Wednesday, 22 May 2019

I-Mab gets USFDA IND approval for its proprietary TJC4

29 January 2019 | News

TJC4 is a fully human anti-CD47 monoclonal antibody that I-Mab discovered and developed internally for cancer immunotherapy.

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, announced recently 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 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 the United States in Q2 2019.

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