Welcome to our dedicated page for Kura Oncology news (Ticker: KURA), a resource for investors and traders seeking the latest updates and insights on Kura Oncology stock.
Kura Oncology, Inc. (symbol: KURA) is a clinical-stage biopharmaceutical company based in San Diego, dedicated to pioneering precision medicines for cancer treatment. Leveraging advances in cancer genomics, Kura develops targeted therapies and companion diagnostics designed to address the genetic underpinnings of various cancers, optimizing treatment efficacy and safety.
The company's flagship product candidate, Tipifarnib, is under investigation for treating both solid tumors and blood cancers. Tipifarnib is a potent farnesyl transferase inhibitor, currently undergoing Phase 1/2 trials in combination with alpelisib for patients with head and neck squamous cell carcinoma.
Another key candidate, Ziftomenib, targets acute myeloid leukemia (AML) with NPM1 and KMT2A mutations. Highlighted by its recent Breakthrough Therapy Designation from the FDA, Ziftomenib is involved in multiple clinical trials, including the KOMET-001 and KOMET-007 studies. Early results show promising efficacy and a favorable safety profile, particularly in the combination with current standards of care like venetoclax and azacitidine.
Kura is also advancing KO-2806, a next-generation farnesyl transferase inhibitor, in a Phase 1 dose-escalation trial as a monotherapy and in combination with other targeted therapies for renal and lung cancers.
Financially, Kura remains robust, with cash reserves projected to support operations through 2027. The company has an ongoing commitment to aggressive research, development, and pre-commercial activities, ensuring continued progression of its promising pipeline.
The company's recent achievements include reporting preliminary clinical data from the KOMET-007 trial and securing additional financing to reinforce its financial position. Kura continues its mission to bring life-saving therapies to patients with high unmet medical needs, aiming to improve and extend the lives of those battling cancer.
Kura Oncology expands its leadership team with key promotions to enhance growth. Mollie Leoni, M.D., becomes Senior Vice President of Clinical Development; Pete De Spain is now Senior Vice President of Investor Relations and Corporate Communications; and Tom Doyle is appointed Senior Vice President of Finance and Accounting. Former CFO Marc Grasso steps down effective February 4, 2022, to focus on family, while remaining as an advisor. The new roles aim to strengthen Kura's strategic objectives in advancing precision medicines for cancer treatment.
The FDA has lifted the partial clinical hold on Kura Oncology's KOMET-001 Phase 1b study of KO-539 for relapsed or refractory acute myeloid leukemia (AML). This decision follows an agreement on a mitigation strategy for differentiation syndrome. Kura is resuming patient screening and enrollment, with promising safety and clinical activity observed in current patients. The trial aims to determine the recommended Phase 2 dose for KO-539, targeting patients with NPM1 mutations and KMT2A rearrangements.
Kura Oncology has initiated the first patient dose in its KURRENT trial, investigating the combination of tipifarnib and alpelisib for treating patients with HRAS- and/or PIK3CA-dependent head and neck squamous cell carcinoma (HNSCC). This trial aims to expand treatment options for up to 50% of HNSCC patients. Preclinical data suggests these oncogenes are co-dependent, and the combination therapy could offer enhanced anti-tumor effects. Tipifarnib has received Breakthrough Therapy designation, focusing on a significant unmet medical need in HNSCC.
Kura Oncology reported promising results from a Phase 2 study of tipifarnib, showing a 56% overall response rate and a median overall survival of 32.8 months in patients with advanced angioimmunoblastic T-cell lymphoma (AITL). Conducted on 65 patients, the study highlighted the effectiveness of farnesyl transferase inhibition in treating this aggressive cancer type. The response rate for AITL patients was notably high at 56%. Tipifarnib was well-tolerated, with common side effects being hematological and gastrointestinal. These findings underscore the potential of tipifarnib in cancer treatments.
Kura Oncology announced new preclinical findings for KO-539, a selective menin inhibitor, at the ASH Annual Meeting in Atlanta. These data demonstrate KO-539's ability to induce growth inhibition and differentiation in AML cells with KMT2A rearrangements or NPM1 mutations. The combination of KO-539 with the standard of care, venetoclax, shows synergistic effects, enhancing survival in aggressive AML models. KO-539 is currently in a Phase 1b clinical trial for relapsed/refractory AML, with an Orphan Drug Designation from the FDA.
Kura Oncology announced a partial clinical hold on its KOMET-001 Phase 1b study of KO-539 for relapsed or refractory acute myeloid leukemia (AML) due to a Grade 5 serious adverse event (a patient death) linked to differentiation syndrome. Current patients may continue treatment, but new enrollments are halted. Kura is collaborating with the FDA to lift the hold. As a result, the company has suspended guidance on enrollment completion and the recommended Phase 2 dose of KO-539 until clarity is achieved regarding the hold.
Kura Oncology announced that its CEO, Troy Wilson, will participate in two virtual investor conferences. The first is a fireside chat at the Evercore ISI 4th Annual HealthCONx Conference on November 30, 2021, at 11:20 a.m. ET. The second is at the JMP Securities Hematology and Oncology Summit on December 7, 2021, at 2:20 p.m. ET. Audio webcasts of both events will be available on Kura's website, with archived replays accessible afterward. Kura is focused on developing precision medicines for cancer treatment, with ongoing trials for promising drug candidates.
Kura Oncology reported its Q3 2021 financial results with a net loss of $33.4 million, compared to $23.8 million in Q3 2020. The company continues to enroll patients in its Phase 1b study of KO-539 for AML, with plans for a comprehensive development strategy. Kura activated the first site for the Phase 1/2 trial of tipifarnib plus alpelisib in HNSCC. As of September 30, 2021, Kura holds $543.4 million in cash, providing a runway into 2024. The upcoming ASH presentation will discuss the potential of KO-539 in combination with venetoclax.
Kura Oncology, Inc. (Nasdaq: KURA) announced its participation in the Credit Suisse 30th Annual Healthcare Conference. The event features a virtual fireside chat with CEO Troy Wilson on November 9, 2021, at 3:30 p.m. ET. Investors can access a live audio webcast on Kura's website, with a replay available afterward. Kura specializes in precision medicines for cancer, focusing on small molecule drug candidates. Key programs include KO-539 for relapsed/refractory AML and Tipifarnib for HRAS mutant head and neck cancer, highlighting the company's innovative approach to oncology.
Kura Oncology, Inc. (Nasdaq: KURA) will release its third quarter 2021 financial results on November 4, 2021, after U.S. markets close. A webcast and conference call, scheduled for 4:30 p.m. ET / 1:30 p.m. PT, will provide financial insights and a corporate update. The call can be accessed by domestic and international callers with specific dial-in information. Kura focuses on innovative cancer treatments, including KO-539 for AML and Tipifarnib for HRAS mutant HNSCC, highlighting its commitment to precision medicine.
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