BOSTON--(BUSINESS WIRE)--Ikena Oncology, a clinical-stage biotechnology company that discovers and develops patient-directed, biomarker-driven therapies, today announced dosing of the first patient in the first Phase 1 clinical trial evaluating IK-175 (formerly KYN-175), an internally-developed, orally administered, selective aryl hydrocarbon receptor (AHR) antagonist, in patients with advanced solid tumors. This Phase 1 study is expected to enroll approximately 50 patients in the US across both the dose escalation and dose expansion portions of the study.
This first-in-human, single-arm, open-label, dose-escalation and expansion study (NCT04200963) is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of IK-175 as a single-agent in patients with locally advanced or metastatic solid tumors, including urothelial carcinoma. The primary objectives of the study include determination of the maximum tolerated dose, characterizing dose-limiting toxicities, and identification of the recommended Phase 2 dose of single-agent IK-175. Secondary objectives include evaluating disease response, including overall response rate, progression-free survival, duration of treatment, disease control rate and duration of response, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Jason Luke, MD, FACP, associate professor of medicine in the Division of Hematology/Oncology and director of the Cancer Immunotherapeutics Center at the University of Pittsburg Medical Centre (UPMC) Hillman Cancer Immunology and Immunotherapy Program, and a clinical investigator on the IK-175 study, commented: “Activated AHR prevents immune recognition in a range of cancers which makes it a highly evocative drug target, especially in patients who do not fully benefit from standard-of-care, including checkpoint inhibitors. Compelling preclinical evidence supports the clinical potential of IK-175, including its ability to potently inhibit AHR activity. We look forward to further elucidating the safety, tolerability and preliminary efficacy of IK-175 in the clinic.”
“Advancing IK-175 into the clinic, less than 3 years after we initiated the discovery program, is a key milestone for Ikena and we are delighted to commence investigation of this promising agent in patients with advanced solid tumors,” said Mark Manfredi, Ph.D., President and Chief Executive Officer of Ikena Oncology. “This accelerated timeline is a testament to our ability to rapidly advance assets from the bench to patients. Assuming a positive outcome from the dose-escalation and expansion portion of this single-agent study, we plan to commence an additional portion of the study to evaluate IK-175 in combination with a checkpoint inhibitor. We look forward to providing updates over the course of the study.”
About IK-175
IK-175 (formerly known as KYN-175) is an internally-developed, orally-administered, selective aryl hydrocarbon receptor (AHR)antagonist which prevents AHR-modulated tumor promotion through its influence on both the tumor and the immune system. Ikena Oncology recently commenced a first-in-human, Phase 1 clinical study (NCT04200963) in which the safety and antitumor activity of IK-175 is being evaluated as a single agent in advanced solid tumors. A patent application with claims directed to IK-175 has been allowed by the United States Patent and Trademark Office. The AHR antagonist program is the subject of a global strategic collaboration with Bristol-Myers Squibb.
About Ikena Oncology
Ikena Oncology is a clinical-stage biotechnology company that discovers and develops patient-directed, biomarker-driven therapies for cancer patients who need life-saving treatment, by understanding what drives their disease. Ikena is advancing five clinical, preclinical and discovery programs: IK-007, an EP4 receptor antagonist; IK-175, an AHR antagonist; IK-412, a kynurenine-degrading enzyme (“Kynase”); discovery-stage molecules targeting the Hippo signaling pathway; and a discovery-stage program against an undisclosed target. Ikena has entered into a global strategic collaboration with Bristol-Myers Squibb on the AHR antagonist and Kynase programs. Ikena has raised capital from top tier investors OrbiMed Advisors and Atlas Venture.
For more information, visit www.ikenaoncology.com, or follow us on Twitter and LinkedIn.