Recently, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (referred to as “ImmuneOnco,” with the stock code 01541.HK on the Hong Kong Stock Exchange) announced that its independently developed VEGF×PD-L1 bispecific antibody IMM2510 has submitted End-of-Phase 2 (EOP2) communication applications for two Phase III registration clinical trials targeting different types of lung cancer to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This marks the entry of IMM2510's clinical development into a critical stage, with the potential to bring new treatment options for patients. 

palverafusp alfa (IMM2510) 

IMM2510 is a PD-L1×VEGF bispecific antibody developed based on ImmuneOnco's “mAb-Trap” technology platform. It exerts anti-tumor effects through multiple mechanisms, including blocking the PD-1 signal to activate T cells, activating NK cells via ADCC, and reshaping the tumor microenvironment by blocking the VEGF signal. Phase I Clinical Study: Data from the Phase I study presented at the 2025 World Conference on Lung Cancer (WCLC) showed that IMM2510 achieved an objective response rate (ORR) of 35.3% and a disease control rate (DCR) of 76.5% in patients with advanced squamous non-small cell lung cancer (SQ-NSCLC) who had previously received immune therapy. The median progression-free survival (PFS) was 9.4 months, with controllable safety. Phase II Clinical Study: Preliminary data from the Phase II study in combination with chemotherapy for first-line treatment of NSCLC showed that the ORR in patients with squamous NSCLC was as high as 80%, with an ORR of 62% in the overall evaluable population, and no dose-limiting toxicity was observed. Based on these positive results, ImmuneOnco plans to further verify the efficacy and safety of IMM2510 in Phase III clinical trials, with the aim of providing a more effective treatment option for patients with lung cancer. 

Dr. Tian Wenzhi, Founder, Chairman, CEO, and CSO of ImmuneOnco, stated: 

"We are very pleased to see the submission of the EOP2 communication applications for the two Phase III registration clinical trials of IMM2510, which marks an important step for us in the field of lung cancer treatment. This is not only an important milestone in the advancement of our company's R&D pipeline but also a solid step towards our mission of 'developing first-class new drugs and benefiting cancer patients.' IMM2510 has already shown significant efficacy and controllable safety in the treatment of lung cancer in the early stages. We look forward to further verifying its potential in Phase III clinical trials and bringing new treatment options to patients with advanced non-small cell lung cancer. We will continue to maintain close communication with regulatory authorities to ensure the smooth progress of clinical research and benefit more patients as soon as possible." 

Dr. Wu Zhuli, Chief Medical Officer of ImmuneOnco, said: 

"The acceptance of the EOP2 communication applications for the two Phase III registration clinical trials of IMM2510 is one of the important milestones for ImmuneOnco's R&D pipeline to move towards commercialization. IMM2510 has already demonstrated significant therapeutic effects and good safety in early clinical studies. We will spare no effort to advance the Phase III clinical trials and ensure their smooth progress. We believe that with a data-driven and patient-centered R&D strategy, IMM2510 has the potential to become a new treatment option for advanced non-small cell lung cancer, bringing more hope and blessings to patients."