Kinnate Biopharma announces ‘positive’ monotherapy dose escalation data

Kinnate Biopharma announced "positive" monotherapy dose escalation data for its investigational, highly selective and potent pan-RAF inhibitor, exarafenib, from Part A1 of its ongoing global Phase 1 KN-8701 clinical trial. These results will be featured in an oral presentation today at 3:35 p.m. ET during the Clinical Trials Mini Symposium Session at the American Association for Cancer Research, or AACR, 2023 Annual Meeting. The data at AACR were based on a February 28, 2023 data cutoff. Sixty patients with a median of three prior therapies had been enrolled into six monotherapy dose escalation cohorts: 25 mg bid, 50 mg bid, 100 mg bid, 200 mg bid, 300 mg bid and 400 mg bid. Treated patients included those with solid tumors driven by BRAF Class I, Class II and Class III alterations or melanoma with NRAS mutations. BRAF and NRAS alterations were identified by local laboratories either in tumor or plasma. As of the data cutoff, all 60 patients enrolled were part of the safety analysis population, of which 49 patients were efficacy evaluable. The company today also provided details around its monotherapy dose expansion strategy and a preliminary update on the combination arm evaluating exarafenib with binimetinib, a MEK inhibitor, in patients with BRAF-altered solid tumors and/or who have NRAS mutant melanoma. "The exarafenib dose escalation data provide striking proof of concept for a monotherapy pan-RAF inhibitor. For the first time, a pan-RAF inhibitor has shown both promising tolerability as a single agent and has achieved compelling breadth of activity with durable responses in targetable mutations. Responses in patients with BRAF Class II or NRAS alterations is meaningful because no approved targeted therapy is available today, and physicians are left with limited treatment options for advanced cancers, which means patients often have poor survival outcomes. I look forward to the further study of exarafenib’s therapeutic potential to address these patients who are currently medically underserved," said Alexander Spira, MD, PhD, FACP, co-director, Virginia Cancer Specialists Research Institute.