Kura Oncology Doses First Patient in Phase 1/2 Clinical Trial of Tipifarnib in Combination with Tipifarnib in Head and Neck Squamous Cell Carcinoma

– Preclinical data suggest HRAS and PI3Kα are co-dependent oncogenes in HNSCC –

– Combination has potential to address up to 50% of patients with HNSCC –

– Initial cohort comprised of patients with PIK3CA-dependent HNSCC –

SAN DIEGO, Dec. 16, 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 dose administration for the first patient in KURRENT, the Company’s Phase 1/2 clinical trial of tipifarnib in combination with alpelisib in patients with HRAS- and/or PIK3CA-dependent head and neck squamous cell carcinoma (HNSCC).

“Despite the approval of immunotherapy, the treatment of recurrent and metastatic HNSCC remains a significant unmet need,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “The KURRENT trial builds on the impressive clinical activity reported for tipifarnib as a monotherapy in HRAS mutant HNSCC and represents an opportunity to significantly expand the potential patient population and target mechanisms of drug resistance.”

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. Preclinical data suggests that HRAS and PI3kα are co-dependent oncogenes in HNSCC, and that combining tipifarnib with a PI3Kα inhibitor has the potential to provide meaningfully greater antitumor activity, relative to inhibiting either target alone.

Earlier this year, Kura announced a clinical collaboration with Novartis to evaluate the combination of tipifarnib and alpelisib in patients with HNSCC whose tumors have HRAS overexpression or PIK3CA mutation and/or amplification. Under the collaboration, Kura maintains global development and commercial rights to tipifarnib.

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