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Instil Bio announces FDA clearance of IND application for AXN-2510

Instil Bio (TIL) announced the clearance of an Investigational New Drug application for AXN-2510 by the U.S. FDA. Instil expects to initiate a phase 1 trial of ‘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 ‘2510 in patients with solid tumors. Additionally, Instil continues to anticipate that initial safety and efficacy results from the ongoing phase 2 study of ‘2510 in combination with chemotherapy in first-line NSCLC in China will be shared in the second half of 2025 by ImmuneOnco.

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