Kura Oncology Announces Clinical Collaboration to Evaluate Tipifarnib in Combination with Alpelisib in Head and Neck Squamous Cell Carcinoma
Excerpt from the Press Release:
SAN DIEGO, July 06, 2021 (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 a clinical collaboration with Novartis to evaluate the combination of tipifarnib and alpelisib in patients with head and neck squamous cell carcinoma (HNSCC) whose tumors have HRAS overexpression or PIK3CA mutation and/or amplification. Tipifarnib is Kura’s farnesyl transferase inhibitor drug candidate currently in a registration-directed trial as a monotherapy in patients with HRAS mutant HNSCC. Novartis’ alpelisib is an inhibitor of phosphatidylinositol-3-kinase (PI3K) with inhibitory activity predominantly against the PI3Kα isoform.
“Our preclinical data suggest that HRAS and PI3Kα are co-dependent pathways involved in the development and maintenance of HNSCC in certain patient populations. Combining tipifarnib with alpelisib has the potential to provide a clinically meaningful increase in anti-tumor activity compared to when inhibiting either pathway alone,” said Stephen Dale, M.D., Chief Medical Officer of Kura Oncology. “We believe this clinical collaboration will enable us to potentially expand the use of tipifarnib to a significantly higher percentage of patients with advanced HNSCC. We look forward to initiating the combination trial in the second half of 2021.”
The Phase 1/2 KURRENT trial is a biomarker-defined cohort study designed to evaluate the safety, determine the recommended combination dosing and assess early anti-tumor activity of tipifarnib and alpelisib for the treatment of HNSCC patients whose tumors are dependent on HRAS and/or PI3Kα pathways, which is approximately 50% of HSNCC patients, according to The Cancer Genome Atlas (TCGA).
Under the collaboration, Kura maintains global development and commercial rights to tipifarnib.
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