Instil Bio Inc. (NASDAQ:TIL) saw its stock jump 10% after the company announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for AXN-2510.
The clinical-stage biopharmaceutical company plans to begin a Phase 1 trial of AXN-2510 as a standalone treatment for patients with relapsed or refractory solid tumors before the end of 2025. The upcoming trial will assess the drug’s safety, efficacy, pharmacokinetics, and pharmacodynamics.
Instil also reaffirmed that initial data from its ongoing Phase 2 study of AXN-2510 in combination with chemotherapy for first-line non-small cell lung cancer (NSCLC) in China—being conducted by ImmuneOnco—is expected in the second half of 2025.
“We are pleased to announce the clearance of the ’2510 IND by the FDA,” said Jamie Freedman, M.D., Ph.D., Chief Medical Officer of Instil Bio. “Evaluating ’2510 in a global population will be a critical milestone in the clinical development of ’2510.”
The FDA’s green light marks a major advancement in Instil Bio’s efforts to expand its pipeline of next-generation cancer therapies.