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Investing.com -- Instil Bio Inc (NASDAQ:TIL) stock surged 10% after the clinical-stage biopharmaceutical company announced the clearance of an Investigational New Drug (IND) application for AXN-2510 by the U.S. Food and Drug Administration.
The company plans to initiate a phase 1 trial of AXN-2510 as monotherapy for patients with relapsed/refractory solid tumors before the end of 2025. This trial will evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of the drug in patients with solid tumors.
Instil Bio also reiterated that initial safety and efficacy results from the ongoing phase 2 study of AXN-2510 in combination with chemotherapy in first-line NSCLC in China are expected in the second half of 2025. This study is being conducted by ImmuneOnco.
"We are pleased to announce the clearance of the ’2510 IND by the FDA," said Jamie Freedman, M.D., Ph.D., Chief Medical (TASE:BLWV) Officer of Instil. "Evaluating ’2510 in a global population will be a critical milestone in the clinical development of ’2510."
The FDA clearance represents a significant step forward in Instil Bio’s clinical development program as it works to advance its pipeline of novel therapies.
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