Chinese CDMO contracted to manufacture Pfizer’s oncology candidate
Kintor Pharmaceuticals, a Suzhou, China-based R&D company, has reached a collaboration agreement with the Chinese contract development and manufacturing organisation (CDMO) CMAB Biopharma, for the development of activin receptor-like kinase-1 (ALK-1) antibody.
This antibody is a humanized monoclonal antibody (mAb) targeting tumor angiogenesis, initially developed by Pfizer. Kintor was licensed exclusive worldwide rights by Pfizer to develop, manufacture, and commercialize ALK-1 in January 2018, and launched Phase II clinical trials for the product in May 2019 in Taiwan.
The drug is currently being tested in combination with nivolumab, in patients with hepatocellular carcinoma (HCC).
Under the agreement, CMAB will provide research and manufacturing services to support clinical development using its cell line development platform. It also will support commercialization and marketing of the product, upon regulatory approvals.
According to CMAB, the companies will work collaboratively in an aim to meet the investigational new drug (IND) application requirements of Chinese and US regulators.
ALK-1 is expressed primarily on vascular endothelial cells and is related to the growth and migration of endothelial cells. By blocking the receptor, ALK-1 can inhibit cancer blood vessel growth, blood flow, and tumor angiogenesis, thus effectively slowing down tumor growth.
During two Phase I clinical trials conducted from 2007 until 2014 by Pfizer in the US, Italy, South Korea, and Japan, the drug demonstrated ‘reasonable’ clinical benefits, according to CMAB, with the potential to be the first fully human therapeutic monoclonal antibody in the world targeting ALK-1.