CMAB Biopharma and Suzhou Kintor Pharmaceuticals announced a comprehensive strategic cooperation agreement for the development and manufacturing of ALK-1 monoclonal antibody (mAb).
ALK-1 mAb, a monoclonal antibody targeting ALK-1 had been studied in two Phase-I clinical trials in the United States, Italy, South Korea and Japan from 2007 to 2014. In these two clinical studies, ALK-1 mAb demonstrated favorable PK and safety profile and reasonable clinical benefits, which suggest that this novel therapeutic antibody has a potential to be a first-in-class in targeting ALK-1, an angiogenesis target. Kintor has been granted the exclusive and worldwide rights to develop, manufacture and commercialize this novel anti-angiogenic drug, and has initiated a Phase II clinical trial in the combination with Nivolumab in the patients with hepatocellular carcinoma (HCC) in Taiwan. This is the first time Pfizer has licensed a Chinese company to develop a new antibody drug for oncology indications, which is expected to become the first fully human therapeutic monoclonal antibody that targets ALK-1 in the world.
According to the agreement, CMAB will provide a full range of CMC research and manufacturing services that meet the IND application requirements of China and the United States. This cooperation will support the clinical development of ALK-1 antibody worldwide by Kintor.
“We are delighted and greatly honored that a comprehensive strategic cooperation agreement can be launched with Kintor. Kintor has been an outstanding player for the development of innovative anti-tumor drugs in China and recruited the top leadership team with drug discovery experience from multinational pharmaceutical companies. This well recognized innovative drug discovery company has delivered strong portfolio across pre-clinical to Phase-III. ALK-1 MONOCLONAL ANTIBODY, a blockbuster large molecule clinical asset, is now in a critical stage of clinical development. To support Kintor's clinical development plan, CMAB will not only provide professional CMC technology and manufacturing services for Kintor, but also make full use of its team's expertise in IND application both in China and the United States. CMAB is also excited for supporting the commercialization and marketing of ALK-1 antibody in the future. In addition, CMAB wants to work with more and more innovative biopharmaceutical companies in China, like Kintor, to help shorten R&D cycles and speed up marketing of biopharmaceutical products. CMAB's high quality service should enable these excellent drug discovery leaders who have committed to the research and development of new drugs being competitive to the world classes of innovative anti-tumor therapies," said by Dr. Yongzhong Wang, CMAB CEO.
“During the discussion of this collaboration agreement, we have been very impressed with the expertise of CMAB's biotechnology team, the world-class production equipment and facilities and the customer-centered attitude toward cooperation. We, therefore, have decided to work together for the development manufacturing of ALK-1 antibody with CMAB,” said by Dr. Youzhi Tong, Kintor’s President and CEO. “With the extensive and comprehensive discussions about this collaboration project, we have felt very confidence in choosing CMAB as our long-term partner. Now we have every reason to believe that CMAB has top-class production equipment and facilities in the world and the capacity in technology integration and mature CDMO expertise. CMAB's technical team with a strong experience in IND application both in China and the United States and a suite of core technologies and a rigorous IP protection system, will help us successful launch of ALK-1 mAb's IND application in China and United States. We believe this productive collaboration will provide cancer patients the novel therapeutic agents with clinical benefits in China and in the world.”