OKI-219

OKI-219 is in Phase I trials for solid tumours. Credit: Nemes Laszlo/Shutterstock. OnKure has announced the successful completion of its merger with Reneo Pharmaceuticals, with the combined entity set to operate under the OnKure Therapeutics name. The shares will commence trading on the Nasdaq Global Market under the “OKUR” ticker symbol. The companies first reached an agreement to combine in an all-stock deal in May 2024. OnKure has also finalised a $65m private placement backed by both new and existing investors. This strategic financial move will extend the company’s cash runway through multiple clinical readouts until the fourth quarter of 2026. See Also: Boehringer kickstarts two Phase III trials as MASH therapy wins breakthrough status The leadership of the merged company will include 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 will feature a mix of members from both OnKure and Reneo, along with Valerie Jansen, who joined at the merger’s closure. Saccomano stated: “We are ecstatic to finalise this merger, and move to accelerate the development of our mutant-specific PI3Kα inhibitor portfolio. “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.” OnKure is engaged in the development of a suite of mutant-selective PI3Kα inhibitors, aiming to enhance treatment efficacy and safety. Its lead product candidate, OKI-219, demonstrates significant selectivity for the mutant oncogene, potentially offering improved outcomes for patients with PI3Kα H1047R mutations. OKI-219 is currently under a Phase I clinical trial, targeting solid tumours including breast cancer. The merger unites OnKure’s expertise in precision oncology with Reneo’s resources, focusing on advancing treatments for oncogenic mutations in PI3Kα. OKI-219 is a pivotal part of the combined company’s pipeline, now progressing through clinical trials.

BOULDER, Colo., Oct. 04, 2024 (GLOBE NEWSWIRE) -- OnKure Therapeutics, Inc. (Nasdaq: OKUR) (“OnKure”), a clinical-stage biopharmaceutical company focused on the development of novel precision medicines in oncology, today announced the completion of its previously announced merger of OnKure, Inc. and Reneo Pharmaceuticals, Inc. (“Reneo”). The combined company will operate under the name OnKure Therapeutics, Inc., and its shares are expected to begin trading on the Nasdaq Global Market on October 7, 2024 under the ticker symbol "OKUR". Concurrent with the closing of the merger, the company completed a $65 million private placement with a group of new and existing investors, including Acorn Bioventures, Cormorant Asset Management, Deep Track Capital, Perceptive Advisors, Samsara BioCapital, Surveyor Capital (a Citadel company), Vestal Point Capital, and other undisclosed investors. Following the transactions, OnKure is expected to have a cash runway through multiple clinical readouts and into Q4-2026. “We are ecstatic to finalize this merger, and move to accelerate the development of our mutant-specific PI3Kα inhibitor portfolio. 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,” said Nicholas Saccomano, Ph.D., President and Chief Executive Officer of OnKure. “Our lead program OKI-219, a highly selective inhibitor of PI3KαH1047R, has the potential to provide benefit to breast cancer patients. With the PIKture-01 trial of OKI-219 well underway, we look forward to releasing early clinical data in the fourth quarter of 2024 and initiating planned combination arms of the PIKture-01 trial.