COLUMBUS, OHIO April 30, 2024 – 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.
Media Inquiries
Marina Corleto
Associate Director, Marketing and Communications
media@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
- 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 – May 11, 2023 – Forge Biologics, a leading manufacturer of genetic medicines, announced today that eight presentations, including four oral presentations, will be delivered during the upcoming 26th 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 utilizes 20 cGMP suites in Columbus, Ohio, the Hearth, 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.
Media Inquiries
Marina Corleto – Forge Biologics
Associate Director, Marketing and Communications
media@forgebiologics.com
Business Development
Magdalena Tyrpien – Forge Biologics
Senior Vice President, Head of Business Development
BD@forgebiologics.com
Client Development
Taleen Barsoumian – Forge Biologics
Vice President, Client Development
CD@forgebiologics.com