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The National Medical Products Administration (NMPA) approved ImmuneOnco‘s application for IMM2510 combined with IMM27M in treatment of advanced solid tumors
2023-10-27
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On October 27, 2023, ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (referred to as "ImmuneOnco"“the company’, Hong Kong Stock Exchange stock code: 01541.HK)  announced that 2 drug candidates independently developed by the company, IMM2510,  a bispecific antibody-receptor recombinant protein targeting PD-L1/VEGFA and IMM27M, an ADCC-enhanced CTLA-4 monoclonal antibody, are proposed to combined for the treatment of advanced solid tumors.  This clinical phase I study was approved by the National Medical Products Administration (NMPA). this is another milestone achievement in the rapid development of ImmuneOnco.

The initial results of the Phase I clinical trial of the IMM2510 have shown great safety profiles and positive efficacy, with tumor response observed in three different dose groups (3mg/kg, 10mg/kg, 20mg/kg). Among them, one PR was observed in each of 3 mg/kg and 10 mg/kg dose groups in patients with lung squamous cell carcinoma who had failed PD1 therapy, and one PR was observed in another thymic adenosquamous cell carcinoma (20 mg/kg). After discussion by the Safety Review Committee SRC, it was unanimously agreed that the RP2D dose of 20mg/kg Q2W as a single drug and proceed to Phase II for further development.

Overall data form the phase I dose escalation clinical trial of the IIMM27M for solid tumors showed that IMM27M was well tolerated, with no dose-limiting toxicities (DLTs) occurring in all subjects across the seven dose groups of 0.1 mg/kg to 7.5 mg/kg. Among them, initial positive tumor response (both obtained PR) was observed in 2 breast cancer patients after multiple lines of treatment (one case was 3 mg/kg, the other was 5 mg/kg); in addition, Tumor shrinkage exceeding 20% SD was observed in melanoma patients (2 mg/kg). After discussion by the Safety Review Committee (SRC), it was unanimously agreed that 5mg/kg Q3W should be used as a single drug RP2D dose and proceed to enter Phase II for further development.

Preclinical efficacy studies shown that IMM2510 produces stronger synergistic anti-tumor activity compared with the combination of VEGF blocking antibody and PD-L1 antibody. Repeated in vivo studies proved that IMM27M has strong anti-tumor activity and can be used in clinical studies in combination with a variety of drugs in the company's pipeline. Dual immune combination therapy of CTLA4 combined with PD1/PD-L1 was proven to have clear clinical synergy.

Dr. Tian, Wenzhi, founder and chairman of ImmuneOnco, said:

     "We are very pleased that our Phase I clinical trial application of IMM2510 combined with IMM27M in the treatment of advanced solid tumors has been approved by the NMPA. The dual immune combination therapy of CTLA4 combined with PD1/PD-L1 has proven to have clear clinical synergy, BMS's "O+Y" The (Opdivo+Yervoy) combination has been approved by the FDA for multiple indications, covering multiple clinical indications such as melanoma, colorectal cancer, renal cell carcinoma, hepatocellular carcinoma, and non-small cell lung cancer; AZ's "D +T" (Durvaluma+Tremelimumab) combination has been approved for liver cancer and non-small cell lung cancer indications. At the same time, Roche's "T+A" (Tecentriq+Avastin) combination has also been approved for marketing in China and the United States as a first-line treatment for advanced liver cancer. These combination therapies all involve two targets. We believe that the triple-target treatment of IMM2510 combined with IMM27M are expected to have better clinical efficacy. We plan to carry out clinical exploratory studies in multiple advanced solid tumors (liver cancer, breast cancer, lung cancer, etc.), and looking forward to bringing good news to cancer patients.


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