Xinda biological anti-CD47 monoclonal antibody completed the first case of drug administration in phase I clinical study in the United States

March 19, 2019 / AP / -- Xinda biopharmaceutical Co., Ltd is a biopharmaceutical company dedicated to R & D, production and sales of innovative drugs for the treatment of major diseases such as tumors and autoimmune diseases Today, it was announced that its self-developed candidate monoclonal antibody against CD47 (R & D Code: ibi188) was administered to the first patient in phase I clinical research in the United States This (cibi188a102) study is a phase I clinical study conducted in the United States to evaluate the efficacy of ibi188 in patients with advanced cancer The main purpose of this study was to evaluate the safety, tolerance and phase II recommended dose of ibi188 in patients with advanced cancer Among them, the phase 1A study mainly explored the initial dose and maintenance dose of ibi188 single drug Cibi188a102 clinical study will be carried out simultaneously with cib188a101 clinical study in China Pharmacokinetic (PK) and pharmacokinetic (PD) data for ibi188 will be evaluated in China and the United States As a hot target in the field of anti-tumor immunotherapy, CD47 is one of the key members of immunosuppressive signaling pathway, which is different from programmed cell death protein 1 (PD-1), PD-1 ligand 1 (PD-L1), cytotoxic T-lymphocyte-related protein 4 (CTLA-4) and so on, acting on the immunosuppressive signal of T-cell detection points CD47 is mainly through the interaction with the inhibitory receptor signal regulatory protein α (SIRP α) It can inhibit the phagocytosis of macrophages and mediate the immune escape mechanism of various malignant tumors However, ibi188 is a monoclonal antibody against the target of CD47 It can block the cd47-sirp α pathway, restore the ability of macrophages to recognize tumor cells and antigen presentation, and achieve the anti-tumor effect through the dual effects of innate immunity and adaptive immunity "Ibi188 is an important product in Xinda biological anti-tumor product pipeline," said Dr Yu Dechao, founder, chairman and President of Xinda biological It has been proved that anti-CD47 mAb has good biological activity in a variety of solid tumors and relapsed / refractory non-Hodgkin's lymphoma At present, the antibody research on the cd47-sirp α signal pathway in the world is mostly in the preclinical or clinical phase I research stage As China's first anti-CD47 monoclonal antibody to obtain clinical trial approval in the United States, we hope to help us evaluate the potential clinical value of this candidate drug as soon as possible through clinical research conducted in both China and the United States at the same time " As for ibi188, ibi188 is a recombinant all human anti-CD47 monoclonal antibody injection, which is intended to be used in the treatment of a variety of tumors including non-Hodgkin's lymphoma and ovarian cancer In vitro and in vivo experiments show that ibi188 can combine with the CD47 antigen on the surface of tumor cells, block the cd47-sirp α signal pathway, inhibit the "don't eat me" signal transmitted by CD47, and promote macrophages to recognize the "eat me" signal transmitted by tumor cells, thus phagocytizing tumor cells and exerting the anti-tumor effect of the body Cibi188a101 study cibi188a101 study is a phase I clinical study conducted in China to evaluate the efficacy of ibi188 in the treatment of advanced cancer The main purpose of this study was to evaluate the safety, tolerability and phase II recommended dose of ibi188 Among them, the phase 1A study mainly explored the initial dose and maintenance dose of ibi188 single drug Cibi188a102 study cibi188a102 is a phase I clinical study conducted in the United States to evaluate the efficacy of ibi188 in patients with advanced cancer The main purpose of this study was to evaluate the safety, tolerability and phase II recommended dose of ibi188 Among them, the phase 1A study mainly explored the initial dose and maintenance dose of ibi188 single drug Cibi188a102 clinical study will be carried out simultaneously with cib188a101 clinical study in China The PK and PD data of ibi188 will be evaluated in China and the United States With regard to Xinda biology, it is the ideal and goal of Xinda biology to develop high-quality biological medicine that people can afford Founded in 2011, Xinda biology is committed to the development, production and sale of innovative drugs for the treatment of major diseases such as cancer On October 31, 2018, Cinda biopharmaceutical was listed on the main board of the stock exchange of Hong Kong Limited, stock code: 01801 At present, the company has established a high-quality technology platform throughout the development cycle of biological innovative drugs, including R & D, pharmaceutical development and industrialization, clinical research and marketing platforms, and has established a product chain including 20 new drug varieties under research, covering four disease areas, including tumor, fundus disease, autoimmune disease, metabolic disease, and 14 varieties have entered clinical trials, including Four varieties were studied in clinical phase III, two McAb products were accepted by the State Food and drug administration, one product (cindilimab injection, trade name: Dabusu ®) was approved by the State Drug Administration for marketing, and the first approved indication was relapsed / refractory typical Hodgkin's lymphoma Xinda biology has set up a team of high-end biomedical development and industrialization talents with international advanced level, including many returned experts, and has reached strategic cooperation with international pharmaceutical companies such as Eli Lilly pharmaceutical, adimab, Incyte and Hanmi of South Korea Xinda bio hopes to work with you to improve the development level of China's biopharmaceutical industry, so as to meet the people's drug access and the people's pursuit of life and health Source: Xinda biology