Forge Biologics Announces Eight Presentations at the Upcoming 2023 Meeting of the American Society of Gene and Cell Therapy (ASGCT)

• Four oral presentations and four scientific poster presentations highlight Forge’s AAV manufacturing capabilities and a clinical update on its FBX-101 AAV gene therapy for patients with Krabbe disease

COLUMBUS, Ohio--(BUSINESS WIRE)--Forge Biologics, a leading manufacturer of genetic medicines, announced today that eight presentations, including four oral presentations, will be delivered during the upcoming 26^th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT), taking place May 16-20, 2023, in Los Angeles, California.

“Forge’s presentations at ASGCT highlight the 2023 accomplishments of our team, particularly cell line and plasmid developments, as we expand our bespoke AAV manufacturing platform capabilities to deliver advanced solutions for gene therapy developers,” said Timothy J. Miller, Ph.D., CEO, President, and Co-Founder of Forge Biologics. “We are delighted to showcase our team’s contributions and Forge’s progress for patients as well we continue to provide solutions for industry-wide gene therapy manufacturing challenges.”

SESSION PRESENTATIONS

Title: The CDMO-Developer Partnership: Solving Complex Challenges in Gene Therapy Development & Manufacturing, Together
Moderator: Timothy J. Miller, Ph.D., CEO, President, and Co-Founder, Forge Biologics
Panelists:

• Paul Bresge, Chief Executive Officer​, Ray Therapeutics
• David Dismuke, Ph.D., Chief Technical Officer, Forge Biologics
• Sadik Kassim, Ph.D., Chief Technical Officer​, Danaher
• Shen Shen, Ph.D., Senior Director, AAV Technologies​, Vertex Pharmaceuticals​

Session: Exhibitor Showcase
Date and Time: Wednesday, May 17, 2023, 9:15-9:45 a.m. PT
Room: 409 AB

Title: Building an Improved Platform Process for AAV Manufacturing
Presenter: David Dismuke, Ph.D., Chief Technical Officer, Forge Biologics
Session: Tools & Technology Forum
Date and Time: Wednesday, May 17, 2023, 3:45-4:00 p.m. PT
Room: Presentation Theater in the Exhibit Hall

Title: Strategic Collaborations Today for the Gene Therapies of Tomorrow
Presenter: Panel hosted by Labcorp featuring John Maslowski, Chief Commercial Officer, Forge Biologics
Session: Industry Sponsored Symposium
Date and Time: Friday, May 19, 2023, 12:00-1:30 p.m. PT
Room: 409 AB

Title: RESKUE: First in Human Phase 1/2 Clinical Trial of Intravenous FBX-101 (AAVrh10.hGALC) Administered After Cord Blood Transplantation in Patients with Infantile Krabbe Disease
Presenter: Maria Escolar, M.D., Chief Medical Officer, Forge Biologics
Session: Gene and Cell Therapy Trials in Progress
Date and Time: Saturday, May 20, 2023, 11:30-11:45am PT
Room: Concourse Hall 150 and 151

POSTER PRESENTATIONS

Title: Development of Chromatography Based Separation of Empty and Full Capsids in rAAV Manufacturing Process
Presenter/poster: Corben Davis, Senior Scientist, Downstream Process Development (Poster Board no. 398)
Date and Time: Wednesday, May 17, 2023, 12:00 p.m. PT

Title: The Impact of the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 on Advanced Therapy Medicinal Product Developers
Presenter/poster: Claire Marasco, Senior Manager, Regulatory Affairs (Poster Board no. 995)
Date and Time: Thursday, May 18, 2023, 12:00 p.m. PT

Title: Navigating the EU Clinical Trial Regulation (536/2014): Key Considerations for ATMP Developers
Presenter/poster: Claire Marasco, Senior Manager, Regulatory Affairs (Poster Board no. 799)
Date and Time: Wednesday, May 17, 2023, 12:00 p.m. PT

Title: Advanced Characterization of DNA Molecules in rAAV Vector and Plasmid DNA Manufacturing Preparations by Next Generation Preparations Sequencing
Presenter/poster: Esko Kautto, Ph.D., Scientist II, Bioinformatics (Poster Board no. 1345)
Date and Time: Friday, May 19, 2023, 12:00 p.m. PT

Full abstracts are available on the ASGCT Annual Meeting website, and conference participants can also access posters through the ASGCT website.

Forge Biologics will be at booth #540 in the Exibitor Hall.

About Forge Biologics

Forge Biologics is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company. Forge’s mission is to enable access to life-changing gene therapies and help bring them from idea to reality. Forge’s 200,000 square foot facility, the Hearth, utilizes 20 cGMP suites in Columbus, Ohio, to serve as its headquarters. The Hearth is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services. Offerings include process and analytical development, plasmid DNA manufacturing, viral vector manufacturing, final fill, as well as regulatory consulting support to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing. By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most. To learn more, visit www.forgebiologics.com.