Kura Oncology, Inc., a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, and Mirati Therapeutics, Inc., a commercial-stage targeted oncology company, announced a clinical collaboration and supply agreement to evaluate the combination of KO-2806, a next-generation farnesyl transferase inhibitor (FTI), and adagrasib (Krazati), a highly selective KRASG12C inhibitor, in patients with KRASG12C-mutated non-small cell lung cancer (NSCLC).
“Recent findings suggest that combining KO-2806 with adagrasib can drive tumour regressions and enhance both duration and depth of antitumor response in preclinical models of KRASG12C-mutated NSCLC,” said Stephen Dale, M.D., chief medical officer of Kura Oncology. “This collaboration highlights the potential to address the urgent need for more durable and effective treatment options for patients with advanced solid tumours, and we look forward to collaborating with Mirati, an established leader in targeted oncology.”
“We are pleased to collaborate with Kura Oncology on this clinical study of KO-2806 with adagrasib. Preclinical work demonstrates the ability of adagrasib, in combination with a FTI, to improve patient outcomes,” said Alan Sandler, M.D., chief medical officer, Mirati Therapeutics. “This collaboration exemplifies the potential combinability of adagrasib as a key differentiation from other KRASG12C inhibitors.”
Under the terms of the agreement, Kura will sponsor the phase 1 study of KO-2806 and adagrasib in patients with KRASG12C-mutated NSCLC. Mirati will supply Kura with adagrasib for the study.
KO-2806 is a next-generation inhibitor of farnesyl transferase designed to improve upon potency, pharmacokinetic and physicochemical properties of earlier FTI drug candidates. Earlier this year, Kura received FDA clearance of its Investigational New Drug application for KO-2806. In addition to KRASG12C NSCLC, KO-2806 has demonstrated encouraging preclinical activity in clear cell renal cell carcinoma (ccRCC). The Company recently dosed the first patients in a Phase 1 dose-escalation trial of KO-2806 (FIT-001). Concurrent with dose escalation as a monotherapy, Kura also plans to evaluate KO-2806 in dose-escalation combination cohorts with other targeted therapies in advanced solid tumours, including adagrasib in KRASG12C-mutated NSCLC and a tyrosine kinase inhibitor in ccRCC.
Adagrasib is being evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated solid tumours, including NSCLC, colorectal cancer, and pancreatic cancer.
Krazati is indicated for the treatment of adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.
This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s).
Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer.
Mirati Therapeutics, Inc. is a commercial stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones.
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