Forge Biologics Announces Nine Presentations at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting

Forge Biologics, a member of Ajinomoto Bio-Pharma Services and leading manufacturer of genetic medicines, today announced that it will deliver nine presentations at the upcoming American Society of Gene and Cell Therapy (ASGCT) 27^thAnnual Meeting, taking place May 7-11, 2024, in Baltimore, Maryland. The presentations include a late-breaking oral presentation, three technical session presentations, and five scientific posters spanning Forge's process development, molecular development, integrated regulatory services, and clinical program advancements.

"As we continue to advance how genetic medicines are manufactured, we are thrilled to present data showcasing our novel molecular findings, platform process improvements, and regulatory knowledge all centered around efficient, safe, and scalable manufacturing of AAV gene therapies," said Timothy J. Miller, Ph.D., President and CEO of Forge. "We are also especially encouraged by a late-breaking oral presentation that our Chief Medical Officer, Dr. Maria Escolar, will be delivering that provides a clinical update on FBX-101 where all five patients with Krabbe disease receiving Forge's gene therapy are walking?a remarkable result. Retention of gross-motor function is one of the most visible and debilitating symptoms seen in patients with Krabbe disease, so this finding is a meaningful clinical outcome."

ORAL PRESENTATION

Title: REKLAIM, A Phase 1b Clinical Trial Using a Novel Immune Modulation Strategy for Systemic Administration of FBX-101 (AAVrh10.GALC) After Umbilical Cord Blood Transplantation for the Treatment of Infantile Krabbe Disease
Presenter: Maria Escolar, M.D., Chief Medical Officer
Date and Time: Friday, May 10, 2024, 8:00-8:15 a.m. ET
Room: Ballroom 4

SESSION PRESENTATIONS

ASGCT Workshop
Title: Preparing for CMC Success: How Early CMC Decision Drives Your Pace and Success to the Clinic
Presenter: David Dismuke, Ph.D., Chief Technical Officer
Date and Time: Tuesday, May 7, 8:25 a.m. ET
Location: Ballroom 3

Tools & Technology Forum
Title: Improving Analytical Tools for AAV Characterization
Presenter: David Dismuke, Ph.D., Chief Technical Officer
Date and Time: Wednesday, May 8, 2:15-2:30 p.m. ET
Location: Exhibit Hall Theater

Sponsored Symposium
Title: Forge's Discovery and Modification of Genetic Elements for Enhanced Productivity and Efficacy of AAV-based Gene Therapies
Presenters:
Angela Adsero, Ph.D., Molecular Development Scientist II
Frank Agbogbo, Ph.D., VP of Process Development
David Dismuke, Ph.D., Chief Technical Officer
Date and Time: Thursday, May 9, 1:30-2:00 p.m. ET
Location: Room 337-338

POSTER PRESENTATIONS

Title: Development of a Scalable Upstream Process for Suspension HEK 293 rAAV Production in Single-Use Bioreactors for Efficient Manufacturing of Gene Therapy Products
Presenter: Danielle Sexton, Senior Scientist II, Process Development
Date and Time: May 8, 12:00 p.m. ET
Poster number: 528

Title: From Benchtop to Cleanroom; Designing an Optimized Platform Purification Process for rAAV Production to Meet the Growing Demand
Presenter: Blake Gursky, Scientist II, Process Development
Date and Time: May 8, 12:00 p.m. ET
Poster number: 527

Title: The Potential of Global Regulatory Harmonization in Gene and Cell Therapy
Presenter: Claire Marasco, Associate Director, Regulatory Affairs
Date and Time: May 8, 12:00 p.m. ET
Poster number: 526

Title: Regulatory Agility: Value of CDMOs Utilizing Platform Technology
Presenter: Angela Coy, Ph.D., Senior Manager, Regulatory Affairs
Date and Time: May 8, 12:00 p.m. ET
Poster number: 905

Title: The Sixth Element: Identification and Evaluation of the Adenovirus L4 22/33K Region as a Requirement for Adeno-Associated Virus Production
Presenter: Angela Adsero, Ph.D., Molecular Development Scientist II, Forge Biologics
Date and Time: May 9, 12:00 p.m. ET
Poster number: 954

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 #827 in the Exhibitor Hall.

About Forge Biologics

Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company, enabling access to life-changing gene therapies by bringing them from concept to reality. Forge's 200,000 square foot facility, the Hearth, is headquartered in Columbus, Ohio, and houses 20 custom-designed cGMP suites with 200,000L of manufacturing capacity. Forge's end-to-end, scalable plasmid and AAV manufacturing services include research-grade manufacturing, process and analytical development, cGMP manufacturing, fill and finish, and integrated regulatory support to help accelerate the timelines of transformative medicines for patients with genetic diseases. To learn more, visit www.forgebiologics.com.