ImmuneOnco Gains NMPA Approval for Phase Ib/II Study of IMM27M in Advanced Tumors

ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II clinical study for its IMM27M. This ADCC-enhanced CTLA-4 monoclonal antibody (mAb) will be combined with the programmed death-1 (PD-1) inhibitor tislelizumab for the treatment of advanced solid tumors.

Comparative Efficacy and Safety
Bristol-Myers Squibb’s (BMS, NYSE: BMY) Yervoy (ipilimumab) combined with Opdivo (nivolumab) has obtained multiple market approvals in the United States for various cancers, including melanoma, colorectal cancer, renal cell carcinoma, hepatocellular carcinoma, and non-small cell lung cancer. In preclinical studies, IMM27M demonstrated significantly better efficacy than ipilimumab at the same dose, with complete tumor elimination achievable at a lower dose of 0.3 mg/kg. The 3mg/kg dose of IMM27M is well tolerated, with no dose-limiting toxicity (DLT) observed.

Clinical Observations
IMM27M has shown a positive therapeutic signal for some patients with advanced solid tumors, such as melanoma and breast cancer. After one to two cycles of treatment, tumors have shrunk by 22.8% and 28.7%, respectively. These findings highlight the potential of IMM27M as a promising treatment option in combination with tislelizumab for advanced cancers.-Fineline Info & Tech

Fineline Info & Tech