Instil Bio, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for AXN-2510. This regulatory clearance is a critical milestone, allowing Instil to proceed with clinical development of its lead asset in the United States.
The company expects 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 is designed to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of AXN-2510 in a U.S. patient population.
Instil also reiterated its anticipation 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 will be shared by ImmuneOnco in the second half of 2025. Evaluating AXN-2510 in a global population is a key step in its clinical development.
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