I-Mab Announces Clinical Collaboration with Merck to Evaluate TJC4 in Combination with KEYTRUDA® (pembrolizumab) in Multiple Cancers

Shanghai, September 23, 2019/PRNewswire/ -- Tianjing Biotechnology (Shanghai) Co., Ltd. (“Tianjing Biotech”), an innovative biopharmaceutical company based in China with a global focus on oncology immunotherapy and autoimmune diseases, announced today that it has established a clinical research partnership with Merck & Co., Inc. (Kenilworth, New Jersey, USA). The two parties will conduct clinical studies on the combination therapy of Tianjing Biotech’s innovative fully human CD47 monoclonal antibody TJC4 and Merck’s PD-1 inhibitor KEYTRUDA® (pembrolizumab) to evaluate the clinical efficacy of this combination in patients with various types of tumors.

Pursuant to the collaboration agreement, Tianjing Biotechnology and MSD will jointly conduct a Phase I clinical trial of the combination therapy. The trial protocol shall be jointly developed and confirmed by both parties, and MSD will provide Tianjing Biotechnology with the clinical trial materials.KEYTRUDA® (pembrolizumab). This study aims to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the combination of TJC4 and KEYTRUDA® in patients with various cancers.

Dr. Zang Jingwu, Founder and Chairman of Tianjing Biotechnology, stated: “TJC4 AntibodyWithHighly differentiated characteristics, currently in the clinical development stage. This collaboration will be a rare opportunity for both parties to further exploreApplication of the Combination of TJC4 and KEYTRUDA® in Various Types of Tumors.

KEYTRUDA® is a registered trademark owned by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA.

About TJC4

TJC4 is one of the most promising tumor immune targets. Currently, some investigational biologics targeting the CD47-SIRPα pathway have side effects involving binding to red blood cells or platelets. Such side effects have been verified in preclinical or clinical trials, for example, causing hematological disorders such as thrombocytopenia and anemia in patients, and producing the so-called "antigen sink effect" that affects pharmacokinetics. Through cascade screening and other design strategies, TJC4 effectively avoids binding to normal red blood cells. In non-primate animal studies, TJC4 did not cause any hematological disorders, while also demonstrating good anti-tumor activity. Currently, TJC4 is undergoing clinical trials in the United States and has received approval for clinical trials from the National Medical Products Administration (NMPA, formerly CFDA) of China.