On March 15, 2023 ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (hereinafter referred to as "ImmuneOnco") reported that the Phase Ib/II clinical study of the Company’s self-developed ADCC-enhanced CTLA-4 antibody drug (project number: IMM27M) jointly with Tislelizumab targeting PD-1 in patients with advanced solid tumors was approved by the National Medical Products Administration (NMPA), which is another milestone in the Company’s development (Press release, ImmuneOnco Biopharma, MAR 15, 2023, View Source [SID1234655685]).
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IMM27M is an IgG1 antibody against the CTLA-4 target. It has been genetically engineered to significantly enhance the ADCC activity. Compared with the same drug Ipilimumab, the drug effect in animals is significantly better than Ipilimumab at the same dose. At a lower dose (0.3mg/ kg) can completely remove the tumor.
The phase I dose-escalation clinical trial of the IMM27M project for solid tumors is progressing smoothly. The first patient has been administered in June 2022, and the 5mg/kg dose group has been achieved so far. Preliminary clinical data of the previous dose (3mg/kg) show that IMM27M is well tolerated, and there has been no dose-limiting toxicity (DLT) so far, and it has shown positive effects on some patients with advanced solid tumors (such as melanoma, breast cancer). The curative effect signal, after one to two cycles of treatment, the tumor shrunk by 22.8% and 28.7%, respectively.
Dr. Tian Wenzhi, Founder and Chairman of ImmuneOnco, said,
We are very pleased that our new generation of CTLA-4 antibody project IMM27M combined with tislelizumab has been approved by the NMPA for Phase Ib/II clinical trials in patients with advanced solid tumors. Repeated in vivo studies have demonstrated that IMM27M has a strong anti-tumor effect It is active and can be combined with multiple drugs in the company’s pipeline for clinical research. The dual-immune combination therapy of CTLA4 combined with PD1/PD-L1 has proven to have a clear clinical synergy. BMS’s ipilimumab combined with O. The indications have been approved by the FDA for marketing, covering multiple clinical indications such as melanoma, colorectal cancer, renal cell carcinoma, hepatocellular carcinoma, non-small cell lung cancer, etc. We believe that IMM27M will have great clinical development value. We will continue to advance the research of the IMM27M project and bring good news to the majority of cancer patients.