OnKure Therapeutics, Inc. (OKUR), a clinical-stage biopharmaceutical company, Tuesday announced encouraging safety, tolerability, and pharmacokinetic data from the ongoing first-in-human study of OKI-219.
OKI-219 was well tolerated across all dose levels, and only grade 1 treatment-related adverse events were reported. These data are consistent with the company's preclinical data and support the continued development of OKI-219.
Additionally, OnKure announced new pre-clinical data that show OKI-219's synergistic activity, inducing regressions, in combination with SERD + CDK4/6 inhibitors, potentially paving the way for clinical trials in multiple lines of therapy. These clinical and preclinical data are scheduled to be presented at the 2024 San Antonio Breast Cancer Symposium (SABCS) on December 12, 2024.
"These initial clinical data support our initiation of Part 1b of the PIKture-01 trial to evaluate OKI-219 in combination with fulvestrant. We look forward to providing mature single agent and initial fulvestrant data in the second half of 2025," said Nicholas Saccomano, President and Chief Executive Officer of OnKure.
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