MILPITAS, Calif.–(BUSINESS WIRE)–ASC Therapeutics (“ASC”), a privately-held gene therapy company focused on developing transformative gene-based medicines for serious diseases, announced today that it has entered into a long-term strategic manufacturing partnership with Vigene Biosciences (“Vigene”), a Maryland-based Contract Develop and Manufacturing Organization (CDMO). Vigene will provide ASC with access to GMP manufacturing including viral vectors and plasmid DNA for its hemophilia A gene therapy clinical program, as well as a manufacturing platform for future gene therapy programs.
“The genetic platform technology developed by ASC is going to change the way serious diseases are treated in the future. We have seen remarkable potency data in our Hemophilia A IND-enabling gene therapy studies,” said Dr. Ruhong Jiang, ASC Founder & CEO.
Dr. Jiang continued, “We are proud to welcome Vigene, a global leader in gene therapy process development and GMP manufacturing with a proven track record and expertise in the field of viral vector manufacturing, to become an integral part of ASC long-term plan. Our partnership provides ASC access to Vigene’s world-class team with expertise for both plasmid DNA and viral vector manufacturing as well as high-caliber QC and QA teams.”
“Vigene is excited to become a long-term CMC partner for ASC with multiple newly built, state-of-the-art GMP suites and high-titer virus producer cell lines, we are well positioned to support ASC for both early-stage and commercial virus production. This partnership will ensure that all ASC clinical deliverables are achieved in a timely fashion,” said Dr. Zairen Sun, Vigene’s President and CEO. “We have a world-class manufacturing team, and this agreement is a testimony for our recognition by top-tier biopharmaceutical companies.”
About ASC Therapeutics
ASC Therapeutics is a biopharmaceutical company dedicated to advancing an integrated and sustainable pipeline focused on gene therapies that correct the root cause of complex and intractable diseases. We are leveraging our AAV-based gene therapy, CRISPR-Cas9 and proprietary gene editing platforms consolidated over 10 years to develop transformative gene-based medicines. ASC is accelerating through clinical trials several lead gene therapies for inherited blood disorders. Our team of industry veterans in discovery, pre-clinical, clinical and CMC gene therapy development and world-class academic and biopharmaceutical partnerships are potentiating our gene therapy capabilities. To learn more about ASC Therapeutics, please visit www.asctherapeutics.com.
About Vigene Biosciences
Vigene Biosciences is an award-winning and private equity backed leader in gene delivery development and manufacturing. Vigene has 16 years of cGMP viral vector production experience. Vigene’s mission is to make gene therapy affordable. Vigene offers IND-enabling and IND-supporting materials as well as FDA- and EMA-compliant commercial products for plasmid, AAV, lentivirus, and adenovirus with proven technologies and track records. The GMP facility features 10 GMP suites including 5 brand-new cGMP suites with 200L-500L single-use stir tank bioreactors for suspension cells as well as iCellis 500 for adherent cells. In 2018 and 2019 Vigene was recognized by INC500. In 2018, Vigene was chosen as the ACG Emerging Company of the Year Award. To learn more about Vigene Biosciences, please visit www.vigenebio.com