Company News
2025-07-02
35● Initiation of US phase 1b/2 trial of IMM2510/AXN-2510 planned in 2H 2025
●Anticipate ImmuneOnco sharing initial safety and efficacy results from phase 2 trial of IMM2510/AXN-2510 + chemo in 1L NSCLC in the second half of 2025
SHANGHAI and DALLAS,TX, July 2, 2025 (GLOBE NEWSWIRE)– ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKEX Code: 1541.HK, “ImmuneOnco”) and Instil Bio, Inc. (Nasdaq: TIL, "Instil") , today announced the clearance of an Investigational New Drug (IND) application for IMM2510/AXN-2510 by the U.S. Food and Drug Administration. 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. “ 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." “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.”
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