OKI-345 / OnKure - LARVOL DELTA

OnKure plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for each of OKI‑345 and OKI‑355 in the first half of 2027 (GlobeNewswire)

IND • Solid Tumor

OnKure Therapeutics…announced that it has entered into a securities purchase agreement for a private placement with certain institutional and accredited healthcare investors, raising gross proceeds of approximately $150 million (GlobeNewswire) - "OnKure intends to use the net proceeds from the private placement to fund the preclinical and clinical development of its next-generation PI3Kα pan-mutant-selective inhibitor candidates in breast cancer and vascular anomalies, as well as for working capital and general corporate purposes....The portfolio includes two next-generation PI3Kα pan-mutant programs, OKI-345 in breast cancer and OKI-355 in vascular anomalies....OnKure plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for each of OKI‑345 and OKI‑355 in the first half of 2027."

Financing • IND • Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

Next-Generation PI3KαPAN Mutant Selective Program (GlobeNewswire) - "OnKure expects to announce its next-generation PI3Kα pan-mutant inhibitor candidate for HR+ metastatic breast cancer in March 2026....OnKure believes its differentiated portfolio of PI3Kα inhibitors has significant potential to address a large and underserved patient population. The Company expects to provide additional details on its PI3Kα pan‑mutant program in 2026."

Pipeline update • Hormone Receptor Positive Breast Cancer

Next-Generation PI3KαPAN Mutant Selective Program (GlobeNewswire) - "The Company is evaluating a series of PI3Kα pan-mutant inhibitor development candidates shown preclinically to have an overall selectivity profile, combinability, and pharmaceutical attributes that the Company believes will produce best-in-class pan-mutant PI3Kα inhibitors. The Company plans to announce additional details in the first quarter of 2026."

Preclinical • Solid Tumor

OnKure Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Business Highlights (GlobeNewswire) - "...Upcoming Anticipated Milestones:...Pan-mutant Program - OnKure believes a PI3Kα 'pan-mutant' inhibitor will need to demonstrate approximately 10-fold selectivity against each of the most common mutations (PI3KαH1047X, PI3KαE542K, and PI3KαE545K) over wild type. OnKure expects to announce its pan-mutant development candidate in the second quarter of 2025."

Pipeline update • Oncology