On September 11, 2023, ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (referred to as "ImmuneOnco", Hong Kong Stock Exchange stock code: 01541.HK) announced that IMM2510, a PD-L1/vEGF bispecific fusion protein independently developed by ImmuneOnco, completed Phase I dose escalation and determined the recommended Phase II dose. This is another important milestone of ImmuneOnco in its rapid development.

The preliminary results of the Phase I clinical trial of the IMM2510 demonstrate that the product have anti-tumor efficacy with tumor objective response observed in three different dose groups (3mg/kg, 10mg/kg, 20mg/kg). Among them, one PR was observed in each of the 3 mg/kg and 10 mg/kg dose groups in patients with lung squamous cell carcinoma who had failed PD1, and one PR was observed in thymic adenosquamous cell carcinoma (20 mg/kg). After discussion by the Safety Review Committee （SRC）,  it was unanimously agreed that the RP2D be dose of 20mg/kg Q2W for monotherapy to enter Phase II development.

On August 17, the Phase II clinical research application of CTLA-4 antibody IMM27M combined with IMM2510, both are independently developed by the company, accepted by the National Medical Products Administration (NMPA). Preclinical efficacy studies demonstrated that IMM2510 produces stronger synergistic anti-tumor activity than that of anti-vEGF combined with PD-L1 antibodies. Repeatable in vivo studies showed 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. It has been well established that dual immunotherapy of anti- CTLA4 combined with anti-PD1/PD-L1 have clear cut synergy in patients.

In addition, the Phase II clinical-IND application for IMM2510 combined with chemotherapy for the treatment of different solid tumor indications such as non-small cell lung cancer and breast cancer has been accepted by CDE.

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

"We are very pleased to see that our IMM2510 completed Phase I dose escalation and determined the recommended Phase II dose. IMM2510 is an antibody-receptor recombinant protein (mAb-Trap) that targets both PD-L1 and vEGF. It inhibits angiogenesis, shrinks tumors, and makes tumor cells more sensitive to immune responses. It also activates T cells, natural killer cells, and macrophages by blocking PD-L1/PD-1 interaction and inducing Fc-mediated ADCC/ADCP activity. There are currently four bispecific molecules targeting both vEGF and PD-L1 in the global pipeline, two of which do not have active IgG1 Fc fragments IMM2510 has an enhanced IgG1 Fc who has powerful ADCC effector functions. So, by angiogenesis inhibition and T cell activation, it modulates the tumor microenvironment and significantly improves treatment efficacy. Preclinical in vivo efficacy studies show that IMM2510 is more effective than that anti-vEGF combined with PD-L1 antibodies, by comparing with combination of two single agents, IMM2510 has a huge competitive advantage in reducing patient affordability. We will continue to promote the research on the IMM2510 and strive to bring good news to the cancer patients as soon as possible."

Dr. Lu, Qiying, chief medical officer/senior vice president of the company, said:

  "It is of great significance for our company today that IMM2510 has completed the patient enrollment in Phase I dose escalation and determined the recommended Phase II dose. There are preliminary positive efficacy signals in relapsed and refractory lung adenocarcinoma, lung squamous cell carcinoma and thymic cancer. For unmet clinical needs, we plan to further develop single drug and combinations of different treatment modes for multiple indications and explore the efficacy in solid tumors, including non-small cell lung cancer, triple-negative breast cancer, soft tissue sarcoma, liver cancer, etc. So far, the company has submitted a Phase II IND application of combination with chemotherapy for different indications, and a Phase II IND application of combination with IMM27 for different solid tumors. We have high hopes and expectations for IMM2510 and look forward to bringing good news to cancer patients."