FDA Clears Instil Bio IND for AXN-2510 Tumor Treatment

Instil Bio, a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for AXN-2510, a novel PD-L1xVEGF bispecific antibody developed to treat multiple solid tumors. Following this clearance, Instil plans to initiate a Phase 1 trial of AXN-2510 as monotherapy for patients with relapsed or refractory solid tumors before the end of 2025, aiming to evaluate safety, efficacy, pharmacokinetics, and pharmacodynamics. Additionally, the company anticipates initial safety and efficacy data from an ongoing Phase 2 study of AXN-2510 in combination with chemotherapy for first-line non-small cell lung cancer in China, expected in the second half of 2025. Jamie Freedman, Instil’s Chief Medical Officer, emphasized that evaluating AXN-2510 in a global population marks a critical milestone in the drug's clinical development. Instil's stock has responded positively to the news, with shares rising significantly, reflecting investor optimism about the drug's potential. The company continues to advance its pipeline of novel therapies with promising clinical data supporting AXN-2510's competitive profile in cancer treatment.