Charles River, ASC Therapeutics Further Grow Gene Therapy Collaboration

Charles River Laboratories International, Inc., a contract development manufacturing organization (CDMO), and ASC Therapeutics, a biopharma company that develops gene editing and allogeneic cell therapies, as well as in vivo gene replacement, have agreed to manufacture ASC618, a second-generation gene therapy for hemophilia A.

Hemophilia A is caused by the lack of the blood clotting factor VIII (FVIII), a protein whose instructions are provided by F8, a gene that is mutated in people with the disease. ASC618 is designed to deliver a shortened, but optimized version of the gene to liver cells. ASC Therapeutics has received Investigational New Drug (IND) clearance, alongside regulatory designations in the US and Europe for its ASC618 program.

The partnership is expected to capitalize on Charles River’s end-to-end CDMO capabilities, as it builds on the company’s various acquisitions in 2021—including Cognate BioServices and Vigene Biosciences. However, the Charles River-ASC relationship actually dates back to 2019 by way of Vigene, specifically adeno-associated virus (AAV) production and purification.

“Our work with Charles River has a strong foundation of trust—strengthening our shared outlook for the future and building confidence in our internal processes and oversight of external capabilities,” says Ruhong Jiang, PhD, CEO of ASC Therapeutics. “As we moved toward the next phase of our therapeutic development, we are excited to work with Charles River to further maximize our manufacturing know-how.”