The world's first bispecific antibody drug simultaneously targeting CD47 and CD20 has been approved clinical trial by NMPA
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. announced that the bispecific antibody drug (project number: IMM0306) independently developed and simultaneously targeting CD47 and CD20 has recently obtained the clinical trial license of NMPA (Acceptance Number: CXSL1900097).This marks that after the IMM01 project targeting CD47 was approved for clinical trial, the second project has entered the stage of clinical trial research, which is another major milestone in the development of the company.
IMM0306 project is a bispecific antibody drug with independent intellectual property rights, which is developed based on the "mAb-trap" technology platform of ImmuneOnco. It relieves the "don't eat me" signal by targeting the immunomodulatory target CD47, and activates NK cells and macrophages through Fc mediated ADCC / ADCP, so as to exert strong tumor immunotherapeutic effect, and evade the positive effect by binding with CD20 on the surface of tumor cells. The binding of CD47 is often found in tissues, thus reducing the target related toxicity of CD47. Preclinical data confirmed that IMM0306 has achieved significant therapeutic effect in many lymphoma models. Meanwhile, IMM0306 has obvious advantages in safety because it does not binding to human red blood cells.
IMM0306 will be launched as soon as possible, which not only provides treatment guarantee for patients with relapse and tolerance of Rituximab, but also is expected to replace Rituximab and its similar drugs in the future. Simultaneously targeting CD20 and CD47 are in the preclinical stage. IMM0306 has been approved for clinical trial, which consolidates the leading position of ImmuneOnco in antibody companies with CD47 target.
Tian Wenzhi, the founder, chairman and general manager of ImmuneOnco, said: " ImmuneOnco has been committed to building a new anti-tumor drug research and development platform with new immune regulation targets, and adhere to the research and development of innovative drugs with independent intellectual property rights. Since the establishment of the company four years ago, relying on independent research and development, the IND approval of two new drugs has been obtained, which fully reflects the firm R & D strength and strong executive power of the company team, and new projects will continue to enter the stage of clinical trial and research. "Here, I would also like to thank the company's R & D team, clinical registration department and all colleagues for their contributions to the phased results of the project!".
IMM0306 is an antibody-receptor recombinant protein (mAb-trap) targeting CD47 and CD20 simultaneously. It is the first in class in the world. It is a bispecific antibody drug with independent intellectual property rights. It can act on tumor disease targets and regulate the immune system at the same time. Preclinical studies have shown that compared with the same kind of drugs, this drug has significant excellent tumor treatment effect, and is expected to replace Rituximab as the first-line drug for B-cell lymphoma in the future.
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. was founded in June 2015 and registered in Zhangjiang High Tech Park, Shanghai. The company is mainly committed to the development and research of tumor immunotherapy products, including bispecific antibodies, new recombinant proteins, and TNAKTM cell therapy. The company's first product, IMM01, is in the phase I clinical trial study, and the second product, IMM0306, has obtained the NMPA clinical trial license and is about to carry out phase I clinical trial research. Several other double target specific protein drugs are in the preclinical research stage.