ASC Therapeutics Appoints Gene and Cell Therapy Manufacturing Veteran Gary Potter to Lead Global Operations

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MILPITAS, Calif .– (COMMERCIAL THREAD) – ASC Therapeutics, a private biopharmaceutical company pioneering the development of transformative in-vivo gene replacement, gene editing and allogeneic cell therapies for hematologic and other rare diseases, announces the appointment of Gary Potter to the position Senior Vice President, Global Operations.

Gary Potter will lead the global teams responsible for the development, manufacturing and supply chain of drugs and pharmaceuticals for gene and cell therapies required for all phases of clinical development and commercialization of all programs. ASC Therapeutics. In addition, he will lead and oversee the development, technology transfer, plant design, engineering and automation, quality assurance and qualification of manufacturing processes developed and executed at company facilities and from manufacturers under contract for use in clinical development non-clinical GLP and cGMP.

Gary graduated from Hamline University, St Paul, Minnesota, with a biology degree and a bachelor’s degree. Prior to joining ASC Therapeutics, he worked at uniQure Inc. as Vice President of Operations, bringing extensive experience and a proven track record of success in managing a global operations team producing gene therapy factor IX. treatment for hemophilia B at two facilities in the United States. and European. With over 30 years of industry experience including leadership roles at Newlink Genetics, Cell Genesys, Amgen, Abgenix and Baxter, he has led the planning and oversight of the design and start-up of cell culture and gene therapy manufacturing, technology transfer, GMP facility operations, engineering, validation and supply chain, regulatory filings and audits, and commercial readiness.

Ruhong Jiang, CEO of ASC Therapeutics, said, “I am extremely confident that Gary Potter brings the necessary expertise, leadership skills and motivation to our global operations, initially focusing on preparing pharmaceuticals for our customers. second generation ASC618 and allogeneic ASC930 gene therapy clinical programs. cell therapy. He is an important asset that complements our experienced global management team and will extend our unique capabilities to fulfill our mission of providing affordable, safe and effective gene and cell therapies. ”

Gary Potter, SVP Global Operations of ASC Therapeutics, said: “I am delighted to join ASC Therapeutics, a leader in transformative gene and cell therapies extraordinarily well positioned to benefit from manufacturing cost reduction opportunities around the world. I am delighted with their pipeline of therapies, technology platforms, R&D, CMC, quality, regulatory and clinical capabilities. I am fully committed to maximizing the productivity of our manufacturing platforms and leading 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.

About ASC618

ASC618 is an AAV8-based gene therapy for the treatment of hemophilia A, affecting approximately 1 in 5,000 living humans. ASC618 incorporates a novel liver-specific promoter and a bioengineered and deleted B-domain FVIII variant. optimized for codons; in preclinical studies, ASC618 shows at least a 10-fold increase in FVIII biosynthesis and secretion compared to native human FVIII genetic constructs derived from bioengineering. ASC618 has the potential to increase the sustainability of coagulation factor biosynthesis and secretion by minimizing cellular stress and induction of the unfolded protein response, which may result in decreased production of FVIII from liver cells.

ASC Therapeutics will conduct a phase 1/2 clinical trial to assess the safety, tolerability and preliminary efficacy of ASC618. The program received IND clearance from the US Food and Drug Administration in 2021 and achieved orphan drug designation in 2020. Study design is available at https://www.clinicaltrials .gov / ct2 / show / NCT04676048

About ASC930

ASC930 is an allogeneic cell therapy based on ready-to-use 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 cells. transplantation to treat hematological conditions. ASC930 cells possess potent immunosuppressive properties and show no potential for differentiation, making them an ideal immunoregulatory cell therapy.

ASC Therapeutics will conduct a Phase 2b clinical trial to assess the safety, tolerability and preliminary efficacy of ASC930. The program received 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 pioneering biopharmaceutical company in 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 extensive 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 l ‘ASC618 for hemophilia A, for which the US IND FDA clearance was recently obtained; 2) gene editing in vivo, initially focusing on ASC518 for hemophilia A; and 3) Allogeneic cell therapy, with the first indication with Decidua stromal cell therapy for acute steroid refractory graft-versus-host disease. To learn more, please visit https://www.asctherapeutics.com/.


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