Medipost Inc., a global leader in stem cell-based therapeutics, has announced the appointment of five senior executives to bolster its U.S. operations and advance CARTISTEM, its flagship regenerative therapy, towards a Phase III clinical trial. This strategic move aims to bring CARTISTEM to patients in the U.S. and fulfill the company's mission to combat degenerative diseases, particularly knee osteoarthritis.
CARTISTEM: A Decade of Clinical Success
CARTISTEM is the world's first regulatory-approved allogeneic human umbilical cord blood-derived mesenchymal stem cell product. Launched in South Korea in 2012 for treating knee osteoarthritis (OA), it boasts over 10 years of real-world clinical data and has been used in more than 30,000 patients. The therapy offers a potential alternative for patients suffering from OA, a condition affecting millions worldwide.
Phase III Trial and North American Expansion
The immediate focus of the U.S. team is securing Investigational New Drug (IND) approval to initiate a Phase III clinical trial. This trial is a crucial step towards a Biologics License Application (BLA) and a successful commercial launch in North America. The trial will evaluate the efficacy and safety of CARTISTEM in a North American patient population, building upon the existing clinical data from South Korea.
Strategic Partnerships and Manufacturing Capabilities
Medipost's recent manufacturing partnership with OmniaBio and the opening of OmniaBio's state-of-the-art cell and gene therapy manufacturing facility in Ontario are pivotal for the scale-up and distribution of CARTISTEM. This collaboration leverages over a decade of expertise in cell and gene therapy manufacturing and analytical technologies, ensuring a robust supply chain for the anticipated commercial demand.
Leadership Team Expansion
The newly appointed executives bring extensive experience in biologics, cell, and gene therapy:
- Adrian Orr, Head of Clinical Development: Orr brings 25 years of experience in osteoarthritis and cartilage repair research.
- Jagannadha Rao Kandula, Ph.D., Head of CMC & Operations: Kandula has over 25 years of experience in scaling protein biologics and cell therapies, including contributions to the approval and commercialization of multiple biologics and cell therapy products at Bristol Myers Squibb.
- Keith Bentlage, Head of Project Management Office: Bentlage has over 30 years of experience leading programs to Phase III trial completion and commercial launch.
- Richard Ong, Head of Quality: Ong brings expertise in quality's impact on process development and manufacturing from Amgen, Shire, Merrimack, and Lonza.
- Raymond Bergeron, Head of Accounting & Controller: Bergeron has over 20 years of experience in biotech and investment management from bluebird bio and Evelo Biosciences.
"Our new leadership team brings an unparalleled wealth of experience, aligning perfectly with our ambitious goals," said Edward Ahn, CEO of MEDIPOST, Inc. "Combined with our track record of success, proven product and strong partnerships, MEDIPOST is ready to embark on its North American Journey and poised to transform the lives of patients suffering from osteoarthritis."
