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NMPA accepted the clinical trial application of IMM01 combined with PD-1 antibody for the treatment of relapsed and refractory malignant tumors

Date:2021-12-14 Views:329


    On December 13, 2021, I ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. announced that the application for the clinical trial, the SIRPαFc fusion protein (IMM01) targeting human CD47, combined with PD-1 antibody to treat relapsed and refractory malignancies, was accepted by the National Drug Products Administration (NMPA). This is another major milestone for ImmuneOnco, which further establishes ImmuneOnco's leading position in the research and development of CD47 targeting drugs.



    The PD-1 antibody is well proven to be effective on a variety of tumors.  But PD-1 immunotherapy is limited by lack of T cells in the tumor tissue ("cold tumors"), most patients failed to effect on PD-1 antibody therapy. Macrophages are innate immune cells and the antigen presenting cells. After activation, they can improve the efficacy of PD-1 antibody and maintain the durability of the efficacy through the following ways: 1) microphages directly swallow tumor cells and process them and present the tumor antigens to T cells so as to induce tumor antigen-specific T cell responses; 2) they release chemokines (such as CXCL9/CXCL10) to recruit T cells to tumor tissues, thereby transforming "cold tumors" into "hot tumors" (figure 1)


Figure 1. Activated macrophages help to raise  the low response rate  and overcome resistance of PD-1 antibodies



    Dr. Tian Wenzhi, founder and chairman of ImmuneOnco, said,     "I am very pleased to see that the clinical trial application of our IMM01 p combined with PD-1 antibody for the treatment of relapsed and refractory malignant tumors has been accepted by the National Food and Drug Administration (NMPA)." Preclinical studies have shown that IMM01 combined with PD-1 antibody has a strong synergistic effect, which can completely eliminate subcutaneous tumors, and the combined effect is significantly better than single target drugs (Figure 2). We believe that IMM01 combined with PD-1 antibody will have superior clinical performance and surely bring good news to cancer patients. "



About IMM01

    MM01 for injection is a new generation of immune checkpoint inhibitor with independent intellectual property rights, which is developed based on the "MAB-TRAP" technical  platform of  ImmuneOnco. Aiming at the immune regulatory CD47, it can activate the phagocytosis of macrophages on tumor cells and present tumor antigens to T cells. Thus, it takes powerful effects of tumor immunology. The IMM01 project faces the challenge of CD47 target drug research and development, and has been granted invention patents in China, Japan and the United States.


About ImmuneOnco

    Founded in June 2015 in the Zhangjiang Hi-Tech Park of the China (Shanghai) Pilot Free Trade Zone, ImmuneOnco focuses on the development and research of anti-tumor immunotherapy products, including bi-specific antibodies, novel recombinant proteins, and TankTM cellular therapy. The common feature of these products is to activate the patient's own immune system to exert the anti-tumor effects, and ultimately inhibit the endless growth of tumor cells and reverse the malignant symptoms, so that the patients gradually return to healthy. So far, several new anti-tumor drugs are in clinical research 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 the "Enterprise Excellence Award" of Shanghai Science and Technology Entrepreneurship in 2017.