NEW YORK – Kinnate Biopharma on Monday said that the US Food and Drug Administration has cleared an investigational new drug application for the RAF inhibitor KIN-2787 and that the firm plans to begin trials of the agent later this year.
Specifically, Kinnate announced plans to evaluate KIN-2787 as a treatment for patients with BRAF-mutated solid tumors. The Phase I/II clinical trial, expected to begin in mid-2021, will be designed to assess KIN-2787's safety, tolerability, pharmacokinetics, and anti-cancer activity for this patient population. The first part of the trial will establish the recommended dose, and the second part will be a dose escalation portion, in which Kinnate evaluates the agent for patients with lung cancer, melanoma, and other solid tumors harboring class I, II, or III BRAF mutations. According to Kinnate, the agent differs from other available BRAF-targeting agents that target only class I BRAF mutations.
San Diego-based Kinnate also announced plans to file an IND with the FDA for its lead FGFR inhibitor candidate, KIN-3248, as a treatment for certain patients with cancers like urothelial tumors or bile duct cancer, in the first half of 2022.
According to a statement from Nima Farzan, Kinnate's CEO, the KIN-2787 IND marks an important step in the firm's transition to a clinical-stage company. The news comes in the wake of a recent announcement that Kinnate has partnered on a joint venture with OrbiMed Asia Partners, OrbiMed Private Investments, and Foresite Capital to develop and commercialize its treatments in China, Hong Kong, Taiwan, and Macau.