545th Edition, February 7, 2023

GERMANTOWN, Md., Jan. 30, 2023 /PRNewswire/ — Deka Biosciences ("Deka"), a biotech company focused on developing novel cytokine therapies to treat cancer and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the investigational new drug (IND) application for DK210 (EGFR) and concluded that Deka may proceed with a Phase 1 clinical trial in the United States. The Phase 1, first-in-human, multicenter clinical study seeks to characterize the safety, and biomarkers for response of DK210 (EGFR) in patients with advanced solid cancer who are overexpressing epidermal growth factor receptors (EGFR) (NCT05704985).

 First placebo-controlled study of an engineered cell therapy

Gaithersburg, MD, January 31, 2023 – Cartesian Therapeutics, a fully integrated, clinical-stage biotechnology company pioneering RNA cell therapies for autoimmune diseases and cancer, has dosed the first participant in its Phase 2b randomized controlled trial (RCT) for generalized myasthenia gravis (MG), an autoimmune disorder that causes muscle weakness and fatigue. The RCT will evaluate the efficacy and safety of the company’s lead asset, Descartes-08, a first-in-class, RNA-engineered chimeric antigen receptor T-cell therapy (rCAR-T).

Stronger sales in Europe and the U.S. helped offset declining demand in Japan for the Medical Business Unit of Japanese industrial conglomerate Canon for the company’s fiscal 2022. The company said that sales in the medical division grew almost 7%, to the highest level in the history of the business unit.

For the year, Canon Medical saw sales of 513.3 billion yen ($3.970 billion), representing growth of 6.9% compared to the full-year 2021 numbers. The medical division’s income before taxes fell by 7% to 31.9 billion yen ($246.7 million) – the prior-year numbers were boosted by an increase in deductions related to a corporate acquisition.

The newly established Advanced Research Projects Agency for Health (ARPA-H) will accelerate cutting-edge biomedical and health research, moving discoveries from the laboratory to patients more quickly, sustainably and equitably than ever before. As the agency seeks to remove roadblocks to solving some of the biggest challenges in health today, Montgomery County, Md., is uniquely positioned to support this crucial federal agency and the ideal home for ARPA-H.

Image: MCEDC

Prince George's County, Maryland based Medcura’s is pioneering a proprietary biosurgical technology that has repeatedly demonstrated the rapid arrest of difficult-to-control surgical bleeding. With help from TEDCO, a Maryland based venture capital leader, Medcura is working to become the next standard of care in surgical bleeding management. In the television program “Stephen Hawking’s Science of the Future” Medcura was featured in an episode as a top innovative product of this decade for its ability to quickly stop bleeds using naturally abundant and highly economical ingredients.

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GAITHERSBURG, M.D. – Transwestern Real Estate Services (TRS) announces Quality Biological, Inc. has signed a 24,000-square-foot lease at Shady Grove Development Park, a 745,000-square-foot, 10-building mixed-use project in Gaithersburg, Maryland. Transwestern Senior Vice Presidents Guy Copperthite and Jim Darby represented Quality Biological in negotiations with property owner Minkoff Development Corporation.

Quality Biological has provided contract manufacturing solutions to the life science and biotech research industry for nearly 40 years. The company takes occupancy of its new space in July 2023.

Tonix Pharmaceuticals Announces Research Agreement with University of Maryland, Baltimore, to Study TNX-1500 (Fc-modified anti-CD40L mAb) for the Prevention of Rejection in Heart Xenograft Transplantation in Animals

Research Study to Assess the Role of TNX-1500 in the Prevention of Heart Xenograft Rejection

Preclinical Xenotransplantation Studies are Expected to Support Regulatory Filings for TNX-1500

CHATHAM, N.J., Feb. 01, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it has entered into a sponsored research agreement with the University of Maryland, Baltimore (UMB), for the prevention of rejection in heart xenograft transplantation in animals utilizing TNX-1500¹, an Fc-modified humanized monoclonal antibody directed against CD40-ligand. UMB’s preclinical studies will utilize genetically-modified porcine hearts supplied by Revivicor, Inc., a subsidiary of United Therapeutics Corporation. The principal investigator is Muhammad M. Mohiuddin, M.D., MBBS, Professor of Surgery, and Director, Cardiac Xenotransplantation Program, University of Maryland School of Medicine.

TEDCO, Maryland’s economic engine for technology companies, Tuesday announced the selection of 24 Maryland companies to participate in the FY2023 FAST SBIR/STTR Proposal Lab cohort.

This program, now in its fifth year, supports companies in the cohort, allowing them to work with TEDCO experts on preparing polished proposals for up to $275,000 in federal awards through the SBIR/STTR Phase 1 program.

The companies in this year’s cohort encompass a variety of technology disciplines, from medical devices to quantum computing to even biomanufacturing.

The Technology Transfer Society – Washington D.C. chapter is running an Introduction to Technology Transfer and Commercialization course in conjunction with Montgomery College. The course will be given in a hybrid format to allow for both virtual and in-person attendance.

This course is intended to provide students with an overview of the entire technology transfer process – moving technologies from the lab to market. This course is a great overview for anyone interested in learning more about the operations of a technology transfer office or those looking to understand how to commercialize their own invention. Students will hear from experienced professionals to broaden their understanding of technology transfer.

This Spring 2023 course (SMB035) will take place starting February 8^th  on the Montgomery College Rockville Campus each Wednesday from 6-8:40 p.m. For more details on the course see here .

Richmond, Virginia, Feb. 02, 2023 (GLOBE NEWSWIRE) — Phlow Corp., a U.S.-based public benefit corporation leveraging advanced manufacturing processes to re-imagine the domestic production of pharmaceutical products critical to U.S. healthcare, announced today the formation of the Phlow Business Advisory Board made up of internationally recognized pharmaceutical, biotech, and healthcare leaders who bring a wealth of knowledge and industry experience to the company; the addition of Melinda Hancock of Sentara Health System to Phlow’s Board of Directors; and the promotion of Dan Hackman from Chief Business Officer to President.

AURP’s BioHealth Caucus will examine topics, including:

• Economic impact of the biotech industry in the U.S.
• New biotech hubs growing in VA, NC, OK, MO, and NH
• Building the biotechnician workforce
• Bio innovation impact from the federal multi-billion-dollar CHIPS + Science Act
• Significance of the Bayh-Dole Act and life science IP to keep the U.S. competitive
• Bio manufacturing in space
• Award winning life science incubators, accelerators, and labs
• Importance of the business press covering the biotechnology community
• NIH funding for small business bio hubs
• Emerging role of quantum computing in drug discovery
• Special presentations from state bio infrastructure in MA and MD
• Plus, an optional tour of Harvard’s Science and Engineering building and Harvard Allston Enterprise Research Park

WIB-Capital Region: 5th Annual HERstory Gala

Thursday, April 27, 2023 – 6:30 p.m. – 9:30 p.m. ET

Join WIB-Capital Region to honor outstanding women in our local bioscience sector!

The HERstory Gala is the premier event for our chapter and its supporters. This elegant event attracts men and women from industry, government, non-profit organizations, and academia across the Capital Region Metro Area. It provides unique opportunities to meet with some of the region's most successful women. This event highlights women trailblazers in the life sciences who have significantly impacted the region. Additionally, awards will be presented to the 2022 WIB Inclusion Grantee and the 2022-2023 Rising Star Award Winner.