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– Data to be featured in two oral presentations on December 8, 2025 – – Broad development program assesses ziftomenib across diverse AML segments and treatment paradigms to inform appropriate use – SAN DIEGO and TOKYO, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA, “Kura”) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced that results from the KOMET-007 combination trial of ziftomenib, a once-daily, oral investigational menin inhibitor, will be featured in two oral p ...

Core Insights - The article highlights the background and achievements of Brendan, a key figure in the biotechnology sector, emphasizing his academic credentials and professional experience in both pharmaceutical and biotech industries [1]. Group 1: Background and Education - Brendan completed a Ph.D. in organic synthesis at Stanford University in 2009 [1]. - He worked for Merck, a major pharmaceutical company, from 2009 to 2013 [1]. Group 2: Professional Experience - Brendan has experience in biotech, including roles in startups such as Theravance and Aspira before joining Caltech [1]. - He was the first employee and co-founder of 1200 Pharma, which spun out of Caltech and secured significant investment in the eight-figure range [1]. Group 3: Investment Focus - Brendan remains an avid investor, particularly focused on market trends and biotechnology stocks [1].

Regulatory Overview - The FDA has approved 34 novel drugs from January to October 2025, compared to 38 during the same period in 2024 [2] - Several biotech stocks are highlighted as they approach key regulatory decisions in November 2025 [2] Arrowhead Pharmaceuticals Inc. (ARWR) - ARWR's New Drug Application for Plozasiran is under FDA review, with a decision expected on November 18, 2025 [3] - Plozasiran targets familial chylomicronemia syndrome, a condition characterized by extremely high triglyceride levels, which can lead to acute pancreatitis [3] - Clinical trials showed significant reductions in triglycerides and the incidence of acute pancreatitis, potentially providing a new treatment option alongside Tryngolza, the only FDA-approved drug for this condition [4] Otsuka Holdings Co. Ltd. (OTSKF) - OTSKF is awaiting the FDA's decision on Sibeprenlimab, scheduled for November 28, 2025 [6] - Sibeprenlimab is an investigational monoclonal antibody for treating immunoglobulin A nephropathy (IgAN), a chronic kidney disease [6] - Clinical trials demonstrated a significant reduction in urine protein-to-creatinine ratio, indicating its potential as a blockbuster drug if approved [8] Bayer (BAYRY) - Bayer's investigational compound Sevabertinib is under priority review by the FDA, with a decision expected on November 28, 2025 [9] - Sevabertinib is proposed for treating advanced non-small cell lung cancer (NSCLC) with HER2 mutations, providing an additional option for previously treated patients [10] Ascendis Pharma A/S (ASND) - The FDA decision on Navepegritide, aimed at treating children with achondroplasia, is due on November 30, 2025 [11] - Achondroplasia is a rare genetic condition affecting over 250,000 people globally, leading to serious complications [12] - Navepegritide is designed for weekly subcutaneous administration, targeting the overactive FGFR3 pathway [13] Kura Oncology Inc. (KURA) - KURA is expecting FDA approval for Ziftomenib on November 30, 2025, for treating relapsed or refractory acute myeloid leukemia (AML) with NPM1 mutations [15] - Ziftomenib has shown significant efficacy in clinical trials, with a market opportunity estimated at $350 million to $400 million annually in the U.S. if approved [17]

SAN DIEGO, Oct. 28, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced it will report third quarter 2025 financial results on Tuesday, November 4, 2025, before the U.S. financial markets open. Kura’s management will host a conference call and webcast at 8:00 a.m. ET / 5:00 a.m. PT to discuss the financial results and provide a corporate update. The live ...

Group 1 - The article does not provide any specific content related to a company or industry, as it appears to be a technical issue regarding browser settings and ad-blockers [1]

Core Insights - Kura Oncology has received a $30 million milestone payment following the dosing of the first patient in the KOMET-017 Phase 3 clinical trials for ziftomenib, an investigational oral menin inhibitor [1] - The KOMET-017 trials are designed to evaluate ziftomenib in combination with both intensive and non-intensive chemotherapy regimens for patients with newly diagnosed NPM1-mutated or KMT2A-rearranged acute myeloid leukemia [2] - Kura Oncology is focused on precision medicines for cancer treatment, with a pipeline targeting cancer signaling pathways and addressing hematologic malignancies and solid tumors [3] Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company dedicated to developing precision medicines for cancer treatment [3] - The company is advancing ziftomenib, a menin inhibitor aimed at specific genetic drivers of acute myeloid leukemias, and is also exploring farnesyl transferase inhibition for solid tumors [3]

Group 1 - Kura Oncology is presenting updates on its farnesyl transferase program at the ESMO 2025 Congress, focusing on clinical data [2] - This presentation is the second part of a series, with the first part discussing preclinical data and rationale presented on September 16 [2] - The company has made available the webcast and slides from the previous presentation on its website [2] Group 2 - The presentation includes forward-looking statements regarding the company's future prospects [3]

Kura Oncology Conference Call Summary Company Overview - **Company**: Kura Oncology (NasdaqGS: KURA) - **Event**: Discussion of FTI clinical data at the ESMO 2025 Congress - **Date**: October 18, 2025 Key Points Industry and Product Focus - **Focus**: Farnesyltransferase inhibitors (FTIs), specifically KO-2806 (DARLI/Farnib) - **Target Indications**: Advanced HRAS-mutant solid tumors, renal cell carcinoma (RCC), and PIK3CA-mutant head and neck cancers [2][3][4] Clinical Data Highlights 1. **KO-2806 Monotherapy in HRAS-Mutant Tumors** - KO-2806 demonstrated encouraging safety and tolerability with manageable adverse events (AEs) such as neutropenia and anemia [11][12] - Monotherapy activity showed stable disease and partial responses in various tumor types, with a notable response rate at lower doses (5-8 mg) [14][16] - Patients exhibited durable responses, with some remaining on treatment for over 20 months [14][15] 2. **Combination Data with Cabozantinib in RCC** - KO-2806 combined with Cabozantinib showed a response rate of 33% to 50% in clear cell RCC patients, with a disease control rate of 80% to 100% [26][27] - The combination was well tolerated, with no significant overlapping toxicities observed [21][22] - Encouraging activity was noted even in patients previously treated with Cabozantinib, indicating potential for resensitization [26][27] 3. **Combination with PI3K Inhibitors in Head and Neck Cancer** - A phase I study combining Tipifarnib (another FTI) with alpelisib showed a nearly 50% response rate in patients with PIK3CA alterations [32][33] - The combination demonstrated robust antitumor activity and manageable safety profiles, addressing adaptive resistance mechanisms [37] Future Development Plans - Kura Oncology plans to complete dose escalation studies for KO-2806 in combination with Cabozantinib and Adagrasib in KRAS G12C-mutant patients [39][40] - The company aims to explore further combinations with PI3K inhibitors and share additional data in the coming year [39][40] Market Potential - The total addressable market for KO-2806 and FTIs is estimated to exceed 200,000 patients across various indications, highlighting significant growth opportunities [41] Additional Insights - The conference emphasized the importance of combining FTIs with targeted therapies to enhance patient outcomes and address challenges in current treatment paradigms [41][42] - The safety profile of KO-2806 is considered a key advantage, allowing for potential combinations with other therapies without significant dose-limiting toxicities [12][21] Conclusion Kura Oncology's ongoing clinical trials and data presentations at ESMO 2025 indicate promising developments in the use of KO-2806 and FTIs in treating various cancers, particularly in combination therapies that enhance efficacy while maintaining safety. The company is positioned to explore further opportunities in the oncology market, leveraging its innovative drug development strategies.

Darlifarnib (KO-2806) Monotherapy in HRAS-Mutant Solid Tumors - Darlifarnib (KO-2806) is a next-generation FTI with enhanced potency and optimized PK properties[18] - In the FIT-001 monotherapy study, encouraging anti-tumor activity was observed in HRAS-mutant solid tumors[25] - One patient with HRAS-mutant salivary gland carcinoma showed a 62.8% tumor shrinkage from baseline after 80 weeks on 5 mg KO-2806[28, 30] - A patient with advanced HRAS-mutant HNSCC showed a 60% tumor shrinkage at week 8 on 8 mg KO-2806[32, 35] Darlifarnib + Cabozantinib Combination in Renal Cell Carcinoma (RCC) - The combination of KO-2806 and cabozantinib demonstrated a manageable safety profile in RCC patients[48, 69] - In ccRCC patients, the ORR ranged from 33% to 50%, and the DCR ranged from 80% to 100%[50, 69] - One patient with ccRCC treated with KO-2806 5 mg + cabozantinib 60 mg showed a 44% reduction in tumor size at week 16[57, 60] - In ccRCC patients with prior cabozantinib exposure, ORR ranged from 17% to 50%[50, 69] Tipifarnib + Alpelisib Combination in HNSCC - The combination of tipifarnib and alpelisib was well-tolerated in PIK3CA-mutant R/M HNSCC patients[79, 91] - An ORR of 47% was observed at a dose of tipifarnib 1200 mg/day + alpelisib 250 mg/day[80, 81, 91] - One patient with PIK3CA R88Q mutation achieved PR with 81% reduction at week 4[85, 88]