Target tumor "don't eat me" signal! Tjc4, a monoclonal antibody of Tianjing biological differentiation CD47, was approved by China nmpa to carry out clinical trials

July 15, 2019 news / BIOON / -- Tianjing Biotechnology (Shanghai) Co., Ltd (i-mab, hereinafter referred to as "Tianjing biotechnology") is an innovative biopharmaceutical company based in China and focusing on tumor immunity and autoimmune disease treatment worldwide Recently, the company announced that China National Drug Administration (nmpa) has approved innovative all human monoclonal antibody tjc4 for CD47 target to carry out new drug clinical trials (ind) The antibody is independently developed by Tianjing biology, and the clinical trials will be aimed at patients with advanced cancer On June 24, 2019, Tianjing biology completed the first patient administration of tjc4 in phase I clinical study in the United States As a key project of Tianjing biological innovation product pipeline, tjc4 has obvious differentiation advantage in the world, and is a CD47 monoclonal antibody with "best in class" development potential Different from other known CD47 antibodies, tjc4 has a unique binding epitope, which can bind to red blood cells to a minimum, has no aggregation, and has no anemia characterization in the toxicity experiment of cynomolgus monkeys CD47 is a kind of glycoprotein widely expressed on the surface of many kinds of cancer cells It can release the signal of "don't eat me" through the connection with SIRP α on the surface of tumor phagocytes and prevent macrophages from phagocytosis Tjc4 can make tumor engulfed by macrophages by blocking the CD47 pathway, and promote the immune response of anti-tumor T cells, which has the potential to become a treatment scheme in the field of tumor immunity Tjc4 (tj011313) is a CD47 monoclonal antibody with differential characteristics, which can minimize the binding with normal red blood cells and reduce the impact on them Different from other known CD47 antibodies, tjc4 has a unique binding epitope, which can bind to red blood cells to a minimum, without agglomeration, and has strong anti-tumor activity, which has been proved in a series of preclinical and toxicological studies including cynomolgus monkey toxicology experiments Dr Shen Huaqiong, President of Tianjing biological research and development, said: "we are honored to receive the approval document of innovative all human monoclonal antibody tjc4 clinical trial (ind) approved by China National Drug Administration, which is another milestone after we and the launch of phase I clinical trial of the project in the United States Through the innovative design of Tianjing biology, the preclinical data of tjc4 shows that tjc4 not only has strong anti-tumor activity, but also avoids the hidden danger of blood system safety, so it is expected to become the "best of its kind" CD47 monoclonal antibody, and then provide a better treatment scheme for patients around the world " As one of the hot targets in the field of anti-tumor immunotherapy, CD47 has been hailed as the next "Star" in the field of tumor immunity after PD1 / PDL1 antibody It is worth mentioning that in October 2018, innovent biology recombined all human anti-CD47 monoclonal antibody (R & D Code: ibi188) was the first Chinese biopharmaceutical company to obtain the approval of clinical trials issued by the US FDA, and became the first Chinese biopharmaceutical company to obtain the approval of the US FDA for the entry of CD47 monoclonal antibody into clinical studies In mid March this year, phase I clinical study (cibi188a102) conducted by ibi188 in the United States completed the first patient administration In China, Xinda biology obtained the approval document of ibi188 drug clinical trial (ind) issued by nmpa in September 2018 In January this year, the first patient administration of phase I clinical study of the drug was completed Original source: i-mab announcements ind approval for its proprietary tjc4, a potentially differentiated CD47 antivirus, to initiate clinical trials in China