ImmuneOnco received FDA approval of IMM2902 as an Investigational New Drug (IND) in the United States
August 21, 2021, Shanghai, China. ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (hereinafter referred to as "ImmuneOnco") declared that the U.S. Food and Drug Administration (FDA) has granted permission to IMM2902, a bi-specific antibody-receptor recombinant protein targeting Human CD47xHER2 for HER2-expressing advanced solid tumors for the Investigational New Drug (IND) application in the United States.
By targeting both CD47 and HER2, IMM2902 is one of the best drug candidates under global clinical researches. IMM2902 project was previously approved by the National Drug Products Administration (NMPA) in China on June 29, 2021, and it is one of three new drug candidates based on CD47 to enter the clinical study. Permission to enter clinical study of IMM2902 by FDA is another important milestone for the company to develop global market.
"We are very pleased to receive FDA approval for the IMM2902 IND in the United States." said Dr. Wenzhi Tian, the founder of ImmuneOnco. “IMM2902 is a bi-specific molecule for CD47 and HER2 developed based on our mAb-Trap technical platform. Through the high affinity to HER2, this molecule preferentially bind to tumor cells. The product has a unique feature that it doesn’t bind to human red blood cells to form ‘Antigenic sink’, thus greatly enhancing the specific synergistic effect of the double targets against tumor. We believe IMM2902 has promising developmental value and huge commercial potential." Dr. Tian is quite confident about the prospects of IMM2902 clinical development.
IMM2902 is a new-generation bispecific drug candidate with global proprietary intellectual property rights, developed based on ImmuneOnco "mAb-Trap" technical platform. IMM2902 targets immune regulatory target CD47 and HER2, to inhibit tumor cell growth by accelerating the endocytosis and degradation of HER2, and to disinhibit and enhance the phagocytosis of macrophages against tumor cells by blocking the "don't eat me" signal mediated by CD47-SIRPα and activating the "eat me" signal mediated by Ig1Fc-FcγR. By the phagocytosis, processed tumor antigen was presented to T cells thereby exerting a powerful effect of tumor immunotherapy. IMM2902 is expected to be used mainly for HER2-expressing advanced solid tumors such as breast cancer, stomach cancer and lung cancer.
Founded in June 2015 at Zhangjiang Hi-Tech Park of China (Shanghai) Pilot Free Trade Zone, ImmuneOnco focuses on development and research of anti-tumor immunotherapy products, including bi-specific 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 return gradually 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.