Solid Biosciences, a life sciences company focused on advancing therapies for Duchenne muscular dystrophy, and Forge Biologics, a cell and gene therapy-focused contract development and manufacturing organization (CDMO), formed a partnership to advance the development and manufacturing of SGT-003, Solid’s next generation gene therapy program for Duchenne. SGT-003 is a preclinical candidate that combines a next-generation and rationally designed capsid with Solid’s proprietary nNOS-containing microdystrophin and has demonstrated enhanced muscle tropism and microdystrophin expression compared to AAV9 in vivo.
 
Forge will provide an adeno-associated viral (AAV) vector process, scale-up engineering and cGMP manufacturing services for SGT-003. The program will employ Forge’s Blaze Vector production platform, and Forge’s proprietary HEK293 suspension Ignition Cells and pEMBR advenovirus helper plasmid, to support Solid’s clinical development. All development and cGMP manufacturing activities will occur at The Hearth, Forge’s 175,000 square foot gene therapy cGMP production facility in Columbus, OH.
 
“We are excited to partner with Forge, a company who shares our high standards for product purity, potency and reproducibility, to further our ability to bring meaningful therapies to patients with Duchenne,” said Joel Schneider, chief operating officer, Solid Biosciences. “As we continue to develop our pipeline, it is important that we have partners who will enhance our expertise. Uniting Forge’s integrated platforms and cGMP gene therapy manufacturing capabilities with our in-depth knowledge in high dose gene therapy development and manufacturing will introduce an additional method to produce AAV gene therapy at Solid, and help to accelerate human proof of concept for SGT-003.”
 
Timothy Miller, Ph.D., president and CEO, Forge, said, “We are thrilled to partner with Solid and look forward to providing support and cGMP manufacturing services as they advance their next-generation AAV gene therapy for Duchenne. Forge’s flexible and scalable manufacturing offerings are an ideal complement to Solid’s development efforts with the shared goal of advancing potential treatments for patients with Duchenne.”