BioHealth Innovation Weekly for August 15, 2023

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August 15, 2023

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BioHealth Capital Region Achieves Top 3 Ranking: A Triumph of Collaboration and Innovation

In 2016, during the Annual BioHealth Capital Region Forum at MedImmune/AstraZeneca in Gaithersburg, Maryland, an ambitious goal was set: to make the BioHealth Capital Region (BHCR) a Top 3 BioHealth cluster in the United States by 2023. That vision has been realized in the latest Genetic Engineering & Biotechnology News “Top 10 U.S. Biopharma Clusters” rankings, marking a significant milestone in the region’s relentless pursuit of excellence, collaboration, and innovation in the BioHealth field.

Rich Bendis, President & CEO of BioHealth Innovation, Inc., stated, “It’s been an incredible journey working with so many dedicated individuals and organizations in the region over the years to meet this goal. The spirit of collaboration and innovation that defines the BioHealth Capital Region has been the driving force behind this success, and I’m proud to be part of this remarkable community.”

How the BioHealth Capital Region Became a Top 3 BioPharma Cluster: Insights from Alex Philippidis, Senior Business Editor at Genetic Engineering & Biotechnology News

How does a BioPharma Cluster ascend the ranks to secure a Top 3 position? What are the key factors propelling the BioHealth Capital Region to achieve its ambitious goal of ranking 3rd by 2023? Join us in this episode of BioTalk, where our host Rich Bendis speaks with Alex Philippidis, Senior Business Editor at Genetic Engineering & Biotechnology News.

In this installment, Alex unveils the intricacies behind his latest Top 10 U.S. Biopharma Clusters, highlighting the impressive rise of the BioHealth Capital Region to its 3rd position. Learn about the origins of these rankings, the trends that have been identified for 2023, and the dynamic shifts within the BioPharma landscape on a regional scale.

Listen now via your favorite podcasting platform:

Global Breakthroughs for a Healthier Future - Registration for the 9th Annual BioHealth Capital Region Forum Now Live

Get ready for an exceptional experience at the 9th Annual BioHealth Capital Region Forum. Registration is now live for this highly anticipated event, taking place on September 19th and 20th, 2023, at the US Pharmacopeia (USP) facility located at 12601 Twinbrook Pkwy, Rockville, MD 20850.

Step into a world of innovation as we proudly present an entirely in-person experience under the theme "Global Breakthroughs for a Healthier Future." After a period of remote events, we're thrilled to bring together industry professionals for face-to-face interactions once again with no registration fees, thanks to our generous event sponsors!

Prepare to be part of the premier gathering for the biopharma sector, as the in-person BioHealth Capital Region Forum attracts over 1,100 registrants annually. Esteemed government officials, academic leaders, and industry executives will converge at this prestigious event, creating a vibrant atmosphere for reconnection, partnership rekindling, and exploration of new growth avenues within the region.

Applications to Compete in the 8th Annual BioHealth Capital Region Crab Trap are Now Being Accepted!

Now in its 8th year, the BioHealth Capital Region Crab Trap continues to grow, attracting applicants from around the region, country, and internationally. The competition highlights entrepreneurs with commercially relevant diagnostics, medical devices, therapeutics, and other transformative health solutions.

This year's Crab Trap winner will be eligible for a package of prizes worth more than $50,000. Prizes for the qualifying Crab Trap winner include:

A $10,000 cash prize from Greenberg Traurig
A $25,000 cash prize from Montgomery County (for a firm headquartered in Montgomery County)
A one-year residency at JLABS @ Washington, D.C. (for a firm of their choice)
$10,000 in Preclinical CRO services from Noble Life Sciences.

Gaithersburg's Georgiamune Inc. Achieves US FDA Clearance for Investigational New Drug (IND) Application and Secures $75 Million in Series A Financing

GAITHERSBURG, Md., Aug. 9, 2023 /PRNewswire/ -- Today, Georgiamune Inc., a privately held, clinical stage biotechnology company, announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for GIM-122, a dual-functioning monoclonal antibody. Furthermore, the company successfully completed a $75M Series A financing, positioning Georgiamune as a promising new biotechnology company in the fields of oncology and autoimmune diseases.

Addimmune, a Clinical Stage Hiv-Focused Gene Therapy Company, to go Public Through Business Combination With 10x Capital Venture Acquisition Corp. III

NEW YORK CITY, NEW YORK and ROCKVILLE, MARYLAND, Aug. 09, 2023 (GLOBE NEWSWIRE) -- NEW YORK CITY, NEW YORK and ROCKVILLE, MARYLAND, Aug. 9, 2023 (GLOBE NEWSWIRE) – American Gene Technologies International Inc. (“AGT”) and 10X Capital Venture Acquisition Corp. III (“10X III”) (NYSE: VCXB), a special purpose acquisition company, today announced that they have entered into a merger agreement for a business combination that would result in the combined company being a publicly listed company (the public company following the business combination to be renamed “Addimmune”). The combined company is expected to trade under the ticker symbol “HIV”. Addimmune is a clinical-stage gene and cell therapy company developing a functional cure for HIV. Prior to the combination, the non-HIV assets will spin-off into an entity that will retain the American Gene Technologies name.

Precigen Announces FDA Confirmation that the Ongoing Phase 1/2 Study of PRGN-2012 AdenoVerse Immunotherapy Will Serve as the Pivotal Study to Support Accelerated Approval

GERMANTOWN, Md., Aug. 9, 2023 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has agreed that the ongoing Phase 1/2 single arm study (NCT04724980) of the first-in-class investigational PRGN-2012 AdenoVerse^™ immunotherapy for the treatment of recurrent respiratory papillomatosis (RRP) will serve as pivotal for the purpose of filing an accelerated approval request for licensure. The FDA also confirmed no additional randomized, placebo-controlled trial will be required to support submission of a biologics license application (BLA). Based on the FDA guidance, the Company plans to initiate a confirmatory study prior to submission of the BLA.

FDA Accepts Baltimore's MyMD Pharmaceuticals’ Investigational New Drug Application (IND) for Phase 2 Study of oral TNF-α inhibitor MYMD-1® in Rheumatoid Arthritis (RA)

BALTIMORE--(BUSINESS WIRE)--MyMD Pharmaceuticals, Inc.^® (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for age-related diseases, autoimmune and inflammatory conditions, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug Application (IND) to evaluate the safety, efficacy, pharmacodynamics and pharmacokinetics of oral TNF-α inhibitor MYMD-1^® in patients with active rheumatoid arthritis (RA). The application was based on preclinical data showing that MYMD-1 significantly reduced swelling and other clinical arthritis measures compared to widely used RA therapy, Enbrel® (etanercept).¹The Company plans to initiate discussions with CRO vendor IQVIA on timing of a Phase 2 study in this indication.

BioBuzz: Catching Up with 2022 Crab Trap Winners Neuroene and Polaris

With federal funding and solutions that address major risks and aim to improve outcomes for warfighters and civilians, Polaris and Neuroene are set to continue their momentum as showcase companies in the DMV life science scene.

By Sam Hopkins

August 8, 2023

As the BioHealth Capital Region and other life sciences sectors continue to evolve and innovate, it’s crucial for start-ups and entrepreneurs to seize every opportunity to showcase their groundbreaking work.

One of those incredible opportunities is this year’s 8th Annual BioHealth Capital Region Crab Trap competition, part of the 9th Annual BioHealth Capital Region Forum. This event has evolved significantly over the years, attracting applicants not only from the region but also from across the country and around the world.

The Technology Transfer Society – Washington D.C. Chapter will be offering an Introduction to Technology Transfer and Commercialization Fall 2023 course in conjunction with Montgomery College

The Technology Transfer Society – Washington D.C. Chapter will be offering an Introduction to Technology Transfer and Commercialization Fall 2023 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, including those from federal labs, to broaden their understanding of technology transfer.