ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study for its investigational drug timdarpacept (IMM01). This drug is the first SIRPαFc fusion protein targeting CD47 to be designed in China. The study will evaluate the safety and efficacy of IMM01 in combination with BeiGene’s (NASDAQ: BGNE) PD-1 inhibitor tislelizumab for the treatment of patients with classic Hodgkin’s lymphoma (cHL) that is difficult to treat.
IMM01 was developed by ImmuneOnco utilizing its proprietary “mAb-Trap” technology platform, which enables the creation of molecules with a dual mechanism of action, exhibiting potent anti-tumor activity. Preclinical in vivo efficacy trials have shown that the combination of IMM01 with targeted therapies or immunotherapies results in significant anti-tumor responses against both hematological and solid tumors. ImmuneOnco has secured patent protection for IMM01 in key markets, including China, Japan, the United States, and the European Union. – Flcube.com
