Instil Bio Receives FDA Clearance to Begin Phase 1 Trial of AXN-2510 for Relapsed or Refractory Solid Tumours
Thursday, July 03, 2025
Instil Bio, Inc., a clinical-stage biopharmaceutical company listed on NASDAQ (TIL), has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for AXN-2510. This is a PD-L1xVEGF bispecific antibody developed for the treatment of relapsed or refractory solid tumours.
The company plans to launch a Phase 1 trial of AXN-2510 as a monotherapy before the end of 2025. The study will assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of the drug in patients with solid tumours.
Instil has also confirmed that initial data from an ongoing Phase 2 trial of AXN-2510 in combination with chemotherapy for first-line non-small cell lung cancer (NSCLC) in China is expected in the second half of 2025. This study is being conducted by ImmuneOnco.
The clearance of the IND by the FDA marks a key step in the global development of AXN-2510.
Source: globenewswire.com
