Instil Bio Gets U.S. FDA IND Clearance For AXN-2510, A PD-L1xVEGF Bispecific Antibody, To Begin Phase 1 Trial In Relapsed/Refractory Solid Tumors

Instil Bio, Inc., a clinical-stage biopharmaceutical company developing innovative therapies, has announced that the U.S. The Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for AXN-2510, also known as ‘2510. Following the IND clearance, Instil plans to begin a Phase 1 clinical trial of ‘2510 as a standalone treatment for patients with relapsed or refractory solid tumors. 

Jamie Freedman, M.D., Ph.D., Chief Medical Officer of Instil, stated, “We are pleased to announce the clearance of the ‘2510 IND by the FDA. Evaluating ‘2510 in a global population will be a critical milestone in the clinical development of ‘2510.”

This trial, expected to start before the end of 2025, will assess the safety, preliminary efficacy, pharmacokinetics, and pharmacodynamics of the investigational therapy in this patient population. In addition to the planned U.S. study, initial safety and efficacy data from an ongoing Phase 2 trial of ‘2510 in combination with chemotherapy for first-line treatment of non-small cell lung cancer (NSCLC) in China is anticipated to be released in the second half of 2025. That trial is being conducted by ImmuneOnco, Instil's development partner.