- Forge Biologics and the TECPR2 Research Foundation have entered a development and manufacturing partnership to advance an AAV gene therapy for TECPR2, an ultra-rare neurodegenerative genetic disease.
- Forge will provide process development, analytical development and qualification, and manufacturing services, including material for toxicology studies.
Forge Biologics, a manufacturer of gene therapies and member of Ajinomoto Bio-Pharma Services, is partnering with the TECPR2 Research Foundation to support development of an AAV gene therapy for patients with TECPR2. The partnership will support the program as it advances toward clinical development.
Under the agreement, Forge will provide process development, analytical development and qualification, and manufacturing services. This includes manufacturing and release of material for toxicology studies. The program will use Forge’s FUEL™ platform, including HEK293 suspension Ignition Cells™, pEMBR™ 2.0 adenovirus helper plasmid, rep/cap plasmids, and program-specific optimization packages.
TECPR2 is an ultra-rare genetic disorder associated with developmental delays and progressive neurological complications. The disease involves TECPR2, which plays a role in autophagy, the cellular process responsible for degrading and recycling damaged or unnecessary cellular components. The investigational therapy is designed to use an AAV vector to deliver a functional copy of the TECPR2 gene, with the goal of addressing the underlying genetic cause.
The program is being advanced by a research team led by Steven Gray, Ph.D., Director of the Gene Therapy Program at UT Southwestern Medical Center, and Xin Chen, M.D., Ph.D., Assistant Professor at UT Southwestern. Their research is focused on advancing the AAV gene therapy toward clinical development.
The collaboration will bring Forge’s manufacturing technology and development capabilities to the TECPR2 program. The company’s FUEL platform is designed to support manufacturing efficiencies, while the partnership will provide development and manufacturing support as the program progresses.
