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AgeX Therapeutics Licensee ImStem Biotechnology Announces FDA has Lifted the Hold and Cleared the Investigational New Drug Application for IMS001 for…

AgeX Therapeutics, Inc. ("AgeX"; NYSE American: AGE), a biotechnology company focused on developing therapeutics for human aging and regeneration, announced today that ImStem Biotechnology, Inc. (Farmington, CT), a biopharmaceutical company pioneering the development of mesenchymal stem cells (hES-MSC) derived from human embryonic stem cells has received notification from the U.S. Food and Drug Administration (FDA) that it has lifted the hold and cleared the Investigational New Drug (IND) application to evaluate IMS001 for the treatment of multiple sclerosis (MS). IMS001 was derived from the pluripotential cell line designated ESI-053 licensed from AgeX.

"Since pluripotent stem cells are capable of differentiating into all human cell types potentially genetically modified in any manner, they open the door to a wide array of new therapies," stated Dr. Michael D. West, PhD, founder and CEO of AgeX. "This collaboration with ImStem is consistent with our aim to make our clinical-grade pluripotent stem cell banks widely available for diverse therapeutic applications."

IMS001 is a formulation of cells derived from AgeX pluripotent stem cells induced to differentiate into mesenchymal cells (hES-MSC) and through a proprietary method using a trophoblast intermediate stage (hence also known as T-MSC) for the treatment of neurological, autoimmune, and rare orphan diseases. IMS001 is an investigational, allogeneic cell product to be administered intravenously to patients suffering from MS. ImStem believes this is the first hES-MSC based allogeneic cell therapy accepted for clinical trial by the FDA. ImStem plans to initiate a phase 1 clinical study in patients with relapsing-remitting, secondary, and primary progressive forms of MS in 2020 in the US.

"The clinical-grade pluripotent stem cell lines from AgeX were the first published GMP-compatible lines ever created," said Xiaofang Wang, MD, PhD, Founder and Chief Technology Officer of ImStem. "As such, they have been widely distributed in the scientific community and demonstrated to meet the needs of industry for relatively rapid product development."

About AgeX Therapeutics

AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics for human aging. Its PureStem and UniverCyte manufacturing and immunotolerance technologies are designed to work together to generate highly-defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeXs revolutionary longevity platform induced Tissue Regeneration (iTR) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. AGEX-iTR1547 is an iTR-based formulation in preclinical development. HyStem is AgeXs delivery technology to stably engraft PureStem cell therapies in the body. AgeX is developing its core product pipeline for use in the clinic to extend human healthspan and is seeking opportunities to establish licensing and collaboration agreements around its broad IP estate and proprietary technology platforms.

For more information, please visit http://www.agexinc.com or connect with the company on Twitter, LinkedIn, Facebook, and YouTube.

About IMS001

IMS001 is an investigational, allogeneic, hES-MSC that has undergone IND-enabling, preclinical biodistribution, engraftment, tumorigenicity, toxicology, immunogenicity, and pharmacology studies. IMS001 has demonstrated preclinical immunomodulatory activities, which may lead to potential therapeutic benefits in a wide array of neurological, autoimmune, and rare orphan diseases with high unmet medical needs.

Previously published in-vitro data, in collaboration with scientists at the University of Connecticut (UConn) Health, have demonstrated potential advantages of hESC-MSCs in terms of their immunomodulatory effects, as well as the potential to stabilize the blood-brain-barrier (BBB). These mechanistic properties may lead to therapeutic benefits in diseases such as MS, potentially reducing relapses, disability progression, and inducing disease arrest.

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About ImStem Biotechnology

ImStem Biotechnology, Inc. is aspiring to revolutionize how serious diseases with significant unmet needs are treated with a new generation of regenerative and cellular therapies. Pioneering research by its current founder and Chief Technology Officer Dr. Xiaofang Wang and Dr. Ren-He Xu, former director of UConn Stem Cell Institute, led to the proprietary state-of-the-art pluripotent stem cell technology, enabling off-the-shelf, allogeneic stem cell-derived products to be manufactured in scale, differentiating itself from the typical challenges imposed by autologous adult cell therapy products. The companys mission is to advance the science and understanding of human pluripotent stem cell based regenerative cellular therapies through novel and creative development pathways and to fulfill unmet medical needs in serious diseases. And its development strategy focuses on neurologic, autoimmune, degenerative, and rare orphan diseases. ImStem Biotechnology, Inc. is a privately held company headquartered in Farmington, CT. For more information, visit http://www.imstem.com.

Forward-Looking Statements

Certain statements contained in this release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical fact including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates" should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of AgeX Therapeutics, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the "Risk Factors" section of AgeXs Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commissions (copies of which may be obtained at http://www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. AgeX specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

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Contacts

Media Contact for AgeX:

Bill Douglass Gotham Communications, LLCbill@gothamcomm.com (646) 504-0890

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Industry Analysis: Should You Buy Halozyme Therapeutics, Inc. (HALO) in Biotechnology? – InvestorsObserver

The 65 rating InvestorsObserver gives to Halozyme Therapeutics, Inc. (HALO) stock puts it near the top of the Biotechnology industry. In addition to scoring higher than 73 percent of stocks in the Biotechnology industry, HALOs 65 overall rating means the stock scores better than 65 percent of all stocks.

Analyzing stocks can be hard. There are tons of numbers and ratios, and it can be hard to remember what they all mean and what counts as good for a given value. InvestorsObserver ranks stocks on eight different metrics. We percentile rank most of our scores to make it easy for investors to understand. A score of 65 means the stock is more attractive than 65 percent of stocks.

Our proprietary scoring system captures technical factors, fundamental analysis and the opinions of analysts on Wall Street. This makes InvestorsObservers overall rating a great way to get started, regardless of your investing style. Percentile-ranked scores are also easy to understand. A score of 100 is the top and a 0 is the bottom. Theres no need to try to remember what is good for a bunch of complicated ratios, just pay attention to which numbers are the highest.

Halozyme Therapeutics, Inc. (HALO) stock is trading at $16.32 as of 11:17 AM on Friday, Mar 20, an increase of $1.42, or 9.53% from the previous closing price of $14.90. The stock has traded between $14.59 and $17.07 so far today. Volume today is below average. So far 1,323,518 shares have traded compared to average volume of 2,074,179 shares.

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Nanoparticles in Biotechnology and Pharmaceuticals Market Growth by Top Companies, Trends by Types and Application, Forecast to 2026 – Bandera County…

Verified Market Research recently published a research report titled, Nanoparticles in Biotechnology and Pharmaceuticals Market Study Report 2020. The research report is created based on historical and forecast data derived from researchers using primary and secondary methods. The Nanoparticles in Biotechnology and Pharmaceuticals market is one of the fastest-growing markets and is expected to witness substantial growth in the forecast years. Reader are provided easy access to thorough analysis on the various aspects such as opportunities and restraints affecting the market. The report clearly explains the trajectory this market will take in the forecast years.

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Nanoparticles in Biotechnology and Pharmaceuticals Market Leading Players:

Nanoparticles in Biotechnology and Pharmaceuticals Market: Competitive Landscape

This section of the report provides complete information about the various manufacturers in the market. The major manufacturers to which the report refers hold a large proportion that require a microscopic appearance. It provides important information about the different strategies of these manufacturers to combat competition and to expand their presence in the market. In addition, the current trends of the manufacturers are checked in order to innovate their product for the future. This report is intended to help the reader understand the market and make business decisions accordingly.

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Executive Summary: It includes key trends of the Nanoparticles in Biotechnology and Pharmaceuticals market related to products, applications, and other crucial factors. It also provides analysis of the competitive landscape and CAGR and market size of the Nanoparticles in Biotechnology and Pharmaceuticals market based on production and revenue.

Production and Consumption by Region: It covers all regional markets to which the research study relates. Prices and key players in addition to production and consumption in each regional market are discussed.

Key Players: Here, the report throws light on financial ratios, pricing structure, production cost, gross profit, sales volume, revenue, and gross margin of leading and prominent companies competing in the Nanoparticles in Biotechnology and Pharmaceuticals market.

Market Segments: This part of the report discusses about product type and application segments of the Nanoparticles in Biotechnology and Pharmaceuticals market based on market share, CAGR, market size, and various other factors.

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Tags: Nanoparticles in Biotechnology and Pharmaceuticals Market Size, Nanoparticles in Biotechnology and Pharmaceuticals Market Trends, Nanoparticles in Biotechnology and Pharmaceuticals Market Forecast, Nanoparticles in Biotechnology and Pharmaceuticals Market Growth, Nanoparticles in Biotechnology and Pharmaceuticals Market Analysis

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America’s Biopharmaceutical Companies Working Around the Clock to Beat Coronavirus – BioSpace

WASHINGTON, March 20, 2020 /PRNewswire/ -- Today, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) underscored the industry's commitmentto finding solutions to prevent, diagnose and treat those with COVID-19, a disease caused by a novel strain of coronavirus. The decades-long investments biopharmaceutical companies have made in new technologies, research and treatments have prepared the industry to act swiftly to respond to the public health crisis.

America's biopharmaceutical companies are working around the clock to:

"I'm confident our industry will achieve its shared goal to beat coronavirus, and our commitment underscores how we are uniquely positioned to do so," said Stephen J. Ubl, president and chief executive officer of PhRMA. "We have deep scientific knowledge gained from decades of experience with similar viruses; the industry has invested billions in technologies that have dramatically shortened the time it takes to decode viruses and develop a potential vaccine; and our companies alone have the ability to manufacture and broadly disseminate vaccines or treatments."

"Researchers at America's biopharmaceutical companies are working around the clock to contain the spread of the novel coronavirus and deliver treatments to those impacted by this deadly disease," said Jim Greenwood, president and CEO of BIO. "Today, we renew our commitment as an industry to help those in need, protect our workforce and ensure any treatments we develop in response to this pandemic are accessible and affordable for everyone. These are the principles that always guide our industry, and they serve as the foundation for our response to this global health crisis."

America's biopharmaceutical companies are working in close collaboration with government agencies and other stakeholders in the quest to beat coronavirus. Everyone has a unique role to play and we are confident that together we can succeed.

View the industry's print ad about our commitment to beat coronavirus here.

View the industry's commitment to beat coronavirus here.

Learn more at PhRMA.org/coronavirusand bio.org/coronavirus.

About PhRMA The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country's leading innovative biopharmaceutical research companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives. Since 2000, PhRMA member companies have invested more than $900 billion in the search for new treatments and cures, including an estimated $79.6 billion in 2018 alone.

About BIO BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces theBIO International Convention, the world's largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.

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Global Agricultural Biotechnology Market 2027:Rising Demand And Forecast Analysis By Major Players Like Evogene Ltd., Canonic ltd., Bayer AG, Valent…

Agricultural biotechnology marketis expected to gain market growth in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market to account to USD 74.55 billion by 2027 growing at a CAGR of 9.94% in the above-mentioned forecast period. Escalated penetration of biotechnology, tissue culture, and molecular breeding and unique plant breeding is defining the success parameters of agricultural biotechnology market.

The Agricultural biotechnology market report keenly considers the market type, size of the organization, availability on-premises, end-users organization type, and the availability in areas such as North America, South America, Europe, Asia-Pacific and Middle East & Africa to analyse the data. Thus, this market research report encompasses various parameters of the market. The analysis and estimations carried out via this Agricultural biotechnology report helps to get the details about the product launches, future products, joint ventures, marketing strategy, developments, mergers and acquisitions and effect of the same on sales, marketing, promotions, revenue, import, export, and CAGR values.

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The major players covered in the agricultural biotechnology market report areKWS SAAT SE & Co. KGaA, ChemChina, Corteva., Limagrain, MITSUI & CO., LTD., AgPlenus ltd., Biomica, Evogene Ltd., Canonic ltd., Bayer AG, Valent BioSciences LLC, Nufarm Limited, Marrone Bio Innovations., Performance Plants Inc., ADAMA Ltd. among other domestic and global players. Market share data is available for global, North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and South America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

Major Topics Covered in this Report:

Chapter 1 Study Coverage

Chapter 2 Executive Summary

Chapter 3 Market Size by Manufacturers

Chapter 4 Production by Regions

Chapter 5 Consumption by Regions

Chapter 6 Market Size by Type

Chapter 7 Market Size by Application

Chapter 8 Manufacturers Profiles

Chapter 9 Production Forecasts

Chapter 10 Consumption Forecast

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Global Agricultural Biotechnology Market Scope and Market Size

Agricultural biotechnology market is segmented on the basis of type, application, organism type, technology, and product. 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.

On the basis of type, agricultural biotechnology market is segmented into molecular diagnostics, molecular markers, tissue culture, vaccines,geneticengineering, and others.On the basis of application, the agricultural biotechnology market is bifurcated into transgenic crops, flower culturing, nutritional supplements, biofuels, antibiotic development, vaccine development and others.On the basis of organism type, theagricultural biotechnologymarket is divided into plants, animals, microbes, and others.On the basis of technology, the agricultural biotechnology market is fragmented into genome editing tools, ribonucleic acid interference [RNAi], biochips, deoxy ribonucleic acid [DNA] sequencing, and synthetic biology.Based on the product, the agricultural biotechnology market is segregated into crop protection products, transgenic seeds, and synthetic biology-enables products. Crop protection products are further sub-categorized into biostimulants, and biopesticides. Transgenic seeds are further sub-segmented into soybean, fruits & vegetables, maize, cotton, and others.

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Ridgeback Biotherapeutics and Drug Innovations Ventures at Emory Partner to Develop Clinical Stage Coronavirus Treatment – Associated Press

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Ridgeback Biotherapeutics is dedicated to working toward finding life-saving and life changing solutions for patients and diseases that need champions. (PRNewsfoto/Ridgeback Biotherapeutics LP)

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Ridgeback Biotherapeutics is dedicated to working toward finding life-saving and life changing solutions for patients and diseases that need champions. (PRNewsfoto/Ridgeback Biotherapeutics LP)

ATLANTA and MIAMI, March 19, 2020 /PRNewswire/ -- Ridgeback Biotherapeutics LP, a closely held biotechnology company, and Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University, today announced a collaboration to rapidly advance DRIVEs EIDD-2801, a promising oral COVID-19 treatment, into human testing. This collaboration combines Ridgebacks unique experience advancing drug development efforts in the midst of an on-going disease outbreak with the three decades of experience that the DRIVE executive team has in antiviral drug development and commercialization.

Under the collaboration, Ridgeback has exclusively licensed DRIVEs EIDD-2801, a promising potential coronavirus treatment for COVID-19, which has broad spectrum activity against a number of diseases of extreme public health concern, including influenza, SARS, MERS, chikungunya, and equine encephalitis (VEE and EEE). EIDD-2801 prevents the replication of multiple strains of coronavirus in vitro, and has been shown to have potent activity against SARS-CoV and MERS-CoV in animal models of infection. Ridgeback Biotherapeutics will be responsible for advancing this promising therapeutic through clinical development and ensuring that EIDD-2801 is available during the current pandemic.

With EIDD-2801 close to entering clinical trials for influenza and its activity against the SARS and MERS coronaviruses, we immediately recognized that EIDD-2801 had the potential for treating COVID-19. Based on our extensive testing, we believe EIDD-2801 will be effective in treating individuals that have been sickened by COVID-19, says George Painter, PhD, Director of the Emory Institute for Drug Development (EIDD) and CEO of DRIVE. Given Ridgeback Biotherapeutics experience in accelerating the development of potential therapeutics in outbreak settings and its proven commitment to global health, we are confident that Ridgeback can quickly advance EIDD-2801 into clinical trials for COVID-19 and initiate steps toward ensuring a rapid development path for this promising drug.

Ridgeback Biotherapeutics has unique experience meeting the challenges of developing novel drug treatments during an ongoing disease outbreak. In 2018, at the beginning of the Ebola outbreak in the Democratic Republic of the Congo (DRC), Ridgeback Biotherapeutics licensed mAb114 (ansuvimab), a promising Ebola therapeutic, from NIAIDs Vaccine Research Center. Ansuvimab demonstrated a highly statistically significant survival benefit (as measured by a reduction in 28-day mortality) in the PALM randomized control trial which was conducted during the 2018-2020 Ebola outbreak in the DRC. Results of that study were published in the New England Journal of Medicine in November 2019 (Mulangu, 2019). Currently, Ridgeback is completing its Biologics Licensing Application (BLA) submission with the U.S. Food and Drug Administration (FDA) for commercial licensure of ansuvimab (mAb114). Under the EIDD-2801 licensing agreement, Ridgeback Biotherapeutics will be responsible for conducting the necessary trials to bring EIDD-2801 to licensure.

As a potent oral antiviral agent, EIDD-2801 represents one of the best options available to impact the current global pandemic. Its broad-spectrum antiviral activity makes it an excellent candidate for treating a variety of infectious diseases including influenza as well as for other emerging infectious diseases like Eastern Equine Encephalitis, says Wendy Holman, CEO of Ridgeback Biotherapeutics. During this unprecedented crisis, Ridgeback looks forward to working with the seasoned drug development team at DRIVE and the dedicated and brave medical, public health and governmental personnel that are on the frontlines of this pandemic both within the United States and abroad. The ability to deliver promising treatments to patients in need is what makes us excited to come to work every day. Ridgeback is uniquely positioned to help advance EIDD-2801 not only for its potential commercial indications, but also for the treatment of diseases that are critical to global health.

The development of EIDD-2801 has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases (NIAID), under contract numbers HHSN272201500008C and 75N93019C00058, and from the Defense Threat Reduction Agency (DTRA), under contract numbers HDTRA1-13-C-0072 and HDTRA1-15-C-0075, for the treatment of Influenza, coronavirus, chikungunya, and Venezuelan Equine Encephalitis Virus.

About EIDD-2801: EIDD-2801 is an orally bioavailable form of a highly potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV2. In laboratory and animal studies of two distinct coronaviruses (SARS-CoV1 and MERS), the bioactive form of EIDD-2801 has been shown to improve pulmonary function, decrease body weight loss and reduce the amount of virus in the lung. EIDD-2801 is expected to begin clinical testing for SARS-CoV2 and influenza in the second quarter of 2020. In addition to activity against SARS-CoV2, EIDD-2801, in laboratory studies, has demonstrated activity against respiratory syncytial virus, influenza, chikungunya, Ebola, Venezuelan equine encephalitis virus, and Eastern equine encephalitis viruses.

About Ridgeback Biotherapeutics LP: Headquartered in Miami, Florida, Ridgeback Biotherapeutics is a privately held, majority woman owned biotechnology company focused on orphan and infectious diseases. Initial funding for Ridgeback Biotherapeutics originated from Wayne and Wendy Holman; two individuals committed to investing in and supporting technologies that will make the world a better place. The team at Ridgeback is dedicated to working toward finding life-saving and life changing solutions for patients and diseases that need champions. Ridgeback is in the process of completing a Biologics Licensing Application with the Food & Drug Administration for mAb114 (ansuvimab) for the treatment of Ebola. Ansuvimab development has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50119C00059.

About DRIVE: DRIVE is a non-profit LLC wholly owned by Emory and started as an innovative approach to drug development. Operating like an early stage biotechnology company, DRIVE applies focus and industry development expertise to efficiently translate discoveries to address viruses of global concern. DRIVEs mission is to discover and develop antiviral drugs for emerging infections, pandemic threats (e.g. COVID-19, swine flu, bird flu, dengue, chikungunya, Ebola, Zika, and viral encephalitis), and for biodefense. Because these diseases are major public health threats, antiviral drugs are critically needed to treat them; however, they are generally not profitable enough for industry to pursue, and thus are considered neglected diseases. DRIVE is unique in that it brings industry expertise to the assets of a leading research University to develop potential antiviral drugs to a de-risked value inflection point that substantially increases the probability of the potential drug being licensed by industry and developed for the ultimate benefit of the public. DRIVEs executive team, led by Dr. George Painter, has over three decades of drug development experience within both large pharmaceutical and biotechnology companies, including leading the development of multiple FDA approved antivirals to treat HIV and Influenza, among other viral diseases, including AZT and Relenza. Learn more at: http://driveinnovations.org/

About Defense Threat Reduction Agency: DTRA was founded in 1998 to integrate and focus the capabilities of the Department of Defense that address the Weapons of Mass Destruction (WMD) threat. The mission of DTRA is to safeguard America and its allies from WMD (chemical, biological, radiological, nuclear, and high yield explosives) by providing capabilities to reduce, eliminate, and counter the threat, and mitigate its effects. Under DTRA, Department of Defense resources, expertise and capabilities are combined to ensure the United States remains ready and able to address the present and future WMD threats.

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Ridgeback Biotherapeutics and Drug Innovations Ventures at Emory Partner to Develop Clinical Stage Coronavirus Treatment - Associated Press

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