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FDA Clears Kinnate Biopharma's IND for FGFR Inhibitor in Bile Duct, Urothelial Cancers

NEW YORK – Kinnate Biopharma said on Tuesday that the US Food and Drug Administration has cleared an investigational new drug application for its pan-FGFR inhibitor KIN-3248 for bile duct and urothelial cancers.

Kinnate now has the agency's permission to begin a planned Phase I clinical trial evaluating KIN-3248 in the first half of this year. The trial is designed to evaluate the agent's safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-cancer activity as a treatment for patients whose tumors harbor FGFR2 or FGFR3 gene alterations. Patients will be eligible to participate in the study regardless of whether they have previously received an FGFR inhibitor.

Following an initial dose escalation portion, the trial will expand into a dose expansion portion including patients with intrahepatic cholangiocarcinoma, urothelial carcinoma, and additional solid tumors with FGFR alterations.

According to Kinnate, FGFR2 gene fusions and FGFR3 activating alterations are predicted oncogenic drivers in roughly 10 percent to 20 percent of cholangiocarcinomas and 20 percent to 35 percent of urothelial cancers. Kinnate's drug is designed to target acquired FGFR resistance alterations in addition to primary FGFR2 and FDFR3 oncogenic alterations. In preclinical studies, the firm said that KIN0-3248 had activity across primary mutations as well as resistance mutations acquired during targeted treatment.

"By targeting clinically relevant and primary FGFR2 and FGFR3 gatekeeper, molecular brake, and activation loop mutations, we believe that KIN-3248 is unique among FGFR inhibitors and has the potential to extend the clinical response of cancer patients with FGFR-altered tumors," Kinnate CEO Nima Farzan said in a statement.

Last year, the FDA also cleared Kinnate's IND for the RAF inhibitor KIN-2787, which the San Diego-based firm is evaluating for BRAF-mutated solid cancers in another Phase I study.