GeneVentiv Therapeutics Announces Positive FDA INTERACT Feedback Supporting Advancement of GENV-HEM Gene Therapy for Hemophilia A with or without Inhibitors

RALEIGH, N.C., Oct. 29, 2025 /PRNewswire/ -- GeneVentiv Therapeutics, Inc., a privately held biotechnology company developing one-time gene therapies for rare and inherited diseases, today announced that it held a successful INTERACT meeting with the U.S. Food and Drug Administration (FDA) for the Company's lead program, GENV-HEM, a novel gene therapy for Hemophilia A with or without inhibitors (antibodies to Factor VIII).

The INTERACT meeting confirmed alignment on GeneVentiv's IND-enabling development plan, including an IND-enabling study and CMC strategy.

"This positive and constructive meeting with the FDA represents a key regulatory milestone for GeneVentiv," said Damon Race, Chief Executive Officer of GeneVentiv Therapeutics. "The Agency's confirmation of our IND-enabling development plan further validates the rigor of our scientific and manufacturing approach and provides a clear path toward first-in-human studies. With regulatory risk now substantially reduced, we are focused on advancing GENV-HEM to IND submission readiness."

Dr. Paris Margaritis, Chief Scientific Officer, added: "We appreciate the FDA's thoughtful engagement and the opportunity to align early on our development strategy. GENV-HEM has demonstrated robust preclinical activity and the potential to address the unmet needs of hemophilia patients with or without inhibitors through durable endogenous Factor Va expression."

GeneVentiv will continue to engage with regulatory authorities as it advances GENV-HEM through IND-enabling studies with a Pre-IND Meeting and IND submission as the next milestones planned for 2026.

About GeneVentiv Therapeutics

GeneVentiv Therapeutics is a biotechnology company developing transformative gene therapies for rare and serious diseases. Its lead program, GENV-HEM, is an AAV-based gene therapy expressing activated Factor V, designed as a one-time treatment for patients with hemophilia A, including those with inhibitors. The company's second program, GENV-002, is a dual-vector CRISPR gene-editing therapy for both Infantile and Late Onset Pompe disease, using a liver-depot strategy to secrete GAA systemically. GeneVentiv's mission is to pioneer therapies that reach every patient within a disease area, not just a select few.

Contact:
Damon Race
919-529-3352
404037@email4pr.com

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SOURCE GeneVentiv Therapeutics