• KT-300 is a novel, oral small-molecule inhibitor of TRIM7 designed to target RAS-driven cancers independent of the underlying RAS mutation
  • KT-300 is designed to bypass mechanisms of resistance, supporting its potential use in patients who acquire resistance to RAS inhibitors
  • Initial clinical data from the Phase 1 first-in-human study of KT-300 expected in 2027

HOUSTON and DURHAM, N.C., Nov. 05, 2026 (GLOBE NEWSWIRE) -- Kayak Therapeutics, Inc. (“Kayak” or the “Company”), a clinical-stage biotechnology company developing novel approaches to targeted cancer therapy, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for KT-300, an oral small-molecule inhibitor of TRIM7 and a potential first-in-class therapy for the treatment of RAS-driven cancers.

Kayak expects to initiate a first-in-human Phase 1 dose-escalation clinical trial in late 2026. The trial, designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of KT-300, will enroll patients with advanced RAS mutant solid tumors, including non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), and others.

“FDA clearance of the IND for KT-300, a potential first-in-class TRIM7 inhibitor, is an important milestone for Kayak and brings our novel approach to RAS-driven cancers into the clinic,” said Josiah Hornblower, CEO of Kayak Therapeutics. “TRIM7 sits at a critical downstream node of the RTK–RAS signaling cascade, and its hyperactivation drives tumor proliferation across a broad spectrum of cancers. Preclinical data demonstrate KT-300 not only blocks TRIM7 activity but does so in a way that is agnostic to the RAS-pathway mutation, and demonstrates anti-tumor activity in the setting of KRAS inhibitor resistance. These data underscore KT-300’s potential as a new therapeutic strategy for patients with RTK–RAS-driven cancers, a population with significant unmet medical need. We are excited to initiate our first study as we work toward initial clinical readouts anticipated in 2027.”

About KT-300

KT-300 is an investigational, potentially first-in-class oral small-molecule inhibitor of TRIM7, a key mediator of RTK–RAS-driven tumor cell proliferation. Preclinical studies from Kayak demonstrate that KT-300 induces robust tumor growth inhibition in both in vitro and in vivo models. KT-300’s anti-tumor activity is RAS-pathway–mutation agnostic, offering broad therapeutic potential for cancers driven by hyperactivated RTK–RAS signaling. Kayak expects to initiate its first-in-human Phase 1 dose-escalation clinical trial by the end of the fourth quarter.

About Kayak Therapeutics

Kayak Therapeutics is a privately held clinical-stage biotechnology company dedicated to discovering and developing innovative therapies for patients with cancer. Kayak’s expertise in drug discovery and research and development led to its lead program, KT-300, a potentially first-in-class inhibitor of the E3 ubiquitin ligase TRIM7, enabling a mutation-agonist approach to targeting the RTK–RAS signaling cascade. The company’s pipeline focuses on novel approaches targeting tumor-intrinsic signaling pathways to overcome resistance and improve patient outcomes. The company has offices in both Houston, Texas, and Durham, North Carolina. For more information, please visit: https://kayaktherapeutics.com/.

Media and Investor Contact:
Conor Richardson
Chief Financial Officer
Kayak Therapeutics, Inc.
InvestorRelations@kayaktherapeutics.com