SHANGHAI /PRNewswire/ -- I-Mab Biopharma ("I-Mab"), a China-based clinical stage biopharmaceutical company exclusively focused on the development of innovative biologics in immuno-oncology and autoimmune diseases, announces on Jan. 25, 2019 that its IND application for TJC4, has been approved by the US Food & Drug Administration (FDA). TJC4 is a fully human anti-CD47 monoclonal antibody that I-Mab discovered and developed internally for cancer immunotherapy.
TJC4 is the third candidate from I-Mab's proprietary discovery pipeline to be approved for clinical trials by the FDA within a month, which represents their commitment to bring potential best-in-class biologics to patients in the world. TJC4 has the potential to be a global best-in-class anti-CD47 monoclonal antibody in that, unlike other known CD47 antibodies under development, it binds to a unique epitope on CD47 that leads to minimal red blood cell binding, resulting in neither hemagglutination in vitro nor anemia in cynomolgus monkeys in toxicological studies. In addition, TJC4 has also shown efficacy in animal models of hematological malignancies and solid tumors as monotherapy and combination therapies.
"This approval lays the foundation for I-Mab's global clinical development of our innovative and globally competitive proprietary candidates in the field of immuno-oncology." Expressed by Dr. Joan Shen, Head of R&D at I-Mab, "We believe that the unique epitope and potential better safety profile clearly differentiate TJC4 from other agents targeting CD47/SIRPα pathway in development, which may translate into improved clinical benefits to patients with various types of malignancies."
This IND enables I-Mab to initiate phase 1/1b clinical trials to assess safety, tolerability, and efficacy of TJC4 in patients with solid tumors and lymphoma as monotherapy and combination therapies. I-Mab expects to initiate the study in several clinical sites across United States in Q2 2019.
CD47 is a glycoprotein overexpressed in a wide variety of cancers and delivers a "don't eat me" signal to macrophages through ligation of signal regulatory protein α (SIRPα) on phagocytes. Blockade of CD47/SIRPα axis enables macrophage phagocytosis of cancer cells and facilitates antitumor T-cell response. The CD47 immune checkpoint represents a potentially effective and widely applicable target for cancer immunotherapy.