I-Mab Receives IND Approval from the US FDA to Initiate Clinical Trials for Its Proprietary TJC4, a Potential Global Best-in-Class Anti-CD47 Monoclonal Antibody
SHANGHAI, Jan. 28, 2019 /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.
I-Mab is a dynamic and fast-growing global company exclusively focused on developing first-in-class and best-in-class biologics in the areas of immuno-oncology and autoimmune diseases through internal R&D capabilities and global partnerships. I-Mab's pipeline is driven by the company's development strategy to address unmet needs in China and to bring innovative assets to the world. The company is on track to initiate additional clinical trials in China and the U.S., including multiple phase II and phase III studies. I-Mab is on a fast track towards becoming an end-to-end fully integrated biopharma company. The company has been well-recognized by capital markets with the recent $220 million Series C financing representing one of the largest amounts ever raised by an innovative biotech company in China. www.i-mabbiopharma.com
Amanda Dai, Associate Director of Public Relations
Claire Xu, Head of US Site
Jielun Zhu, CFO