On September 23, 2019 I-Mab Biopharma ("I-Mab"), a China and U.S.-based clinical stage biopharmaceutical company exclusively focusing on the discovery and development of potential first-in-class and best-in-class biologics in immuno-oncology and autoimmune diseases, reported that it has entered into a clinical research collaboration agreement with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ., USA, to evaluate the combination of I-Mab’s TJC4 and MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with multiple cancer types (Press release, I-Mab Biopharma, SEP 23, 2019, View Source [SID1234539726]).
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Under this collaboration agreement, MSD will supply KEYTRUDA (pembrolizumab) to I-Mab for use in clinical studies in combination with TJC4, a fully human anti-CD47 monoclonal antibody. Both parties will collaborate on a Phase 1 clinical trial, based on an agreed and finalized protocol, to evaluate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of TJC4 and KEYTRUDA in patients with multiple cancer types.
"TJC4 is a highly differentiated anti-CD47 antibody currently under clinical development. This collaboration will provide an excellent opportunity to further explore therapeutic potential of combining TJC4 with KEYTRUDA across different tumor types." said Dr. Jingwu Zang, Founder and Chairman of I-Mab.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
About TJC4
CD47 represents one of the most promising immuno-oncology targets. The current investigational drugs targeting the CD47-SIRPa pathway have undesirable properties of binding to human red blood cells (RBC) or platelets. Such unwanted binding properties have been shown in pre-clinical and clinical settings to cause hematologic side-effects, e.g., anemia and thrombocytopenia, and the so-called "antigen sink effect" that affects pharmacokinetics of the investigational drugs. TJC4 is a highly differentiated monoclonal antibody made, by design, to recognize a unique epitope on CD47 and avoid strong binding to red blood cells. As such, TJC4 did not cause anemia in non-human primate studies，while it was shown to maintain anti-tumor activities. TJC4 is currently under clinical development in the U.S. and has been granted an IND approval by the National Medical Products Administration (NMPA) to start clinical trials in China.