Twitter and LinkedIn.

Novavax Forward Looking StatementsStatements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:

InvestorsNovavax, Inc.Erika Schultz | 240-268-2022ir@novavax.com

Solebury TroutJennifer Porcelli | 646-378-2962jporcelli@soleburytrout.com

Novavax MediaAmy Speak | 617-420-2461Laura Keenan | 410-419-5755media@novavax.com

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Novavax to Participate in University of Oxford Com-COV2 Study Comparing Mixed COVID-19 Vaccine Combinations - BioSpace

Washington State-based AmunBio and Chicago-based NorthShore University HealthSystems Research Institute have agreed to collaborate in the development and the commercialization of an innovative technology platform of novel immunotherapeutic oncolytic viruses. AmunBio has an exclusive option to license this technology.

The proprietary platform technology has the potential to generate a strong pipeline of patient-centric next-generation immunotherapeutic oncolytic viruses.

The conceptOncolytic viruses are a form of immunotherapy that uses native or reprogrammed viruses to infect and selectively kill cancerous cells. The concept of using viruses in killing cancer is, however, not new. At the turn of the nineteenth century, when the existence of viruses was first recognized, there has been considerable interest in using viruses as possible agents of tumor destruction.

The use of viruses in cancer treatment was not the result of true understanding and discerning theory of a possible therapy, but rather, was based on the observation that, in some cases, patients diagnosed with cancer or hematological malignancies who contracted an infectious disease went into brief periods of clinical remission

Early case reports emphasized regression of cancers during naturally acquired virus infections, providing the initial basis for clinical trials where body fluids containing human or animal viruses were used to transmit infections to cancer patients.

In one case, in a patient diagnosed with leukemia, it was well recognized that the contraction of influenza produced beneficial effects. And while doctors were not able to report cases where an accompanying infectious disease led to a complete cure of leukemia, they believed that a treatment based upon the causal infection would, potentially, provide an alternative to the hopelessness of the ordinary treatment of leukemia.'[1]

And while in this approach of infecting cancer patients the immune system arrested the impact of the viruses in most cases, and the viruses failed to impact tumor growth, when, in immunosuppressed patients, infection persisted, tumors regressed. However, morbidity as a result of the infection of normal tissues was unacceptably high, ending attempts to develop novel virus-based treatment options.[2]

In the 1950s and 1960s, with the advent of rodent models and new methods for virus propagation, researchers attempted to develop viruses with greater tumor specificity, but success was limited, and, again, most researchers abandoned their research in finding a virus to kill cancer in the 1970s and 1980s. [2]

ResurgenceHowever, more recently, there has been a resurgence of interest in finding viruses that can be used to target and attack tumors that have already formed. Some of these modifiied virusesbut not allare known as oncolytic viruses and represent a promising approach to treating cancer. And today, the development of oncolytic viral therapies, which represents a unique therapeutic paradigm within Immuno-Oncology, is rapidly gaining momentum.

In November 2005 research and development of oncolytic viruses got a welcome boost when Chinese medical regulators approved Shanghai Sunway Biotechs genetically modified adenovirus oncorine (H101). This drug was the worlds first oncolytic viral therapy for the treatment of nasopharyngeal carcinoma in combination with chemotherapy after the phase III clinical trial. At the same time, the company also bought the rights to Onyx-15 (dl1520), an almost identical oncolytic virus* developed by Onyx Pharmaceuticals which was scheduled to be included into phase III clinical trials for lung cancer in 2000.

Onyx-15The development of Onyx-15 began in 1996 when Frank McCormick***, Ph.D. FRS, the co-founder of Onyx Pharmaceuticals and one of the companys biochemists, initiated and led various drug discovery efforts.

McCormick believed that an adenovirus without its E1B gene, which inactivates the host cells p53 gene, would be able to selectively kill cancer cells. He believed that because normal cells harboring the modified virus, the defenseless virus would be subject to p53-mediated cell cycle arrest, preventing the virus from replicating. Cancer cells lacking p53 would be thus be unable to halt viral replication and would be lysed, with multiplied viruses bursting out to infect and destroy the entire tumor.

Unfortunately, while McCormicks hypothesis seemed brilliant, it was also incorrect. Research shoeed that Onyx-15 was not specific for p53-null cells. However, in early human trials, the oncolytic virus still killed tumor cells preferentially and was superior to chemotherapy alone. In its phase III trial with oncorine, Shanghai Sunway Biotech reported a 79% response rate for oncorine plus chemotherapy, compared with 40% for chemotherapy alone.

While various key opinion leaders and experts believe that a completed phase III trial of Onyx-15 would have resulted in FDA approval, the development and phase III clinical trial of the oncolytic virus was suspended when Pfizer acquired Warner-Lambert, Onyxs development partner.

Looking back, if approved, Onyx-15 would, as some experts suggest, been made obsolete by better oncolytic viruses. One of the reasons is that the deletion of E3 limited the potency of Onyx-15. But the suspension of the phase III trial stigmatized the development of oncolytic viruses because, as a result, many researchers inaccurately assumed that Onyx-15 trial failed. In reality, the trial never started.

MelanomaIn 2015, the U.S. Food and Drug Administration (FDA) approved the first oncolytic virus immunotherapy for the treatment of cancer called talimogene laherparepvec or T-VEC (Imlygic; Amgen). The treatment is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Talimogene laherparepvec involves a herpes virus that has been engineered to be less likely to infect healthy cells as well as cause infected cancer cells to produce the immune-stimulating GM-CSF protein.

While in clinical trials and following regulatory approval oncolytic viruses have indeed met the challenge and have become a valuable tool in the anti-cancer armamentarium, there is still much work that needs to be done in the development of novel immunotherapeutic agents based on this approach.

AgreementThe Research Institute has granted an exclusive option to AmunBio covering intellectual property and technology related to an immunotherapeutic oncolytic virus platform. This technology forms the core of AmunBios proprietary, multimodal therapeutic approach utilizing direct destruction of cancer cells and immune system activation.

The technology is based on more than 20 years of research by Prem Seth, Ph.D., Director, Gene Therapy Program at NorthShore, and AmunBios founder and Chief Scientific Officer, and his associates.

AMUN-003The agreement between AmunBio and NorthShore University HealthSystems Research Instituteincludes the development of AMUN-003, an adenovirus-based immunotherapeutic Immuno-Oncology agent, which is being developed for the treatment of multiple solid tumors, including (triple-negative) breast cancer (TNBC) and melanoma, and the ongoing development of additional immunotherapeutic oncolytic viruses.

Following a planned Investigational New Drug (IND) application, which is expected in late 2021/early 2022, AmunBio is planning multiple Phase I clinical trials of AMUN-003 alone or in combination with checkpoint inhibitors.

AmunBios AMUN-003 blocks suppression of the immune response inside the tumor stimulates the recruitment of cancer-killing immune cells and avoids non-specific inflammation. AMUN-003 can be administered both locally as well as systemically.Preclinical studies with AMUN-003 in breast cancer alone, compared to prior oncolytic virus constructs, demonstrated near-complete breast cancer inhibition. [3]

Based on preclinical studies, we believe that AMUN-003 may lead to long-term protection from cancer recurrence, Seth said.

Incidence of cancerWe believe that in the treatment of cancer, there are still not enough new options, noted Cecilia Zapata-Harms, MS, MHA, AmunBio Chief Operations Officer.

While last year, in 2020, the world focused on the SARS-CoV-2 pandemic, more than 9 million people worldwide lost their fight against cancer. *** [4] Among them were more than 600,000 Americans. Our novel viral immunotherapeutic approach may result in significantly more efficacious treatment options, promising to dramatically improve the outcome for many patients diagnosed with cancer, she observed.

We are delighted to be partnering with NorthShore and to be part of ongoing research initiatives to improve the lives of patients, said Zapata-Harms, commenting on research collaboration with the Research Institute.

Breakthrough researchThe Research Institute is the research arm of NorthShore University and supports the organizations core mission to preserve and improve human life through academic excellence and innovative research. The scientists at the research are involved in a wide range of research activities, from lab-based translational research and advanced imaging to clinical trials. As part of this, NorthShore providing the infrastructure and resources for research, which include both administrative and regulatory oversight of investigative studies. The organization has a long history of firsts.

Were humbled by the fact that the same institution, where in the early 1920s George Frederick Dick, MD, and Gladys Henry Dick, MD pioneered the development of a toxin for the prevention of scarlet fever, stands behind our work in developing engineered oncolytic virus for Immuno-Oncology. Its also the same institution where the American pediatrician Louis Wendlin Sauer, MD, in the 1930s, perfected a vaccine used to prevent pertussis (whooping cough), and, more recently, scientists have developed novel treatment options for diseases like MRSA, reducing infection rates through the study of preventative screenings and diagnostic testing, said Andrei R. Shustov, MD, a member of AmunBio Scientific Advisory Board.[5][6]

Oncolytic viruses represent a unique therapeutic approach within Immuno-Oncology and AmunBio platform technology is expected to result in a fundamental shift, augmenting novel treatment modalities compared to, what we believe, is possible today, said, Stephen R. Wachtel, Ph.D., Assistant Vice President, Research Operations at NorthShore.

With the collaboration between the Research Institute and AmunBio were able to address many of the challenges that have prevented previous endeavors from delivering on the full potential of immunotherapeutic oncolytic viruses within Immuno-Oncology, allowing us to discover and develop novel drug candidates for some of the most challenging cancers, Wachtel concluded.

Note*The only difference between the two oncolytic viruses is a slightly larger deletion in H101s E3 gene, which affects immune response**Worldwide, an estimated 19.3 million new cancer cases (18.1 million excluding nonmelanoma skin cancer) and almost 10.0 million cancer deaths (9.9 million excluding nonmelanoma skin cancer) occurred in 2020. Around the world, much work is being done to develop new treatment options.***Today Frank McCormick, Ph.D. FRS, professor in the University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center

Clinical trialsSystemic Chemotherapy Combined With Recombinant Human Adenovirus Type 5 and Endostatin Injections for Treatment Malignant Hydrothorax in NSCLC Patients NCT02579564Intraperitoneal Injection of Oncolytic Viruses H101 for Patients With Refractory Malignant Ascites NCT04771676

Highlights of prescribing informationTalimogene laherparepvec (Imlygic; Amgen, Inc) [Prescribing Information]

Reference[1] Kelly E, Russell SJ. History of oncolytic viruses: genesis to genetic engineering. Mol Ther. 2007 Apr;15(4):651-9. doi: 10.1038/sj.mt.6300108. Epub 2007 Feb 13. PMID: 17299401.[2] Data on file AmunBio[3] Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021 Feb 4. doi: 10.3322/caac.21660. Epub ahead of print. PMID: 33538338.[4] Dick GF, Dick GH. Scarlet Fever. Edinb Med J. 1934 Jan;41(1):1-13. PMID: 29645766; PMCID: PMC5314226.[5] Pittman M. History of the development of pertussis vaccine. Dev Biol Stand. 1991;73:13-29. PMID: 1778306.

Featured image: A microscopic view of a virus with a depth of field. Photo courtesy: 2020 2021 AmunBio, Inc. Used with permission

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AmunBio and NorthShore University to Advance Cancer Immunotherapy with Engineered Oncolytic Viruses - OncoZine

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- StrideBio, Inc., a leading developer of novel adeno-associated viral (AAV)-based gene therapies, today announced the signing of a multi-technology collaboration with Duke University that will enable novel next-generation gene therapies against a broad range of disorders. StrideBio is advancing multiple products incorporating these technologies with an initial program targeting a novel treatment for the pediatric neurological disorder Alternating Hemiplegia of Childhood (AHC).

The agreements announced today provide StrideBio an exclusive license to multiple technologies that will enable best-in-class next-generation gene therapies developed at Duke University. Included are novel engineered AAV vectors which complement StrideBios existing STRIVETM capsid engineering platform, having been selected through a cross-species evolution that results in significantly enhanced tropism and potency versus AAV9 across a wide range of tissues such as CNS, skeletal and cardiac muscle. Data on these novel vectors were presented by Duke researcher and StrideBio co-founder, Aravind Asokan, Ph.D., at the American Society of Gene & Cell Therapy 23rd Annual Meeting in an abstract titled Cross Species Evolution of Synthetic AAV Strains for Clinical Translation (Gonzalez et al., ASGCT 2020, Abstract 24). In addition, StrideBio has licensed exclusive rights covering a novel use of IgG-degrading enzyme IdeZ to clear neutralizing antibodies in conjunction with AAV gene therapy administration. This innovative approach was recently published by members of the Asokan Lab in a manuscript titled Rescuing AAV gene transfer from neutralizing antibodies with an IgG-degrading enzyme (Elmore et al., JCI Insight, 2020, 5(19): e139881). Finally, StrideBio obtained license rights to a novel gene therapy approach for the treatment of AHC recently published by Duke researcher Mohamad Mikati, M.D., in a manuscript titled AAV Mediated Gene Therapy in the Mashlool, Atp1a3Mashl/+, Mouse Model of Alternating Hemiplegia of Childhood (Hunanyan et al., Human Gene Therapy, February 12, 2021).

Under the Master Sponsored Research Agreement (SRA), StrideBio will fund collaborative work to advance novel gene therapies initially against AHC and other undisclosed targets. AHC is a devastating pediatric neurological disorder with mutations in a causative gene, ATP1A3, that was first identified by a team of Duke University researchers, including Dr. Mikati, in 2012. StrideBio will work closely with Dr. Mikati using a mouse model of AHC developed in his lab to select and rapidly advance a novel gene therapy candidate to the clinic, leveraging the engineered AAV vectors developed by StrideBio along with its manufacturing and translational development capabilities.

The Master SRA between StrideBio and Duke University also provides a framework for additional new programs to be brought under the collaboration. These programs will aim to utilize novel engineered AAV capsids developed by StrideBio to improve potency, evade neutralizing antibodies and enhance specific tropism to tissues of interest. One additional undisclosed program targeting the CNS vasculature has been initiated.

We are very excited to partner with Duke University to advance these technologies that can improve and expand on the potential benefits of gene therapies for patients who desperately need them, stated Sapan Shah, Ph.D., Chief Executive Officer, StrideBio, Inc. We look forward to working together with a fantastic group of Duke researchers and clinicians to bring next-generation AAV-based gene therapies to patients with rare CNS diseases and beyond, starting with Alternating Hemiplegia of Childhood.

This License and Master Sponsored Research Agreement will ensure that these innovative technologies receive the resources and expertise necessary to develop treatments that can ultimately benefit patients. We are delighted to have StrideBio as a partner on this important effort in the gene therapy area, commented Robin Rasor, Executive Director of the Office of Licensing and Ventures, Duke University.

Specific terms were not disclosed, but include equity, upfront and milestone-driven payments, and sponsored research commitments from StrideBio to Duke University, along with royalties on future product sales.

About StrideBio Founded in 2015 based on the groundbreaking research of Mavis Agbandje-McKenna, Ph.D., and Aravind Asokan, Ph.D., StrideBio, Inc., is a fully integrated gene therapy company focused on creating best-in-class genetic medicines with life-changing or curative potential for children and adults. Our proprietary structure-inspired adeno-associated viral (AAV) vector engineering platform (STRIVE) creates unique and differentiated capsids that overcome current limitations of first-generation gene therapies. Key targeted improvements include reduced seroprevalence, improved tropism for specific cell types, liver de-targeting and increased gene transfer efficiency, with the potential for improved safety and reduced doses in the clinic. StrideBio is advancing a robust pipeline of gene therapy candidates enabled by these novel engineered capsids, initially focused on genetically defined CNS and cardiovascular disorders. Combined with our genetic construct design expertise and in-house manufacturing capability at a 1000L scale, we are well positioned to advance novel best-in-class AAV gene therapies. StrideBio is based in a state-of-the-art 40,000-square-foot facility in Research Triangle Park, N.C., which houses our offices, research labs and in-house AAV manufacturing facilities. For more information, please visit http://www.stridebio.com or follow us on LinkedIn.

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StrideBio Announces a Multi-technology License and Master SRA with Duke University to Advance Next-generation Gene Therapies - BioSpace

Cell and gene therapies are overlapping fields of research and treatments. While both aim to treat and potentially cure diseases, they have slightly differing approaches and have different historical backgrounds. Due to growing interest surrounding this field, the general public still has much to learn and understand about each of these potentially life-saving therapies.

Below, we provide a general overview and brief historical context for each type of therapy.

Cell therapyis the process of replacing damaged or dysfunctional cells with new, healthy ones by transferring live cells into a patient. These can be autologous (also known as self-to-self, using cells from the patient receiving the treatment) or allogeneic (using cells from a donor for the treatment). While this field of treatment has recently begun to expand, some forms of cell therapy like the cancer-treating hematopoietic stem cell transplantation(HSCT) have been in practice for decades.

While many people have heard of bone marrow transplants, few realize that this procedure is a stem cell therapy. While stem cells can be derived from many sources, such as umbilical cord blood and mobilized peripheral blood, bone marrow derived stem cell therapy is the most commonly used today and has been for more than 50 years.

The first transfusion of human bone marrow was given to a patient with aplastic anemia in 1939. After World War II researchers diligently worked to restore bone marrow function in aplasia patients caused by exposure to radiation produced by the atomic bomb. After a decade of work they were able to show, in a mouse model, that aplasia could be overcome by bone marrow treatment.

The first allogeneic HSCT, which led the way to current protocols, was pioneered by E. Donnall Thomas and his team at the Fred Hutchinson Cancer Research Center and reported in the New England Journal of Medicine in 1957. In this study six patients were treated with radiation and chemotherapy and then received intravenous infusion of bone marrow rich stem cells from a normal donor to reestablish the damaged or defective cells. Since then the field has evolved and expanded worldwide. While almost half of HSCT are allogeneic, the majority of HSCT are autologous, the patient's own stem cells are used for treatment, which carries less risk to the patient.

In 1988, scientists discovered that they could derive stem cells from human embryos and grow the cells in a laboratory. These newly derived stem cells, referred to as embryonic stem cells (hESCs), were found to be pluripotent, meaning they can give rise to virtually any other type of cell in the body. This versatility allows hESCs cells to potentially regenerate or repair diseased tissue and organs. Two decades after they were discovered, treatments based on hESCs have been slow in coming because of controversy over their source and concerns that they could turn into tumours once implanted. Only recently, testing has begun as a treatment for two major diseases: heart failure and type 1 diabetes.

In 2006, researchers made a groundbreaking discovery by identifying conditions that would allow some cells to be 'reprogrammed' genetically. This new type of stem cell became known as induced pluripotent stem cells (iPSCs). Since this discovery, the field has expanded tremendously in the past two decades. Stem cell therapies have expanded in use and have been used to treat diseases such as type 1 diabetes, Parkinson's and even spinal cord injuries.

There has also been a growing focus on using other immune cells to treat cancer. Therapies such as CAR T-cellare dependent upon a patient's T-cells, which play a critical role in managing the immune response and killing cells affected by harmful pathogens. These cells are then reengineered to target and kill certain cancerous cells. Several CAR T-cell therapies have been FDA approved, with the first approval being given in 2017 for Yescarta and Kymriah, to be used for the treatment of B-cell leukemia in children and young adults.

Gene therapyis a process that modifies the expression of a gene or alters the biological process of living cells for therapeutic use. This process can take the form of replacing a disease-causing gene with a new, healthy one, inactivating the mutated gene, or introducing a new gene to help the patient's body fight a disease.

While the use of gene therapy to treat humans is fairly new, the science behind it has been used in science for decades. Farmers and geneticists have collaborated for years on crop improvement using cross pollination, genetic engineering and microinjection techniques to create stronger, more resilient crops.

The first human patient to be treated with gene therapy was a four-year old girlsuffering from severe combined immunodeficiencyin 1990. She received treatment for a congenital disease called adenosine deaminase (ADA). Since then, gene therapies have been used to treat diseases such as cancer, cystic fibrosis and hemophilia.In 2017, the FDA gave its first approval of a gene therapy called Luxturna, which is used to treat patients with established genetic vision loss that may result in blindness. Gene therapies are still being studied and developed, with over 1,000 clinical trialscurrently underway.

ThermoGenesis Holdings Inc., is a pioneer and market leader in the development and commercialization of automated cell processing technologies for the cell and gene therapy fields. We market a full suite of solutions for automated clinical biobanking, point-of-care applications and large-scale cell processing and manufacturing with a special emphasis on the emerging CAR-T immunotherapy market. We are committed to making the world a healthier place by creating innovative solutions for those in need.

For more information on the CAR-TXpress multi-system platform, please contact our Sales team.

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Thermogenesis Holdings Inc. published this content on 13 April 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 April 2021 07:10:03 UTC.

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Europes refusal to permit its farmers to cultivate genetically engineered (GE) crops led to the avoidable emission of millions of tonnes of climate-damaging carbon dioxide, a new scientific analysis reveals.

The opportunity cost of the EUs refusal to allow cultivation of GE varieties of key crops currently totals 33 million tonnes of CO2 per year, the experts say.

This is equivalent to 7.5 percent of greenhouse gas (GHG) emissions from the entire European agricultural sector, or roughly what might be emitted each year by 10-20 coal-fired power stations.

Given that farmers in North and South America adopted GE crops from the late 1990s onward, this analysis implies that over subsequent decades the additional carbon emitted due to the EUs opposition to genetic engineering will likely be in the hundreds of millions of tonnes.

The findings result from from the fact that GE versions of major crops produce a higher yield because they can better resist damage from insects and competition from weeds.

With Europes farmers condemned to lower total agricultural yields because of GE crop non-adoption, more farmland globally has to be kept in production or plowed up which otherwise might be available for forests to sequester carbon in trees and soil.

The new analysis will make uncomfortable reading for environmental groups that have long combined advocacy for climate mitigation with a steadfast opposition to GMOs because it implies that their opposition to genetic engineering might be substantially worsening the climate emergency.

The paper is co-authored by Emma Kovak and Dan Blaustein-Rejto both from the California-based ecomodernist think tank the Breakthrough Institute and Matin Qaim, from the University of Goettingen, Germany. It is published as a pre-print on the bioRxiv server in advance of formal peer review.

The calculation was made by estimating to what extent GHG emissions could have been avoided if the EUs level of adoption of GE varieties of five major crops (maize, soybean, cotton, canola and sugar beet) in 2017 had been equal to that of the United States.

Our results suggest that GHG emissions reductions from the yield increases in GE crops are substantial and should be included in future analyses, writes lead author Kovak.

The researchers also note that their findings are particularly relevant right now because a possible reassessment of the EUs harsh regulatory regime for biotech crops is currently underway.

However the EUs current policy trend pushes in the opposite direction. As Kovak explains, Europes new Farm-to-Fork Strategy under the European Green Deal aims to expand organic farming, which has lower yields and would be associated with significant increases in global GHG emissions through causing land-use change elsewhere.

She concludes: Rather than offshoring environmental damage to other nations, as the European Green Deal does, the EU should increase agricultural productivity through embracing new crop technologies, thus contributing to global environmental benefits.

The authors, however, caution that their assumptions mean that there are substantial uncertainties in the analysis. They assume, for instance, that increased yields in Europe would lead to a proportionate decrease in production elsewhere.

In reality, while the land-sparing effects of crop yield increases are well established, the magnitude can vary widely according to differing circumstances.

However, uncertainties also mean that the estimated annual GHG savings of 33 million tonnes could on the other hand be a big underestimate. In particular, the analysis does not take into account Europes influence on Africa and Asia, where the EUs refusal to allow farmers to cultivate GE crops has been hugely influential.

Nor does it take into consideration what might have happened if crops more widely grown in Europe than in North America in particular wheat and barley had been genetically engineered to allow similar yield improvements as have been seen in maize, cotton and soy.

At the moment no GE varities of wheat or barley are cultivated widely due to intense and long-standing opposition from politicians and anti-GMO activists. If these crops had been available to farmers in standard GE insect- and weed-resistant varieties, Europes agricultural productivity might have increased substantially.

The researchers conclude on a hopeful note, pointing out that new gene editing technologies will likely further increase the diversity of desirable crop-trait combinations. If these crops are permitted in Europe and elsewhere, huge climate mitigation benefits from future GE crops might still be realized.

Image: European Commission

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