IMM40H was approved almost simultaneously by China NMPA and US FDA for clinical trial research
On August 29, 2022, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (hereinafter referred to as "ImmuneOnco" and the company) announced that the newly developed humanized IgG1 CD70 antibody (project number: IMM40H) has been approved by the US FDA and China NMPA for Clinical trial research almost simultaneously. This is the third IND approval from the FDA so far (previously, IMM0306 and IMM2902) and it is another important milestone in clinical development of the company.
CD70 highly and widely expresses in many tumor tissue. Its ligand CD27 expresses on regulatory T (Treg) cells. CD70/CD27 interaction activates Treg cells which depress Tumor immunity. In vivo efficacy studies show that IMM40H has strong antitumor activities. Subcutaneously implanted tumors can be eliminated completely after 2-3 treatments at low doses.
Chairman, Founder of ImuneOnco, Dr.Tian Wenzhi said:
"I am very pleased that the IMM40H we newly developed is approved by the US FDA and China NMPA for clinical trial research. We feel confident about clinical developmental value of IMM40H. We will actively promote clinical trial research and strive to bring it to the market as soon as possible, so as to benefit the cancer patients as soon as possible. "