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mRNA Technology Gave Us the First COVID-19 Vaccines. It Could Also Upend the Drug Industry – TIME

Tuesday, January 12th, 2021

No! The doctor snapped. Look at me!

I had been staring her in the eyes, as she had ordered, but when a doctor on my other side began jabbing me with a needle, I started to turn my head. Dont look at it, the first doctor said. I obeyed.

This was in early August in New Orleans, where I had signed up to be a participant in the clinical trial for the Pfizer-BioNTech COVID-19 vaccine. It was a blind study, which meant I was not supposed to know whether I had gotten the placebo or the real vaccine. I asked the doctor if I would really been able to tell by looking at the syringe. Probably not, she answered, but we want to be careful. This is very important to get right.

I became a vaccine guinea pig because, in addition to wanting to be useful, I had a deep interest in the wondrous new roles now being played by RNA, the genetic material that is at the heart of new types of vaccines, cancer treatments and gene-editing tools. I was writing a book on the Berkeley biochemist Jennifer Doudna. She was a pioneer in determining the structure of RNA, which helped her and her doctoral adviser figure out how it could be the origin of all life on this planet. Then she and a colleague invented an RNA-guided gene-editing tool, which won them the 2020 Nobel Prize in Chemistry.

The tool is based on a system that bacteria use to fight viruses. Bacteria develop clustered repeated sequences in their DNA, known as CRISPRs, that can remember dangerous viruses and then deploy RNA-guided scissors to destroy them. In other words, its an immune system that can adapt itself to fight each new wave of virusesjust what we humans need. Now, with the recently approved Pfizer-BioNTech vaccine and a similar one from Moderna being slowly rolled out across the U.S. and Europe, RNA has been deployed to make a whole new type of vaccine that will, when it reaches enough people, change the course of the pandemic.

Drs. Ugur Sahin and Ozlem Tureci, Co-founders, BioNTech. In January 2020, before many in the Western world were paying attention to a new virus spreading in China, Dr. Ugur Sahin was convinced it would spur a pandemic. Sahin, who in 2008 co-founded the German biotech company BioNTech with his wife Dr. Ozlem Tureci, went to work on a vaccine and by March called his contact at Pfizer, a much larger pharmaceutical company with which BioNTech had previously worked on an influenza vaccine using mRNA. Less than a year later, the Pfizer-BioNTech COVID-19 vaccine became the first ever mRNA vaccine available for widespread use. Even so, Sahin, BioNTechs CEO, and Tureci, its chief medical officer, maintain that BioNTech is not an mRNA company but rather an immunotherapy company. Much of the couples workboth at BioNTech and at their previous venture, Ganymedhas focused on treating cancer. But it is mRNA, and the COVID-19 vaccine made possible by the technology, that has pushed the famously hardworking couple into the limelightand helped them become one of the richest pairs in Germany, though they reportedly still bicycle to work and live in a modest apartment near their office.

Dina LitovskyRedux for TIME

Up until last year, vaccines had not changed very much, at least in concept, for more than two centuries. Most have been modeled on the discovery made in 1796 by the English doctor Edward Jenner, who noticed that many milkmaids were immune to smallpox. They had all been infected by a form of pox that afflicts cows but is relatively harmless to humans, and Jenner surmised that the cowpox had given them immunity to smallpox. So he took some pus from a cowpox blister, rubbed it into scratches he made in the arm of his gardeners 8-year-old son and then (this was in the days before bioethics panels) exposed the kid to smallpox. He didnt become ill.

Before then, inoculations were done by giving patients a small dose of the actual smallpox virus, hoping that they would get a mild case and then be immune. Jenners great advance was to use a related but relatively harmless virus. Ever since, vaccinations have been based on the idea of exposing a patient to a safe facsimile of a dangerous virus or other germ. This is intended to kick the persons adaptive immune system into gear. When it works, the body produces antibodies that will, sometimes for many years, fend off any infection if the real germ attacks.

One approach is to inject a safely weakened version of the virus. These can be good teachers, because they look very much like the real thing. The body responds by making antibodies for fighting them, and the immunity can last a lifetime. Albert Sabin used this approach for the oral polio vaccine in the 1950s, and thats the way we now fend off measles, mumps, rubella and chicken pox.

At the same time Sabin was trying to develop a vaccine based on a weakened polio virus, Jonas Salk succeeded with a safer approach: using a killed or inactivated virus. This type of vaccine can still teach a persons immune system how to fight off the live virus but is less likely to cause serious side effects. Two Chinese companies, Sinopharm and Sinovac, have used this approach to develop vaccines for COVID-19 that are now in limited use in China, the UAE and Indonesia.

Another traditional approach is to inject a subunit of the virus, such as one of the proteins that are on the viruss coat. The immune system will then remember these, allowing the body to mount a quick and robust response when it encounters the actual virus. The vaccine against the hepatitis B virus, for example, works this way. Using only a fragment of the virus means that they are safer to inject into a patient and easier to produce, but they are often not as good at producing long-term immunity. The Maryland-based biotech Novavax is in late-stage clinical trials for a COVID-19 vaccine using this approach, and it is the basis for one of the two vaccines already being rolled out in Russia.

The plague year of 2020 will be remembered as the time when these traditional vaccines were supplanted by something fundamentally new: genetic vaccines, which deliver a gene or piece of genetic code into human cells. The genetic instructions then cause the cells to produce, on their own, safe components of the target virus in order to stimulate the patients immune system.

For SARS-CoV-2the virus that causes COVID-19the target component is its spike protein, which studs the outer envelope of the virus and enables it to infiltrate human cells. One method for doing this is by inserting the desired gene, using a technique known as recombinant DNA, into a harmless virus that can deliver the gene into human cells. To make a COVID vaccine, a gene that contains instructions for building part of a coronavirus spike protein is edited into the DNA of a weakened virus like an adenovirus, which can cause the common cold. The idea is that the re-engineered adenovirus will worm its way into human cells, where the new gene will cause the cells to make lots of these spike proteins. As a result, the persons immune system will be primed to respond rapidly if the real coronavirus strikes.

This approach led to one of the earliest COVID vaccine candidates, developed at the aptly named Jenner Institute of the University of Oxford. Scientists there engineered the spike-protein gene into an adenovirus that causes the common cold in chimpanzees, but is relatively harmless in humans.

The lead researcher at Oxford is Sarah Gilbert. She worked on developing a vaccine for Middle East respiratory syndrome (MERS) using the same chimp adenovirus. That epidemic waned before her vaccine could be deployed, but it gave her a head start when COVID-19 struck. She already knew that the chimp adenovirus had successfully delivered into humans the gene for the spike protein of MERS. As soon as the Chinese published the genetic sequence of the new coronavirus in January 2020, she began engineering its spike-protein gene into the chimp virus, waking each day at 4 a.m.

Her 21-year-old triplets, all of whom were studying biochemistry, volunteered to be early testers, getting the vaccine and seeing if they developed the desired antibodies. (They did.) Trials in monkeys conducted at a Montana primate center in March also produced promising results.

Bill Gates, whose foundation provided much of the funding, pushed Oxford to team up with a major company that could test, manufacture and distribute the vaccine. So Oxford forged a partnership with AstraZeneca, the British-Swedish pharmaceutical company. Unfortunately, the clinical trials turned out to be sloppy, with the wrong doses given to some participants, which led to delays. Britain authorized it for emergency use at the end of December, and the U.S. is likely to do so in the next two months.

Johnson & Johnson is testing a similar vaccine that uses a human adenovirus, rather than a chimpanzee one, as the delivery mechanism to carry a gene that codes for making part of the spike protein. Its a method that has shown promise in the past, but it could have the disadvantage that humans who have already been exposed to that adenovirus may have some immunity to it. Results from its clinical trial are expected later this month.

In addition, two other vaccines based on genetically engineered adenoviruses are now in limited distribution: one made by CanSino Biologics and being used on the military in China and another named Sputnik V from the Russian ministry of health.

There is another way to get genetic material into a human cell and cause it to produce the components of a dangerous virus, such as the spike proteins, that can stimulate the immune system. Instead of engineering the gene for the component into an adenovirus, you can simply inject the genetic code for the component into humans as DNA or RNA.

Lets start with DNA vaccines. Researchers at Inovio Pharmaceuticals and a handful of other companies in 2020 created a little circle of DNA that coded for parts of the coronavirus spike protein. The idea was that if it could get inside the nucleus of a cell, the DNA could very efficiently churn out instructions for the production of the spike-protein parts, which serve to train the immune system to react to the real thing.

The big challenge facing a DNA vaccine is delivery. How can you get the little ring of DNA not only into a human cell but into the nucleus of the cell? Injecting a lot of the DNA vaccine into a patients arm will cause some of the DNA to get into cells, but its not very efficient.

Some of the developers of DNA vaccines, including Inovio, tried to facilitate the delivery into human cells through a method called electroporation, which delivers electrical shock pulses to the patient at the site of the injection. That opens pores in the cell membranes and allows the DNA to get in. The electric pulse guns have lots of tiny needles and are unnerving to behold. Its not hard to see why this technique is unpopular, especially with those on the receiving end. So far, no easy and reliable delivery mechanism has been developed for getting DNA vaccines into the nucleus of human cells.

That leads us to the molecule that has proven victorious in the COVID vaccine race and deserves the title of TIME magazines Molecule of the Year: RNA. Its sibling DNA is more famous. But like many famous siblings, DNA doesnt do much work. It mainly stays bunkered down in the nucleus of our cells, protecting the information it encodes. RNA, on the other hand, actually goes out and gets things done. The genes encoded by our DNA are transcribed into snippets of RNA that venture out from the nucleus of our cells into the protein-manufacturing region. There, this messenger RNA (mRNA) oversees the assembly of the specified protein. In other words, instead of just sitting at home curating information, it makes real products.

Scientists including Sydney Brenner at Cambridge and James Watson at Harvard first identified and isolated mRNA molecules in 1961. But it was hard to harness them to do our bidding, because the bodys immune system often destroyed the mRNA that researchers engineered and attempted to introduce into the body. Then in 2005, a pair of researchers at the University of Pennsylvania, Katalin Kariko and Drew Weissman, showed how to tweak a synthetic mRNA molecule so it could get into human cells without being attacked by the bodys immune system.

Stphane Bancel, CEO, Moderna. Modernas COVID-19 vaccine was first tested in humans less than three months after news of the novel virus broke. But that lightning-fast development process belies the years of work that got Moderna to where it is today. The startup was founded in 2010 with the belief that mRNA technology, then still fairly new, could help treat any number of ailments. CEO Stphane Bancel, pictured above, joined a year later. Moderna wasnt originally focused on vaccines, but over time, its scientists began working toward vaccines against several infectious diseases as well as some forms of cancer. That experience came in handy when the COVID-19 pandemic arrived, leaving the world clamoring for a vaccine that could fight the deadly virusand fast. Bancels company took the challenge in stride, using its mRNA platform to develop a vaccine around 95% effective at protecting against COVID-19 disease in less than a year.

Cody OLoughlinThe New York Times/Redux

When the COVID-19 pandemic hit a year ago, two innovative young pharmaceutical companies decided to try to harness this role played by messenger RNA: the German company BioNTech, which formed a partnership with the U.S. company Pfizer; and Moderna, based in Cambridge, Mass. Their mission was to engineer messenger RNA carrying the code letters to make part of the coronavirus spike proteina string that begins CCUCGGCGGGCA and to deploy it in human cells.

BioNTech was founded in 2008 by the husband-and-wife team of Ugur Sahin and Ozlem Tureci, who met when they were training to be doctors in Germany in the early 1990s. Both were from Turkish immigrant families, and they shared a passion for medical research, so much so that they spent part of their wedding day working in the lab. They founded BioNTech with the goal of creating therapies that stimulate the immune system to fight cancerous cells. It also soon became a leader in devising medicines that use mRNA in vaccines against viruses.

In January 2020, Sahin read an article in the medical journal Lancet about a new coronavirus in China. After discussing it with his wife over breakfast, he sent an email to the other members of the BioNTech board saying that it was wrong to believe that this virus would come and go as easily as MERS and SARS. This time it is different, he told them.

BioNTech launched a crash project to devise a vaccine based on RNA sequences, which Sahin was able to write within days, that would cause human cells to make versions of the coronaviruss spike protein. Once it looked promising, Sahin called Kathrin Jansen, the head of vaccine research and development at Pfizer. The two companies had been working together since 2018 to develop flu vaccines using mRNA technology, and he asked her whether Pfizer would want to enter a similar partnership for a COVID vaccine. I was just about to call you and propose the same thing, Jansen replied. The deal was signed in March.

By then, a similar mRNA vaccine was being developed by Moderna, a much smaller company with only 800 employees. Its chair and co-founder, Noubar Afeyan, a Beirut-born Armenian who immigrated to the U.S., had become fascinated by mRNA in 2010, when he heard a pitch from a group of Harvard and MIT researchers. Together they formed Moderna, which initially focused on using mRNA to try to develop personalized cancer treatments, but soon began experimenting with using the technique to make vaccines against viruses.

In January 2020, Afeyan took one of his daughters to a restaurant near his office in Cambridge to celebrate her birthday. In the middle of the meal, he got an urgent text message from the CEO of his company, Stphane Bancel, in Switzerland. So he rushed outside in the freezing temperature, forgetting to grab his coat, to call him back.

Bancel said that he wanted to launch a project to use mRNA to attempt a vaccine against the new coronavirus. At that point, Moderna had more than 20 drugs in development but none had even reached the final stage of clinical trials. Nevertheless, Afeyan instantly authorized him to start work. Dont worry about the board, he said. Just get moving. Lacking Pfizers resources, Moderna had to depend on funding from the U.S. government. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, was supportive. Go for it, he declared. Whatever it costs, dont worry about it.

It took Bancel and his Moderna team only two days to create the RNA sequences that would produce the spike protein, and 41 days later, it shipped the first box of vials to the National Institutes of Health to begin early trials. Afeyan keeps a picture of that box on his cell phone.

An mRNA vaccine has certain advantages over a DNA vaccine, which has to use a re-engineered virus or other delivery mechanism to make it through the membrane that protects the nucleus of a cell. The RNA does not need to get into the nucleus. It simply needs to be delivered into the more-accessible outer region of cells, the cytoplasm, which is where proteins are constructed.

The Pfizer-BioNTech and Moderna vaccines do so by encapsulating the mRNA in tiny oily capsules, known as lipid nanoparticles. Moderna had been working for 10 years to improve its nanoparticles. This gave it one advantage over Pfizer-BioNTech: its particles were more stable and did not have to be stored at extremely low temperatures.

Katalin Kariko, Senior vice president, BioNTech. In 1995, after years of struggle, Hungarian-born Katalin Kariko was pushed off the path to full professorship at the University of Pennsylvania. Her work on mRNA, molecules she believed could fundamentally change the way humans treat disease, had stalled. Then, in 1997, she met and began working with immunologist Drew Weissman. In 2005, they published a study describing a modified form of artificial mRNAa discovery, they argued, that opened the door to mRNAs use in vaccines and other therapies. Eventually, Kariko and Weissman licensed their technology to the German company BioNTech, where Kariko, shown here in a portrait shot by a photographer working remotely, is now a senior vice president. Her patience paid off this year. The mRNA-based Pfizer-BioNTech coronavirus vaccine, which Kariko helped develop, has been shown to be 95% effective at preventing COVID-19.

Dina LitovskyRedux for TIME

By November, the results of the Pfizer-BioNTech and Moderna late-stage trials came back with resounding findings: both vaccines were more than 90% effective. A few weeks later, with COVID-19 once again surging throughout much of the world, they received emergency authorization from the U.S. Food and Drug Administration and became the vanguard of the biotech effort to beat back the pandemic.

The ability to code messenger RNA to do our bidding will transform medicine. As with the COVID vaccines, we can instruct mRNA to cause our cells to make antigensmolecules that stimulate our immune systemthat could protect us against many viruses, bacteria, or other pathogens that cause infectious disease. In addition, mRNA could in the future be used, as BioNTech and Moderna are pioneering, to fight cancer. Harnessing a process called immunotherapy, the mRNA can be coded to produce molecules that will cause the bodys immune system to identify and kill cancer cells.

RNA can also be engineered, as Jennifer Doudna and others discovered, to target genes for editing. Using the CRISPR system adapted from bacteria, RNA can guide scissors-like enzymes to specific sequences of DNA in order to eliminate or edit a gene. This technique has already been used in trials to cure sickle cell anemia. Now it is also being used in the war against COVID. Doudna and others have created RNA-guided enzymes that can directly detect SARS-CoV-2 and eventually could be used to destroy it.

More controversially, CRISPR could be used to create designer babies with inheritable genetic changes. In 2018, a young Chinese doctor used CRISPR to engineer twin girls so they did not have the receptor for the virus that causes AIDS. There was an immediate outburst of awe and then shock. The doctor was denounced, and there were calls for an international moratorium on inheritable gene edits. But in the wake of the pandemic, RNA-guided genetic editing to make our species less receptive to viruses may someday begin to seem more acceptable.

Throughout human history, we have been subjected to wave after wave of viral and bacterial plagues. One of the earliest known was the Babylon flu epidemic around 1200 B.C. The plague of Athens in 429 B.C. killed close to 100,000 people, the Antonine plague in the 2nd century killed 5 million, the plague of Justinian in the 6th century killed 50 million, and the Black Death of the 14th century took almost 200 million lives, close to half of Europes population.

The COVID-19 pandemic that killed more than 1.8 million people in 2020 will not be the final plague. However, thanks to the new RNA technology, our defenses against most future plagues are likely to be immensely faster and more effective. As new viruses come along, or as the current coronavirus mutates, researchers can quickly recode a vaccines mRNA to target the new threats. It was a bad day for viruses, Modernas chair Afeyan says about the Sunday when he got the first word of his companys clinical trial results. There was a sudden shift in the evolutionary balance between what human technology can do and what viruses can do. We may never have a pandemic again.

The invention of easily reprogrammable RNA vaccines was a lightning-fast triumph of human ingenuity, but it was based on decades of curiosity-driven research into one of the most fundamental aspects of life on planet earth: how genes are transcribed into RNA that tell cells what proteins to assemble. Likewise, CRISPR gene-editing technology came from understanding the way that bacteria use snippets of RNA to guide enzymes to destroy viruses. Great inventions come from understanding basic science. Nature is beautiful that way.

Isaacson, a former editor of TIME, is the author of The Code Breaker: Jennifer Doudna, Gene Editing, and the Future of the Human Race, to be published in March. After the Pfizer vaccine was approved, he opted to remain in the clinical trial and has not yet been unblinded.

This appears in the January 18, 2021 issue of TIME.

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Moss-based expression firm receives 60m in funding – BioProcess Insider – BioProcess Insider

Tuesday, January 12th, 2021

German biotech Eleva has received funding to advance its candidate CPV-101, produced using a moss-based expression system.

Venture capitalist firm Zukunftshonds Heilbronn has invested up to 60 million ($73 million) in funding to progress drug candidate CPV-101 through the clinic. A spokesperson for Eleva told us we are developing CPV-101 for kidney-associated complement diseases such as aHUS, IgA Nephropathy, PNH, C3G.

The firm has developed a manufacturing process that produces biopharmaceuticals using moss called BryoTechnology.

Image: iStock/Svetlana Monyakova

Eleva told BioProcess Insider fermentation is done in Sartorius STR single use fermenters with unmodified cell culture bags and is done using established routines and equipment used commonly in mammalian cell-based production.

The company claims that BryoTechnology benefits from the absence of animal derived components and human viruses [] and batch to batch stability. Eleva added the manufacturing process is very robust and stable (unsensitive to change in pH, temp and salt). The glycosylation pattern is very stable, also upon scale up and tech transfer we do not see any changes in the glycosylation pattern.

Bjrn Voldborg, director of CHO cell line development at the Technical University of Denmark, previously discussed the problems that surround glycosylation at BPI Europe, telling delegates if you have the wrong glycans the protein may actually trigger immune responses.

Eleva said where glycosylation is crucial for the mode of action or for the efficacy of the molecule [it is] especially suited for the production in moss.

We have previously reported the limitations mammalian and bacterial cell lines have alongside documenting the growing interest in plant-derived alternatives.

Whatever system used, cells are engineered to produce the desired biologic drug substance in the highest yield and purity possible. Yet, with mammalian cell culture being notoriously expensive, plant-cells have become an alternative choice of platform due to their cost-effective expression system, free of animal proteins.

Eleva is not alone in its quest for plant-based substitutes, Sanofis deal with Dyadic showcased the demand for CHO alternatives. However, Eleva claims to be the only company using moss as an expression platform to make biologics.

Moss produces complex molecules (proteins, enzymes, antibodies, metabolites) with human-like glycosylation the spokesperson told us, adding antibodies produced in moss show >40-fold ADCC enhancement compared to antibodies produced in mammalian systems.

When asked what advantages a moss-based system has over mammalian, microbial and other plant-based systems, Eleva said moss combines the best of two worlds: it is a higher eukaryote same as mammalian cells and is haploid organism same as microbials.

The firm added: Contrary to other plant-based systems such as tobacco, moss has a haploid genome, making genetic engineering as easy as in microbials.

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Kombucha Inspires Creation of a Microbial Living Material – Technology Networks

Tuesday, January 12th, 2021

Scientists have created a living material made from microbes that can respond to stimuli from their surrounding environment. It is hoped the material could find diverse applications in contaminant detection, highlighting damage, for example, to packaging, delivering nutrients or therapeutics and even in creating living photographs.Biological systems are able to assemble and arrange tissues and structures, building in changes that reflect external stimuli, in ways beyond the capability of man-made materials. Consequently, the development of materials with these capabilities is highly desirable for monitoring purposes. Engineered living materials (ELMs) such as these have been created previously, however, the stringent growth conditions required for the microbes used have restricted their use to trained personnel. Scaling up production to facilitate their use as a technology has also consequently proved challenging. This latest research, published today in Nature Materials, however, overcomes these problems by taking its inspiration from the fermented drink kombucha.

Kombucha is a fermented culture of yeast and bacteria used to make a tea drink thought to have beneficial health properties. The kombucha mother culture from which the tea is made normally contains one or two strains of bacteria and at least two strains of yeast that live in symbiosis.

Scientists from Imperial College London and Massachusetts Institute of Technology combined genetically engineered bakers yeast - the yeast typically found in kombucha is hard to engineer - with cellulose-producing bacteria to create a mutually beneficial symbiotic culture. The Komagataeibacter rhaeticus bacteria used was isolated from a kombucha mother culture and produces large quantities of cellulose that acts as a scaffold to support multi-functional enzymes produced by the yeast.

The researchers were able to engineer the yeast according to the needs of their system, for example to produce enzymes that fluoresced or that broke down target molecules. The systems for genetically engineering bakers yeast are well established and fast, meaning that new strains with particular desired characteristics can be created quickly. The simple growth conditions required by the kombucha-style culture also mean that any new combination can quickly be established and bulked up ready for use. Both of these features make this a favorable ELM system.

In a press release, senior author Professor Tom Ellis from Imperial College London said, The genetic toolbox for engineering these bacteria is underdeveloped compared to the number of tools available for manipulating yeast DNA. That is why we chose to use this division-of-labor strategy so we could first focus on engineering the yeast cells and explore the possibilities of various living functional materials."

The malleable nature of the yeast engineering system gives it utility in many areas opens doors to adapting the system to many purposes. In the study, the team incorporated yeast capable of sensing estradiol, a hormone found as an environmental pollutant, but this is just one example of the many possible applications. The team foresee that it could even be used to deliver essential nutrients or release therapeutics in response to stimuli.

Although we are still far from a future in which people can cheaply grow their own biological sensors, our new system moves us forward by creating materials that are scalable and therefore more likely to be useful in the real world, commented Dr Charlie Gilbert, one of the studys authors.

ReferenceGilbert C et al. Living materials with programmable functionalities grown from engineered microbial co-cultures. Nat. Mater. (2021). https://doi.org/10.1038/s41563-020-00857-5

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Men in their 30s get Covid most – The Daily Star

Tuesday, January 12th, 2021

Males aged between 30 and 39 constitute the largest share of the Covid-19 patients in Bangladesh, reveals a study.

It also finds a rising trend of the asymptomatic cases in the country as the pandemic continues to rage.

The study was carried out on 1,021 people, who recovered four weeks prior to being interviewed after undergoing treatment at six hospitals. The study period was from April 1 to June 30, 2020.

The paper titled "A multi-centric, cross-sectional study on Covid-19 in Bangladesh: clinical epidemiology and short-term outcomes in recovered individuals" has recently been published in New Microbes and New Infections journal.

The research, conducted by researchers from seven academic and medical organisations in Dhaka, Chattogram and Mymensingh, found that recovered patients suffered from a number of complications, including sleep disturbance, pains and aches, weakened attention span, anxiety and depression, memory loss, and complications with mobility.

It revealed that 75 percent of the patients were males and highest 30 percent of them were aged between 30 and 39.

Dr Mustak Ibn Ayub, a co-author of the paper and a teacher of genetic engineering and biotechnology at Dhaka University, said the study is a great effort on understanding the heterogeneity among Covid patients in Bangladesh. "It shows that asymptomatic cases are on the rise in Bangladesh. It has also answered some questions of the scientists such as whether BCG vaccine has any protective effects against SARS-cov-2 infection."

The study also found that comorbid patients were more likely to experience mobility problems, weakness and problems in performing regular activities.

It revealed that among different age groups, the 20-39 cohorts showed the highest infection rate and in terms of gender, the prevalence of Covid-19 infection in males was three times more than that in females.

"The majority of the cases [62 percent] reported indirect contact with confirmed cases, whereas 48.5 percent admitted that they frequently went out of their homes before being infected and diagnosed," read the report.

It further showed that 50 percent of the respondents had come into close contact with confirmed cases and 40.6 percent had 341 Covid-19 positive family members.

"So, it can be easily concluded from this data that community transmission is very common in Bangladesh and hence social distancing and other preventive measures should be fully implemented to prevent further deterioration," said the report.

It found that half of the symptomatic novel coronavirus patients were overweight.

Dr Adnan Mannan, lead author of the paper and also a teacher of genetic engineering and biotechnology at Chittagong University, said they did not find any significant relationship between blood groups and chance of getting Covid-19.

He said novel coronavirus infection is prevalent among comorbid patients, especially diabetic, hypertensive and cardiovascular disease patients. Post-Covid complications were also found among asymptomatic patients.

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superficium proposes secluded retreat for biohacker communities within utah desert – Designboom

Tuesday, January 12th, 2021

for their prize-winning entry to arch out louds 2020 HOME competition, architectural practice superficium presents biohackers residence, a communal retreat for biohacker hobbyists. proposed to be situated within the red rock desert landscape in utah, the project speculates the use of 3D-printed, bio-integrated materials to generate a protective architectural tissue.

all images courtesy of superficium studio

since the availability of home-use biotechnology kits, do-it-yourself biohacker communities have surged along with an increasing synthesis between home and laboratory superficium shares. here, the retreat offers its occupants a malleable architecture, which imagines elements to be repurposed or replaced with self-printed bio-integrated materials. the cellular organization of the shell can then be reprogrammed for internal environmental comfort or sterilization according to the users needs for their own self-experimentation.

an external view on the approach of the residence

secluded within the rocky scenery, the retreat could offer biohackers a safe haven for remote practice and self-administration, while they look to challenge what it means to be human. communal areas are designed to support biohacking activities, such as organic 3D printing and workstations with CRISPR technology, which enables cellular reprogramming through genetic engineering.

plan view showing how the proposal integrates into the desert landscape

interior view of the communal lounge

cutaway axonometric showing the body therapy units, CRISPR editing workstation, and organic 3D printer

section showing living and storage units

detailed view of bio-integrated materials

a breakaway piece from the wider collection of living units the external tissue is intended to be reprogrammed by its users to regulate heating and extract solar energy

project info:

name:biohackers residencearchitecture office: superficium studio

designboom has received this project from our DIY submissions feature, where we welcome our readers to submit their own work for publication. see more project submissions from our readers here.

edited by: myrto katsikopoulou | designboom

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Animal bio-tech – AG INFORMATION NETWORK OF THE WEST – AGInfo Ag Information Network Of The West

Tuesday, January 12th, 2021

USDA could soon oversee parts of federal animal biotechnology regulations as part of a recently announced advance notice of proposed rule making. Under Secretary for Marketing and Regulatory Programs Greg Ibach says the proposed transfer of regulatory oversight from the Food and Drug Administration would cover agricultural animals modified or produced by genetic engineering. What we're seeing through this process is for those adjustments that are made to animals, primarily for food, labor, fiber, that we would have those regulatory authorities moved over to USDA APHIS directly providing that oversight under their animal health statutes. And the Food Safety and Inspection Service would conduct pre slaughter, food safety risk assessments. Usda and FDA would work together to develop a modernized regulatory framework that is risk based and scientifically sound. The proposed rulemaking is currently under a 60 day comment period. The FDA and USDA have sat down and spent months talking about how we might regulate animal biotech. And advanced notice of proposed rulemaking will set forth some parameters. But it's really asking the industry, are we on the right track? Have the framework that we're putting together? Will this work for you? Is this something that can help us move things through the regulatory process in a timely manner? Is this something that consumers can understand and have confidence in? So it's going to be very important for the industry, the developers, as well as the consumers, as well as farmers to weigh in, to let USDA and FDA know how they feel about this proposed framework.

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UK feed and pig industries welcome UK consultation on gene editing – FeedNavigator.com

Tuesday, January 12th, 2021

Robert Sheasby, CEO of the AIC, the voice of the UK feed and the agri-supply sector, said:

The AIC warmly welcomes the launch of this government consultation on gene editing in crops and livestock. We have long sought to support sustainable modern commercial agriculture in the UK, and this is the opportunity for our members to put forward their views on this development in technology. We would encourage the industry at large to respond.

EU legislation controlling the use of GMOs was retained in the UK at the end of the transition period, after December 31, 2020. This retained legislation requires that all GE organisms are classified as GMOs irrespective of whether they could be produced by traditional breeding methods.

The UK's Department of Food, Rural Affairs and the Environment (Defra) said it is its view that organisms produced by GE or by other genetic technologies should not be regulated as GMOs if they could have been produced by traditional breeding methods.

Leaving the EU provides an opportunity to consult on the implications of addressing this issue. We recognize there is a spectrum of opinions on these topics, and we are consulting to provide an opportunity for all views to be shared."

Speaking at the Oxford Farming Conference, where the consultation was launched, UK environment secretary, George Eustice, said:

Gene editing has the ability to harness the genetic resources that mother nature has provided, in order to tackle the challenges of our age. This includes breeding crops that perform better, reducing costs to farmers and impacts on the environment, and helping us all adapt to the challenges of climate change.Its potential was blocked by a European Court of Justice ruling in 2018, which is flawed and stifling to scientific progress. Now that we have left the EU, we are free to make coherent policy decisions based on science and evidence. That begins with this consultation.

Consulting with academia, environmental groups, the food and farming sectors and the public is the beginning of this process that, depending on the outcome, will require primary legislation scrutinized and approved by the UK parliament, stressed Defra.

Professor Robin May, the chief scientific officer of the UKs Food Standards Agency (FSA), also welcomed the review, saying:

The UK prides itself in having the very highest standards of food safety, and there are strict controls on GM crops, seeds and food which the FSA will continue to apply moving forward. As with all novel foods, GE foods will only be permitted to be marketed if they are judged to not present a risk to health, not to mislead consumers, and not have lower nutritional value than existing equivalent foods. We will continue to put the consumer first and be transparent and open in our decision-making. Any possible change would be based on an appropriate risk assessment that looks at the best available science.

Sir David Baulcombe, professor of botany in the Department of Plant Sciences at the University of Cambridge, said the overwhelming view of public sector scientists is that the Nobel Prize winning methods for gene editing can accelerate the availability of crops and livestock for sustainable, productive and profitable agriculture.

The UK National Pig Association (NPA) said that gene editing technology could potentially deliver long-term benefits for pig production.

In the NPA's response to the Nuffield Council of Bioethics call for evidence on genome editing in September 2019, its senior policy adviser, Rebecca Veale, identified the potential value of gene editing tools in improving the efficiency of pig production.

"The opportunities for application are long. We might be in a better place to tackle diseases such as ASF and PRRS and we might be able to reduce emissions in pig production or exploit nutritional availability in feed better.

"Afew countries have made small steps to utilizing this technology, but these have been limited. Our industry cannot be disadvantaged by a lack of access to such a tool and any future policy must be clear not to breach ethical boundaries, but to have flexibility to allow the use of the technology to be exploited to its full potential. Any future developments are reliant on support for the research required to explore the opportunities available, she added.

Responding to the consultation, the director of anti-GM campaign group, GM Freeze, Liz ONeill said:

"People have many concerns about the use of genetic engineering in food and farming so public engagement is vital but it has to be done well. Unfortunately this consultation has started very badly. Its been launched in the midst of an unprecedented health crisis; it has a clear bias in favour of removing vital safeguards; and the text of the consultation grossly misrepresents the nature of highly experimental new GM techniques.

"Instead of working with people to understand their concerns, Defra is pushing the high-tech, quick-fix agenda favoured by industrial farming corporations. GM Freeze will, of course, be submitting evidence and we encourage everyone who wants to know what they are eating to do the same, but the government should be doing much more to protect our food, our farms and the natural environment."

Aside from gene editing, the consultation will also begin a longer-term project to gather evidence on updating the UK approach to genetic modification by gathering information on what controls are needed and how best to deliver them, said Defra.

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Global CRISPR Technology Market Report 2020: COVID-19 Growth and Change – Market is Expected to Recover to Reach $1.55 Billion in 2023 – Forecast to…

Tuesday, January 12th, 2021

DUBLIN, Jan. 6, 2021 /PRNewswire/ -- The "CRISPR Technology Global Market Report 2020-30: COVID-19 Growth and Change" report has been added to ResearchAndMarkets.com's offering.

CRISPR Technology Global Market Report 2020-30: COVID-19 Growth and Change provides the strategists, marketers and senior management with the critical information they need to assess the global crispr technology market.

Major players in the CRISPR technology market are Thermo Fisher Scientific, GenScript Biotech Corporation, CRISPR Therapeutics AG, Editas Medicine, Horizon Discovery Plc., Integrated DNA Technologies, Inc. (Danaher), Origene Technologies, Inc., Transposagenbio Biopharmaceuticals (Hera Biolabs), Intellia Therapeutics Inc., and GeneCopoeia, Inc.

The global CRISPR technology market is expected to increase from $0.76 billion in 2019 to $0.92 billion in 2020 at a compound annual growth rate (CAGR) of 20.91%. The exponential growth is mainly due to the COVID-19 outbreak that has led to the research for drugs for COVID-19 with gene-editing using CRISPR technology. The market is expected to reach $1.55 billion in 2023 at a CAGR of 19.13%.

The CRISPR technology market consists of sales of CRISPR technology products and services which is a gene-editing technology that allows researchers to alter DNA sequences and modify gene function. The revenue generated by the market includes the sales of products such as design tools, plasmid & vector, Cas9 & gRNA, libraries & delivery system products and services that include design & vector construction, screening and cell line engineering.

These products and services are used in genome editing/genetic engineering, genetically modifying organisms, agricultural biotechnology and others which include gRNA database/gene library, CRISPR plasmid, human stem cell & cell line engineering by end-users. The end-users include pharmaceutical & biopharmaceutical companies, biotechnology companies, academic & research institutes and contract research organizations.

North America was the largest region in the CRISPR technology market in 2019. Europe was the second-largest region in the CRISPR technology market in 2019.

In 2019, Cardea Bio Inc., a US-based biotechnology infrastructure company that manufactures biology-gated transistors (Cardean transistors) that utilizes biocompatible graphene instead of silicon and replaces optical signal observations with direct electrical molecular signal analysis, merged with Nanosens Innovations, Inc. The merger is aimed at accelerating the development of the genome sensor that combines Nanosens' CRISPR-Chip technology with Cardea's graphene biosensor infrastructure and is the first DNA search engine globally that runs on CRISPR-Chip technology. Nanosens will be operating as a subsidiary of Cardea Bio. Nanosens Innovations, Inc. is a US-based biotechnology company that develops CRISPR-Chip and FEB technology.

The CRISPR technology market covered in this report is segmented by product type into design tools; plasmid and vector; CAS9 and G-RNA; delivery system products. It is also segmented by application into genome editing/ genetic engineering; genetically modified organisms; agricultural biotechnology; others and by end-user into industrial biotech; biological research; agricultural research; therapeutics and drug discovery.

Stringent government regulations are expected to retard the growth of the CRISPR technology market during the period. There is no existence of internationally agreed regulatory framework for gene editing products and countries are in the process of evaluating whether and to what extent current regulations are adequate for research conducted with gene editing and applications and products related to gene editing. In July 2018, the Court of Justice of the European Union ruled that it would treat gene-edited crops as genetically modified organisms, subject to stringent regulation.

In April 2019, the Australian government stated that the Office of the Gene Technology Regulator (OGTR) will regulate only the gene-editing technologies that use a template, or that insert other genetic material into the cell. According to an article of 2020, in India, as per the National Guidelines for Stem Cell Research, genome modification including gene-editing by CRISPR-Cas9 technology of stem cells, germ-line stem cells or gamete and human embryos is restricted only to in-vitro studies. Thus, strict regulations by the government present a threat to the growth of the market.

Several advancements in CRISPR technology are trending in the market during the period. Advancements in technology will help in reducing errors, limiting unintended effects, improving the accuracy of the tool, widening its applications, developing gene therapies and more. In 2019, a study published in Springer Nature stated the development of an advanced super-precise new CRISPR tool that allows researchers more control over DNA changes. This tool seems to have the capability of providing a wider variety of gene edits which might potentially open up conditions that have challenged gene-editors.

Also, in 2020, another study in Springer Nature stated that researchers have used enzyme engineering to boost the accuracy of the technique of error-prone CRISPR-Cas9 system to precisely target DNA without introducing as many unwanted mutations. The advancements in CRISPR technology will result in better tools that are capable of providing better outcomes.

The application of CRISPR technology as a diagnostic tool is expected to boost the market during the period. The Sherlock CRISPR SARS-CoV-2 kit is the first diagnostic kit based on CRISPR technology for infectious diseases caused due to COVID-19. In May 2020, FDA announced the emergency use authorization to the Sherlock BioSciences Inc's Sherlock CRISPR SARS-CoV-2 kit which is a CRISPR-based SHERLOCK (Specific High-sensitivity Enzymatic Reporter unLOCKing) diagnostic test.

This test helps in specifically targeting RNA or DNA sequences of the SARS-CoV-2 virus from specimens or samples such as nasal swabs from the upper respiratory tract and fluid in the lungs from bronchoalveolar lavage specimens. This diagnostic kit has high specificity and sensitivity and does not provide false negative or positive results. Widening the application of CRISPR technology for the diagnosis of infectious diseases will increase the demand for CRISPR technology products and services.

Key Topics Covered:

1. Executive Summary

2. CRISPR Technology Market Characteristics

3. CRISPR Technology Market Size And Growth

3.1. Global CRISPR Technology Historic Market, 2015 - 2019, $ Billion

3.1.1. Drivers Of The Market

3.1.2. Restraints On The Market

3.2. Global CRISPR Technology Forecast Market, 2019 - 2023F, 2025F, 2030F, $ Billion

3.2.1. Drivers Of The Market

3.2.2. Restraints On the Market

4. CRISPR Technology Market Segmentation

4.1. Global CRISPR Technology Market, Segmentation By Product Type, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

4.2. Global CRISPR Technology Market, Segmentation By Application, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

4.3. Global CRISPR Technology Market, Segmentation By End-User, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

5. CRISPR Technology Market Regional And Country Analysis 5.1. Global CRISPR Technology Market, Split By Region, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion 5.2. Global CRISPR Technology Market, Split By Country, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/vnvkue

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Media Contact:

Research and Markets Laura Wood, Senior Manager [emailprotected]

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Prognostic Significance of CDH1, FN1 and VIM for Early Recurrence in P | CMAR – Dove Medical Press

Tuesday, January 12th, 2021

Aleksandar Bogdanovic,1,2 Jovana Despotovic,3 Danijel Galun,1,2 Nemanja Bidzic,1,2 Aleksandra Nikolic,3 Jovana Rosic,2 Zoran Krivokapic1,2,4

1HPB Unit, Clinic for Digestive Surgery, Clinical Center of Serbia, Belgrade, 11 000, Serbia; 2School of Medicine, University of Belgrade, Belgrade 11 000, Serbia; 3Laboratory for Molecular Biology, Institute of Molecular Genetics and Genetic Engineering, University of Belgrade, Belgrade, 11 000, Serbia; 4Serbian Academy of Sciences and Arts, Belgrade 11 000, Serbia

Correspondence: Aleksandar BogdanovicClinical Center of Serbia Clinic for Digestive Surgery, Koste Todorovica 6, Belgrade 11 000, SerbiaTel +381 64 2461104Email aleksandarbogdanovic81@yahoo.com

Purpose: There are limited data on expression of epithelialmesenchymal transition (EMT) markers in patients with colorectal liver metastases (CRLM). The study aim was to evaluate the expression and prognostic significance of E-cadherin (CDH1), fibronectin (FN1) and vimentin (VIM) in patients with CRLM after curative-intent liver resection.Patients and Methods: Thirty patients with CRLM managed by curative-intent liver resection were included in this prospective pilot study. Blood samples, colorectal liver metastases and surrounding non-tumor liver tissue were collected. Expression of CDH1, FN1 and VIM was analyzed by quantitative real-time polymerase chain reaction. Expression in CRLM and non-tumor liver tissue was compared, while expression in serum was correlated with CRLM expression. One-year recurrence-free survival was compared between patients with low and high CDH1, FN1 and VIM expression.Results: The expression of CDH1 was similar in CRLM and non-tumor liver tissues, while FN1 and VIM expression was significantly lower in metastatic tissue (P=0.003 and pP< 0.001, respectively). Serum expression of CDH1 and VIM was detected in 66.7% and 93.3% of patients, respectively, while FN1 was not detected in any of the patients. The correlation of CDH1 and VIM expression between CRLM and serum was not statistically significant. Decreased CDH1 expression in CRLM and decreased VIM expression in serum were associated with early recurrence after surgical treatment of CRLM.Conclusion: Lower expression of CDH1 in CRLM and lower serum expression of VIM were found to be associated with early recurrence after liver resection for CRLM.

Keywords: epithelialmesenchymal transition, CDH1, VIM, FN1, colorectal liver metastasis, colorectal cancer

This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License.By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

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What the emerging new strain of the Coronavirus means for the vaccine – WATN – Local 24

Tuesday, January 12th, 2021

A local doctor explains what's in the COVID-19 vaccine and how it works.

MEMPHIS, Tenn Concerns about the COVID-19 vaccine remain.

It's the first vaccine without a living virus, but some are concerned over what's in the COVID-19 vaccine.

"This vaccine is the result of, really, some genetic engineering. They are able to sequence the virus, decode it and find the genetic code for just a part of the virus, specifically the spike that is located on the outside of the virus," said Dr. Bruce Randolph of the Shelby County Health Department.

He says that's the part of the virus that attaches to the human cell.

Worried the vaccine arrived too soon?

COVID-19 may have entered American consciousness about 9 months ago, but scientists have studied different forms of the Coronavirus for years.

The variations go back some 10-thousand years.

Researchers are also keeping an eye on a new variant called B-1-17 found in a few states, but not yet in Tennessee.

"This particular virus is five times more easier to transmit than the Coronavirus we are dealing with at the current time," said Randolph.

For example, Randolph explains if COVID-19 takes 100 droplets for infection, this new strain might only take 10.

With 72-thousand COVID cases just reported in Shelby County a new strain would cause great concern.

"If this variant strain hit Shelby County those number could be as much as 5 times higher," said Randolph.

Researchers believe the current vaccine will provide immunity for that new strain.

the Memphis-Shelby County task force are urging everybody to get educated, talk to your doctor, get vaccinated and keep up with your card.

"You would be able to go wherever and present your card and say I need my second dose and the provider would know exactly when you last received, if it's indeed time for you to receive your second dose and what vaccine you received because you shouldn't mix them."

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Myeloid Therapeutics Launches with Over $50 Million in Financing and Two Clinical Trials – BioSpace

Tuesday, January 12th, 2021

CAMBRIDGE, Mass., Jan. 6, 2021 /PRNewswire/ -- Myeloid Therapeutics, Inc., a company harnessing and reprogramming myeloid cells for treating cancers, launched today with over $50 million in financing to initiate multiple clinical trials in 2021. The Company combines advanced gene and cell engineering capabilities with substantial biologics knowledge to elucidate and redirect the power of myeloid cells to treat cancers, particularly solid tumors and those that are poorly served by existing therapies. Myeloid has advanced its lead development candidates through preclinical studies, implemented its manufacturing platform and plans to dose patients in the first half of this year.

The Company's scientific founders include Ronald Vale, Ph.D., a world-renowned biochemist and cell biologist, and executive director of the Howard Hughes Medical Institute (HHMI) Janelia Research campus; and hematologist, oncologist and Pulitzer-Prize winning author Siddhartha Mukherjee, M.D., D.Phil. Newpath Partners led the financing round with participation from 8VC, Hatteras Venture Partners and Alexandria Venture Investments.

With this funding, Myeloid will initiate clinical trials for the Company's programs, which target T cell lymphoma, glioblastoma and other solid tumors. The team will also continue to design and advance a broad pipeline of targeted myeloid cell therapies, including primed myeloid cells, myeloid multi-specific engagers and other development candidates created with Myeloid's novel mRNA delivery technologies. The Company expects to enter the clinic with its two lead programs in glioblastoma and T cell lymphoma in 2021.

"I believe Myeloid is best positioned to leverage the unique power of myeloid cells to help patients fighting cancers that until now, have been very difficult to treat," said Dr. Mukherjee. "Despite the promise of current cell therapies, many challenges remain when it comes to targeting specific types of cancers, including solid tumors, and in efficiently manufacturing treatments. I'm thrilled to help develop Myeloid's transformative treatment modality, which has the potential to overcome many of these challenges."

"Myeloid cells play a critical role in orchestrating the body's immune responses, including by directly killing cells, bacteria and viruses through a number of disease-fighting mechanisms," said Michael Dee Gunn, M.D., Professor of Medicine and Immunology at Duke University, and a pioneer in the research of molecular mechanisms of innate immunity and inflammation and a member of Myeloid's Scientific Advisory Board. "This novel class of cell therapies has strong potential to benefit patients with the highest unmet medical needs."

ATAKTM Cell Platform

The Company's ATAK platform was inspired by Drs. Vale and Mukherjee, who envisioned the disease-fighting power of myeloid cells versatile cells with effector functions capable of targeting and eliminating cancerous cells, along with other harmful cells in the body. Within the oncolytic setting, the ATAK platform is being applied to harness the innate abilities of myeloid cells, to specifically recognize and engulf cancer cells, to produce anti-tumor agents, promote anti-tumor adaptive immunity, alter the tumor microenvironment and ultimately to kill cancer. In addition to reprogramming monocytes to target difficult-to-treat cancers, the platform offers Myeloid and its partners many additional advantages, including novel mRNA-based protein and gene delivery, a library of intermixed cell receptors, and chimeric antigen receptors (CARs) that may be applied to enhance treatment effects or to engineer novel tri- and bi-specific cell engagers.

Myeloid is currently focused on advancing two categories of novel ATAK therapies: ATAK CAR monocytes and ATAK primed monocytes. ATAK CAR monocytes are myeloid cells with innate immune receptor-inspired CARs to recognize and kill cancer. ATAK primed monocytes function like cell vaccines, programmed to trigger T cells to kill cancer cells.

Manufacturing candidates from the ATAK platform benefit from speed and scalability in manufacturing process development. The Myeloid team can scale manufacturing rapidly, from product concept to clinical use. In addition, current products derived from the ATAK platform have a single-day cell manufacturing process. Given the observed strengths of the manufacturing process, Myeloid reasonably envisions same-day ATAK platform treatment, especially relevant upon clinical presentation of aggressive tumors. The Company is also in the process of developing "off the shelf" approaches in order to advance the full range of clinical delivery options.

Myeloid Leadership and Scientific Advisory Board

As co-founder and Chief Executive Officer of Myeloid, Daniel Getts, Ph.D., MBA, oversees the Company's portfolio and growth strategies. Dr. Getts is a repeat biotech entrepreneur, having led research at TCR2 through its IPO and the development of the first cell therapy to show clinical responses in ovarian cancer. Before that, he co-founded Cour Pharmaceuticals Development Company.

The Company's Scientific Advisory Board includes world-renowned scientists whose expertise span oncology, immunology, cell therapy, synthetic biology and genetic engineering:

"Our mission is to apply our energy and significant research capabilities to design and develop truly transformative treatments," said Dr. Getts. "We built Myeloid's ATAKTM platform to overcome many limitations of existing cell therapies, in part by embracing the natural tendencies of monocytes to penetrate solid tumors and catalyze immune reactions. By harnessing the power of monocytes, which are the cells that comprise the largest population of immune cells in the tumor microenvironment, we are working to bring new therapies to patients. We have also designed and successfully implemented an efficient, flexible manufacturing process that sets a new threshold for cell therapies. We are very pleased to have the support of this strong group of investors, who enable us to further develop the ATAK platform, to advance multiple solid tumor programs into the clinic, and to bring forward new transformative programs as we broaden Myeloid's pipeline."

"Myeloid cells are the body's front-line-disease-fighting tools, and they are critical in the orchestration of adaptive immune responses. These myeloid cells are overrepresented in solid cancers and I have been fascinated with their therapeutic potential since researching them during my medical training," said Thomas Cahill, M.D., Ph.D., Myeloid co-founder and Managing Partner of Newpath Partners. "Most other cell therapies focus on reprogramming the adaptive immune system and they have truly improved patient outcomes, especially with respect to liquid tumors. To expand on this promise, the next logical step was to empower the cells at the front lines of solid tumors. By engineering myeloid cells, the Company is developing an extremely versatile and potent class of new therapeutic agents. I look forward to continuing to support this team through their first wave of clinical trials and beyond."

About Myeloid Therapeutics

Myeloid Therapeutics is an immunology company focused on combining biology insights with cutting-edge technologies to harness myeloid cells and eradicate cancer and other diseases. With broad clinical applications possible, the Company is presently advancing its cell therapy product candidates, derived from its ATAKTM platform technology, with initial applications in T cell lymphoma and a primed monocyte approach to treating glioblastoma. The ATAK platform is scalable to multiple treatment modalities and to other disease areas in collaboration. Myeloid expects to enter the clinic with its two lead programs in the first half of 2021. For more information, visit https://www.myeloidtx.com/.

Media Contact:Sarah SuttonGlover Park Groupssutton@gpg.com202-337-0808

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22nd Century Group Expands VLN Tobacco Growing Program to Support Anticipated Demand of the Company’s Reduced Nicotine Content Cigarettes -…

Tuesday, January 12th, 2021

WILLIAMSVILLE, N.Y., Jan. 11, 2021 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE American: XXII), a leading plant-based, biotechnology company that is focused on tobacco harm reduction, very low nicotine content tobacco, and hemp/cannabis research, announced today that the Company will significantly expand its growing program for VLN reduced nicotine content tobacco based on the Companys latest sales projections. This new planting for VLN tobacco is in addition to the Companys sizeable inventory of VLN tobacco, which is earmarked for the launch and initial sales of 22nd Centurys VLN reduced nicotine content cigarettes. 22nd Centurys Modified Risk Tobacco Product (MRTP) application for VLN cigarettes is currently in the final stage of review with the U.S. Food and Drug Administration (FDA). Once authorization is granted, 22nd Century will begin marketing its VLN cigarettes, which contain 95% less nicotine than conventional cigarette brands. Having the only combustible cigarette with a modified exposure claim authorized by the FDA could serve as a catalyst for 22nd Centurys commercial sales as capturing even a small fraction of U.S. tobacco sales could result in exponential growth in the Companys revenues and market capitalization.

We are prepared to launch our VLN cigarettes within 90 days after receiving marketing authorization from the FDA, said James A. Mish, chief executive officer of 22nd Century Group. There are more than 34 million smokers in the United States and research shows that a majority of these smokers are looking for alternatives. When shown samples of VLN, 60 percent of adult smokers in our studies indicated an interest in using VLN cigarettes. Additionally, in a 2019 U.S. Center for Disease Control and Prevention (CDC) survey, 80 percent of U.S. smokers favored reducing nicotine levels in cigarettes. We believe adult smokers will be very interested in VLN, and this new crop of VLN tobacco will help us to fulfill the expected demand based on our latest sales projections.

Mish continues, In addition to introducing VLN to smokers in the U.S., we are absolutely committed to licensing our technology to every cigarette manufacturer, so that they can comply with the FDAs plan to make all cigarettes non-addictive. We look forward to the tobacco industry joining our efforts to truly reduce the harm caused by smoking and protect future generations from ever becoming addicted to cigarettes.

In partnership with select tobacco farmers, 22nd Century will plant this new VLN tobacco throughout the U.S. tobacco belt, thereby creating a new income stream for Americas struggling family farmers. The Companys proprietary, reduced nicotine content tobacco contains, on average, just 0.5 milligrams of nicotine per gram of tobacco - a remarkable reduction in nicotine versus conventional cigarette tobaccos which often contain 20 mg to 30 mg nicotine per gram of tobacco.

With 95 percent less nicotine than typical cigarettes, VLN cigarettes will serve as a vanguard for the FDAs ground-breaking Comprehensive Plan for Tobacco and Nicotine Regulation. Published in 2017, the plan aims to set a product standard for cigarettes that achieves minimally or non-addictive levels of nicotine. The FDA projects that within the first year of implementing a mandate, it will help more than five million adult smokers to quit smoking and will save more than eight million American lives by the end of the century.

Within 90 days of the FDAs authorization of its MRTP application, the Company plans to rollout VLN King and VLN Menthol King cigarettes to retail tobacco outlets in the U.S. The launch of VLN will be paired with a compelling marketing campaign to introduce adult tobacco smokers to the worlds lowest nicotine content cigarette.

About 22nd Century Group,Inc.22nd Century Group, Inc. (NYSE American: XXII) is a leading plant biotechnology company focused on technologies that alter the level of nicotine in tobacco plants and the level of cannabinoids in hemp/cannabis plants through genetic engineering, gene-editing, and modern plant breeding. 22nd Centurys primary mission in tobacco is to reduce the harm caused by smoking through the Companys proprietary reduced nicotine content tobacco cigarettes containing 95% less nicotine than conventional cigarettes. The Companys primary mission in hemp/cannabis is to develop and commercialize proprietary hemp/cannabis plants with valuable cannabinoid profiles and desirable agronomic traits.

Learn more atxxiicentury.com, on Twitter@_xxiicenturyand onLinkedIn.

Cautionary Note Regarding Forward-Looking StatementsExcept for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Forward-looking statements typically contain terms such as anticipate, believe, consider, continue, could, estimate, expect, explore, foresee, goal, guidance, intend, likely, may, plan, potential, predict, preliminary, probable, project, promising, seek, should, will, would, and similar expressions. Actual results might differ materially from those explicit or implicit in forward-looking statements. Important factors that could cause actual results to differ materially are set forth in Risk Factors in the Companys Annual Report on Form 10-K filed on March 11, 2020 and in its subsequently filed Quarterly Report on Form 10-Q. All information provided in this release is as of the date hereof, and the Company assumes no obligation to and does not intend to update these forward-looking statements, except as required by law.

Investor Relations & Media Contact:Mei KuoDirector, Communications & Investor Relations22nd Century Group, Inc.(716) 300-1221mkuo@xxiicentury.com

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Star Wars Set Up Palpatine’s Return, But Rise of Skywalker Ignored It – Screen Rant

Tuesday, January 12th, 2021

Star Wars: The Rise of Skywalker brought Palpatine back from the dead - but it had actually all been set up in forgotten tie-ins years ago.

Star Wars set up Palpatine's resurrection and return years ago, back in 2015 - and the sequel trilogy, in particular Star Wars: The Rise of Skywalker, totally ignored it. Emperor Palpatine coming back to power drove the plot ofThe Rise of Skywalker, and Lucasfilm initially claimed it was the plan all along.It didn't take long for that claim to be exposed, however, when Colin Trevorrow admittedthat Palpatine's returnwas J.J. Abrams' idea. "Its honestly something I never considered," he observed. "I commend him for it. This was a tough story to unlock, and he found the key."

Oddly,The Rise of Skywalkeravoided revealing how Palpatine survived. It's taken tie-ins to confirm the Emperor had a clone body prepared on the hidden Sith planet of Exegol. When he died inReturn of the Jedi, his spirit fled to this last Sith stronghold. Unfortunately, the plan was hasty, and the clone bodycouldn't contain Palpatine's dark side spirit. By the time ofStar Wars: The Rise of Skywalker, his body was decaying and he was looking for a new one.

Related:Every Upcoming Star Wars Movie & Release Date

Oddly enough,Star Wars canon had already set up Palpatine's return - and forgotten all about it.Chuck Wendig's "Aftermath" trilogy explored the end of the Galactic Civil War, telling the story of the Empire's collapse afterReturn of the Jedi. Significantly, it featured two Palpatine loyalists - one of whom was convinced the Emperor would return. In one key scene, the two performed some sort of dark side ritual, involving a Sith mask and a Holocron. The ceremony was never explained, but YupeTashu clearly believed it somehow bound him to the resurrected Emperor.

"Tashu gambols down in front of the artifacts, his fingertips dancing along their cases. He mutters to himself, and Rax sees that he's chewed his own lips bloody. "Are you ready?" he asks Palpatine's old adviser.

"I am," Tashu says, turning. His cheeks are wet with tears. His teeth slick with red. "Palpatine lives on. We will find him again out there in the dark. Everything has arranged itself as our Master foretold. All things move toward the grand design. The sacrifices have all been made."

Not all of them, Rax thinks.

"You must be clothed in the raiment of darkness," Rax says. "The mantle of the dark side is yours to wear, at least for a time. At least until we can find Palpatine and revivify him, bringing his soul back to flesh anew."

The "Aftermath" trilogy treated Yupe Tashu as a fanatic, and as a result readers assumed this was nothing but a joke - one aimed at the Emperor's resurrection in the old Expanded Universe. They could be forgiven for this assumption, because Wendig included a lot of sly digs at other EU plots. With the benefit of hindsight, of course, it's now positively prescient.

At roughly the same time, writer Kieron Gillen was penning aDarth Vader series set shortly after the firstStar Wars movie. This revealed the Emperor hadsponsored a scientist named Cylo, an expert in cloning and genetic engineering. He had pioneered a technique of creating a personality map that could be stored and downloaded into clone bodies - essentially a technological way of transferring a soul from one body to another."Add memory banks and plug-in calculations, and I am an immortal system," Cylo explained.This, too, effectively foreshadowsStar Wars: The Rise of Skywalker; it establishes the Emperor was definitely interested in cloning as a way of conquering death.

It's just ironic Lucasfilm essentially forgot all these possible clues,and readers who had followed this setup through the books and comics didn't see any of it paid off in the sequels, as Palpatine's return doesn't come until Star Wars: The Rise of Skywalker(without any clear ties to the pre-established canon), making it all seem rather abrupt.

More: All Star Wars Movies, Ranked Worst To Best

Mission: Impossible 7 Star Agrees With Message Behind Tom Cruise Rant

Tom Bacon is one of Screen Rant's staff writers, and he's frankly amused that his childhood is back - and this time it's cool. Tom's focus tends to be on the various superhero franchises, as well as Star Wars, Doctor Who, and Star Trek; he's also an avid comic book reader. Over the years, Tom has built a strong relationship with aspects of the various fan communities, and is a Moderator on some of Facebook's largest MCU and X-Men groups. Previously, he's written entertainment news and articles for Movie Pilot.A graduate of Edge Hill University in the United Kingdom, Tom is still strongly connected with his alma mater; in fact, in his spare time he's a voluntary chaplain there. He's heavily involved with his local church, and anyone who checks him out on Twitter will quickly learn that he's interested in British politics as well.

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Star Wars Set Up Palpatine's Return, But Rise of Skywalker Ignored It - Screen Rant

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Why I Got the Russian Vaccine – The New York Times

Tuesday, January 12th, 2021

MOSCOW A nurse, needle in hand, asked me brusquely if I was ready. I said yes. A quick injection followed, then instructions to wait a half-hour in the hospital corridor for the possibility of anaphylactic shock, which thankfully never came.

Last Monday, I put aside my misgivings and got the first dose of Russias coronavirus vaccine, called Sputnik V, made at a factory outside of Moscow from genetically modified human cold viruses.

Like so much else in Russia, the rollout of Sputnik V was entangled in politics and propaganda, with President Vladimir V. Putin announcing its approval for use even before late-stage trials began. For months, it was pilloried by Western scientists. Like many Russian citizens distrustful of the new vaccine, saying they would wait to see how things turned out before getting it themselves, I had my doubts.

Consider how the rollout went: With the approval back in August, Russian health officials were quick to assert they had won the vaccine race, just as the country had won the space race decades ago with the Sputnik satellite. In fact, at the time, several other vaccine candidates were further along in testing.

A series of misleading announcements followed. The vaccines backers claimed a national inoculation campaign would begin in September, then in November; it ramped up only last month, no earlier than the kickoff of vaccinations in Britain and the United States.

Then came suspicions aired in foreign reporting that the Russian government, already eyed warily in medical matters over accusations of poisoning dissidents and doping Olympic athletes, was now cooking the books on vaccine trial results, perhaps for reasons of national pride or marketing.

As if to outperform the perceived competition, when Pfizer and the German pharmaceutical company BioNTech reported trial results showing more than 91 percent efficacy for their candidate vaccine, the Kremlin-connected financial company backing Sputnik V asserted its trials showed 92 percent efficacy.

When Moderna then reported 94.1 percent efficacy, the Russian company again claimed superiority, saying it achieved 95 percent. Officials later conceded, when the late-stage trials were complete, that Sputnik Vs results showed an efficacy rate of 91.4 percent.

But from the perspective of a recipient, did that matter? The final reported result still offers a nine out of 10 chance of avoiding Covid-19, once the vaccine has taken effect. Skepticism from Western experts focused mostly on the questionable early approval, not the vaccines design, which is similar to the one produced by Oxford University and AstraZeneca.

While public apprehension hasnt completely subsided, and the developers have yet to release detailed data on adverse events observed during the trials, the Russian government has now vaccinated about one million of its own citizens and exported Sputnik V to Belarus, Argentina and other countries, suggesting that any harmful side effects overlooked during trials would by now have come to light.

In the end, the politicized rollout only served to obscure the essentially good trial results what appears to be a bona fide accomplishment for Russian scientists continuing a long and storied practice of vaccine development.

In the Soviet period, tamping down infectious diseases was a public health priority at home and exporting vaccines to the developing world an element of Cold War diplomacy.

While the exact order of vaccine recipients may vary by state, most will likely put medical workers and residents of long-term care facilities first. If you want to understand how this decision is getting made, this article will help.

Life will return to normal only when society as a wholegains enough protection against the coronavirus. Once countries authorize a vaccine, theyll only be able to vaccinate a few percent of their citizens at most in the first couple months. The unvaccinated majority will still remain vulnerable to getting infected. A growing number of coronavirus vaccines are showing robust protection against becoming sick. But its also possible for people to spread the virus without even knowing theyre infected because they experience only mild symptoms or none at all. Scientists dont yet know if the vaccines also block the transmission of the coronavirus. So for the time being, even vaccinated people will need to wear masks, avoid indoor crowds, and so on. Once enough people get vaccinated, it will become very difficult for the coronavirus to find vulnerable people to infect. Depending on how quickly we as a society achieve that goal, life might start approaching something like normal by the fall 2021.

Yes, but not forever. The two vaccines that will potentially get authorized this month clearly protect people from getting sick with Covid-19. But the clinical trials that delivered these results were not designed to determine whether vaccinated people could still spread the coronavirus without developing symptoms. That remains a possibility. We know that people who are naturally infected by the coronavirus can spread it while theyre not experiencing any cough or other symptoms. Researcherswill be intensely studying this question as the vaccines roll out. In the meantime, even vaccinated people will need to think of themselves as possible spreaders.

The Pfizer and BioNTech vaccine is delivered as a shot in the arm, like other typical vaccines. The injection wont be any different from ones youve gotten before. Tens of thousands of people have already received the vaccines, and none of them have reported any serious health problems. But some of them have felt short-lived discomfort, including aches and flu-like symptoms that typically last a day. Its possible that people may need to plan to take a day off work or school after the second shot. While these experiences arent pleasant, they are a good sign: they are the result of your own immune system encountering the vaccine and mounting a potent response that will provide long-lasting immunity.

No. The vaccines from Moderna and Pfizer use a genetic molecule to prime the immune system. That molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily bubble that can fuse to a cell, allowing the molecule to slip in. The cell uses the mRNA to make proteins from the coronavirus, which can stimulate the immune system. At any moment, each of our cells may contain hundreds of thousands of mRNA molecules, which they produce in order to make proteins of their own. Once those proteins are made, our cells then shred the mRNA with special enzymes. The mRNA molecules our cells make can only survive a matter of minutes. The mRNA in vaccines is engineered to withstand the cell's enzymes a bit longer, so that the cells can make extra virus proteins and prompt a stronger immune response. But the mRNA can only last for a few days at most before they are destroyed.

The Soviet Union and United States cooperated in eliminating smallpox through vaccination. Virology was central to the Soviet Unions biological weapons program, which continued in secrecy long after a 1975 treaty banned the weapons.

In 1959, a husband-and-wife team of Soviet scientists successfully tested the first live polio virus vaccine using their own children as the first trial subjects. That followed a Russian tradition of medical researchers testing potentially harmful products on themselves first.

Last spring, the chief developer of Sputnik V, Aleksandr L. Gintsburg, followed in this custom by injecting himself even before the announcement that animal trials had wrapped up.

Russian promoters have compared the vaccine to the Kalashnikov rifle, simple and effective in its operation. I was even lucky in avoiding some of the common side effects of Sputnik V, such as a raging headache or a fever.

With many of my fears alleviated, another reason I chose to get inoculated with a product of Russian genetic engineering was more basic: It was available. Russian clinics have not been dogged by the lines or logistical snafus reported at vaccination sites in the United States and other countries.

In Moscow, the best days of winter come in early January as the country slumbers through a weeklong holiday, the traffic thins and the citys bustling chaos gives way to a quiet, snowy beauty. Vaccination sites were also lightly attended.

Russias vaccination campaign began with medical workers and teachers and then expanded. It is now open to people older than 60 or with underlying conditions that render them vulnerable to more severe disease, and to people working in a widening list of professions deemed to be at high risk: bank tellers, city government workers, professional athletes, bus drivers, police officers and, conveniently for me, journalists. Its unclear whether Russias production capacity is sufficient to meet demand long term.

For now, with so many Russians deeply skeptical of their medical system and the vaccine, there is no great clamor for the shot. The first site I visited, while reporting back in December, closed early because so few people had turned up.

In the capital, the vaccine has, paradoxically, appealed to educated people, a group that is traditionally a hotbed of political opposition to Mr. Putin, the chief promoter of the vaccine. When it came to a decision about health, many rolled up their sleeves.

I got the second component of Sputnik in my shoulder, Andrei Desnitsky, an academic at the Institute of Oriental Studies who has been chronicling his experience with vaccination, wrote on Facebook.

To followers posting comments, he said, hysterics in the style of You sold out, you bastard, to the bloody regime and They take us all for idiots, will be deleted.

Like Mr. Desnitsky, I was willing to take my chances. At Polyclinic No. 5 on a snowy morning, I filled out a form asking about chronic diseases, blood disorders or heart ailments. I showed my press pass as proof of my profession. A doctor asked a few questions about allergies. I waited an hour or so for my turn in a beige-tiled hospital corridor.

Sitting nearby was Galina Chupyl, a 65-year-old municipal worker. What did she think of getting vaccinated?

I am happy, of course, she said. Nobody wants to get sick.

I agreed.

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Illumination at the limits of knowledge – The Economist

Tuesday, January 12th, 2021

Jan 7th 2021

ALL THE technologies discussed in this report are moving forward apace. The companies which provide machinery to solar-cell manufacturers are ceaselessly trying to make more efficient use of silicon and less costly modules. In universities and elsewhere researchers are looking at ways to add a second layer to such cells so as to capture energy at wavelengths silicon ignoresthough their best attempts so far do not last very long outdoors.

Advances in manufacturing and design are making LEDs ever better sources of illumination. In more and more screens they backlight the liquid-crystal shutters which brighten pixels by detenebration. Some screens already do without shuttering, using liquid-crystal-free arrays of micro-LEDs to produce images that offer better contrast and use less energy. In information technology the division of labour that sees data processing done by electrons and data transmission by photons is under attack; switches that could be programmed to do some information processing while keeping that information in the form of photons would allow data to flow around data centres more quickly and efficiently. Laser beams of slightly different wavelengths are being packed ever more densely into optical fibres, with more bits encoded into every symbol stamped on to their light. The current record for data transfer down a single fibre, held by researchers at UCL, a British university, is 178 terabits a second.

But if you want to see lasers which push the boundaries of the possible in the most dramatic of ways, you have to turn to those made, not for practical applications, but to further science. Wherever researchers require ludicrous amounts of power or precision, theres every chance that they are using a laser, some sort of digital photon detector, or both. To see the cutting edge of what light can do, head for a lab.

The National Ignition Facility (NIF) at Lawrence Livermore National Laboratory in California is a case in point: walking its halls evokes a sense of the technological sublime which is all but visceral. The 192 laser beams from the 100-metre-long, xenon-pumped beamlines that fill its two warehouse-sized clean rooms converge on a peculiarly perforated spherical chamber. When NIF is operational a tiny bubble at the centre of that chamber is illuminated with 500 terawatts, which is to say 500,000GW.

Given that the worlds total electricity generating capacity is less than 5TW, how is a 500TW system possible? The answer is brevity. Because power is energy divided by time, a relatively small amount of energy can provide a huge amount of power if it is delivered quickly enough. The NIF fires for only a few tens of nanoseconds (billionths of a second) at a time. Each blink-and-you-miss-it 500TW blast thus delivers only a kilowatt-hour or so of energy.

Using such a gargantuan device to provide such a modest amount of energy seems bizarre. But NIFs job requires the energy to be delivered with great spatial precision and almost instantaneously. Only then can it heat the lasers tiny targets to temperatures and pressures otherwise reached only in the centres of stars and the blasts of nuclear weaponsconditions which can fuse atomic nuclei. Congress paid billions for the NIF on the basis that it might open the way to making nuclear fusion of this sort a practical energy source. It has not delivered on those dreams. But it has provided new insights into astrophysics as well as experimental data relevant to the design and maintenance of hydrogen bombs, which is Lawrence Livermores main concern.

Physicists are not the only scientists entranced by lasers. One of the workhorses of genetic engineering is green fluorescent protein (GFP). The instructions for making GFP are easily added to genes for other proteins. When poked with finely focused lasers these modified proteins fluoresce, thus revealing their whereaboutsa handy way of learning which proteins cells put where.

A remarkable refinement of this technique, first demonstrated in 2011, is to turn the cell itself into a laser. Engineer a cell to produce GFP, put it between two mirrors and pump energy in and the proteins light will be amplified in just the same way as it would in a piece of ruby or neodymium-doped glass. Light-emission microscopy based on this possibility amplifies the light given off by fluorescent proteins and other light-emitting markers.

Photons can also be used to change how cells behave. By engineering proteins to be sensitive to light and then turning that light on and off, researchers can change what cells doincluding the ways they do, or dont, transmit nerve impulses. Laser light flashed on to the nerves of a suitably engineered flatworm, or shone down optical fibres into the brain of a mouse, allows researchers to turn different parts of the nervous system on and off and observe the changes in behaviour that follow. This optogenetic puppeteering provides all sorts of new insights into the machinery of the brain. With all due respect to those using photons to explore the strange interconnectedness of things in quantum mechanicswhich Einstein famously described as spookyphotons that can literally change a mind in mid-thought may be the spookiest of all.

The degree to which light-based techniques are changing sciences across the board can be seen in the past decades decisions by the Nobel Physics Committee. In 2014 the committee recognised a physical breakthrough in the production of lightthe development of blue LEDs, a technical tour de force which made the production of white light cheaper and easier than ever before. Since then the physics prize has been awarded to three different ways of using lasers either for experiments in the lab or observations of the world. A tour of these prize-winning accomplishments allows a last celebration of this golden age of light.

Start with pure power. A technique called chirped-pulse amplification, developed by Donna Strickland and Grard Mourou when they were both at the University of Rochester, allows lasers far more powerful than the NIFlasers which work in the petawatt range. It provides a way around the unfortunate fact that, above a certain power level, even a very short pulse will melt any laser trying to amplify it further. Chirp amplification solves the problem by stretching pulses out in both space and time. An intense packet of photons that is, say, a millimetre long, and thus passes through any machine in just three trillionths of a second, can be chirped into one that is a metre long and lasts a full three billionths of a second. This stretched pulse is low-power enough to be amplified, after which it can be compressed back into its original form as a burst just as short as ever but now containing many more photons.

Labs around the world now use this technique to produce bursts of light both far shorter and far more powerful than those at NIF using much cheaper equipment. This allows them to study nuclear processes that are even more extreme than fusion. If the pulses can be made 1,000 times shorter stillwhich Dr Mourou, at least, thinks is possible, given a decade or sothey could achieve something no other technology has yet managed: the creation of matter (and antimatter) from scratch.

Einsteins work dispensed with the need for an all-pervading luminiferous aether. But the fields evoked by quantum electrodynamics (QED), the mid-20th-century culmination of work on electromagnetism, quantum theory and relativity, populate empty space with something else instead: very faint possibilities. And QED says that, if light gets sufficiently intense, its photons will interact with these possibilities to bring forth brand new electrons from empty space. Einsteins insight that mass can be converted into energy has been proven many times, most terribly in nuclear weapons. Creating material particles from massless light alone would be a remarkable turning of the tables, and one that ought to provide new insight into the quantum fields involved.

After power, pressure. The momentum of photons is tiny; but when applied to tiny things it can do useful work. In the 1960s Arthur Ashkin of Bell Labs realised that, if a small transparent object is placed on the edge of a laser beam it will move to the beams centre (provided that the beam is brighter at the centre than the edge). This is because the photons that pass through the object have their path bent outward, away from the beam: conservation of momentum requires the object thus diverting them to move in the opposite direction. If, once caught up in the beam, the object strays from its bright centre, the light pressure will bring it back.

In the 1970s Dr Ashkin put this idea into practice, using laser beams as optical tweezers with which to manipulate microscopic beads. In the 1980s he got the technique to work on individual bacteria and virus particles, while his student Steven Chu used a variant to trap individual atomswork that won Dr Chu and colleagues a Nobel prize in 1997. The increasing use made of his tweezers in biology saw Dr Ashkin follow in his students footsteps in 2018, sharing the prize with Dr Strickland and Dr Mourou.

And then there is precision. Einsteins general theory of relativity, promulgated in 1915, explains gravity in terms of the distortions masses impose on spacetimespacetime being, to Einstein, simply the thing that clocks and rulers measure. His special theory of relativity had laid out the case for light being the ultimate ruler, a view that measurement professionals now share; the General Conference on Weights and Measures defines the metre not as the length of a specific rod in a vault in Paris, as it once did, but as the distance a photon in a vacuum travels in 1/299,792,458 of a second. Thus if you want to see ripples in spacetimesuch as those which relativity says must be produced when two very large masses pirouette around each otherlight is the best sort of ruler to use.

The Laser Interferometer Gravitational-wave Observatory (LIGO) consists of two such rulers. Its twin detectors, one in Louisiana and one in Washington state, both feature 4km-long perpendicular arms along which laser beams of truly phenomenal stability bounce back and forth (see chart). Instruments mounted at the point where the beams cross compare their phases in order to detect transitory differences in the arms lengths. Their precision is equivalent to that which would be needed to detect a hairs-breadth change in the distance to a nearby star.

On September 14th 2015 LIGO picked up the shiver in spacetime produced by the merger of two black holes 1.3bn light-years away. In 2017 the Nobel Physics Committee, free of naysaying ophthalmologists, awarded the prize to Rainer Weiss, Kip Thorne and Barry C. Barish, the three scientists who had done most to make that observation happen.

Their extraordinary measurement was treated, quite rightly, as a slightly late 100th-birthday present for Einsteins truly remarkable intellectual achievement. It was also an extraordinary demonstration of what can be done with photons. A century of work by scientists and engineers has taken the energy packets that Einstein first imagined in 1905 and produced a range of technologies with capabilities little short of the miraculousa collective achievement far greater than any single act of genius. Relativity is remarkable. Putting photons to use has been revolutionary.

This article appeared in the Technology Quarterly section of the print edition under the headline "New enlightenments"

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Exacis Biotherapeutics Announces Its Launch and mRNA Technology In-Licensing For Targeted CAR-NK And CAR-T Cell Cancer Therapies – BioSpace

Tuesday, January 12th, 2021

CAMBRIDGE, Mass., Jan. 6, 2021 /PRNewswire/ -- Exacis Biotherapeutics, Inc., a development-stageimmuno-oncology company working to harness the immune system to cure cancer,today announcedits formation along with completion of in-licensing of certain technologies from Factor Bioscience, a leading cell sciences company. The exclusive license allows Exacis to create allogeneic engineered T and NK cells from induced pluripotent stem cells (iPSC). Exacis'next generation approachavoids useof DNA andviruses by usingmRNA.The technologies will be used for generatingiPSC and for performing genetic editing to create stealthed, allogeneic cell products, termed ExaCAR-Tor ExaCAR-NKcells.

Exacis also announcedthe addition of key members to its leadership team, Scientific Advisory Board and Board of Directors. Gregory Fiore, MD,a Harvard trained physician, seasoned pharmaceutical executiveand serial entrepreneur, has been named Chief Executive Officer.Dr. Fiore is joined on the management team by co-founder and Head of Discovery and Development, James Pan, PhD,an entrepreneur andbiologics expert. DimitriosGoundis, PhD, formerly CEO of MaxiVAX, a private Swiss immuno-oncology company, joins Exacis as the Chief Business Officer.

Exacis was launched by Factor Bioscience with an exclusive license to its intellectual property for developing targeted, allogeneic cell therapies for cancer treatment. Factor CEO Matthew Angel, PhD,is the Chair of Exacis'Scientific Advisory Board and is joined on the SAB by Factor Co-Founder Christopher Rohde, PhD, Eric Westin, MD,and Gunnar Kaufmann, PhD. Exacis' Board of Directors is chaired by Mark Corrigan,MD, a highly successfuldrug developer,biotechnology CEO and Board Chairperson.

Commenting on the new endeavor, Dr. Fiore said, "This is a wonderful opportunity to create innovative, next-generation NK and T cell therapies to improve outcomes and experiences for patients with challenging liquid and solid tumors."

Exacis' Board Chairman Corrigan added, "The ground- breaking science Exacis has in-licensed, along with the team we are building, provide a strong foundation for developing successful targeted cell therapies for the treatment of cancer."

Exacis has secured initial seed funding and is seeking to raise Series A funding in early 2021. The company has initiated discussions with several potential development collaborators.

About Exacis Biotherapeutics

Exacis is a development stage biotechnology company focused on harnessing the human immune system to cure cancerby engineering off-the-shelf NK and T cell therapies aimed at liquid and solid tumors.Exacis was founded in 2020 with an exclusive license to a broad suite of patents covering the use oftechnologies developed by Factor Biosciences.

About Factor Bioscience

Founded in 2011, Factor Bioscience develops technologies for engineering cells to advance the study and treatment of disease. It actively licenses its technologies to entities wishing to conduct commercial research, sell tools, reagents and other products, perform commercial services for third parties, and develop human and veterinary therapeutics. Factor Bioscience is privately held and is headquartered in Cambridge, MA.

About T and Natural Killer (NK) Cell Therapies

T and NK cells are types of human immune cells that are ableto recognize and destroy cancer cells and can be modified through genetic engineering to target specific tumors.

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SOURCE Exacis Biotherapeutics, Inc.

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Does Organic Mean Non-GMO? Here’s the Difference Between the Two – Green Matters

Tuesday, January 12th, 2021

Furthermore, there's somewhat of a gray area when it comes to understanding what organic means, and its relationship to genetically modified organisms (GMOs). Does an organic label automatically mean the item is non-GMO? Is organic always considered non-GMO? And what does non-GMO mean anyway? Keep reading to learn more about organic standards and non-GMO.

An organic label refers to an organism (plant, crop, food, or fabric) that has been produced without the aid of chemical or synthetic fertilizers, pesticides, herbicides, insecticides, or fungicides. In order to reach the certification standard of organic, items cannot be grown using antibiotics or artificial growth hormones either. If items have used fertilizers, pesticides, artificial growth hormones, or antibiotics during the growing process, these items are referred to as conventional.

Is organic better? There are absolutely environmental and health benefits to buying organic. According to Organic Trade Association, such benefits include promoting public health and health of the environment, no use of toxic pesticides and petroleum-based fertilizers, increased levels of nutrients and antioxidants, no use of artificial preservatives, colorings, added flavors, or ionizing radiation, and no antibiotics, growth hormones, or artificial drugs.

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Organic regulations also constitute specific regulations about soil, ensuring the soil in which organic seeds are grown is healthy and promotes biodiversity, which is another meaningful environmental benefit.

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In order to live up to the stringent organic standards, an item may not be genetically modified. According to USDA, the use of GMOs in organic products is explicitly prohibited in the definition of what organic is. The USDA states, The use of genetic engineering, or genetically modified organisms (GMOs), is prohibited in organic products. This means an organic farmer cant plant GMO seeds, an organic cow cant eat GMO alfalfa or corn, and an organic soup produced cant use any GMO ingredients.

You may be wondering, though: What guarantee is there that farmers wont use GMOs in their alleged organic products? Well, the USDA makes it difficult for farmers to get an organic certification. First, farmers have to prove that they can meet USDA organic standards. The website continues, To meet the USDA organic regulations, farmers and processors must show they arent using GMOs and that they are protecting their products from contact with prohibited substances, such as GMOs, from farm to table.

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The USDA also has a National List of Allowed and Prohibited Substances for organic products and GMOs arent the only items on the list. The list also prohibits ash from manure burning, arsenic, calcium chloride, lead salts, potassium chloride, rotenone, sodium fluoaluminate, sodium nitrate, strychnine, and tobacco dust.

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Yes, according to the USDAs very vigorous standards, all foods labeled organic are inherently also non-GMO. This means organic foods have not been genetically modified in anyway. In the example of organic meat, this means an organic cow was not fed any feed that was genetically modified either.

That being said, certain foods are at a higher risk for being genetically engineered or modified in some way, so if youre looking to only eat non-GMO, you might want to only eat these foods if they specifically are labeled organic or non-GMO. According to CNN, vegetables that are high-risk for GMOs include edamame, sweet corn, yellow summer squash, zucchini, and papaya from Hawaii or China. So, make sure to buy those organic.

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Prganic seeds are also non-GMO. An organic farmer is not allowed, under the USDAs standards, to plant genetically modified seeds. According to a 2014 article from the USDAs blog, organic seeds are described as a fundamental right from the start.

The article states, The use of organic seed is also an important aspect of organic certification. During each farms annual review and inspection, certifying agents also verify that certified operations use organic seed varieties."

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Certifying agents also make sure that USDA organic products meet all of the organic standards, including reviewing substances and inputs used to treat seeds and planting stock.

The article also adds, Like other organic products, seeds used in organic agriculture cannot be genetically engineered or be treated with prohibited substances.

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To ensure that organic seeds get proper treatment on organic farms, the USDA works with the National Organic Program (NOP), the Organic Seed Alliance (OSA), and the Association of Official Seed Certifying Agencies (AOSCA). These organizations collaborate to better understand the organic seed market and to help farmers locate seed producers and supplies. This is a direct response to an increased demand for organic seeds, as the demand for organic food increases.

To help with this increase in demand, the NOP aided the USDA in the creation of the AOSCA Organic Seed Finder, a website that works to connect organic seed vendors with potential customers. The website allows users to search specific categories such as vegetables, fruits, herbs and flowers, and field crops, to accurately curate searches based on what the user is looking for.

The USDA states, Certifying agents and organic operations can use this tool to locate available organic seed and ensure the integrity of those seeds.

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UPDATED: Bluebird spins itself into two companies, severing gene therapy and cancer units – Endpoints News

Tuesday, January 12th, 2021

Bluebird bio, once one of biotechs flashiest companies, is taking a sweeping step as it looks to right the ship after a series of high-profile setbacks: splitting the company in two.

The Cambridge-based company will split itself into a unit focused on cancer and a unit focused on rare disease, severing the cell therapy and gene therapy units that the biotech rode to prominence. CEO Nick Leschly explained the move as a practical one, reflecting the different kinds of expertise in the disease areas.

You dont build an oncology company by hiring people who are experts in severe genetic disease, nor do you do vice versa, Leschly told WSJ. A lot of this comes down to priorities and focus.

Yet the move comes as bluebirds stock has lost much of its initial luster, as bluebird has struggled to turn strong data into commercial therapies and investors moved on to newer gene therapy companies such as CRISPR Therapeutics.

And it will effectively end Leschlys day-to-day involvement in the biotech he has become synonymous with and a gene therapy field where he long served as the most prominent CEO. Leschly will lead the as-yet-unnamed newco, while Andrew Obenshain, their longtime European chief, will lead bluebird bio. Leschly will hang on as bluebirds executive chair.

Analysts were skeptical that the approach was the solution. In a note to investors, Piper Sandlers Tyler Van Buren said bluebird had struggled to replenish its pipeline over the years, despite significant funding, and he worried that they didnt have enough assets or cash to sustain multiple companies.

Ultimately, while these two franchises are different, we are not convinced that their respective pipelines are robust enough to sustain the independent entities, he wrote, and we believe some investors appreciated the balance of the two franchises.

The companys stock $BLUE, which has fallen dramatically from its 2011 peak, when it was worth over $11 billion, remained flat at just under $49.

After commanding attention with curative data for a sickle cell gene therapy and numerous remissions in trials for a multiple myeloma cell therapy, bluebird has struggled to bring both past the finish line.

After their most recent delay, the company remains nearly two years away from submitting their sickle cell gene therapy to the FDA. The FDA is now reviewing the multiple myeloma cell therapy ide-cel, now partnered with Bristol Myers Squibb, but the agency initially served the company with a refuse-to-file letter for submitting insufficient manufacturing information.

The gene therapy, known as Zynteglo, was approved in Europe for another rare blood disease, beta thalassemia. But the $1.8 million price tag bluebird placed on it shocked analysts and industry watchers and, with the pandemic hitting shortly after their official launch, the company had yet to sell a single unit as of their November Q3 filing.

Despite the setbacks, the company still remains at the front of a now crowded pack to commercialize a sickle cell cure, and analysts peg peak sales for ide-cel as high as $900 million. Bluebird also has an immunotherapy for Merkel cell carcinoma and a gene therapy for cerebral adrenoleukodystrophy in clinical development.

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Hamsters genetically engineered by USU researchers are on the front lines of COVID-19 vaccine trials in Belgium – KSL.com

Thursday, December 3rd, 2020

LOGAN Genetically engineered golden Syrian hamsters developed by Utah State University researchers played a key role in animal trials of a possible vaccine to protect against the virus that causes COVID-19.

The Rega Institute in Leuven, Belgium, has used the hamsters produced by professor Zhongde Wang and his lab at USU to test the safety and effectiveness of a possible vaccine.

Details of the research conducted by the Rega Institute and its findings were published online in the journal Nature this week.

The candidate vaccine was found to be safe and effective in several animal models by a team of scientists at the institute.

Animal models play a vital role in vaccine research "because we cannot directly test them in humans. We need to use animal models, (it's) very critical," Wang said.

Wang said two pairs of hamsters were shipped to the Belgium lab in 2018 to start a breeding colony in an agreement with his lab.

"The scientists in my lab and I are very gratified that our research is contributing to combating this raging COVID-19 pandemic," Wang said in a statement.

"We also feel grateful for the excellent support from USU's Laboratory Animal Research Center to help us to carry out the research."

The Wang lab, established at USU in 2012, developed the first genetic hamster models in the world. The models are used in more than a dozen labs and institutions including the National Institutes of Health, the U.S. Army Medical Research Institute of Infectious Diseases, and Public Health Agency of Canada.

Hamsters from Wang's lab are also utilized in COVID-19 and other studies in USU's Institute for Antiviral Research.

"We pioneered development of genetic engineering techniques in this species and now we have about 30 different models. These are 30 different genetic modifications," Wang said in an interview Wednesday,

Typically, rodents carry many disease-causing organisms without becoming sick. The USU lab genetically engineered the golden Syrian hamsters to be susceptible to viruses that infect humans.

Viruses frequently attach to receptors in humans that are not present in animals, which limits effective testing of potential drugs to prevent or treat diseases. Hamsters from Wang's lab have a human gene inserted into their DNA for the receptor to which this coronavirus binds to facilitate testing, according to a university press release.

Because the hamsters are designed specifically to react to disease challenges more like humans, it takes fewer experiments to verify results, which expedites the process and can reduce numbers of animals used in research.

"We take animal welfare extremely seriously, and only the minimum numbers of animals required are used," said Wang, a professor in the Department of Animal, Dairy and Veterinary Sciences, in an article posted on a university website.

"In addition to that, all procedures are approved by Institutional Animal Care and Use Committees. It is essential to use these animals in vaccine studies before trials can be done in human subjects."

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Hamsters genetically engineered by USU researchers are on the front lines of COVID-19 vaccine trials in Belgium - KSL.com

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Combination enhances solid tumor immunotherapy | 2020-12-02 – BioWorld Online

Thursday, December 3rd, 2020

Combining metabolic intervention with T-cell immunotherapy is safe and resulted in improved efficacy in two mouse models of solid tumors, providing an alternative combination strategy for boosting solid tumor immunotherapy, according to a new study by scientists at China Pharmaceutical University (CPU).

The study proves the concept of cell-surface anchor-bioengineering, which can be readily adapted to other combinations of cell therapy and metabolic drugs and/or antibodies, the authors reported in the November 25, 2020, edition of Science Translational Medicine.

"We have constructed a cell-surface anchor-bioengineered T cell combining metabolic and T-cell therapy, then shown this strategy be safe and effective against solid tumors in mice," said lead researcher Can Zhang, a professor in the Center of Advanced Pharmaceuticals and Biomaterials at CPU in Nanjing.

T-cell therapy has achieved considerable clinical and preclinical success in treating hematologic malignancies, but has had limited therapeutic effects in solid tumors.

Most studies have focused on combining proinflammatory cytokines or immune checkpoint inhibitors with T cells to improve efficacy, but that approach is effective only in a fraction of patients, and has toxicity risks.

The oxygen- and nutrient-deprived tumor microenvironment has been shown to impede T-cell infiltration, survival, and function, limiting the benefit of solid tumor T-cell therapy.

T-cell metabolic pathways offer potential intervention targets. For example, T-cell function requires cell membrane cholesterol to cluster T-cell receptors (TCRs) and form an immune synapse. Cholesterol metabolic modulation plus T-cell therapy may thus improve solid tumor immunotherapy.

Avasimibe is an effective cholesterol acetyl-CoA acetyltransferase 1 (ACAT1) inhibitor, which increases plasma membrane cholesterol, thereby promoting TCR clustering and improving T-cell effector function.

"ACAT1 is the major enzyme of cholesterol esterification in CD8+ T cells, and it has recently been shown that inhibiting ACAT1 activity via avasimibe can significantly potentiate the effector function of these T cells," said Zhang.

Moreover, "avasimide has previously progressed to phase III trials in atherosclerosis patients, in whom it showed a good safety profile," she told BioWorld Science.

This established safety and efficacy led to the hypothesis that combining avasimide with T-cell therapy might boost solid tumor immunotherapy, but it has been challenging to optimize the two modalities as a combination therapy.

Thus it is necessary to develop combinatorial technologies that maximize both treatments, whereby genetically engineered T cells can be used to produce designed protein drugs.

Unfortunately, heterogeneous expression of engineered proteins and toxicity potential reduces this strategy's efficacy and small molecule drugs cannot be genetically manipulated.

An alternative to genetic engineering involves 'backpacking' nanoparticle drugs onto the T-cell surface via chemical conjugation or ligand-receptor interaction to augment T-cell function and increase the therapeutic efficacy of combinations.

However, previous studies have shown that backpacking may impair T-cell physiological functions, due to long-term occupation of T-cell membrane biomolecules or altered T-cell glycometabolism.

Thus, technology involving backpacking nanoparticle drugs onto the T-cell surface needs to be further improved to reduce the impact of backpacking on T-cell function.

In their new Science Translational Medicine study, Zhang and her team attached liposomal avasimide onto the T-cell surface by lipid insertion and a click molecular insertion technique, without disturbing T-cell physiological function.

They demonstrated that avasimide could be retained on the T-cell surface during circulation and extravasation then locally diffused to increase the T-cell membrane cholesterol concentration, inducing rapid TCR clustering and sustained T-cell activation.

Treatment with cell-surface anchor-engineered T cells, including mouse TCR transgenic CD8+ T cells or human chimeric antigen receptor T (CAR T) cells, resulted in superior antitumor efficacy in mouse models of melanoma and glioblastoma.

Moreover, glioblastoma was completely eradicated in 3 of 5 mice receiving surface anchor-engineered CAR T cells, whereas saline-treated control mice survived no more than 64 days. Regarding safety, the administration of bioengineered T cells showed no apparent systemic side effects in these mouse tumor models.

"Although safety findings made with engineered T cells in mice can reflect safety in humans to some extent, potential interspecies differences should also be considered," noted Zhang. These findings show that cell-surface anchor-engineered T cells hold translational potential, because of their simple generation and their good safety profile, but further developmental work is necessary.

"We need to optimize preparation techniques to improve the yield of bioengineered T cells and to develop integrated and automated production techniques, in order to realize large-scale production," said Zhang.

"It will also be necessary to establish quality standards and corresponding rapid detection methods during each production stage, all of which might take several years or more," said Zhang.

"This new therapeutic strategy of combining metabolic intervention and CAR T therapy, including the use of different CAR T cells, might also be effective in diverse solid tumors," she said.

"Our group will continue to investigate the safety and efficacy of cell-surface-modification technologies that can be deployed to various cell types, including neutrophils, natural killer cells and so forth."

Here is the original post:
Combination enhances solid tumor immunotherapy | 2020-12-02 - BioWorld Online

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