Shanghai, China, January 14, 2026 – ImmuneOnco Biopharmaceuticals (Shanghai) Inc. ("ImmuneOnco", HKEX stock code: 01541.HK) announced that the Investigational New Drug (IND) application for a Phase II/III clinical trial of palverafusp α (IMM2510), the company's proprietary PD-L1×VEGF bispecific antibody, as monotherapy and in combination with chemotherapy for primary advanced or recurrent endometrial cancer has been officially approved by the National Medical Products Administration (NMPA). This milestone marks IMM2510's formal expansion into gynecologic oncology—a field with significant unmet medical needs—following its development in lung cancer.

palverafusp a (IMM2510) Targets Treatment Gap in Endometrial Cancer

IMM2510 is a VEGF×PD-L1 bispecific antibody developed based on ImmuneOnco's "mAb-Trap" technology platform. It exerts anti-tumor effects through multiple mechanisms, including blocking the PD-1/PD-L1 signaling pathway to activate T cells, disrupting VEGF signaling to remodel the tumor microenvironment, and inducing antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

In July 2025, IMM2510 received FDA approval to initiate Phase I clinical trials in the United States. Regarding combination strategies, Phase II IND applications for IMM2510 plus chemotherapy in neoadjuvant/adjuvant settings for non-small cell lung cancer (NSCLC) and esophageal cancer have also been approved, enabling a differentiated development approach through innovative trial designs.

IMM2510 has already demonstrated remarkable potential in IO-refractory NSCLC: Phase I data showed that among 17 previously-treated advanced squamous NSCLC patients, the objective response rate (ORR) reached 35.3%, disease control rate (DCR) was 76.5%, and median progression-free survival (PFS) was 9.4 months.

Endometrial cancer is one of the most common malignant tumors among women worldwide, with rising incidence and limited treatment options for advanced or recurrent patients. The bispecific antibody's "immunotherapy plus anti-angiogenesis" synergistic mechanism provides a solid scientific rationale for its application in endometrial cancer, which is characterized by high VEGF expression and a complex immune microenvironment.

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

"Endometrial cancer represents a significant milestone in IMM2510's indication expansion. The tumor microenvironment of endometrial cancer features both hyperactive angiogenesis and immune evasion, which aligns perfectly with the dual-target 'VEGF×PD-L1' design of IMM2510's molecular mechanism. This study will not only validate the universal applicability of our platform technology in gynecologic oncology but also establish a cross-tumor-type development paradigm from lung cancer to women's cancers, offering a systematic solution for IO-refractory solid tumor patients globally."

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

"We are very pleased that IMM2510 has received CDE approval in China for the Phase II/III IND application in first-line advanced endometrial cancer. The approved study is a multicenter, randomized, controlled trial designed to evaluate the efficacy and safety of IMM2510 plus standard therapy compared to existing first-line standard-of-care treatments in advanced endometrial cancer patients. Endometrial cancer is one of the most common malignant tumors among women worldwide, with limited treatment options and poor prognosis for advanced patients. The company will work closely with investigators and healthcare partners to accelerate validation of the clinical benefits this therapy can bring to patients."