ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd announced that the U.S. Food and Drug Administration (FDA) has granted fast-track designation to its bispecific antibody (BsAb)-receptor recombinant protein IMM2902, targeting human CD47 and HER2. The product is the only CD47/HER2 BsAb to enter clinical trials globally.
Drug Profile
IMM2902 inhibits tumor cell growth by accelerating HER2 endocytosis and degradation and enhancing macrophage phagocytosis of tumor cells. It blocks the “don’t eat me” signal mediated by CD47-SIRPα and activates the “eat me” signal via IgG1Fc-FcγR. The drug is designed to address immune regulatory targets CD47 and HER2.
Clinical Development
ImmuneOnco has initiated a Phase I clinical study in China and the U.S. to evaluate IMM2902’s efficacy in advanced HER2-positive and HER2-low solid tumors, including breast cancer, gastric cancer, non-small cell lung cancer, and cholangiocarcinoma.-Fineline Info & Tech
