Investigational New Drug (IND) application for the product of bispecific CD47xHer2 accepted by the US Food and Drug Administration (FDA)
Shanghai, China, July 28, 2021 ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has accepted an IND application for the first-in-class bispecific antibody-receptor recombinant protein (IMM2902).
IMM2902 is a CD47 x HER2 bispecific recombinant protein aiming at indications of solid tumors. This project is at the forefront of global research and has been approved by the National Food and Drug Administration (NMPA) of China on June 29, 2021. It is the third new product of ImmuneOnco based on CD47 entered the clinical study. The acceptance of the IND application of FDA is another major milestone for the company.
‘We are very pleased that our IMM2902 IND application has been accepted by the FDA,’ said Dr. Wenzhi Tian, the founder of ImmuneOnco, ‘IMM2902 is a bispecific molecule for CD47 and Her2 developed based on our mAb-Trap technology. By the high affinity to Her2, the molecule makes it possible that the drug preferentially bind tumor cells without binding to human red blood cells and avoiding "Antigenic Sink", thus greatly enhances the specific synergistic effect against tumor. We truly believe that IMM2902 has great value for further clinical development.’ Dr. Tian is quite confident about the prospects of IMM2902 in clinical development.
Founded in June 2015 in the Zhangjiang Hi-Tech Park of the China (Shanghai) Pilot Free Trade Zone, ImmuneOnco focuses on development and research of anti-tumor immunotherapy products, including bispecific antibody-traps (mAb-Traps), novel recombinant proteins, and target-activated NK cell therapy. Our compounds aim to activate patients’own immune system to exert anti-tumor effects, and ultimately inhibit endless growth of tumor cells and reverse malignant symptoms, so that patients can gradually return to being healthy. Currently, several new anti-tumor products are in clinical development stage. ImmuneOnco is recognized by authorities as one of the ‘Top 50 Start-up Enterprises with the Most Investment Potential in Shanghai’ in 2016, the "Excellent Enterprise" in the 2017 China Innovation and Entrepreneurship Competition, and one of the winners of the "Enterprise Excellence Award" of Shanghai Science and Technology Entrepreneurship in 2017.
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