BOULDER, Colo. - OnKure Therapeutics Inc. (NASDAQ: OKUR), a clinical-stage biopharmaceutical company with a market capitalization of $201 million, has announced preliminary safety and pharmacokinetic data from its ongoing first-in-human trial of OKI-219, a PI3KαH1047R inhibitor aimed at treating certain solid tumors, including breast cancer. According to InvestingPro analysis, the company's development efforts are supported by strong analyst optimism, with price targets ranging from $31 to $40. The study showed that OKI-219 was well-tolerated across all doses with no serious treatment-related adverse events (TRAEs) and no dose interruptions, delays, reductions, or discontinuations due to adverse events (AEs).
Patients have been treated with three dose levels of OKI-219 as a single agent, with the highest dose at 900 mg twice daily demonstrating steady-state exposure levels that are consistent with robust antitumor activity seen in preclinical models. These findings support the continuation of the drug's development.
The trial, known as PIKture-01, is a global, multi-center phase 1a/1b study that evaluates OKI-219 both as monotherapy and in combination with other cancer drugs like fulvestrant or trastuzumab in subjects with advanced solid tumors harboring a PI3KαH1047R mutation.
OnKure also reported new preclinical data indicating that OKI-219, when used in combination with other standard-of-care therapies, induced regressions in mutant-selected solid tumors, including breast cancers. These data will be presented at the 2024 San Antonio Breast Cancer Symposium (SABCS) on December 12, 2024.
The company has begun Part 1b of the PIKture-01 trial to evaluate OKI-219 in combination with fulvestrant, with initial data expected in the second half of 2025. OnKure is also pursuing additional early-stage discovery programs targeting oncogenic mutations of PI3Kα, aiming to announce a pan-mutant development candidate in the first half of 2025. InvestingPro data reveals the company's financial health score as WEAK, with a current ratio of 0.65 and negative EBITDA of $45.12 million, reflecting typical metrics for a clinical-stage biotech company. Subscribers to InvestingPro can access additional financial metrics and 7 more exclusive ProTips to better evaluate investment potential in clinical-stage biotech companies.
This announcement is based on a press release statement from OnKure Therapeutics, Inc. and does not constitute an endorsement of the company or its products. The safety and efficacy of OKI-219 have not yet been established, and the findings are subject to further clinical investigation.
In other recent news, OnKure Therapeutics has been the subject of several significant updates. Leerink Partners initiated coverage on OnKure, assigning an Outperform rating and a price target of $33, signaling confidence in the company's potential. They highlighted OnKure's work on treatments targeting the PI3Kα pathway, a key factor in various types of cancer. OnKure's lead asset, OKI-219, is being developed with high expectations, particularly for treating HR+ breast cancer with H1047R mutations.
Furthermore, OnKure announced a change in its independent registered public accounting firm, transitioning from Ernst & Young LLP to KPMG LLP. This development follows OnKure's merger with Legacy OnKure, for which KPMG had previously served as an auditor. Another firm, Oppenheimer, has also initiated coverage on OnKure with an Outperform rating, citing the potential of OnKure's drug candidate, OKI-219.
OnKure has also been in the spotlight due to a merger with Reneo Pharmaceuticals. This merger, approved by Reneo stockholders, results in OnKure becoming a direct, wholly-owned subsidiary of Reneo. In line with this merger, Reneo announced the departure of Chief Development Officer, Ashley F. Hall, as part of the company's severance benefit plan. These recent developments mark significant events in the trajectory of both OnKure and Reneo.
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