Kestrel Therapeutics Receives FDA Approval To Begin Clinical Testing Of KRAS-Targeting Drug KST-6051

Kestrel Therapeutics Inc., a clinical-stage biotechnology company focused on developing next-generation small-molecule inhibitors targeting mutant KRAS, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for KST-6051. KST-6051 is an investigational oral small-molecule inhibitor designed to target KRAS.

Kestrel plans to advance KST-6051 into clinical testing and expects to initiate a first-in-human Phase 1 dose-escalation trial, named FALCON, by the end of the first quarter. This trial is designed to evaluate the safety, tolerability, and preliminary anti-tumor activity of KST-6051. The study will enroll patients with advanced or metastatic KRAS-mutant solid tumors, including pancreatic ductal adenocarcinoma, colorectal cancer, non-small cell lung cancer, and other KRAS-driven cancers.

Dr. Frank G. Haluska, President and Chief Executive Officer of Kestrel Therapeutics, highlighted the significance of the IND clearance. He said, “IND approval for KST-6051 is a major milestone for Kestrel and an important step forward for patients with KRAS-driven cancers. KST-6051 embodies our next-generation approach to pan-KRAS inhibition, utilizing our proprietary Switch-II pocket chemistry to target KRAS in both its ON and OFF states. We are eager to begin our first clinical study and look forward to the initial clinical readouts, which are anticipated in late 2026.”

The initiation of the FALCON trial marks a key step in Kestrel’s ongoing efforts to develop innovative therapies for patients with cancers driven by KRAS mutations, addressing an area of high unmet medical need. With KST-6051, Kestrel aims to provide a new therapeutic option that could potentially improve outcomes for patients with difficult-to-treat solid tumors.