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OnKure Therapeutics (NASDAQ: OKUR) announced encouraging preliminary data from its PIKture-01 trial of OKI-219, a mutant-selective PI3KαH1047R inhibitor. The drug showed positive safety and tolerability across all dose levels, with no dose interruptions or reductions required. Of 17 treated patients, the most common treatment-related adverse events were mild Grade 1 effects.
At 900 mg twice daily, OKI-219 demonstrated steady-state exposure levels with near-continuous coverage. Two patients with HR+/HER2- breast cancer showed prolonged stable disease, with one patient maintaining >95% reduction in PIK3CAH1047R ctDNA after seven months of treatment. The company has initiated Part 1b of the trial, evaluating OKI-219 in combination with fulvestrant, with initial data expected in 2H-2025.
OnKure Therapeutics (NASDAQ: OKUR) has rescheduled its investor call to review preliminary data from the PIKture-01 trial of OKI-219 to Tuesday, December 10, 2024, at 7:00 a.m. CT, moved from the previously announced December 13 date. The call will coincide with the publication of posters at the 2024 San Antonio Breast Cancer Symposium (SABCS).
Two posters will be presented at SABCS: one showing preliminary results from the PIKture-01 first-in-human study of OKI-219, and another demonstrating OKI-219's enhanced activity in pre-clinical PI3KαH1047R mutant breast cancer models. The PIKture-01 trial investigates OKI-219 as monotherapy in advanced solid tumors and in combination with endocrine or HER2-Targeted therapy for advanced breast cancer.
OnKure Therapeutics (NASDAQ: OKUR), a clinical-stage biopharmaceutical company specializing in precision oncology medicines, has announced its participation in the Stifel 2024 Healthcare Conference. Nicholas Saccomano, Ph.D., President and CEO, will deliver a corporate presentation on November 18, 2024, at 1:50 p.m. ET in New York.
The presentation will be accessible via live webcast through the 'Events' section of OnKure's website, with a replay available for approximately 90 days following the event.
OnKure Therapeutics (NASDAQ: OKUR) announced the presentation of two abstracts featuring preliminary clinical and preclinical data for OKI-219, their mutant-selective PI3KαH1047R inhibitor, at the 2024 San Antonio Breast Cancer Symposium (SABCS). The presentations will cover results from the PIKture-01 first-in-human study and preclinical data on OKI-219's enhanced activity in breast cancer models. The symposium will be held both virtually and in-person from December 10-13, 2024. OnKure will host a conference call on December 13 to discuss the preliminary data and provide a corporate update.
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