The clinical research trial application of the first bispecific antibody drug targeting CD47 and CD20 at home and abroad was accepted by NMPA
ImmuneOnco Biopharmaceuticals Technology (Shanghai) Co., Ltd. announced that it was the first bispecific anti-CD47 and CD20 drug (project number: IMM0306) independently developed by the company at home and abroad, and recently received the acceptance of clinical trials by the National Drug Administration (NMPA) (acceptance number: CXSL1900097). The successful acceptance of the application marks that the company will enter the clinical trial research stage after the IMM01 project targeting CD47 has been approved for clinical trial research, and the bispecific antibody drugs targeting CD47 and CD20 will also enter the clinical trial research stage, which is another major milestone in the company's development.
IMM0306 project is a bi-specific antibody drug with independent intellectual property rights based on ImmuneOnco "mAb-Trap" technology platform. It targets CD47, a target of immune regulation. By activating the phagocytosis of macrophages to tumor cells, and presenting the phagocytosis-treated tumor antigens to T cells, it can play a powerful role in tumor immunity. Targeting CD20, by binding with CD20 on the surface of cancer cells, can play the role of antibody drugs and kill cancer cells. Pre-clinical data confirm that IMM0306 has a significant therapeutic effect in a variety of tumor models, and because IMM0306 does not bind to human erythrocyte, it has obvious advantages in safety.
IMM0306 is expected to replace Rituximab and its analogues as soon as possible and expand into more unsatisfactory areas of cancer treatment. Previously, the global bispecific antibody drugs targeting CD47 and CD20 were in the pre-clinical stage. IMM0306 was approved for clinical trials, which consolidated the advanced position of ImmuneOnco in the antibody companies that developed CD47 targets, and also in the leading position of bispecific antibody research and development companies.
Dr. Tian Wenzhi, founder of ImmuneOnco
Tian Wenzhi, founder, chairman and general manager of ImmuneOnco, said: "ImmuneOnco has been committed to building a new anti-cancer drug research and development technology platform for immunoregulatory targets. We are confident that the IMM0306 project will pass the NMPA once. In addition to IMM0306, several other dual-target specific protein drugs have also shown good prospects for development, and new projects will continue to enter the stage of clinical trials. I hope that in the near future, one new drug after another will come into being. We will continue to plough deeply in the field of anti-cancer, accelerate the pace of research and development, and develop high-quality bio-medicines that are affordable to the general public. We are committed to developing into a world-renowned biopharmaceutical research and development company, contributing to the development of China's biopharmaceutical industry. "Here, I sincerely thank all the members of the company for their outstanding performance. It is their hard work that has made the company achieve one milestone after another."
IMM0306 is an antibody-receptor recombinant protein (mAb-Trap) targeting CD47 and CD20 at the same time. It is the first-in-Class in the world. It is a bi-specific antibody drug with fully independent intellectual property rights of ImmuneOnco. It can act on both tumor disease target and immune system target. Pre-clinical studies have shown that this drug has remarkable therapeutic effect on tumors compared with other drugs.
ImmuneOnco Biopharmaceuticals Technology (Shanghai) Co., Ltd. was founded in June 2015 and registered in Shanghai Zhangjiang High-tech Park. The company is mainly committed to the development of immunotherapy products for cancer, including bispecific antibodies, new recombinant proteins, and CAR-NK cell therapy. The common feature of our products is to stimulate the immune system of patients to play an anti-tumor effect, and ultimately inhibit the growth of cancer cells, reversing the resulting series of malignant symptoms, so that patients gradually return to a healthy body state.
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