OnKure Therapeutics, Inc. (OKUR), a clinical-stage biopharmaceutical company, has recently disclosed promising findings regarding the safety, tolerability, and pharmacokinetics of OKI-219 from its ongoing first-in-human trial. Across all dosage levels, OKI-219 was well-tolerated, with only grade 1 treatment-related adverse events reported, aligning with the company's preclinical expectations and endorsing the drug's further development.
Furthermore, OnKure has revealed new preclinical results demonstrating OKI-219's synergistic effect when combined with SERD and CDK4/6 inhibitors, showing potential in inducing tumor regressions. This could lead to the initiation of clinical trials for various therapeutic applications. Both clinical and preclinical data are set to be presented at the 2024 San Antonio Breast Cancer Symposium (SABCS) on December 12, 2024.
"Our initial clinical findings encourage us to commence Part 1b of the PIKture-01 trial, focusing on the evaluation of OKI-219 in combination with fulvestrant. We anticipate sharing comprehensive data on the single agent and preliminary results with fulvestrant in the latter half of 2025," stated Nicholas Saccomano, President and CEO of OnKure.
