admin Reporting to the Sr. VP of Global Operations, the Director of Gene and Cell therapy will be responsible for drug substance and drug product process development, manufacturing and supply chain for gene and cell therapies activities for all phases of clinical development and commercialization for all ASC Therapeutics programs.
In vivo gene editing in liver tissues may be able to rescue patients younger than 18 years who are not eligible for gene replacement therapies, with hemophilia as a prime example
Hemophilia News Today by Marta Figueiredo, PhD | June 20, 2022 ASC Therapeutics has joined forces with Charles River to scale the manufacturing of ASC618, its second-generation virus-based gene therapy for hemophilia A. The agreement expands upon their current collaboration, begun in 2019 that focused on achieving Good Manufacturing Practice (GMP)-virus manufacturing and establishing processes for adeno-associated virus (AAV) production and … Read more
Expanded relationship will build upon established processes initiated in 2019 to meet ASC Therapeutics clinical program WILMINGTON, Mass.–(BUSINESS WIRE)–Charles River Laboratories International, Inc. (NYSE: CRL) and ASC Therapeutics, a privately held biopharmaceutical company pioneering the development of transformative in vivo gene replacement, gene editing and allogeneic cell therapies, today announced they have agreed to manufacture ASC618, a … Read more
Public, private and non-profit organizations have joined forces to create a standardized approach that will reduce up-front costs and lower barriers to developing novel gene therapies for rare and ultra-rare diseases MILPITAS, Calif.–(BUSINESS WIRE)–ASC Therapeutics, a privately held biopharmaceutical company pioneering the development of transformative in-vivo gene replacement, gene editing and allogeneic cell therapies has joined … Read more
First known bovine model used to demonstrate safety and efficacy in gene replacement therapy MSUD is a severe genetic disease with liver transplantation or dietary restriction as the only treatments currently available CORRECTION…by ASC Therapeutics MILPITAS, Calif.–(BUSINESS WIRE)–Please replace the release dated May 16, 2022 with the following corrected version due to multiple revisions. “The … Read more
Podium presentation highlights significant transduction and transgene expression in pharmacokinetic studies in mice, non-human primates and a humanized liver model Poster presentation focuses on pharmacology, toxicology and safety studies Poster presentation focuses on the development of a novel transduction assay to evaluate in-vitro relative Infectivity MILPITAS, Calif.–(BUSINESS WIRE)–ASC Therapeutics, a privately held biopharmaceutical company pioneering … Read more
The U.S. Food and Drug Administration (FDA) has given fast track designation to ASC618, an investigational one-time gene therapy for hemophilia A in the pipeline of ASC Therapeutics. Fast track status works to speed the development and regulatory review of treatments for serious disorders that show a potential to fill an unmet need. The Committee for Orphan Medicinal Products … Read more
We are very pleased with the FDA’s and EMA’s regulatory decisions regarding ASC618. This brings us one step closer for providing a truly novel therapeutic approach for hemophilia A, providing potentially a functional cure for patients who currently require life-long care.