+86-21-58356573
LANGUAGE

Company news

The world's first bispecific antibody drug targeting CD47 and CD20 simultaneously has obtained NMPA clinical trial license

2019-11-22 0:00:00Click:25

    ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. announced that the company's independently developed bispecific antibody drug (Project No.: IMM0306) targeting CD47 and CD20 simultaneously has recently obtained the clinical trial license (acceptance No.: CXSL1900097) from the National Drug Administration (NMPA). This marks that the second project of the company has entered the clinical trial research stage after the IMM01 project targeting CD47 has obtained the clinical trial research license, which is another major milestone of the company's development.

 

    The IMM0306 project is a bispecific antibody drug with independent intellectual property rights developed based on the "mAb-Trap" technology platform ofImmuneOnco. It can remove the "don't eat me" signal by targeting the immune target CD47, activate NK cells and macrophages through ADCC/ADCP mediated by Fc, and generate strong tumor immunotherapy effect. It can avoid and correct by combining with CD20 on the surface of tumor cells The combination of CD47 in normal tissue can reduce the target related toxicity of CD47. The data of preclinical study confirmed that IMM0306 had significant therapeutic effect in various lymphoma models, and had obvious advantages in safety because IMM0306 was not combined with human erythrocytes.

 

    IMM0306 will be launched as soon as possible, which will not only provide treatment guarantee for patients with relapse and tolerance treated by Rituximab, but also be expected to replace Rituximab and its similar drugs in the future. Previously, the global bispecific antibody drugs targeting both CD47 and CD20 are in the preclinical research stage. IMM0306 was approved for clinical trial, which consolidated the leading position of ImmuneOnco in the antibody company developing with CD47 target.

 

    Tian Wenzhi, founder, chairman and general manager of ImmuneOnco, said: "ImmuneOnco has always been committed to building a new anti-tumor drug research and development technology platform for immune regulation targets, and insisting on innovative drug research and development with independent intellectual property rights. Since the establishment of the company four years ago, relying on independent research and development, the company has obtained IND approval documents for two new drugs, which fully reflects the firm R&D strength and strong execution of the company's team. In the future, new projects will continue to enter the clinical trial stage. ". "Here, I would like to thank the R&D team, clinical registration department and all colleagues for their contributions to the phased results of the project!".

  

About IMM0306

    IMM0306 is an antibody receptor recombinant protein (mAb-Trap) targeting at both CD47 and CD20, which is the first in class in the world. It is a bispecific antibody drug with independent intellectual property rights of ImmuneOnco. The drug can act on tumor target and regulate immune system at the same time. The preclinical study showed that the drug has remarkable and excellent tumor treatment effect compared with the similar drugs, and it is expected to replace Rituximab as the first-line drug for B-cell lymphoma in the future.

 

About ImmuneOnco

    Founded in June 2015, ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. is registered in Zhangjiang High Tech Park, Shanghai. The company is mainly engaged in the development and research of tumor immunotherapy products, mainly including bispecific antibodies, new recombinant proteins, and TANKTM cell therapy. The company's first product, IMM01, is in the process of phase I clinical trial research. 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 pre clinical research stage.