SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Ambys Medicines, a cell and gene therapy company focused on transforming the treatment of severe liver disease by unlocking the full potential of hepatocyte transplantation, today announced that John Choi, MS, RAC, has joined as Vice President, Regulatory Affairs. John joins as Ambys prepares its IND for its lead program, AMI-918, an allogeneic, off-the-shelf investigational cell therapy aimed at providing functional liver support in the acute setting.
"John brings a wealth of experience in the cell and gene therapy space, working successfully across all aspects of regulatory affairs and throughout various development phases and therapeutic areas," said Ronald Park, M.D., Chief Executive Officer at Ambys Medicines. "And most importantly, John's deep understanding of regulatory processes and team-building skills will be invaluable to Ambys as regulatory capabilities become critical in the preparation of our first IND, anticipated for late next year."
John is a seasoned regulatory affairs professional with more than 18 years of experience in drug development and global/US regulatory affairs at various biotech companies. He has developed regulatory strategies and led the submissions activities throughout the product lifecycle, including early discovery to marketing application approval and commercialization. He has hands-on experience in cell therapy, gene therapy, and other novel modalities, as well as in rare and complex diseases. John joins Ambys from Platelet BioGenesis, where he led the regulatory affairs function and spearheaded the pre-IND and IND activities for the company's novel allogeneic cell therapy program. Previously, he was Senior Director of Regulatory Affairs Strategy at Rubius, where he supported the company's pre-IND and IND submissions for their early-stage oncology programs. John also held regulatory affairs leadership roles at ImmunoGen, Mallinckrodt Pharmaceuticals, Questcor Pharmaceuticals, Intercell, and ICON Clinical Research. John earned his M.S. in biotechnology and B.A. in biology from Johns Hopkins University and holds a Regulatory Affairs Certification from the Regulatory Affairs Professionals Society.
"The team at Ambys is doing incredibly important and impressive work in developing a new approach to cell therapy to treat serious liver disease," said Choi. "The company is entering a critical transition period of moving towards an IND for AMI-918, and I'm excited to join the team to help ensure the success of our programs."
Over the past several decades, liver diseases have risen to become one of the leading causes of death and illness. More than 1.3 million people die each year worldwide, and the prevalence continues to grow. If successful, Ambys' platform of cell therapies can address a spectrum of unmet needs, including the more intractable long-term progression of severe liver disease and certain genetically driven liver diseases.
In late September, the company presented data demonstrating the ability of their in vivo bioreactor to expand mature, fully functional human hepatocytes and announced the opening of its 52,000 sqft GMP facility. These are important milestones for the company as they prepare for their pre-IND meeting early next year and critical steps towards Ambys' goal of providing an off-the-shelf treatment capable of revolutionizing care for patients with severe liver disease.
About AMI-918
Liver diseases remain one of the most underserved areas of modern medicine. Despite progress with a few diseases, severe liver diseases are not effectively addressed. Until now, the field has had to choose between promoting hepatocyte proliferation or function. Ambys' proprietary in vivo bioreactor has solved for both expansion and function, generating the first and only mature, off-the-shelf hepatocyte cell therapy that will be available at therapeutic doses. AMI-918 is an allogeneic, off-the-shelf hepatocyte cell therapy for the potential on-demand treatment of patients in acute settings, in conjunction with immunosuppression.
About Ambys Medicines
Ambys Medicines is a cell and gene therapy company focused on unlocking the full potential of hepatocyte transplantation and transforming the treatment of severe liver disease. Ambys' proprietary cell therapy platform potentially solves the supply constraints that have hindered progress, catalyzing the field and fundamentally transforming the approach to treating severe liver disease. Our lead program, AMI-918, and future engineered hepatocyte cell therapies are being developed across the spectrum of severe liver disease, including those of acquired and genetic origins. Visit us at ambys.com and follow us on Twitter, LinkedIn, and Instagram.
