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 for hematologic and other rare disorders announces the appointment of Gary Potter as Senior Vice President, Global Operations.
Gary Potter will lead the global teams responsible for drug substance and drug product process development, manufacturing, and supply chain for gene and cell therapies required for all phases of clinical development and commercialization for all ASC Therapeutics programs. Furthermore, he will lead and oversee the development, technology transfer, facility design, engineering and automation, quality assurance and qualification of manufacturing processes developed and executed at company facilities and at contract manufacturers for use in GLP non-clinical and cGMP clinical development.
Gary graduated from Hamline University, in St Paul, Minnesota with a degree in Biology and has a B.A. degree. Prior to joining ASC Therapeutics, he served at uniQure Inc. as Vice President of Operations, bringing extensive experience and a proven track record of success managing a global operations staff producing next-generation gene therapy factor IX for hemophilia B at two facilities in the US and Europe. With over 30 years of industry experience, including leadership roles at Newlink Genetics, Cell Genesys, Amgen, Abgenix and Baxter, he led planning and oversight of cell culture manufacturing and gene therapy facility design and start-up, technology transfer, GMP facility operations, engineering, validation and supply chain, regulatory filings and audits and commercial readiness.
Ruhong Jiang, ASC Therapeutics’ CEO said “I am extraordinarily confident that Gary Potter brings the right expertise, leadership skills and motivation for our global operations, focusing initially on drug product readiness for our clinical programs for ASC618 second-generation gene therapy and ASC930 allogeneic cell therapy. He is a strong asset complementing our experienced global leadership team and will expand our unique capabilities to fulfill our mission to deliver affordable, safe and effective gene and cell therapies.”
Gary Potter, ASC Therapeutics’ SVP Global Operations, stated “I am thrilled to join ASC Therapeutics, a leader in transformative gene and cell therapies extraordinarily well positioned to benefit from cost-reduction opportunities in manufacturing across the world. I am thrilled with their pipeline of therapies, technology platforms, R&D, CMC, quality, regulatory and clinical capabilities. I am fully committed to optimize productivity in our manufacturing platforms and to lead cross-functional teams in fast-paced, high-pressure environments. Joining this experienced and skilled global leadership team will enhance my strategic and tactical contribution to the explosive growth of operational and manufacturing challenges and opportunities in gene and cell therapy.”
ASC618 is an AAV8-based gene therapy for the treatment of hemophilia A, affecting approximately 1 of every 5000 live-born males. ASC618 incorporates a novel liver-specific promoter and a bioengineered, codon-optimized B domain-deleted FVIII variant; in preclinical studies, ASC618 exhibits at least a 10-fold increase in the biosynthesis and secretion of FVIII compared with native human FVIII bioengineered gene constructs. ASC618 has the potential to increase durability of clotting factor biosynthesis and secretion by minimizing cellular stress and induction of the unfolded protein response, which may lead to diminished FVIII production from liver cells.
ASC Therapeutics will conduct a phase 1/2 clinical trial to evaluate the safety, tolerability, and preliminary efficacy of ASC618. The program received IND clearance from the U.S. Food and Drug Administration in 2021 and was granted Orphan Drug Designation in 2020. The study design is available at https://www.clinicaltrials.gov/ct2/show/NCT04676048
ASC930 is an allogeneic cell therapy based on off-the-shelf Decidua Stromal Cells obtained from the fetal membrane of the maternal placenta for the treatment of acute steroid-refractory Graft-versus-Host Disease, a common complication of patients receiving allogeneic hematopoietic stem cell transplantation to treat hematologic conditions. ASC930 cells possess potent immunosuppressive properties and do not display any differentiation potential, making them an ideal immunoregulatory cell therapy.
ASC Therapeutics will conduct a phase 2b clinical trial to evaluate the safety, tolerability, and preliminary efficacy of ASC930. The program was granted Orphan Drug Designation from the FDA in 2021. The study design is available at https://clinicaltrials.gov/ct2/show/NCT04883918
About ASC Therapeutics
ASC Therapeutics is a biopharmaceutical company pioneering the development of gene replacement therapies, in-vivo gene editing and allogeneic cell therapies for hematological and other rare diseases. Led by a management team of industry veterans with significant global experience in gene and cell therapy, ASC Therapeutics is developing multiple therapeutic programs based on three technology platforms: 1) In-vivo gene therapies, initially focusing on ASC618 for hemophilia A, for which U.S. FDA IND clearance was recently obtained; 2) In-vivo gene editing, initially focusing on ASC518 for hemophilia A; and 3) Allogeneic cell therapy, with the first indication with a Decidua Stromal Cell-based therapy for steroid-refractory acute Graft-versus-Host Disease. To learn more please visit https://www.asctherapeutics.com/.