- Forge Biologics and The Progeria Research Foundation have entered a manufacturing agreement to support the development of SamPro-2, an investigational gene therapy for Hutchinson-Gilford Progeria Syndrome.
- Forge will provide process development and cGMP manufacturing services to support IND-enabling studies for the AAV-based gene therapy.
Forge Biologics has entered into a manufacturing agreement with The Progeria Research Foundation (PRF) to support the development and manufacturing of SamPro-2, an investigational gene therapy for Hutchinson-Gilford Progeria Syndrome. The collaboration aims to advance the therapy toward clinical development for patients living with the rare genetic condition characterized by rapid aging.
Under the agreement, Forge will provide manufacturing services to support Investigational New Drug (IND)-enabling studies for SamPro-2. The company will contribute process development, cGMP manufacturing, regulatory consultation, and its FUEL™ platform technologies as part of its gene therapy manufacturing capabilities.
SamPro-2 is designed as an in vivo gene-editing therapy using an adeno-associated virus (AAV) delivery system. The therapy applies a base-editing strategy intended to correct the single DNA mutation in the lamin A gene that causes Progeria. The program is part of PRF’s Path to Cure Progeria initiative.
“The era of Progeria gene therapy has arrived. Our hope is that SamPro-2 will give children and young adults with Progeria the longer, healthier lives they deserve. We are extremely grateful to be working with Forge Biologics, whose manufacturing expertise is essential to move this work from the laboratory towards clinical trials.”
Leslie Gordon, M.D., Ph.D., co-founder and medical director of PRF
According to Forge, the partnership combines PRF’s long-standing research program with its own contract manufacturing capabilities to help advance the gene therapy program toward clinical trials for patients affected by Progeria.