A400/EP0031 Obtains IND Approval from FDA

Kelun-Biotech announced that the U.S. Food and Drug Administration (FDA) has recently approved the Investigational New Drug Application (IND) of the company’s small molecule RET kinase inhibitor A400 (KL590586) submitted by its collaboration partner Ellipses Pharma (internally named EP0031) for RET gene mutated malignant tumors. The approval is a key step for A400/EP0031 to start a global Phase I/II clinical study.

A400/EP0031 is a next-generation highly specific small-molecule RET kinase inhibitor (SRI). Kelun-Biotech has initiated the clinical study of A400/EP0031 in China and is currently in the dose-escalation stage. This approved Phase I/II clinical study in the U.S. will recruit patients with thyroid cancer and non-small cell lung cancer patients with RET gene mutation, including those who have previously received treatment with first-generation RET inhibitors. The safety, tolerability, and efficacy of A400/EP0031 will be evaluated.

The study is planned to be conducted at sites in the United States and Europe, with the first patient in the dose-escalation phase expected to complete enrollment in the third quarter of 2022. In addition, Ellipses Pharma will soon submit applications to regulators in the U.K. and E.U. to accelerate the launch of clinical research centers outside the U.S.