Kura Oncology, Inc. reports news on its precision oncology business, including commercialization of KOMZIFTI™ (ziftomenib), an FDA-approved once-daily oral menin inhibitor for adults with relapsed or refractory NPM1-mutated acute myeloid leukemia. Company updates also cover small-molecule drug candidates designed to target cancer signaling pathways across hematologic malignancies and solid tumors.
Recurring KURA developments include financial results, corporate updates, clinical data presentations, collaboration-related milestones, healthcare conference participation and Nasdaq inducement grants. News on darlifarnib (KO-2806) follows the company’s farnesyl transferase inhibitor program, including studies in combination with cabozantinib for clear cell renal cell carcinoma.
Kura Oncology and Kyowa Kirin have announced a global strategic collaboration for developing and commercializing ziftomenib, a selective oral menin inhibitor for acute leukemias. The deal includes a $330 million upfront payment to Kura and potential milestone payments totaling $1.2 billion. The companies will share 50/50 profits in the U.S., with Kura leading U.S. operations and Kyowa Kirin having exclusive rights outside the U.S. The collaboration aims to advance ziftomenib through various development stages, including frontline indications and combinations. Kura expects to submit a New Drug Application in 2025 and initiate Phase 3 frontline studies in AML patients.
Kura Oncology and Kyowa Kirin have announced a global strategic collaboration for developing and commercializing ziftomenib, a selective oral menin inhibitor for acute myeloid leukemia (AML) treatment. Kura will receive a $330 million upfront payment and up to $1.2 billion in milestone payments. The companies will share 50/50 profits in the U.S., with Kura leading U.S. operations and Kyowa Kirin having exclusive rights outside the U.S. The collaboration includes development for frontline indications and combination therapies. Kura expects to submit a New Drug Application in 2025 and estimates a U.S. market opportunity of up to $3 billion annually in the frontline setting.
Kura Oncology has released its Q3 2024 financial results and corporate updates. Key highlights include the expected topline results from the registration-directed trial of ziftomenib in R/R NPM1-mutant AML in early 2025. Additionally, data from 100 patients in the Phase 1a study of ziftomenib will be presented at the ASH Annual Meeting. The Phase 1b expansion study of ziftomenib is now enrolling at 600 mg across all cohorts. Preclinical data supports the potential of ziftomenib in GIST, with a proof-of-concept study expected in 1H 2025. The first patient has been dosed in the study of KO-2806 and adagrasib in KRASG12C-mutated NSCLC. Financially, Kura reported a net loss of $54.4 million for Q3 2024, compared to $38.6 million in Q3 2023. R&D expenses rose to $41.7 million from $29.3 million, and G&A expenses increased to $18.2 million from $13.1 million. The company holds $455.3 million in cash, cash equivalents, and investments, expected to fund operations into 2027.
Kura Oncology (KURA) announced two abstracts from the KOMET-007 combination trial of ziftomenib will be presented at the ASH Annual Meeting in San Diego (December 7-10, 2024). The trial combines ziftomenib with standard treatments in NPM1-mutant and KMT2A-rearranged acute myeloid leukemia (AML) patients.
Key highlights include: All four Phase 1a dose-escalation cohorts advanced to Phase 1b expansion at 600 mg; 100% of NPM1-m AML patients and 84% of KMT2A-r patients remained on study; No DLTs or ziftomenib-induced QTc prolongation reported. The data suggests promising safety profile and robust activity in combination with standard treatments.
Kura Oncology (Nasdaq: KURA) announced it will release its third quarter 2024 financial results after U.S. market close on Thursday, November 7, 2024. The company will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT on the same day, featuring management's discussion of financial results and a corporate update. Investors can access the call via phone or watch the webcast through the company's website.
Cartography Biosciences has appointed Troy E. Wilson, Ph.D., J.D. as an independent director to its Board of Directors. Wilson, a 25-year biopharma industry veteran, is currently President, CEO, and co-founder of Kura Oncology (NASDAQ: KURA). He brings extensive experience in founding and leading biotech companies, including Avidity Biosciences, Araxes Pharma, and Wellspring Biosciences. Cartography, an oncology company developing antibody therapeutics, aims to leverage Wilson's expertise as it advances its pipeline of novel programs targeting tumors more precisely than existing treatments.
Kura Oncology (KURA) reported promising preclinical data for its menin inhibitor ziftomenib in treating gastrointestinal stromal tumors (GIST). The combination of ziftomenib and imatinib demonstrated robust antitumor activity in both imatinib-sensitive and resistant GIST models. The data shows the combination works through a synthetic lethal mechanism, with ziftomenib targeting epigenetic vulnerabilities in GIST tumors. Following FDA clearance of the IND application in August 2024, Kura plans to initiate a proof-of-concept study combining ziftomenib with imatinib in advanced GIST patients after imatinib failure in 1H 2025.
Kura Oncology (Nasdaq: KURA) announced upcoming presentations of new preclinical data for its next-generation farnesyl transferase inhibitor (FTI) KO-2806 at the EORTC-NCI-AACR Symposium in Barcelona. The data supports combining KO-2806 with KRASG12C inhibitors and pan-RAS inhibitors for cancer treatment.
Two presentations will showcase how KO-2806 can re-sensitize KRAS G12C NSCLC tumors to KRAS G12C mutant-specific inhibitors and sensitize colorectal cancers to pan-RAS inhibition. The company believes KO-2806 could enhance antitumor activity and become a valuable combination partner for targeted therapies in large solid tumor indications.
Kura Oncology (Nasdaq: KURA) has announced the publication of its KOMET-001 Phase 1 study results for ziftomenib in The Lancet Oncology. The study evaluated the safety, tolerability, and clinical activity of ziftomenib in relapsed/refractory acute myeloid leukemia (AML). Key findings include:
1. Promising clinical activity with manageable toxicity in heavily pretreated patients.
2. Marrow blast reduction, neutrophil and platelet recovery, transfusion independence, and clearance of measurable residual disease.
3. Determination of the recommended phase 2 dose (RP2D).
The company has completed enrollment for the Phase 2 portion of KOMET-001, a registration-directed trial in patients with NPM1-mutant AML. Topline data from this trial is expected in early 2025.
Kura Oncology (Nasdaq: KURA) has appointed Michael Vasconcelles, M.D., to its Board of Directors. Dr. Vasconcelles brings over 25 years of oncology drug development experience to the clinical-stage biopharmaceutical company. He currently serves as a Senior Advisor at Frazier Healthcare Partners and has held executive positions at ImmunoGen, Flatiron Health, Unum Therapeutics, Takeda/Millennium, Genzyme, and Sanofi Oncology.
The appointment comes at a key inflection point for Kura Oncology as it advances its menin inhibitor and farnesyl transferase inhibitor (FTI) programs for cancer treatment. Dr. Vasconcelles' expertise in R&D, regulatory affairs, and leadership across various companies is expected to be valuable in progressing these therapies through clinical trials and towards commercialization.