On July 2, 2025 ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKEX Code: 1541.HK, "ImmuneOnco") and Instil Bio, Inc. (Nasdaq: TIL, "Instil"), reported the clearance of an Investigational New Drug (IND) application for IMM2510/AXN-2510 by the U.S. Food and Drug Administration (Press release, ImmuneOnco Biopharma, JUL 2, 2025, View Source [SID1234655711]).

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Instil expects to initiate a Phase 1b/2 trial of IMM2510/AXN-2510 as monotherapy for patients with relapsed/refractory solid tumors before the end of 2025. The trial is designed to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of IMM2510/AXN-2510 in patients with solid tumors. Additionally, Instil continues to anticipate data from the ongoing phase 2 study of IMM2510/AXN-2510 in combination with chemotherapy in front-line NSCLC in China to be shared in the second half of 2025 by ImmuneOnco.

Dr. Wenzhi Tian, CEO of ImmuneOnco said: "We are pleased to announce that IMM2510/AXN-2510, a product of our collaboration with Instil Bio, has received clearance to proceed to the Phase 1b/2 clinical trial in the United States. This represents a significant step forward in our joint efforts.We are also looking forward to the disclosure of preliminary safety and efficacy data from the Phase 2 clinical trial of IMM2510 in combination with chemotherapy for the first-line treatment of non-small cell lung cancer in the second half of 2025. These results will provide further validation of its clinical efficacy. We are dedicated to continuing the advancement of this project with the aim of delivering more effective therapeutic options to patients worldwide."

Jamie Freedman, M.D., Ph.D., Chief Medical Officer of Instil said: "We are pleased to announce the clearance of the IMM2510/AXN-2510 IND by the FDA. Evaluating IMM2510/AXN-2510 in a global population will be a critical milestone in the clinical development of IMM2510/AXN-2510."