Canada’s CPDC will help CellBion with the development, manufacturing, and clinical supply
CellBion said Wednesday it has signed a development, manufacturing, and supply agreement with the Centre for Probe Development and Commercialization (CPDC), a Canadian radiopharmaceuticals company, for Lu-177-radiolabelled prostate-specific membrane antigen (PSMA-DGUL) therapeutic agent.
Under the accord, CPDC will develop and manufacture CellBion’s drug product for phase 2 clinical supply to Korea to expand the treatment to North America.
CellBion is developing a novel PSMA-targeted radiotherapeutic to treat prostate cancer. Lu-177-PSMA (DGUL) is now in phase 2 clinical trials in Korea and has shown a relatively high blood-to-cancer accumulation rate and a low kidney uptake rate compared to competing drugs.
“We are delighted to be working with CPDC and to offer our product, Lu-177-PSMA-DGUL, to the North American market,” CellBion CEO Kim Kwe-on said. “We are impressed with the caliber of work and the professionalism provided by the entire CPDC team and very much look forward to the successful delivery of our program to provide clinical supply of our lead product to Korea and extend it to North America.”
CPDC is known for its global presence and expertise as a CDMO (contract development and manufacturing organization) for the GMP (good manufacturing practice) manufacturing and global distribution of radiotherapeutics.
“We are very excited to be working with CellBion,” CPDC CEO Bruno Paquin said. “CPDC has an excellent track record at manufacturing and supplying radiopharmaceuticals for multiple international clients.”
Expanding the company’s portfolio in Asia is a significant milestone as it thrives on supporting its partners from early clinical development to commercial manufacturing, Paquin added.
CellBion’s program will benefit from the unique value proposition that CPDC offers, with the in-house production of n.c.a. Lu-177 (in partnership with Isotopic Molecular Imaging) in addition to its manufacturing, analytical, regulatory, and quality expertise, to enable the uninterrupted and reliable supply of CellBion’s drug product globally, the company said.