On December 16, 2021 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported 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) (Press release, Kura Oncology, DEC 16, 2021, View Source [SID1234597305]).
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"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.
About KURRENT
The 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. These patients account for approximately 50% of HNSCC, according to The Cancer Genome Atlas (TCGA). The initial cohort in the trial is comprised of patients who have PIK3CA-dependent HNSCC. For more information about the trial, refer to www.kuraoncology.com/kurrent/.
About HNSCC
Head and neck squamous cell carcinoma (HNSCC) is the seventh most common cancer worldwide, accounting for more than 500,000 new cases each year. Despite advances in immunotherapy, the prognosis for advanced HNSCC patients remains poor, with an estimated median overall survival of 13-15 months in patients when stratified by PD-L1 expression. Although the anti-epidermal growth factor receptor (EGFR) antibody, cetuximab, was approved more than a decade ago, development of biomarker-directed therapies in HNSCC has been stymied by the limited number of druggable targets in the genomic landscape and the challenge of managing drug refractory recurrent/metastatic HNSCC.
About Tipifarnib
Tipifarnib is a potent, selective and orally bioavailable inhibitor of farnesyl transferase, which has been granted Breakthrough Therapy and Fast Track Designations by the FDA for the treatment of patients with HRAS mutant HNSCC. In addition to HNSCC, tipifarnib has demonstrated encouraging clinical activity in multiple additional genetically defined tumor types. Kura has received multiple issued patents for tipifarnib, providing patent exclusivity in the U.S. and foreign countries.