- This agreement represents the first strategic cooperation between two of the key players in biopharmaceutical industries in Suzhou, China
- ALK-1 (Activin receptor-like kinase-1) antibody was originally developed by Pfizer who completed two Phase I clinical trials in more than 100 patients with advanced solid tumors in the United States, Italy, South Korea, and Japan.
- Kintor has been granted exclusive and worldwide rights to develop, manufacture and commercialize this novel anti-angiogenic antibody drug, which is expected to become the first fully human therapeutic monoclonal antibody (mAb) that targets ALK-1 globally.
Suzhou, China /PRNewswire/ - CMAB Biopharma (Suzhou) Inc. ("CMAB"), a pure-play CDMO business in biologics and Suzhou Kintor Pharmaceuticals, Inc. ("Kintor"), an innovative biopharmaceutical enterprise, announced a comprehensive strategic cooperation agreement for the development and manufacturing of Kintor's ALK-1 mAb.
ALK-1 mAb has 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 combination with nivolumabin 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 strategic cooperation will support the clinical development of ALK-1 antibody worldwide by Kintor. Importantly, this collaboration is based upon CMAB's sophisticated CMC process development and manufacturing platform, experienced R&D team in IND applications in both China and the United States, and an impeccable product quality system.
"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 a top leadership team with drug discovery experience from multinational pharmaceutical companies. This well recognized innovative drug discovery company has delivered a strong portfolio across pre-clinical development to Phase-III clinical trials. 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 to support 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 confident 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 successfully launch 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."
About CMAB Biopharma
CMAB Biopharma is a flexible full-service CDMO dedicated to providing bespoke development and manufacturing services of antibodies and biologics for clients in China and across the globe. Our adaptable, service-oriented business enables clients to take their innovative concepts for tomorrow's medicines from DNA to clinical product today.
To find out more about our dynamic new CDMO, please visit www.cmabbio.com/en
Founded in 2009, Suzhou Kintor Pharmaceuticals, Inc. ("Kintor"), is devoted to the research and development of "best-in-class" and "first-in-class" innovative drugs and the development of industrialized platforms. All the products of the company are new drugs of Category 1 for prostate cancer, breast cancer, liver cancer, hair loss and other diseases, with over 50 global patents available and many projects included in "State Major New Drug Development Program" under the 12th and 13th Five-year Plans of China. Proxalutamide, one of Kintor's main products, undergoes clinical trials synchronically in China and the United States, with one Phase-III clinical research fully carried out in China as second- and first-line therapies for mCRPC indications and a Phase-II clinical trial being conducted in the United States, and a Phase-I/Ib clinical trial being completed in China for indications of metastatic breast cancer and a Phase-Ic clinical trial of drug combination being carried out for indications of metastatic breast cancer; ALK-1 mAb preparation has become the first new antibody drug authorized by Pfizer for global development, which has gone through two Phase-I clinical trials on 100 subjects in the United States and other countries, and also is in progress of one Phase II clinical trial of combination with Nivolumab in Taiwan for indications of HCC; pyrilutamide, a therapy for androgenetic alopecia, was completed under one Phase-I clinical trial in both China and the United States, and will go through Phase-II clinical trials in both China and the United States very soon. Furthermore, Kintor's R&D pipeline also covers mTOR inhibitors, Hedgehog/SMO inhibitors, c-Myc inhibitors and AR-Degraders, among others. In 2018, Kintor was honored to become the "Unicorn Cultivation Enterprises of Suzhou and Suzhou Industrial Park".
To find out more about our dynamic, please visit www.kintor.us/