OnKure Therapeutics, the result of a merger between OnKure Inc. and Reneo Pharmaceuticals, has announced that it will continue to advance the clinical development of OKI-219, a mutant-specific PI3Kα inhibitor. The combined company began trading on the Nasdaq Global Market under the ticker symbol “OKUR” on Monday.
The merger was finalized with a concurrent $65 million private placement, ensuring financial support through multiple clinical readouts and extending into the fourth quarter of 2026. This funding will primarily support the ongoing Phase I clinical trial of OKI-219, which targets solid tumors, including specific types of breast cancer.
OKI-219: A Selective PI3Kα Inhibitor
OKI-219 is designed as a selective inhibitor of PI3Kα H1047R, a mutation present in certain cancers. The drug is currently in Phase I clinical trials. According to OnKure, OKI-219 demonstrates significant selectivity for the mutant oncogene, potentially leading to improved outcomes for patients with PI3KαH1047R mutations.
"We are ecstatic to finalize this merger and move to accelerate the development of our mutant-specific PI3Kα inhibitor portfolio," said Nicholas Saccomano, CEO of OnKure. "Combined with our unique expertise in PI3K-mutated cancers, we aim to fully target and exploit the vulnerabilities of this oncogenic menace for the benefit of patients suffering needlessly."
Leadership and Strategic Focus
The leadership team of the merged company includes Nicholas Saccomano as president and CEO, Samuel Agresta as chief medical officer, Dylan Hartley as chief scientific officer, and Jason Leverone as chief financial officer. The board of directors includes members from both OnKure and Reneo, along with Valerie Jansen.
OnKure is focused on developing mutant-selective PI3Kα inhibitors to improve treatment efficacy and safety. The company anticipates releasing early clinical data for OKI-219 later this year. The strategic focus is on cancers with PI3Kα mutations, aiming to provide more targeted and effective therapies.
Financial Position
Following the completion of the merger and private placement, OnKure Therapeutics reports having approximately $139 million in cash, cash equivalents, and short-term investments. This financial position is expected to support the company through key clinical milestones and into late 2026.
