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The Centre for Probe Development and Commercialization expands into Asia and executes a development, manufacturing, and clinical supply agreement for 177Lu-PSMA (DGUL) With South Korea-based CellBion

25 maggio 2022 | 15.01
LETTURA: 3 minuti

HAMILTON, ON, May 25, 2022 /PRNewswire/ -- The Centre for Probe Development and Commercialization (CPDC) is pleased to announce the initiation of a development, manufacturing, and supply agreement with CellBion for Lu-177-radiolabelled PSMA (DGUL) therapeutic agent. Under the terms of the agreement, CPDC will develop and manufacture CellBion's drug product for Phase II clinical supply in South Korea with the goal of expanding into North America.

CPDC is known for its global presence and expertise as a CDMO (Contract Development and Manufacturing Organization) for the GMP manufacturing and global distribution of radiotherapeutics. "We are very excited to be working with CellBion" said Dr. Bruno Paquin, CEO of CPDC, "CPDC has an excellent track record at manufacturing and supplying radiopharmaceuticals for multiple international clients. Expanding our portfolio in Asia is a significant milestone as we thrive to support our partners from early clinical development to commercial manufacturing."

Based in Seoul, South Korea, CellBion is developing a novel PSMA-targeted radiotherapeutic for the treatment of prostate cancer. Lu-177-PSMA (DGUL) is currently in Phase II clinical trials in South Korea and has shown relatively high blood-to-cancer accumulation rate and a low kidney-uptake rate compared to competing drugs.

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 Isotopia Molecular Imaging) in addition to its manufacturing, analytical, regulatory and quality expertise,  to enable uninterrupted and reliable supply of CellBion's drug product globally.

"We are delighted to be working with CPDC and to offer our product, Lu-177-PSMA (DGUL), to the North American market" said Dr. Kweon Kim, CEO of CellBion. "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 in order to provide clinical supply of our lead product in South Korea and extend it to North America".

 About Centre for Probe Development and Commercialization (CPDC):

The Centre for Probe Development and Commercialization (CPDC) is located in Hamilton, Ontario, Canada. CPDC is a global leader in the discovery, development and commercialization of next-generation radiopharmaceuticals that was created with the support of multiple stakeholders, including the Networks of Centres of Excellence (NCE), McMaster University and the Ontario Institute for Cancer Research (OICR). Since its foundation in 2008, CPDC has established a renowned, robust and reliable platform for the manufacturing and global supply of innovative diagnostic and therapeutic radiopharmaceuticals used daily for the detection and treatment of human diseases such as cancer. For more information about CPDC, please visit: www.imagingprobes.ca or contact info@imagingprobes.ca.

About CellBion:

CellBion is a biopharmaceutical company focused on the development and commercialization of radiopharmaceutical agents for the diagnosis and treatment of cancer. CellBion is developing a portfolio of clinical stage products that addresses theranostics in oncology and the precise diagnosis of macrophages.  For more information about CellBion, please visit www.cellbion.co.kr or contact seungtae.on@cellbion.co.kr.

About Lu-177-PSMA (DGUL):

CellBion's lead product, Lu-177-PSMA (DGUL) is currently undergoing phase 2 clinical trial in South Korea for patients with metastatic castration-resistant prostate cancer. Lu-177-PSMA (DGUL) has the same PSMA binding motif and the dose of radiation as PluvictoÒ (Lu-177-PSMA-617), but is expected to have better efficacy and safety because of its stable endogenous metabolism and its efficient excretion from the body.

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