On December 1, 2022, ImmuneOnco Biopharmaceuticals (Shanghai) Inc.(hereinafter referred to as "ImmuneOnco") announced that phase II clinical studies of the first domestic SIRPαFc fusion protein targeting human CD47, IMM01，combined with PD-1 monoclonal antibody for solid tumors and lymphomas were officially launched.

The data from clinical phase I study of IMM01 monotherapy is encouraging. From a quite low dose level, some patients with advanced lymphoma have been clinically benefited with good safe profile. IMM01 does not bind to human red blood cells, avoiding the "antigen sink effect", due to its differential molecular design. The molecule weight of IMM01 is only about half of the antibody so has better tissue permeability and bioavailability. What is more, preclinical in vivo drug efficacy test showed that IMM01 was very useful to combine with other targeting agents and immunotherapy drugs to gain synergic tumor suppressive activity.

PD-1 monoclonal antibody has been proven to have superior curative effect on a variety of tumors, but only responsive to small portion of patients due to limitation by the content of infiltrated T cells in tumor tissue, lack of infiltrated T cell is called "cold tumor". Macrophages are innate immune cells and antigen-presenting cells. After activated, they can turn ‘cold tumor’ to ‘hot tumor’ so as to improve curative effect of PD-1 monoclonal antibody and maintain for a long time.

1) Macrophages directly ‘swallow’ tumor cells and present tumor antigens to T cells to induce tumor antigen-specific T cell responses.

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

Dr. Tian，Wenzhi, founder and chairman of ImmuneOnco, said，

 "I am very pleased to see that the phase II clinical trial of our IMM01 combined with PD-1 monoclonal antibody against solid tumors and lymphoma has been officially launched. Preclinical studies have shown that IMM01 combined with PD-1 monoclonal antibody has strong synergistic effects. Among patients enrolled in the phase I, it demonstrated good safety profile and tolerance. We are confident about clinical studies, IMM01 combined with PD-1 monoclonal antibody will show superior clinical efficacy and good safety. We hope to bring good news to more cancer patients as well."

Dr. Qiying Lu, Chief Medical Officer/Senior Vice President of ImmuneOnco said:

"This is an important milestone. IMM01 is our key product and one of the important cornerstones of our company in the field of anti-tumor immunotherapy. This product has a variety of combination therapies (including AZA, PD-1 monoclonal antibody and other drugs) ) has entered phase II clinical development in multiple indications, covering hematological tumors and solid tumors. At present, more than 150 patients have been enrolled in multiple indications including solid tumors, lymphoma, AML, MDS, and CMML. It showed good safety and tolerability, as well as encouraging preliminary efficacy in various tumor indications. We look forward to rapidly advancing the clinical development of IMM01 products, bringing new treatment options to tumor patients to meet unmet clinical needs."