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NMPA approved phase Ib/II clinical trial application of ImmuneOnco for IMM01 combined with PD-1 antibody in the treatment of relapsed and refractory malignant tumors

On February 22, 2022, ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (hereinafter referred to as "ImmuneOnco") announced that National Medical Products Administration (NMPA) approved Phase Ib/II clinical trial application of the first domestic SIRPα-Fc fusion protein drug candidate targeting human CD47 (IMM01) combined with PD-1 antibody for the treatment of relapsed/ refractory malignant tumors. So far, 6 clinical trial applications related to IMM01 have been approved, which further establishes leading position of the company in the field of drug R&D targeting CD47.

The preliminary data from IMM01 phase I clinical trial is encouraging. At the low dose levels, it has benefited some advanced lymphoma patients with a good safety profile. These clinical manifestations are based on the differentiated molecular design of IMM01. IMM01 is designed and screened not binding to human erythrocytes so as to avoid the "antigen sink effect". The molecule itself has low immunogenicity so that there is no ADA after administration in human. IMM01 has only half of the regular IgG molecular weight so has good tissue permeability and bioavailability. What is more, in preclinical in vivo efficacy tests, when IMM01 was used in combination with targeting drugs and immunotherapy drugs, it demonstrated strong tumor-inhibiting activity and synergistic effect against solid tumors.

PD-1 antibody has also been shown to have superior curative effect on a variety of tumors, but limited by the content of T cells in tumor tissue (such as "cold tumor"), most patients do not have a good response to PD-1 antibody therapy.

It is well proven that strong synergistic effects happen when PD1 antibody combined with CD47/SIRPa inhibitors. Macrophages are innate immune cells and 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) By directly phagocytosing tumor cells, macrophages can present the processed tumor antigens to T cells to induce tumor antigen-specific T cell responses.

    2) Macrophages release chemokines (such as CXCL9/CXCL10) to induce T cells to the tumor tissue, thereby transforming "cold tumors" into "hot tumors".

Dr. Tian Wenzhi, Founder, Chairman and CEO of ImmuneOnco, said:

 "I am very pleased to see that clinical trial application of our IMM01 combined with PD-1 antibody for the treatment of relapsed and refractory malignant tumors approved by the National Medical Products Administration (NMPA). Preclinical studies have shown that IMM01 combined with PD-1 antibody has a strong synergistic effect. We are optimistic and confident that synergistic use of IMM01 with PD-1 antibody will have superior clinical performance and will bring good news to the cancer patients."