BioHealth Innovation Weekly for December 05, 2023

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December 05, 2023

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Emergent BioSolutions Receives $75 Million Contract Option from BARDA to Procure Doses of CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted)

GAITHERSBURG, Md., Nov. 28, 2023 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that the Biomedical Advanced Research and Development Authority (BARDA) within the Administration for Strategic Preparedness and Response at the United States Department of Health and Human Services has awarded a $75 million option to Emergent’s existing contract (HHSO100201600030C) for the acquisition of newly licensed anthrax vaccine CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted). Deliveries are expected to begin this calendar year and be complete by the end of the first quarter of 2024.

Previously known as AV7909, CYFENDUS™ vaccine was approved by the U.S. Food & Drug Administration (FDA) in July 2023 as a two-dose anthrax vaccine for post-exposure prophylaxis use in individuals 18 years of age and older. Anthrax is considered a high-priority national security threat and has the potential for major public health impact.

citybiz (A BHI Client) Interviews Richard Hughen, CEO of Linshom Medical

Richard Hughen’s thirty years of professional medical device experience spans three Fortune 500 and four start-up companies with two successful exits to date. He is currently CEO of Linshom Medical, a start-up developing a novel continuous predictive respiratory monitoring device for the patient bedside and home. Ric was an investor and member of the executive team that built start-up CSA Medical, from a technology license (Navy) through product development, animal trials, clinical trials, five FDA clearances, CE mark, three rounds of funding ($50M), commercial growth and a 2019 sale to Steris. Ric was Managing Director of LearnWare, a life science focused e-learning start-up, which was successfully built and sold to a private equity fund.

He is currently a reviewer for the National Science Foundation’s SBIR/STTR program, an Entrepreneur in Residence for Johns Hopkins Tech Ventures and on the advisory board for George Mason University’s Bioengineering Alliance. He is founder of Life Science Planning, a strategic consultancy for life science companies with focus on fast paced start-up, early stage and emerging growth companies. Earlier in his career, Ric led various senior management, marketing, training and sales teams for Johnson & Johnson, BD, Abbott and Cordis. Ric holds MBA and BS degrees from The Pennsylvania State University. When not working, he is typically outside training for triathlon competition.

MIMETAS and Yamaha Motor Sign Joint Marketing Agreement to Advance Automated Human Disease Model Applications for Drug Development

LEIDEN, the Netherlands, November 29, 2023 / B3C newswire / -- MIMETAS, a leader in human 3D disease modeling, and Yamaha Motor Co., Ltd., a developer of the CELL HANDLER™, announce a strategic joint marketing agreement aimed at advancing therapeutic development using human-relevant models throughout the early drug development pipeline. The collaboration combines MIMETAS’ comprehensive disease modeling and assay development expertise with Yamaha Motor's state-of-the-art CELL HANDLER, an automated system for selecting, picking and imaging spheroids, tissues and organoids.

Bas Trietsch, CTO of MIMETAS, emphasized the significance of this collaboration, stating, “Introducing patient-relevant 3D disease models into the drug development pipeline is key to developing new therapeutics for unsolved diseases. However, most of these models lack a vascular system and integrated immune cells, which are critical for studying disease processes and therapy efficacy. One of the primary challenges with complex biological models lies in the variability of growth rate and morphology, making high-throughput, robust assays challenging and time consuming. To address these challenges, state-of-the-art automation, such as the Yamaha Cell Handler, is critical.” “By combining our technologies, we will improve the quality and robustness of tissue model applications in high-throughput,” said K. Matsuno, General Manager of Medical Device Business Division of Yamaha Motor. “Together, we can make advanced 3D human disease models suitable for all stages of early drug development.”

REGENXBIO Announces Dose Escalation in AFFINITY DUCHENNE® Trial

ROCKVILLE, Md., Nov. 29, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that the first patient received RGX-202 at dose level 2 in the Phase I/II AFFINITY DUCHENNE^®trial. RGX-202 is an investigational one-time AAV Therapeutic for Duchenne muscular dystrophy (Duchenne), using the NAV^® AAV8 vector to deliver a transgene for a novel microdystrophin that includes the functional elements of the C-Terminal (CT) domain as well as a muscle-specific promoter to support a targeted therapy for improved resistance to muscle damage associated with Duchenne.

"Progressing to dose level 2 is an important milestone in our updated strategic plans and for accelerating the development of RGX-202," said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. "There is a large unmet need for new therapies for boys with Duchenne, and the market is capable of supporting multiple gene therapies. We believe RGX-202 has unique, differentiating features that support its potential to be a best-in-class product."

424 Capital Announces Investment in VaLogic

WAKEFIELD, Mass., Nov. 29, 2023 /PRNewswire/ -- 424 Capital announced today that it has completed a significant investment in VaLogic, a leading provider of GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) compliance software and services based in Frederick, MD. This strategic move by 424 Capital aims to expedite positive clinical outcomes by enabling pharmaceutical and biotechnology organizations to focus on the research, development, and production of cutting-edge therapeutics in a compliant and effective manner.

Founded in 2001 by CEO Bill Robertson, VaLogic provides a comprehensive range of software and compliance services to the life science and biotechnology market. These services help organizations and facilities maintain GMP compliance and enact high standards while focusing on advancing life-saving therapeutics.

VaLogic offers advisory and facility design, full commissioning and qualification, cleanroom environmental monitoring, HEPA/cleanroom certifications, calibration, preventative maintenance, and a proprietary SaaS software called LogiPoint™ for continuous monitoring of critical facilities and equipment.

ATCC Announces Award from NIAID to Consolidate its BEI Resources and NIH HIV Reagent Programs

The Biological and Emerging Infections Research Resources Program (BEI-RRP) contract, which merges the two programs, represents the fourth recompete award with NIAID since 2003.

MANASSAS, Va.--(BUSINESS WIRE)--ATCC, the world’s premier biological materials management and standards organization, today announced a seven-year contract from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to continue the management of the BEI Resources Program. NIAID has made an initial award of over $21.5 million, with further funding expected if all project milestones are met. This contract will merge the NIH HIV Reagent Program with the BEI Resources Program under the Biological and Emerging Infections Research Resources Program (BEI-RRP) umbrella. ATCC has managed the BEI Resources Program since 2003 and the NIH HIV Reagent Program since 2020. This important merger will allow researchers to have streamlined access to all priority pathogens for human health under one program.

“Through our successful collaboration with NIAID, we have helped consolidate ten other repositories that provide critical materials to the infectious disease research community,” said ATCC chairman and CEO Raymond H. Cypess, DVM, Ph.D. “At ATCC, we understand why curated, high-quality biomaterials, reagents, and products are critical to achieving credible research results. We also recognize why streamlining access to these items is essential so researchers can develop the diagnostic tests, vaccines, and therapies needed to improve human health.”

Baltimore's MIRA Pharmaceuticals Releases Breakthrough Data from Artificial Intelligence Simulations

AI Simulation on MIRA1a Showcases Significant Potential Advantages Over Plant-Based Medical Marijuana Related to Anxiety, Appetite and Cognition

BALTIMORE, Dec. 4, 2023 /PRNewswire/ -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), an innovative pre-clinical-stage pharmaceutical company focused on neurologic and neuropsychiatric disorders, has released new data from artificial intelligence (AI) simulations that show that, compared to plant-based medical marijuana, there may be significant potential advantages to the therapeutic potential of MIRA1a, such as its potential to offer a superior anti-anxiety treatment, increased cognition and without the increased appetite associated with THC.

The simulations on MIRA1a were conducted in conjunction with the Company's strategic collaboration with InSilicoTrials, a company specializing in leveraging AI and simulations to enhance drug and medical device development.

Sara Nayeem, M.D., Experienced Biopharmaceutical Venture Investor, Joins Enavate Sciences as Executive Vice President, Investments

MENLO PARK, Calif., Dec. 4, 2023 /PRNewswire/ -- Enavate Sciences, a portfolio company of Patient Square Capital, is pleased to announce that Sara M. Nayeem, M.D. has joined the firm as Executive Vice President, Investments. Dr. Nayeem reports to James Boylan, Chief Executive Officer of Enavate Sciences, and will serve an integral role in the origination, evaluation, and selection of Enavate investments, as well as support Enavate partner companies on governance, partnerships, fundraising, and other strategic initiatives.

Dr. Nayeem has 20 years of banking and institutional investing experience. She most recently served as Partner at Avoro Ventures, a biopharma venture fund she helped launch in 2021. Previously she was a Partner at New Enterprise Associates, Inc. (NEA), where she spent 12 years as part of the biopharma investing group. Prior to joining NEA, Dr. Nayeem was an Associate with Merrill Lynch's Global Healthcare Group, where she advised biotechnology and medical device companies. She began her career as an Investment Banking Analyst at Morgan Stanley.

Get Pre-Application Support through the NHLBI Innovator to Entrepreneur Program!

The National Heart Lung and Blood Institute (NHLBI) in partnership with the National Institute of Allergy and Infectious Diseases (NIAID) will be providing training and resources for a new Innovator to Entrepreneur Program (ITEP). ITEP is designed to assist aspiring entrepreneurs by providing them with cohort-based training covering key elements of company launch, business strategy development, IP protection, market research, customer discovery, startup financing and SBIR/STTR grantsmanship.

This new program encourages participation in the SBIR/STTR program by underrepresented groups, Women-Owned Small Businesses, socially/economically disadvantaged small businesses, and small businesses located in HUBZones programs.

Attend the Informational Webinar on December 6th at 2PM ET to learn more about the new ITEP program. Information about ITEP is available on the ITEP website. ITEP will begin accepting applications of interest on December 8th.