Kestrel Therapeutics Announces IND Clearance by U.S. FDA of KST-6051, a Potential Best-in-Class Pan-KRAS Inhibitor, Enabling Initiation of Phase 1 Trial
WATERTOWN, Mass., March 05, 2026 (GLOBE NEWSWIRE) -- Kestrel Therapeutics Inc. (“Kestrel” or the “Company”), a clinical stage biotechnology company developing next-generation small-molecule inhibitors targeting mutant KRAS, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for KST-6051, an investigational, oral, small-molecule inhibitor designed to target KRAS.
Kestrel is advancing KST-6051 into the clinic and expects to initiate a first-in-human Phase 1 dose-escalation clinical trial FALCON by the end of the first quarter. The trial, designed to evaluate safety, tolerability and preliminary anti-tumor activity, will enroll patients with advanced or metastatic KRAS-mutant solid tumors, including pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), and others.
“IND approval for KST-6051 is a significant milestone for Kestrel and an important step forward for patients with KRAS-driven cancers,” said Dr. Frank G. Haluska, President and Chief Executive Officer of Kestrel Therapeutics. “KST-6051 represents our next-generation approach to pan-KRAS inhibition, leveraging proprietary and unique Switch-II pocket chemistry to target KRAS in both the ON- and OFF-states. We are excited to initiate our first study as we work toward initial clinical readouts anticipated in late 2026.”
About KST-6051
KST-6051 is a potential best-in-class, oral pan-KRAS inhibitor, developed for the treatment of KRAS-driven cancers. KST-6051 is a potent and selective inhibitor of KRAS with activity against KRAS in both its active (GTP-bound) and inactive (GDP-bound) states. Preclinical data demonstrate robust on-target pathway modulation, anti-proliferative activity, and efficacy at well-tolerated doses in multiple human KRAS mutant tumor models. The Company is initiating a Phase 1 study in patients with KRAS-mutant advanced/metastatic solid tumors. Its clinical development will ultimately address pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), and other KRAS-driven malignancies.
About Kestrel Therapeutics, Inc.
Kestrel Therapeutics is a privately held clinical stage biotechnology company pioneering small-molecule therapies that directly address oncogenic drivers of cancer, focusing on next-generation inhibitors of mutated KRAS proteins. KRAS is estimated to be mutated in approximately 30% of all malignancies. The Company’s lead candidate, KST-6051 offers the potential to treat a broad spectrum of KRAS-driven solid tumors, an area of significant unmet patient need. Based in Watertown, MA, Kestrel is backed by leading life-science investors including Pfizer Ventures and Santé Ventures and led by a team with deep expertise and a record of success in oncology drug discovery and development.
Investor Contact:
Elizabeth Wharton
Kestrel Therapeutics, Inc.
Elizabeth.Wharton@KestrelTherapeutics.com
Sandya von der Weid
LifeSci Advisors, LLC
Svonderweid@LifeSciAdvisors.com
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