StemCell Therapy

DetailsCategory: DNA RNA and CellsPublished on Thursday, 21 January 2021 17:52Hits: 651

Clinical trial will utilize a single-protocol Phase 1/2/3 design

UX701 manufacturing complete at commercial quality and scale using HeLa PCL technology

First patient to be dosed in the first half of 2021

NOVATO, CA, USA I January 21, 2021 I Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for serious rare and ultra-rare genetic diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for UX701, an investigational AAV9 gene therapy being evaluated for the treatment of Wilson Disease. Enrollment in a seamless single-protocol Phase 1/2/3 study is expected to begin in the first half of 2021. This will be the companys third in-house clinical gene therapy program and the second program in the clinic with the HeLa producer cell line manufacturing system.

FDA IND clearance allows for the advancement of this new gene therapy into the clinic and brings forward the hope for a new treatment for patients with Wilson Disease. UX701 has the potential to directly address the underlying basis of disease by restoring the normal transport and excretion of copper, said Eric Crombez, M.D., Chief Medical Officer of the Ultragenyx Gene Therapy development unit. The seamless Phase 1/2/3 clinical trial design will allow us to efficiently evaluate safety and efficacy of UX701 before studying an optimal dose in a larger number of patients to support registration. We appreciate the agencys support for a novel clinical trial design that could bring this important potentially new treatment to the greatest number of patients as efficiently as possible.

Study Design

UX701 will be studied in a seamless, single-protocol Phase 1/2/3 clinical trial. Manufacture and testing of GMP-grade drug product to supply the clinical study are complete using the companys proprietary HeLa 2.0 producer cell line (PCL) process at the 2,000 liter scale.

Stage 1 (evaluation of initial safety and dose finding)

In the first stage of the study, the safety and efficacy of three dose levels of UX701 will be evaluated in 27 patients (nine per cohort), randomized 2-to-1 (gene therapy versus placebo). The dose cohorts will be enrolled sequentially using ascending doses. The patients will be followed for 52 weeks before transitioning to long-term follow-up and selecting a pivotal dose. The dose will be determined based on the safety profile, changes in biomarkers of copper metabolism (e.g. 24-hr urinary copper, ceruloplasmin concentration, ceruloplasmin activity, non-ceruloplasmin bound copper, and total serum copper), and the reduction in the use of the current standard (SOC), copper chelator and/or zinc.

Stage 2 (optimal dose evaluation for pivotal clinical data generation)

The second and pivotal stage will use the dose selected from Stage 1 and enroll an additional 63 patients, randomized 2-to-1 (gene therapy versus placebo). The co-primary endpoints in Stage 2 will evaluate the effect of UX701 on copper regulation based on 24-hour urinary copper concentration and percent reduction in SOC at Week 52. Key secondary endpoints in Stage 2 include the effect of UX701 on additional biomarkers of copper metabolism and patient- and clinician-reported outcomes from a modified Wilson Disease Functional Rating Scale.

Stage 3 (long-term follow-up)

All patients in Stage 1 and Stage 2 who are randomized to receive placebo may be eligible to receive UX701 at the Stage 2 dose. Patients receiving UX701 will be continued to be monitored for long term safety and durability of response.

About Wilson Disease

Wilson disease is a rare inherited disorder caused by mutations in the ATP7B gene, which results in deficient production of ATP7B, a protein that transports copper. Loss of function of this copper-binding protein results in the accumulation of copper in the liver and other tissues, most notably the central nervous system. Patients with Wilson disease experience hepatic, neurologic and/or psychiatric problems. Those with liver disease can experience such symptoms as fatigue, lack of appetite, abdominal pain and jaundice, and can progress to fibrosis, cirrhosis, life-threatening liver failure and death. Wilson disease can be managed by reducing copper absorption or removing excess copper from the body using life-long chelation therapy, but unmet needs exist because some treated patients experience clinical deterioration and debilitating side effects. Wilson disease affects more than 50,000 individuals in the developed world.

About UX701

UX701 is an investigational AAV type 9 gene therapy designed to deliver stable expression of a truncated version of the ATP7B copper transporter following a single intravenous infusion. It has been shown in preclinical studies to improve copper distribution and excretion from the body and reverse pathological findings of Wilson liver disease. UX701 was granted Orphan Drug Designation in the United States and European Union.

About Ultragenyx

Ultragenyx is a biopharmaceutical company committed to bringing novel products to patients for the treatment of serious rare and ultra-rare genetic diseases. The company has built a diverse portfolio of approved therapies and product candidates aimed at addressing diseases with high unmet medical need and clear biology for treatment, for which there are typically no approved therapies treating the underlying disease.

The company is led by a management team experienced in the development and commercialization of rare disease therapeutics. Ultragenyxs strategy is predicated upon time- and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency.

For more information on Ultragenyx, please visit the companys website at http://www.ultragenyx.com.

SOURCE: Ultragenyx Pharmaceutical

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Ultragenyx Announces FDA Clearance of Investigational New Drug (IND) Application for UX701, a New Gene Therapy for the Treatment of Wilson Disease |...

BEIJING: Chinese Scientists have developed a new gene therapy that showed some reversal effects of ageing in mice and extend their lifespans.

However, scientists presume that the findings may one day contribute to similar treatment for humans.

The method, detailed in a paper in the Science Translational Medicine journal earlier this month, involves inactivating a gene called kat7 which the scientists found to be a key contributor to cellular ageing.

The specific therapy they used and the results were a world first, said co-supervisor of the project Professor Qu Jing, 40, a specialist in ageing and regenerative medicine from the Institute of Zoology at the Chinese Academy of Sciences (CAS).

These mice show after 6-8 months overall improved appearance and grip strength and most importantly they have an extended lifespan for about 25%, Qu said.

The team of biologists from different CAS departments used the CRISPR/Cas9 method to screen thousands of genes for those which were particularly strong drivers of cellular senescence, the term used to describe cellular ageing.

Read more: Latest on coronavirus: South Africa strain may resist antibody treatments

They identified 100 genes out of around 10,000, and kat7 was the most efficient at contributing to senescence in cells, Qu said.

Kat7 is one of tens of thousands of genes found in the cells of mammals. The researchers inactivated it in the livers of the mice using a method called a lentiviral vector.

We just tested the function of the gene in different kinds of cell types, in the human stem cell, the mesenchymal progenitor cells, in the human liver cell and the mouse liver cell and for all of these cells we didnt see any detectable cellular toxicity. And for the mice, we also didnt see any side effect yet.

Despite this, the method is a long way from being ready for human trials, Qu said.

Its still definitely necessary to test the function of kat7 in other cell types of humans and other organs of mice and in the other pre-clinical animals before we use the strategy for human ageing or other health conditions, she said.

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Chinese scientists develop gene therapy that could delay ageing and extend lifespan - Geo News

Article content continued

They identified 100 genes out of around 10,000, and kat7 was the most efficient at contributing to senescence in cells, Qu said.

Kat7 is one of tens of thousands of genes found in the cells of mammals. The researchers inactivated it in the livers of the mice using a method called a lentiviral vector.

We just tested the function of the gene in different kinds of cell types, in the human stem cell, the mesenchymal progenitor cells, in the human liver cell and the mouse liver cell and for all of these cells we didnt see any detectable cellular toxicity. And for the mice, we also didnt see any side effect yet.

Despite this, the method is a long way from being ready for human trials, Qu said.

Its still definitely necessary to test the function of kat7 in other cell types of humans and other organs of mice and in the other pre-clinical animals before we use the strategy for human aging or other health conditions, she said.

Qu said she hopes to be able to test the method on primates next, but it would require a lot of funding and much more research first.

In the end, we hope that we can find a way to delay aging even by a very minor percentagein the future.

(Reporting by Martin Quin Pollard; Editing by Kim Coghill)

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Chinese scientists develop new gene therapy that can delay the aging process - National Post

Jan. 25, 2021, FNF Research (fnfresearch.com) offering a comprehensive analysis of the Updated Latest Report 2020 [2020-2026] Cell and Gene Therapy Consumables Market Report by Quantitative Research Incorporating Impact Of Economic And Non-economic Aspects where users can benefit from the complete market research report with all the required useful information about this market. Based on the Cell and Gene Therapy Consumables market development status, competitive landscape, and development model in different regions of the world, this report is dedicated to providing niche markets, potential risks, and comprehensive competitive strategy analysis in different fields. From the competitive advantages of different types of products and services, the development opportunities and consumption characteristics and structure analysis of the downstream application fields are all analyzed in detail.

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Analysis of the market segment includes the two major product and service categories as well as the end-user. Such a segmentation enables a granular view of the market that is needed to understand the finer nuances.

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Amgen Inc.

ATLANTA BIOLOGICALS

bluebird bio Inc.

Cook

Dendreon Pharmaceuticals LLC

Fibrocell Science Inc.

General Electric

Kolon TissueGene Inc.

Orchard Therapeutics plc.

Pfizer Inc.

PromoCell GmbH

RENOVA THERAPEUTICS

Sibiono GeneTech Co. Ltd.

Spark Therapeutics Inc.

Vericel

Helixmith Co. Ltd.

Vitrolife

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Cell and Gene Therapy Consumables Market Historic Data (2020-2026):

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Cell and Gene Therapy Consumables Market Analysis with Increasing Business Opportunities, Outstanding Investment Rate and Growth Opportunities Up To...

NEW YORK and CLEVELAND, Jan. 25, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that the company held a successful Type B meeting with the U.S. Food and Drug Administration (FDA) to align with the Agency on the companys proposal regarding co-primary endpoints for the pivotal Phase 3 VIITAL study of EB-101 in recessive dystrophic epidermolysis bullosa (RDEB). Following the meeting, Abeona is proceeding with its plan to enroll between 10 to 15 patients with RDEB, comprising approximately 35 large chronic wound sites treated in total.

We appreciate the clarity provided by the FDA and we are pleased to be aligned with the Agency on the co-primary endpoints for the Phase 3 VIITAL study, said Michael Amoroso, Principal Executive and Chief Operating Officer of Abeona. Following the successful completion of the FDA meeting,we continue with all necessary steps to enroll our next patient in the VIITAL study and aim to complete enrollment in 2021.

The co-primary endpoints of the study are: 1) the proportion of RDEB wound sites with greater than or equal to 50% healing from baseline, comparing treated with untreated wound sites at Week 24 (Month 6) as determined by direct investigator assessment; and 2) pain reduction associated with wound dressing change assessed by the mean differences in scores of the Wong-Baker FACES scale between treated and untreated wounds at Week 24 (Month 6).

As previously announced, data from a Phase 1/2a clinical trial presented at the 2020 Society for Pediatric Dermatology Annual Meeting showed that wound healing of 50% or greater following EB-101 treatment in patients with RDEB was associated with no pain at treated sites at three-, four- and five-years post-treatment, compared with presence of pain in 53% of wound sites at baseline.

Jodie Gillon, Vice President and Chief Patient Officer of Abeona commented, We greatly appreciate the level of clarity we received from the FDA as we continue to work with our clinical study partners at Stanford University Medical Center and patient advocacy groups to enroll additional patients in the VIITAL study.

Investigators at Stanford University Medical Center are currently enrolling eligible patients into the VIITAL study. Additional information about the trial, including eligibility criteria, is available at https://www.abeonatherapeutics.com/clinical-trials/rdeb and https://clinicaltrials.gov/ (Identifier: NCT04227106).

About Recessive Dystrophic Epidermolysis Bullosa Recessive dystrophic epidermolysis bullosa (RDEB) is a rare connective tissue disorder characterized by severe skin wounds that cause pain and can lead to systemic complications impacting the length and quality of life. People with RDEB have a defect in the COL7A1 gene, leaving them unable to produce functioning type VII collagen which is necessary to anchor the dermal and epidermal layers of the skin. There is currently no approved treatment for RDEB.

About EB-101 EB-101 is an autologous, gene-corrected cell therapy currently being investigated in the pivotal Phase 3 VIITAL study for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a rare connective tissue disorder without an approved therapy. The EB-101 VIITAL study is a randomized clinical trial enrolling 10 to 15 RDEB patients with approximately 30 large, chronic wound sites treated in total. Treatment with EB-101 involves using gene transfer to deliver COL7A1 genes into a patients own skin cells (keratinocytes and its progenitors) and transplanting them back to the patient to enable normal Type VII collagen expression and facilitate wound healing. Abeona produces EB-101 for the VIITAL study at its fully-functional gene and cell therapy manufacturing facility in Cleveland, OH. In a Phase 1/2a clinical trial, EB-101 provided durable wound healing for RDEB patients lasting 2+ to 5+ years, including for the largest, most challenging wounds that affect the majority of the RDEB population.

About Abeona Therapeutics Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing gene and cell therapies for serious diseases. Abeonas clinical programs include EB-101, its autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa in Phase 3 development, as well as ABO-102 and ABO-101, novel AAV-based gene therapies for Sanfilippo syndrome types A and B (MPS IIIA and MPS IIIB), respectively, in Phase 1/2 development. The Companys portfolio also features AAV-based gene therapies for ophthalmic diseases with high unmet medical needs. Abeonas novel, next-generation AIM capsids have shown potential to improve tropism profiles for a variety of devastating diseases. Abeonas fully functional, gene and cell therapy GMP manufacturing facility produces EB-101 for the pivotal Phase 3 VIITAL study and is capable of clinical and commercial production of AAV-based gene therapies. For more information, visit http://www.abeonatherapeutics.com.

Forward-Looking StatementsThis press release contains certain statements that are forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and that involve risks and uncertainties. These statements include statements about the Companys aim to complete enrollment of patients in our VIITAL study in 2021. We have attempted to identify forward-looking statements by such terminology as may, will, believe, estimate, expect, and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances), which constitute and are intended to identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, numerous risks and uncertainties, including but not limited to the potential impacts of the COVID-19 pandemic on our business, operations, and financial condition, the outcome of our announced strategic review, continued interest in our rare disease portfolio, our ability to enroll patients in clinical trials, the outcome of any future meetings with the U.S. Food and Drug Administration or other regulatory agencies, the impact of competition, the ability to secure licenses for any technology that may be necessary to commercialize our products, the ability to achieve or obtain necessary regulatory approvals, the impact of changes in the financial markets and global economic conditions, risks associated with data analysis and reporting, and other risks disclosed in the Companys most recent Annual Report on Form 10-K and subsequent quarterly reports on Form 10-Q and other periodic reports filed with the Securities and Exchange Commission. The Company undertakes no obligation to revise the forward-looking statements or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws.

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Abeona Therapeutics Announces Successful Type B Meeting with FDA for Pivotal Phase 3 VIITAL Study of EB-101 in Recessive Dystrophic Epidermolysis...

Databridgemarketresearch.com Present Cancer Gene Therapy Market Industry Trends and Forecast to 2027 new report to its research database. This report is always helpful to business or organization in every subject of trade for taking better decisions, solving the toughest business questions and minimizing the risk of failure. The studies of this report carefully analyzes the market status, growth rate, future trends, market drivers, opportunities, challenges, risks, entry barriers, sales channels, and distributors. The most advanced tools and techniques have been used to structure this Cancer Gene Therapy Market report such as SWOT analysis and Porters Five Forces Analysis. Moreover, different segments of the market taken into consideration in this market research report give better market insights with which reach to the success gets extended.

Cancer gene therapy market is expected to gain market growth in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market to account to USD 6407.88 million by 2027 growing with the CAGR of 32.54% in the above-mentioned forecast period. The high success rate of cancer gene therapy along with clinical trial and preclinical trial is gaining popularity among the patient which is leading towards the market.

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The major players covered in the cancer gene therapy market report are Adaptimmune, GlaxoSmithKline plc, bluebird bio, Inc, Merck & Co., Inc., CELGENE CORPORATION, Anchiano Therapeutics, Achieve Life Sciences, Inc among other domestic and global players.

Competitive Landscape and Cancer Gene Therapy Market Share Analysis

Cancer gene therapy market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies focus related to cancer gene therapy market.

Global Cancer Gene Therapy Market Scope and Market Size

Cancer gene therapy market is segmented on the basis of therapy and end user. The growth amongst these segments will help you analyse meagre growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.

Increase in funding of research and development in the activities of cancer gene therapy along with rise in prevalence of cancer is likely to accelerate the growth of the cancer gene therapy market in the forecast period of 2020-2027. On the other hand, the favourable government regulations for therapy is further going to boost various opportunities that will lead to the growth of the cancer gene therapy market in the above mentioned forecast period.

High cost involved in gene therapy along with unwanted immune responses wills likely to hamper the growth of the cancer gene therapy market in the above mentioned forecast period.

This cancer gene therapy market report provides details of new recent developments, trade regulations, import export analysis, production analysis, value chain optimization, market share, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographical expansions, technological innovations in the market. To gain more info on Cancer gene therapy market contactData Bridge Market Researchfor anAnalyst Brief, our team will help you take an informed market decision to achieve market growth.

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Cancer Gene Therapy Market Country Level Analysis

Cancer gene therapy market is analysed and market size insights and trends are provided by country, therapy and end user as referenced above.

The countries covered in the cancer gene therapy market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

North America dominates the cancer gene therapy market due to the advanced healthcare infrastructure along with rise in R & D expenditure, while Asia-Pacific is expected to grow with the highest growth rate in the forecast period of 2020 to 2027 due to the improving healthcare infrastructure and government initiatives.

The country section of the cancer gene therapy market report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as consumption volumes, production sites and volumes, import export analysis, price trend analysis, cost of raw materials, down-stream and upstream value chain analysis are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.

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Healthcare Infrastructure Growth Installed Base and New Technology Penetration

Cancer gene therapy market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipment, installed base of different kind of products for cancer gene therapy market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the cancer gene therapy market. The data is available for historic period 2010 to 2018.

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Cancer Gene Therapy Market : Future Prospects With Covid-19 Impact Analysis 2027 | Top Players- Adaptimmune, GlaxoSmithKline plc, bluebird bio, Inc -...

The 59 rating InvestorsObserver gives to INmune Bio Inc (INMB) stock puts it near the top of the Biotechnology industry. In addition to scoring higher than 72 percent of stocks in the Biotechnology industry, INMBs 59 overall rating means the stock scores better than 59 percent of all stocks.

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INmune Bio Inc (INMB) stock is up 0.53% while the S&P 500 is lower by -0.61% as of 11:25 AM on Monday, Jan 25. INMB is up $0.11 from the previous closing price of $20.72 on volume of 238,786 shares. Over the past year the S&P 500 is up 17.71% while INMB is up 332.16%. INMB lost -$0.97 per share the over the last 12 months.

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The market has been high on Puma Biotechnology Inc (PBYI) stock recently. PBYI gets a Bullish score from InvestorsObserver's Stock Sentiment Indicator.

In investing, sentiment generally means whether or not a given security is in favor with investors. It is typically a pretty short-term metric that relies entirely on technical analysis. That means it doesnt incorporate anything to do with the health or profitability of the underlying company.

Sentiment is how investors, or the market, feels about a stock. There are lots of ways to measure sentiment. At the core, sentiment is pretty easy to understand. If a stock is going up, investors must be bullish, while if it is going down, sentiment is bearish.

InvestorsObservers Sentiment Indicator looks at price trends over the past week and also considers changes in volume. Increasing volume can mean a trend is getting stronger, while decreasing volume can mean a trend is nearing a conclusion.

For stocks that have options, our system also considers the balance between calls, which are often bets that the price will go up, and puts, which are frequently bets that the price will fall.

Puma Biotechnology Inc (PBYI) stock has gained 9.25% while the S&P 500 is down -0.49% as of 11:32 AM on Monday, Jan 25. PBYI has risen $1.03 from the previous closing price of $11.14 on volume of 295,323 shares. Over the past year the S&P 500 is up 17.85% while PBYI has risen 51.18%. PBYI lost -$1.43 per share in the over the last 12 months.

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Puma Biotechnology is a biotechnology company focused on developing novel therapeutics for the treatment of cancer. Puma licenses the commercial rights to its current drug candidates. The company expects to augment its product pipeline by acquiring, through license or otherwise, additional drug candidates for research and development and potential commercialization. In evaluating potential drug candidates, Puma employs disciplined decision criteria favoring drug candidates that have undergone at least some clinical study.

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Achieve Life Sciences Inc (ACHV) is near the top in its industry group according to InvestorsObserver. ACHV gets an overall rating of 62. That means it scores higher than 62 percent of stocks. Achieve Life Sciences Inc gets a 75 rank in the Biotechnology industry. Biotechnology is number 33 out of 148 industries.

Trying to find the best stocks can be a daunting task. There are a wide variety of ways to analyze stocks in order to determine which ones are performing the strongest. Investors Observer makes the entire process easier by using percentile rankings that allows you to easily find the stocks who have the strongest evaluations by analysts.

These scores are not only easy to understand, but it is easy to compare stocks to each other. You can find the best stock in an industry, or look for the sector that has the highest average score. The overall score is a combination of technical and fundamental factors that serves as a good starting point when analyzing a stock. Traders and investors with different goals may have different goals and will want to consider other factors than just the headline number before making any investment decisions.

Achieve Life Sciences Inc (ACHV) stock has risen 5.69% while the S&P 500 has fallen -0.61% as of 11:25 AM on Monday, Jan 25. ACHV is higher by $0.67 from the previous closing price of $11.78 on volume of 375,583 shares. Over the past year the S&P 500 has risen 17.71% while ACHV is higher by 10.18%. ACHV lost -$8.76 per share the over the last 12 months.

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Where Does Achieve Life Sciences Inc (ACHV) Stock Fall in the Biotechnology Field? - InvestorsObserver

After a period of extreme volatility during 2020, it unexpectedly turned out to be a positive year for the equity markets and an extraordinary year for scientific progress. During the year, the Trust's share price appreciated 36.1% (share price total return, GBP) versus the benchmark, Nasdaq Biotech Index, that appreciated 23.2% - an outperformance of 12.9%. Similarly, the net asset value of the Trust appreciated 29.8%, outperforming the benchmark by 6.6% (all total return).

We can all agree that 2021 will be very difficult to predict with a pandemic raging the world, initial vaccination campaigns having just started, and a virus mutating and changing its infectability (Source: http://www.nextstrain.org).

The prevailing consensus view predicts that vaccination campaigns, with several vaccines on a global scale, will eventually lead to a broad immunity that will change the pandemic-nature of the Covid-19 infection to become endemic and manageable in a manner similar to many other viral infections. The view, at least from equity markets' perspective, is that they would have a strong finish at the end of 2021, on the back of strong economic recovery.

However, negative scenarios can also be envisioned: In the near-term, China might see a rise in the number of infected people which would lead to another hard lockdown resulting in negative economic impact. Given Japan's recent historical negative experiences of vaccinations, the nation's government may not be able to convince its citizens to vaccinate, creating a lingering national epidemic. The Covid-19 virus might mutate to increase the severity of the infection rate or render the current vaccination programs less effective - a scary scenario but as an investor one needs to take these potential outlier events into consideration.

Our outlook is positive, but as always, we closely monitor any developments which may impact our view. It is difficult not to have a positive outlook for the sector in the near-, mid-, and long-term, as innovation is constantly delivering more and more therapies, evidenced by:

Figure 1: New drug approvals in the US 2010-2020

Figure 1

Data sourced from Food and Drug Administration (FDA)

The result of the U.S. election was a narrow, but still decisive, win for the Democrat Party. In addition, the Senate was a tie, but with Vice President Kamala Harris having the final vote, the Democrats gained control of the Senate. Healthcare is clearly on the agenda for the Democrats, with Obamacare in focus. We do not expect to see new legislation introducing major changes to the healthcare system, but we keep a close eye on legislation leading to price pressure in particular subsectors. We remain agnostic to therapeutic areas but see more opportunities in oncology and rare diseases, with short- to mid-term scientific advancements in neurology and psychiatry leading to increased therapies for these historically difficult to treat areas. Additionally, gene sequencing is generating new genetic targets to a variety of diseases at record speed.

Biotech valuations are said by some to be in a 'bubble'. Clearly the small cap names have become more expensive - an area we currently are cautious about. Larger companies, with proven sales and revenue track records, are less expensive compared to the small cap names and we see more investment opportunities in this subsector. Interest rates are low, with Central Banks declaring that they will be lower for longer and monetary policy is expected to remain lax. Fiscal policy remains a focal point with stimulus packages being announced in response to the pandemic. Money Supply in response to the pandemic has had a sharp expansion (see figure 2 below). In our view, inflation of financial and other fixed assets is inevitable in the short to medium term.

Figure 2: Federal Reserve Money Supply M2 - 5 years

Figure 2

Source: Bloomberg

Disclaimer

International Biotechnology Trust plc published this content on 22 January 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 22 January 2021 07:21:01 UTC

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International Biotechnology Trust : Themes for 2021 - marketscreener.com

If we're looking to avoid a business that is in decline, what are the trends that can warn us ahead of time? Businesses in decline often have two underlying trends, firstly, a declining return on capital employed (ROCE) and a declining base of capital employed. Ultimately this means that the company is earning less per dollar invested and on top of that, it's shrinking its base of capital employed. In light of that, from a first glance at Level Biotechnology (GTSM:3118), we've spotted some signs that it could be struggling, so let's investigate.

For those who don't know, ROCE is a measure of a company's yearly pre-tax profit (its return), relative to the capital employed in the business. To calculate this metric for Level Biotechnology, this is the formula:

Return on Capital Employed = Earnings Before Interest and Tax (EBIT) (Total Assets - Current Liabilities)

0.11 = NT$58m (NT$714m - NT$184m) (Based on the trailing twelve months to September 2020).

Thus, Level Biotechnology has an ROCE of 11%. In absolute terms, that's a satisfactory return, but compared to the Healthcare industry average of 8.5% it's much better.

View our latest analysis for Level Biotechnology

Historical performance is a great place to start when researching a stock so above you can see the gauge for Level Biotechnology's ROCE against it's prior returns. If you'd like to look at how Level Biotechnology has performed in the past in other metrics, you can view this free graph of past earnings, revenue and cash flow.

We are a bit worried about the trend of returns on capital at Level Biotechnology. Unfortunately the returns on capital have diminished from the 18% that they were earning five years ago. On top of that, it's worth noting that the amount of capital employed within the business has remained relatively steady. Companies that exhibit these attributes tend to not be shrinking, but they can be mature and facing pressure on their margins from competition. So because these trends aren't typically conducive to creating a multi-bagger, we wouldn't hold our breath on Level Biotechnology becoming one if things continue as they have.

In the end, the trend of lower returns on the same amount of capital isn't typically an indication that we're looking at a growth stock. Investors must expect better things on the horizon though because the stock has risen 3.4% in the last five years. Either way, we aren't huge fans of the current trends and so with that we think you might find better investments elsewhere.

If you'd like to know more about Level Biotechnology, we've spotted 3 warning signs, and 1 of them is potentially serious.

For those who like to invest in solid companies, check out this free list of companies with solid balance sheets and high returns on equity.

PromotedIf youre looking to trade Level Biotechnology, open an account with the lowest-cost* platform trusted by professionals, Interactive Brokers. Their clients from over 200 countries and territories trade stocks, options, futures, forex, bonds and funds worldwide from a single integrated account.

This article by Simply Wall St is general in nature. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. *Interactive Brokers Rated Lowest Cost Broker by StockBrokers.com Annual Online Review 2020

Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com.

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Does Level Biotechnology's (GTSM:3118) Returns On Capital Reflect Well On The Business? - Simply Wall St

BOSTON & LOUISVILLE, Ky.--(BUSINESS WIRE)--Talaris Therapeutics, Inc., a privately held biotechnology company developing transformative cell therapies that have the potential to induce durable immune tolerance across a range of indications, today announced the appointment of Sapna Srivastava, Ph.D., and Gaurav Shah, M.D., as independent representatives to its Board of Directors.

Sapna and Gaurav are both experienced biotechnology leaders with deep industry knowledge and a track record of value creation across many different settings. Their expertise and strategic insights will be instrumental to Talaris as it executes its ongoing Phase 3 trial and pursues additional applications for its unique cell therapy, said Francois Nader, M.D., Chairman of the Board. On behalf of the Board, Im pleased to welcome them to Talaris and look forward to partnering with them to advance our important mission of delivering transformative cell therapies to patients with immune and blood disorders.

Dr. Srivastava, who will also become the Chairperson of Talaris Audit Committee, has almost 20 years of experience as a senior executive in the biopharmaceutical industry and on Wall Street. Most recently, she was the Chief Financial and Strategy Officer for Abide Therapeutics (acquired by Lundbeck). Prior to Abide, she was the Chief Financial and Strategy Officer for Intellia Therapeutics, where she played a key role in leading the companys financial operations, private and public equity financings, strategic alliances and direction. Previously, Dr. Srivastava was a senior biotechnology analyst at Goldman Sachs, Morgan Stanley and ThinkEquity Partners, LLC. She began her career as a research associate at J.P. Morgan. She has also served as an independent board member and strategy advisor to several therapeutically focused biotechnology companies and non-profit organizations. She currently serves on the Board of SQZ Biotechnologies and Asclepix Therapeutics. Dr. Srivastava received a Ph.D. in neuroscience from New York University and a B.Sc. from St. Xavier's College in India.

Dr. Shah is the founding Chief Executive Officer and President of Rocket Pharma, with a pipeline comprised of first-in-class gene therapies for rare and devasting inherited genetic diseases. Prior to this role, Dr. Shah was Global Program Head in the Cell & Gene Therapies Unit at Novartis, where he had strategic oversight of 12 functions and helped spearhead pivotal trials with CART-19 for patients with leukemia and lymphoma. Dr. Shah started his career in industry at ImClone/Eli Lilly as a Medical Director overseeing oncology trials focused on monoclonal antibodies. He graduated from Harvard College with a degree in behavioral neuroscience. He received his M.D. from Columbia, completed his internal medicine residency at Brigham and Womens Hospital, and hematology/oncology fellowship training at Memorial Sloan Kettering.

About Talaris Therapeutics

Talaris Therapeutics, Inc. is a late-clinical stage biotechnology company that is developing transformative cell therapies with the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients as well as induce durable remissions in patients with severe autoimmune and immune-mediated disorders. Talaris is backed by a number of leading life sciences investors and maintains corporate offices in Boston, Mass., and its cell processing facility in Louisville, Ky. http://www.TalarisTx.com.

Read more here:
Talaris Therapeutics Adds Two Experienced Biotechnology Executives to its Board of Directors - Business Wire

Dublin, Jan. 21, 2021 (GLOBE NEWSWIRE) -- The "Nanoparticles in Biotechnology, Drug Development and Drug Delivery Systems" report has been added to ResearchAndMarkets.com's offering.

The scope of the report includes an overview of the global market for nanoparticles in biotechnology, drug development, and drug delivery, and analyses of global market trends, using 2019 as the base year and forecasting 2020 through 2025 with compound annual growth rate (CAGR) projections.

The report includes an analysis of leading and emerging drug products for each nanoparticle type. Profiles of manufacturers of leading products and their specific products are provided. This report also assesses companies poised to introduce products during the forecast period and discusses how these introductions will change the face of the competitive environment. The competitive environment is examined with a special focus on how new products will alter the quality of life of patients receiving nanoparticle-associated drugs.

Market figures are based on revenues at the manufacturer level and are projected in 2019 dollar value. Inflation is not computed into the projection figures. Trends are assessed based on projected sales for existing products, for new product introductions, expanded markets for existing products, and other factors affecting the market included in this report are forecasted by product, product category, and company.

The study is arranged to offer an overview of existing nanoparticle technology and of drug markets; it is accompanied by nanoproduct, company, geography, and mechanism of action, with forecasts broken down and covered by geographic region or country.

Patent and clinical trial information are reviewed for various candidate nano-drugs. The status of approvals of drugs in each segment by the FDA and regulatory agencies in other countries is reviewed.

Figures are reported in U.S. dollars and in each case reflect currency fluctuations within the performance of revenue change. Revenue figures do not account for variation in local currencies. All market share data presented is on a global basis unless specifically noted.

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The Report Includes:

43 tables

An overview of the global nanoparticles in biotechnology, drug development, and drug delivery market

Estimation of the market size and analyses of market trends, with data from 2019, estimates for 2020, and projection of CAGR through 2025

Highlights of the drug development, formulation, and the development of new drug delivery systems and detailed product analyses within health and wellness subsegments

Information on nanomedicine and biomedical nanoparticle products and coverage of the next-generation vaccines

Evaluation of current market trends, market size, market forecast, and detailed analysis of drivers, challenges, and opportunities affecting the market growth

Discussion on the role of nanotechnology in COVID-19 vaccine production, components, and methods in the vaccine design for COVID-19 and challenges for vaccine disruptions

Assessment of various approaches for the treatment of COVID-19, and detailed description of structure and penetration of coronavirus

Details of clinical trials of nanoparticle drugs and drug delivery systems

A look at the patents, licensing, mergers and acquisitions, and market share analysis of the key companies of the industry

Company profiles of major players including Bristol-Myers Squibb Co., GlaxoSmithKline PLC, Hofmann-La Roche Inc., Merck & Co., and Novartis AG

Key Topics Covered:

Chapter 1 Introduction

Chapter 2 Summary and Highlights

Chapter 3 Market Overview

Introduction to Nanoparticles

Liposomes

Quantum Dots

Dendrimers

Macromolecule Nanoparticles

Brief History of Nanoparticles

Nanoparticles in Biotechnology

Nanoparticles in Drug Development

Nanoparticles in Drug Delivery Systems

Nanoparticles in Diagnostic Imaging

Major Players in Nanoparticle Drug Delivery Field

Major Nanoparticle/Nanocrystal Drug Revenues

Chapter 4 Market Breakdown by Product Type

Nanoparticles in Biotechnology

Nanoparticles in Drug Development

Nanoparticles in Drug Delivery Systems

Nanoparticles in Diagnostic Imaging

Distribution of Nanobiotechnology and Nanomedicine Companies

Chapter 5 Structure of Nanoparticles

Chapter 6 Production of Nanoparticles

Methods of Nanoparticle Formation

Self-Assembly Production

Methods of Stabilization

Methods of Drug Introduction

Polymeric Nanoparticles

Micelles

Liposomes

Gold and Silicon Nanoparticles

Dendrimers

Methods for Loading Biological Molecules into Nanoparticles

Nanocrystal Drugs

Problems with Large-Scale Nanoparticles Production

Chapter 7 Nanoparticles in Biotechnology

Research and Development

Stem Cell Research

Cellular Repair

Paramagnetic and Superparamagnetic Nanoparticles

Biosensors and Quantum Dots

Nanoparticle Research Collaborative Programs

Chapter 8 Nanoparticles in Drug Development and Formulation

Bio Separations

Rapid Drug Analysis

Removal of Impurities and Toxins

Using Nanoparticles to Incorporate Insoluble Drugs

Gold and Silver Nanoparticles in Biomedicine

DNA Nanoparticle Development of DNA-Specific Drugs

Chapter 9 Nanoparticles in Drug Delivery Systems

Nanoparticles in Drug Delivery Applications

Designing a Nanoparticle Drug Delivery System

Nanoparticle Drug Stability

Size Homogeneity of Nanoparticle Preparations

Drug Loading of Nanoparticles

Drug Release from Nanoparticles

External Triggers for Releasing Drugs from Nanoparticles

Binding/Incorporation of Biomolecules to Nanoparticles

Nanoparticle Toxicity

Large Scale Manufacturing

Methods of Administration of Nanoparticle Drugs

Oral Administration

Injection Administration

Transdermal Patch

Implantation Administration

Inhalation Administration

Nanoparticles Suitable for Drug Delivery Systems

Lipid-Based Nanoparticles

Micelle Nanoparticles

Dendrimer Nanoparticles

Polymeric Nanoparticles

Metal-Based Nanoparticles

Biological Macromolecule Nanoparticles

Nanocrystals

Nanoparticle Drug Delivery Systems Now Available

Antibiotic Nanoparticles

Anti-Tumor and Small Molecule Delivery by Nanoparticle

Release of Anti-Cancer Drugs from Nanoparticles

Biomacromolecules Delivered by Nanoparticles

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Nanoparticles in Biotechnology, Drug Development and Drug Delivery Systems, 2020 Report - Overview, Structure, Production, COVID-19, Patents,...

A new market study report by The Insight Partners on the DNA Sequencing Market has been released with reliable information and accurate forecasts for a better understanding of the current and future market scenarios. The report offers an in-depth analysis of the global market, including qualitative and quantitative insights, historical data, and estimated projections about the market size and share in the forecast period. The forecasts mentioned in the report have been acquired by using proven research assumptions and methodologies. Hence, this research study serves as an important depository of the information for every market landscape. The report is segmented on the basis of types, end-users, applications, and regional markets.

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What is DNA Sequencing?

DNA sequencing is a process in which various DNA strands can be sequenced through massive parallelization. This sequencing involves both Sangers method of DNA sequencing and non-Sangers methods of DNA sequencing. Advantages such as lower cost, high accuracy and speed, and accurate results even from low sample input are offered by DNA sequencing over microarray and other genomic analysis methods. DNA sequencing is used in various applications such as biomarker discovery, oncology studies, personalized medicine, forensics, and others. It has streamlined nucleotide analysis and consists of widely replaced conventional tools of genomics, especially microarray, genotyping, and others.

The key market drivers for DNA Sequencing Market Includes, rising applications of DNA sequencing in various fields along with technological advancements in the field of DNA sequencing. Moreover, increasing R&D investments by companies is also expected to boost market growth during forecast period. Whereas, accuracy and standardization concerns along with legal issues with DNA sequencing is expected to restrain market growth during forecast period.

The Emerging Players in the DNA Sequencing Market includes

An Overview of the Impact of COVID-19 on this Market:

Due to the pandemic, we have included a special section on the Impact of COVID 19 on the DNA Sequencing Market which would mention How the Covid-19 is Affecting the DNA Sequencing Industry, Market Trends and Potential Opportunities in the COVID-19 Landscape, Covid-19 Impact on Key Regions and Proposal for DNA Sequencing Players to fight Covid-19 Impact.

The research provides answers to the following key questions:

The study conducts SWOT analysis to evaluate strengths and weaknesses of the key players in the DNA Sequencing market. Further, the report conducts an intricate examination of drivers and restraints operating in the market. The report also evaluates the trends observed in the parent market, along with the macro-economic indicators, prevailing factors, and market appeal with regard to different segments. The report predicts the influence of different industry aspects on the DNA Sequencing market segments and regions.

DNA Sequencing Market: Regional analysis includes:

This report strategically examines the micro-markets and sheds light on the impact of technology upgrades on the performance of the DNA Sequencing market.

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Thanks for reading this article; you can also customize this report to get select chapters or region-wise coverage with regions such as Asia, North America, and Europe.

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The Insight Partners is a one stop industry research provider of actionable intelligence. We help our clients in getting solutions to their research requirements through our syndicated and consulting research services. We are committed to provide highest quality research and consulting services to our customers. We help our clients understand the key market trends, identify opportunities, and make informed decisions with our market research offerings at an affordable cost.

We understand syndicated reports may not meet precise research requirements of all our clients. We offer our clients multiple ways to customize research as per their specific needs and budget

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How DNA Sequencing Market: Impact Of COVID-19 On Biotechnology Industry Abbott Laboratories, SIEMENS AG, Thermo Fisher Scientific, Inc., Danaher...

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company on January 21, 2021 at the virtual B. Riley Oncology Investor Conference. A replay of the presentation will be available for 30 days beginning at approximately 1:30 p.m. PST on January 21, 2021 on the Companys website at http://www.pumabiotechnology.com.

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

Further information about Puma Biotechnology may be found at http://www.pumabiotechnology.com.

Excerpt from:
Puma Biotechnology to Present at the B. Riley Oncology Investor Conference - Business Wire

The Global Biotechnology Separation Systems Market Business Perspective, Comprehensive Analysis, and Forecast 2021-2025 throughout the forecast period. Biotechnology Separation Systems market report provides comprehensive research upgrades and data linked to promoting increases, requirement, and opportunities in the World.

Global Biotechnology Separation Systems Market Report is an idea and in detail study of the present state expected at the major drivers, market strategies, and key players enlargement. The study also involves the important Achievements of the market, Research & Development, new product launch, product responses, and regional growth of the most important competitors operating in the market on a universal and local scale.

DOWNLOAD FREE SAMPLE REPORT: https://www.eonmarketresearch.com/sample/78340

Biotechnology Separation Systems Market Research Report Will Be Sympathetic For:

The Top Key Players Profiled In This Report Are:

DanaherThermo Fisher ScientificBDMerckGE HealthcareAgilentSysmexAlfa WassermannShimadzu

The analysis offers detailed segmentation of this global Biotechnology Separation Systems market-based on Services, Product-Types, Applications and also Regional Analysis

By Type:

General Type

By Applications:

CommercialScientific Research

Major regional sections studied in this research comprise using its new bifurcation as above stated and significant nations as North America, Europe, Asia-Pacific, Middle East, and Africa, and South America. This segmentation includes the requirement for Biotechnology Separation Systems predication on different services and products in most areas and states. Europe has ruled Biotechnology Separation Systems markets. North America and the Asia Pacific are growing at high speed in Biotechnology Separation Systems market as a result of employment, traditional tools, and advancements.

Any Questions? Feel Free To Enquire Here. We will Put You On The Right Path:https://www.eonmarketresearch.com/enquiry/78340

Table of Content:

Chapter 1 About the Biotechnology Separation Systems Industry

Chapter 2 Global Market Competition Landscape

Chapter 3 Global Biotechnology Separation Systems Market share

Chapter 4 Supply Chain Analysis

Chapter 5 Company Profiles

Chapter 6 Globalisation and Trade

Chapter 7 Distributors and Customers

Chapter 8 Import, Export, Consumption and Consumption Value by Major Countries

Chapter 9 Global Biotechnology Separation Systems Market Forecast through 2027

Chapter 10 Key success factors and Market Overview

ACCESS FULL REPORT:https://www.eonmarketresearch.com/global-biotechnology-separation-systems-market-research-report-2021-2025-78340

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Eon Market Research (EMR) is a market research-based company that empowers data-driven companies. We provide accurate and well-informed market research reports, Real-Time with Real Application. Good research methodology proves to be effective and concise knowledge that uses complex decisions from day-to-day to day-to-day life to help us manage vision, intention and well-armed strategies. At EON Market Research, we are constantly striving for excellence in the techniques and consistency of research in our studies.

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Global Biotechnology Separation Systems Market Research Report Provides An In-Depth Insight Of Size, Future Trends, Growth Opportunities & Top Key...

EAST SETAUKET, NY, Jan. 19, 2021 (GLOBE NEWSWIRE) -- Lixte Biotechnology Holdings, Inc. (NASDAQ: LIXT), a clinical-stage drug discovery company developing pharmacologically active drugs for use in cancer treatment, today announced an agreement on a Phase 1b clinical trial with City of Hope, a world-renowned independent cancer research and treatment center. The trial will assess the combination of Lixtes first-in-class protein phosphatase inhibitor LB-100 with a standard regimen for untreated, extensive stage-disease small cell lung cancer (ED-SCLC).

LB-100 will be given in combination with carboplatin, etoposide and atezolizumab, an FDA approved but marginally effective regimen, in previously untreated ED-SCLC. The dose of LB-100 will be escalated with fixed doses of the 3-drug regimen to reach a recommended Phase 2 dose (RP2D). Patient entry will then be expanded so that a total of 12 patients will be evaluable at the RP2D to confirm its safety and to look for objective evidence of potential therapeutic activity as assessed by objective response rate, duration of overall response, progression-free-survival and overall survival.

John S. Kovach, M.D., Lixte founder and chief executive officer, said Small cell lung cancer (SCLC) comprises approximately 15% of all lung cancers worldwide with about 30,000 new cases annually in the US. Although this very aggressive neuroendocrine tumor is much more sensitive to cytotoxic chemotherapy and radiation than the most common type of lung cancer, SCLC patients soon relapse after treatment and have a dismal prognosis. Recently, the addition of an immune blocker, atezolizumab, to carboplatin plus etoposide showed the first significant but modest improvement in median progression free survival from 4.3 to 5.2 months, and in median overall survival from 10.3 to 12.3 months.

Kovach continued, In animal models, LB-100 significantly enhances the antitumor activity of cytotoxic chemotherapy in general, and in particular, the combination of carboplatin and etoposide against SCLC cells without enhancing toxicity. Mice models may not be predictive for humans, but if the extensive preclinical data showing LB-100 increases the effectiveness of chemotherapy applies to patients, we should see clear evidence of therapeutic benefit even in this early trial.

Ravi Salgia, M.D., Ph.D., the trials principal investigator and City of Hopes Arthur & Rosalie Kaplan Chair in Medical Oncology, said, City of Hope is in constant pursuit of more effective therapies for its cancer patients, and this therapeutic combination could be one for patients with small cell lung cancer, which is currently difficult to treat, particularly after a patient has relapsed. We look forward to working with Lixte on this important trial that we hope will make more therapeutic options available for patients with small cell lung cancer.

About City of Hope

City of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases. Founded in 1913, City of Hope is a leader inbone marrow transplantation and immunotherapy such asCAR T cell therapy. City of Hopes translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodiesandnumerous breakthrough cancer drugsare based on technology developed at the institution. AccessHopeTM, a wholly owned subsidiary, was launched in 2019 and isdedicated to serving employers and their health care partners by providing access to City of Hopes exceptional cancer expertise. A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nations Best Hospitals in cancer by U.S. News & World Report. Its main campus is located near Los Angeles, withadditional locationsthroughout Southern California and in Arizona. For more information aboutCity of Hope, follow us onFacebook,Twitter,YouTubeorInstagram.

About Lixte Biotechnology Holdings, Inc.

Lixte Biotechnology Holdings, Inc. (Nasdaq: LIXT) is a clinical-stage pharmaceutical company dedicated to discovering drugs for more effective treatments for many forms of cancer and other serious common diseases. A major driver of cancer is defects in the switches that turn the biochemical pathways in cells on and off. Most cancer research over the past 30 years has focused on the on switches because the off switches, especially the master off switch protein phosphatase (PP2A), were believed to cause intolerable toxicity in patients. Lixte has achieved a breakthrough with its novel, first-in-class lead compound, PP2A inhibitor LB-100, by demonstrating that it is readily tolerated in cancer patients at doses associated with anti-cancer activity. This innovative approach encourages cancer cells, weakened by chemo or other cancer therapies, to continue to replicate, leading to the more efficient death and elimination of those cells from the body. Lixte has partnered with top medical institutions and leading academic research centers to advance the clinical development of its compounds. The LB-100 compound, of which there are no competitors in the clinic, is currently being tested in three clinical studies with others in planning. lixte.com

Forward-Looking Statements

This announcement contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. For example, statements regarding the Company's financial position, business strategy and other plans and objectives for future operations, and assumptions and predictions about future product demand, supply, manufacturing, costs, marketing and pricing factors are all forward-looking statements. These statements are generally accompanied by words such as "intend," anticipate," "believe," "estimate," "potential(ly)," "continue," "forecast," "predict," "plan," "may," "will," "could," "would," "should," "expect" or the negative of such terms or other comparable terminology. The Company believes that the assumptions and expectations reflected in such forward-looking statements are reasonable, based on information available to it on the date hereof, but the Company cannot provide assurances that these assumptions and expectations will prove to have been correct or that the Company will take any action that the Company may presently be planning. However, these forward-looking statements are inherently subject to known and unknown risks and uncertainties. Actual results or experience may differ materially from those expected or anticipated in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, regulatory policies, available cash, research results, competition from other similar businesses, and market and general economic factors. This discussion should be read in conjunction with the Company's filings with the United States Securities and Exchange Commission athttp://www.sec.gov/edgar.shtml.

Lixte Contact:info@lixte.comGeneral Phone: (631) 830-7092Investor Phone: (888) 289-5533

Excerpt from:
Lixte Biotechnology and City of Hope to Initiate Phase 1b Clinical Trial of Lixte's Lead Compound LB-100 to Treat Small Cell Lung Cancer -...

Report Highlights

Several significant developments have aided and accelerated the growth of markets in biotechnology, in the period of review. Notable recent advancements in biotechnology are CRISPR, Spheroids for drug development, Quantitative Cell Based Assay using high content analysis platform and Luciferase based high-throughput screening assay. Such technologies assure the wide adoption of cell line technologies for drug development, simplify the gene editing process making it cost-effective.

Companies operating in cell line market are investing huge amount in setting up manufacturing units with advanced state of art facility and expanded production facilities. At the same time, the genetic sequencing technology is advancing at a great pace especially in the healthcare sector in diagnosis of various cancers.

Gene therapy technology has opened new avenues which places emphasis on curing disease that do not have an effective therapeutic availability. Johnson & Johnson, together with the University of Pennsylvania, is developing a third-generation AAV-based gene therapy for Alzheimers disease. The goal is to use AAV viral delivery to initiate the expression of therapeutic anti-Alzheimers antibodies in the brain. Novartis launched Zolgensma for the treatment of spinal muscular atrophy. The research represents a novel way to get biologics into the brain to treat Alzheimers disease and other neurological diseases. This is expected to pave way for further innovations in AAV-based gene therapy.

For in-depth competitive analysis, buy [emailprotected]https://www.trendsmarketresearch.com/checkout/12599/Single

The sector continuously faces some challenges related to marketing, paying for innovation, pricing pressures from the government organizations.

Paying for development costs is always most critical part for the manufacturers. In 2019, gene therapies and many cell biology technologies are developed to address the needs of some important diseases and proven to be effective. However, this comes for a high cost. For example, Zolgensma, a viral vector based gene therapy for the treatment of spinal muscular atrophy costs around $5 million. It is important to figure out how to pay for the innovation which is quite challenging.

The pricing and paying for getting the products to market are important challenges. The innovation may take several years from clinical trial phase to get launched in the market. The investors may be disappointed if the company doesnt show expected profits and loses the hope while stock prices fall. This means that companies must carefully manage expectations and maintain balance.

It includes highlights of reports published in 2019 on the following biotech markets:

Covid 19 Impact[emailprotected] https://www.trendsmarketresearch.com/report/covid-19-analysis/12599

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Biotechnology Research Market 2023: Potential growth, attractive valuation make it is a long-term investment Reviewindependent - Reviewindependent

Overview Of Pharmaceutical and Biotechnology Machines Industry 2020-2025:

This has brought along several changes in This report also covers the impact of COVID-19 on the global market.

The Pharmaceutical and Biotechnology Machines Market analysis summary by Reports Insights is a thorough study of the current trends leading to this vertical trend in various regions. Research summarizes important details related to market share, market size, applications, statistics and sales. In addition, this study emphasizes thorough competition analysis on market prospects, especially growth strategies that market experts claim.

The report offers detailed coverage of Pharmaceutical and Biotechnology Machines industry and main market trends. The market research includes historical and forecast market data, demand, application details, price trends, and company shares of the leading Pharmaceutical and Biotechnology Machines by geography. The report splits the market size, by volume and value, on the basis of application type and geography.

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Pharmaceutical and Biotechnology Machines Market competition by top manufacturers as follow:Air LiquideLinde HealthcarePraxairAir ProductsTaiyo Nippon SansoMatheson GasAtlas Copco ABMesser GroupSOL GroupNorcoSicgil India LimitedShenzhen GaofaShenwei MedicalBeijing OrientNanning Lantian

The Type Coverage in the 55 Market are::-OxygenNitrous OxideMedical AirOthers(Nitrogen, Carbon Dioxide and Helium)

55 Market Segment by Applications, covers:-Hospitals (Labs & Clinics)Home HealthcareUniversities/Research InstitutionsPharmaceutical & Biotechnology Industries

The global Pharmaceutical and Biotechnology Machines market has been segmented on the basis of technology, product type, application, distribution channel, end-user, and industry vertical, along with the geography, delivering valuable insights.

Market segment by Regions/Countries, this report coversNorth AmericaEuropeChinaRest of Asia PacificCentral & South AmericaMiddle East & Africa

Major factors covered in the report:

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The analysis objectives of the report are:

Our report offers:

Market share assessments for the regional and country level segments. Market share analysis of the top industry players. Strategic recommendations for the new entrants. Market forecasts for a minimum of 9 years of all the mentioned segments, sub segments and the regional markets. Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations). Strategic recommendations in key business segments based on the market estimations. Competitive landscaping mapping the key common trends. Company profiling with detailed strategies, financials, and recent developments. Supply chain trends mapping the latest technological advancements.

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Pharmaceutical and Biotechnology Machines Market Business Opportunities and Future Scope by 2025 Praxair, Air Liquide, Air Products, Linde Healthcare...

A rating of 88 puts Acer Therapeutics Inc (ACER) near the top of the Biotechnology industry according to InvestorsObserver. Acer Therapeutics Inc's score of 88 means it scores higher than 88% of stocks in the industry. Acer Therapeutics Inc also received an overall rating of 72, putting it above 72% of all stocks. Biotechnology is ranked 32 out of the 148 industries.

Trying to find the best stocks can be a daunting task. There are a wide variety of ways to analyze stocks in order to determine which ones are performing the strongest. Investors Observer makes the entire process easier by using percentile rankings that allows you to easily find the stocks who have the strongest evaluations by analysts.

This ranking system incorporates numerous factors used by analysts to compare stocks in greater detail. This allows you to find the best stocks available in any industry with relative ease. These percentile-ranked scores using both fundamental and technical analysis give investors an easy way to view the attractiveness of specific stocks. Stocks with the highest scores have the best evaluations by analysts working on Wall Street.

Acer Therapeutics Inc (ACER) stock is trading at $3.65 as of 11:48 AM on Friday, Jan 22, a loss of -$0.07, or -1.88% from the previous closing price of $3.72. The stock has traded between $3.39 and $3.70 so far today. Volume today is light. So far 344,395 shares have traded compared to average volume of 1,326,749 shares.

Click Here to get the full Stock Score Report on Acer Therapeutics Inc (ACER) Stock.

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Is Acer Therapeutics Inc (ACER) The Right Choice in Biotechnology? - InvestorsObserver