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ImmuneOnco’s IMM2510S Subcutaneous Formulation Completes First Patient Dosing in Phase I Clinical Study, Ushering in a New Era of Convenient Dual-Target Therapy
2026-07-21
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SHANGHAI, China, July 21, 2026 — ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (“ImmuneOnco”; HKEX Stock Code: 01541.HK) announced today that the first patient has been successfully dosed in the Phase I clinical study of IMM2510S, a subcutaneous injection formulation of palverafusp alfa (IMM2510), an in-house developed VEGF×PD-L1 dual-target agent. This milestone is expected to provide a novel treatment option for patients with advanced solid tumors through a more convenient and safer route of administration.


IMM2510 is a VEGF×PD-L1 dual-target agent developed on ImmuneOnco’s proprietary mAb-Trap platform. It exerts its antitumor effects through multiple mechanisms, including the activation of T cells via blockade of the PD-1/PD-L1 signaling pathway, remodeling of the tumor microenvironment through VEGF signaling inhibition, and the induction of antibody-dependent cellular cytotoxicity (ADCC) and phagocytosis (ADCP). Since the initial Investigational New Drug (IND) application was submitted in 2020, the clinical development of IMM2510 has progressed steadily. Monotherapy with IMM2510 has demonstrated promising efficacy in later-line squamous non-small cell lung cancer (SQ-NSCLC). Furthermore, multiple Phase II IND applications have been approved for IMM2510 in combination with chemotherapy in the perioperative setting for resectable SQ-NSCLC and esophageal squamous cell carcinoma (ESCC), as well as for advanced or recurrent endometrial cancer. Additionally, the combination of IMM2510 and IMM27M has shown remarkable antitumor potential in a Phase Ib study, demonstrating early signs of efficacy and good tolerability in solid tumors, including ESCC, that have progressed on prior immunotherapy.


To address the clinical pain points associated with traditional intravenous (IV) administration—such as prolonged hospitalization, high healthcare resource utilization, and poor patient adherence—ImmuneOnco successfully developed the subcutaneous formulation IMM2510S, leveraging its proprietary hyaluronidase technology platform. Utilizing recombinant human hyaluronidase (rHuPH20), this formulation enables rapid, large-volume subcutaneous delivery of macromolecular drugs. It optimizes pharmacokinetic profiles by reducing peak drug concentrations and extending exposure time, thereby further enhancing both the safety and efficacy of the treatment. The successful first dosing of IMM2510S marks the successful translation of ImmuneOnco’s innovation in subcutaneous delivery, bringing a more convenient therapeutic option to patients with advanced solid tumors.


Dr. Wenzhi Tian, Chairman, Chief Executive Officer, and Chief Scientific Officer of ImmuneOnco, stated, “The successful first patient dosing in the Phase I clinical study of the IMM2510S subcutaneous formulation is a significant milestone in our commitment to a ‘patient-centric’ approach. By transitioning from intravenous to subcutaneous administration, we are not merely optimizing a dosage form; we are fundamentally reshaping the patient treatment experience. We look forward to IMM2510S demonstrating efficacy and safety profiles in subsequent clinical studies that are comparable to, or even superior to, those of the IV formulation, so that it can benefit a broader population of patients with advanced solid tumors as soon as possible.”


Dr. Zhuli Wu, Chief Medical Officer of ImmuneOnco, commented, “We are thrilled to have completed the first subcutaneous dosing of IMM2510S today. We will continue to advance the Phase I clinical trial and subsequent clinical development with rigorous scientific standards. Our goal is to bring this innovative combination of ‘highly efficacious dual-targeting and convenient formulation’ to market as soon as possible, providing solutions for patients to overcome immunotherapy resistance and improve treatment adherence.”