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) 27thAnnual 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.
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Media Inquiries Marina Corleto Associate Director,
Marketing and Communications mcorleto@forgebiologics.com
Families and Clinician Inquiries Maria Escolar, M.D. Chief
Medical Officer advocacy@forgebiologics.com
Business Development Magdalena Tyrpien Chief Business
Officer BD@forgebiologics.com