OnKure Therapeutics, a new force in the pharmaceutical landscape, has just entered the market with a bang. The company, formed through the merger of OnKure Therapeutics Inc and Reneo Pharmaceuticals Inc, has secured $65 million in funding and is poised to challenge existing treatments for breast cancer. Their flagship drug, OKI-219, is a third-generation PI3Kα inhibitor, designed to tackle a significant issue in the current treatment landscape: toxicity.
Current leading treatments, such as Novartis’s Piqray (alpelisib), have proven effective but come with significant side effects. OKI-219 aims to circumvent this hurdle by offering greater selectivity for the H1047R mutation, a common occurrence in breast cancer. This, in theory, could make OKI-219 a more tolerable and potentially more effective option for patients.
The analyst at Oppenheimer, who initiated coverage on OnKure with an Outperform rating and a $35 price target, believes OKI-219 has the potential to become the go-to treatment for breast cancer patients with this specific mutation. They highlight the drug’s ability to address the limitations of existing treatments, particularly the off-target toxicity concerns associated with alpelisib.
The market opportunity for OKI-219 is significant. Approximately 40% of HR+ breast cancer patients carry the PI3Kα mutation, which translates to around 25,000 new cases in the U.S. every year. The analyst estimates a market potential exceeding $1 billion, highlighting the immense commercial opportunity for OnKure.
While OKI-219 exhibits strong selectivity for the H1047R mutation, it is less selective for helical mutants. OnKure acknowledges this tradeoff and is actively developing pipeline programs to address this limitation. The company is currently running a Phase 1 trial for OKI-219 in patients with solid tumors and the PI3KαH1047R mutation, including breast cancer.
OnKure’s entry into the market comes at an opportune time. Alpelisib, despite its effectiveness, has seen its annual sales plateau at approximately $500 million. The analyst believes that the toxicity concerns associated with alpelisib may be hindering its potential for greater commercial success.
With the market potential for PI3Kα inhibitors exceeding $1 billion, OnKure’s OKI-219 is poised to challenge the status quo and potentially become a leading treatment option for breast cancer patients with specific mutations. The company’s dedication to addressing the toxicity concerns associated with existing treatments, combined with its focus on developing solutions for a broader range of mutations, sets the stage for a potentially successful foray into the breast cancer treatment market.
