Core Insights - Kura Oncology has initiated the KOMET-015 Phase 1 clinical trial to evaluate ziftomenib in combination with imatinib for patients with advanced gastrointestinal stromal tumors (GIST) after imatinib failure [1][3] - The combination of ziftomenib and imatinib has shown robust and durable antitumor activity in both imatinib-sensitive and imatinib-resistant GIST preclinical models [1][2] Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, with ziftomenib being a key investigational menin inhibitor [8] - The company has received Breakthrough Therapy Designation from the FDA for ziftomenib in treating relapsed/refractory NPM1-mutant acute myeloid leukemia (AML) [7][8] Clinical Trial Details - The KOMET-015 trial is designed to assess the safety, tolerability, and preliminary antitumor activity of ziftomenib combined with imatinib in adults with GIST who have shown disease progression on imatinib [3][4] - The trial will evaluate primary objectives including safety and tolerability, and secondary endpoints such as overall response rate (ORR) and progression-free survival (PFS) [3] Market Context - Approximately 4,000 to 6,000 new cases of GIST are diagnosed annually in the U.S., with limited treatment options available for advanced cases [2][5] - Most patients develop resistance to imatinib within two years, highlighting the need for new therapeutic options [2][6] Preclinical Findings - Preclinical studies indicate that the combination of ziftomenib and imatinib exerts antitumor activity through a synthetic lethal mechanism, targeting vulnerabilities in GIST tumors [2][3] - The combination has the potential to delay or overcome resistance to imatinib in patients [2]

Core Insights - OnKure Therapeutics, Inc. reported a net loss of $17.4 million for Q4 2024, with cash and cash equivalents of approximately $110.8 million expected to fund operations through multiple clinical readouts into Q4 2026 [1][5][10]. Financial Performance - Research and development (R&D) expenses for Q4 2024 were $14.4 million, an increase from $8.8 million in Q4 2023, primarily due to higher clinical trial and manufacturing costs [8]. - General and Administrative (G&A) expenses rose to $4.3 million in Q4 2024 from $1.1 million in Q4 2023, driven by increased personnel-related costs and consulting expenses [9]. - The net loss per share for Q4 2024 was $1.37, compared to $30.14 per share in Q4 2023 [10]. Business Highlights - OnKure is advancing three PI3Ka inhibitor programs, with one in clinical development and another expected to be announced in Q2 2025 [2]. - The PIKture-01 trial has shown encouraging preliminary safety and tolerability data for the OKI-219 monotherapy, with no dose-limiting toxicities observed [7]. - The company initiated patient dosing in Part B of the PIKture-01 trial, evaluating OKI-219 in combination with fulvestrant for metastatic breast cancer [6][7]. - A merger with Reneo Pharmaceuticals closed on October 4, 2024, along with a $65 million financing, leading to a name change and new ticker symbol "OKUR" [6]. Upcoming Milestones - Additional data from the PIKture-01 trial is expected in the second half of 2025, along with the announcement of a pan-mutant selective program [6][3]. - OnKure aims to demonstrate approximately 10-fold selectivity of its pan-mutant inhibitor against common mutations over wild type [6].