TECPR2 Research Foundation and Forge Biologics announce AAV development and manufacturing partnership to advance Gene Therapy for TECPR2. * Program brings together research from Steven Gray, Ph.D., and his lab at UT Southwestern with Forge's development and manufacturing expertise to advance an AAV gene therapy for patients with TECPR2 BOCA RATON, Fla. and COLUMBUS, Ohio - September 29, 2026 - The TECPR2 Research Foundation, a nonprofit organization established to advance research and development of a treatment for patients with TECPR2, and Forge Biologics ("Forge"), a leading manufacturer of gene therapies and member of Ajinomoto Bio-Pharma Services, today announced a development and manufacturing partnership to advance an AAV gene therapy for patients with TECPR2, an ultra-rare neurodegenerative genetic disease. Under the partnership, Forge is providing process development, analytical development and qualification, and manufacturing services, including the manufacture and release of material for toxicology studies, to support the program's continued advancement. The program is leveraging Forge's proprietary FUEL(TM) platform, including its HEK293 suspension Ignition Cells(TM), pEMBR(TM) 2.0 adenovirus helper plasmid, rep/cap plasmids, and program-specific optimization packages, designed to drive manufacturing efficiencies. "For our families, this has never simply been a research program. It began with a few children and a commitment to do everything we could to create a path forward for everyone living with TECPR2," said David Ogman, co-founder of the TECPR2 Research Foundation. "That mission has brought together an incredible group of scientists and partners who believe, as we do, that children with ultra-rare diseases deserve the same opportunity for scientific progress as anyone else." "Forge shares that sense of purpose, and we are grateful to have their team and expertise behind us as we take these important steps toward a life-changing treatment," said Michael Kaplan, M.D., co-founder of the TECPR2 Research Foundation. TECPR2 is an ultra-rare genetic disorder associated with developmental delays and progressive neurological complications. TECPR2 plays an important role in autophagy, the cellular process responsible for degrading and recycling damaged or unnecessary cellular components. The investigational gene 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 of the disease. The gene therapy program is being advanced by a research team led by AAV gene therapy pioneer Steven Gray, Ph.D., Director of the Gene Therapy Program at UT Southwestern Medical Center, together with Xin Chen, M.D., Ph.D., Assistant Professor at UT Southwestern. Their research is focused on advancing the TECPR2 Research Foundation's AAV gene therapy toward clinical development. "At the heart of this partnership is a shared belief in what gene therapy can make possible for patients and families," said John Maslowski, president and chief executive officer of Forge. "When we developed our FUEL(TM) platform, we set out to improve manufacturing efficiency so treatments could reach more patients, with the needs of both larger patient populations and ultra-rare diseases in mind. For programs like TECPR2, making the most of every manufacturing run is critical. We are honored to bring our manufacturing technology and expertise to a program that is so deeply personal to the TECPR2 community." About TECPR2 TECPR2-related disorder is an ultra-rare genetic neurodevelopmental and neurodegenerative condition caused by pathogenic variants in the TECPR2 gene. TECPR2 plays an important role in autophagy, a cellular process involved in the degradation and recycling of cellular components. The disease can cause developmental delays and progressive neurological complications, including respiratory dysfunction. The investigational TECPR2 gene therapy program uses an AAV vector to deliver a functional copy of the TECPR2 gene and is being developed with the goal of addressing the underlying genetic cause of the disease. About the TECPR2 Research Foundation The TECPR2 Research Foundation is a nonprofit founded by physicians and families worldwide with a single mission: to advance research and curative treatments for TECPR2, a rare and fatal childhood disease also known as SPG49 or HSAN9. The foundation unites families, leading clinicians, geneticists, and biotech partners to accelerate first of its kind therapeutics for children living with the disease. To learn more, visit www.tecpr2.org. About Forge Biologics Forge Biologics is a gene therapy contract development and manufacturing organization (CDMO) enabling access to life-changing gene therapies by helping bring them from concept to reality. Headquartered in Columbus, Ohio, Forge operates the Hearth, a 200,000-square-foot facility with 20 custom-designed cGMP suites and 20,000 L of bioreactor capacity. Forge provides end-to-end AAV development and manufacturing services from research scale through commercial production, leveraging its proprietary FUEL(TM) platform designed to get more doses from every run. Forge is part of Ajinomoto Bio-Pharma Services, a global network of specialized CDMOs within the Ajinomoto Group. To learn more, visit www.forgebiologics.com. Media Inquiries TECPR2 Research Foundation: Michael Kaplan, M.D. Co-Founder, Executive Director [email protected] Forge Biologics: Marina Corleto Associate Director, Marketing & Communications [email protected] Client Development: Taleen Barsoumian Senior Vice President, Commercial [email protected] Forge Biologics September 29, 2026 July 21, 2026 "Providing a new visual restoration treatment option for patients living with retinitis pigmentosa is central to our mission," said Yusaku Katada, M.D.,... June 16, 2026 Under the partnership, Forge is providing Skylark with process development, current good manufacturing practice (cGMP) manufacturing, and analytical... May 11, 2026 "At ASGCT, Forge Biologics is proud to showcase how its FUEL(TM) platform is enabling more doses per batch, improving scalability for broader... May 5, 2026 Epicrispr Biotechnologies and Forge announce a strategic partnership to support the development and manufacturing of...

Forge, TECPR2 Research Foundation strike AAV gene therapy development, manufacturing partnership. Forge will provide process and analytical development, and leverage its proprietary manufacturing efficiency platform. September 29, 2026 Content Marketing Editor Editor's Take: This partnership helps advance a gene therapy program for an ultra-rare condition that primarily affects children. Forge Biologics and the TECPR2 Research Foundation announced a development and manufacturing partnership to advance an adeno-associated virus (AAV) therapy. TECPR2-related disorder is an ultra-rare, genetic, neurodevelopmental and neurodegenerative condition caused by pathogenic variants in the TECPR2 gene. It is classified as a childhood disease, also known as SPG49 or HSAN9. More TECPR2 details. Importantly, TECPR2 has a role in autophagy - a cellular process that degrades or recycles damaged or unnecessary cellular components. The disease can cause certain developmental delays and progressive neurological complications, including respiratory dysfunction, and can be fatal. The investigational AAV gene therapy, then, uses an AAV vector to deliver a functional copy of the TECPR2 gene. This ideally addresses the underlying genetic cause of the disease. How Forge helps. The terms of the partnership charge Forge with providing process development, analytical development and qualification, and manufacturing services. Included therein is the manufacture and release of material for toxicology studies that support the program's continuing advancement. A research team at the University of Texas (UT) Southwestern Medical Center is helping advance the program toward clinical development. Forge is leveraging its proprietary Fuel platform, which helps drive manufacturing efficiencies. Gene therapy possibilities. "This partnership is a shared belief in what gene therapy can make possible," Forge President and CEO John Maslowski said. "For programs like TECPR2, making the most of every manufacturing run is critical. We are honored to bring our manufacturing technology and expertise to a program that is so deeply personal." "For our families, this has never simply been a research program," TECPR2 Research Foundation Co-Founder David Ogman said. "It began with a few children and a commitment to do everything we could to create a path forward... These scientists and partners believe, as we do, that children with ultra-rare diseases deserve the same opportunities as anyone else." Forge Biologics is a member of Ajinomoto Bio-Pharma Services. Add us as a preferred source on Google. Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.