July 13 ,2019，Beijing, I-Mab Biopharma (“I-Mab”), a clinical stage biotech company exclusively focusing on discovery and development of innovative biologics in immuno-oncology and autoimmune diseases, announces that the National Medical Products Administration (NMPA) has approved its investigational new drug (IND) application for TJC4，a differentiated fully human CD47 monoclonal antibody internally developed for the treatment of advanced malignant tumors. Previously on June 24, 2019, I-Mab announced the first patient dosing of TJC4 in a phase I clinical study in the US.
As a pivotal drug candidate from I-Mab’s innovative pipeline, TJC4 is a potential global best-in-class CD47 Monoclonal Antibody. 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.
“We are delighted to receive the IND clearance of TJC4 from the NMPA to start clinical studies in China. This is another significant progress after we initiated the phase 1 study in the United States.” Expressed by Dr. Joan Shen, Head of R&D at I-Mab, “By design and from the pre-clinical data, we believe TJC4 has the great potential to become a best-in-class agent treating cancer patients worldwide.”
About CD47 and TJC4
CD47 is a glycoprotein over-expressed in a wide variety of cancers and delivers a “don’t eat me” signal to tumor-engulfing macrophage through its ligand known as SIRPα. Blockade of CD47 by TJC4 enables macrophage to engulf cancer cells as a potential treatment option for cancers. TJC4 also known as TJ011133 is a differentiated CD47 monoclonal antibody and designed to minimize inherent binding to normal red blood cells by this class of monoclonal antibodies yet preserve its strong anti-tumor activities. TJC4 recognizes a unique epitope on CD47 and exhibits a minimal binding to red blood cells. The hematologic safety advantage of TJC4 has been demonstrated in a series of robust pre-clinical and toxicological studies including those in cynomolgus monkeys, while it maintains superb anti-tumor activities.
I-Mab is a dynamic and fast-growing global biotech company focusing on developing innovative biologics of first-in-class and best-in-class potential in the therapeutic areas of immuno-oncology and autoimmune diseases. I-Mab’s pipeline of clinical and pre-clinical stage assets is driven by the company’s Fast-to-Market and Fast-to-PoC development strategies through internal R&D capabilities and global partnerships. I-Mab’s vision is to address unmet needs through drug innovation in the target therapeutic areas in China and the world. I-Mab is on track to become an end-to-end fully integrated biopharma company. The company is well-recognized by capital markets to have successfully raised approximately $380 million USD in the past three years, with the recent $220 million USD Series C financing representing one of the largest amounts ever raised by an innovative biotech company in China. For more information, please see the Company's website at www.i-mabbiopharma.com.