This article has been updated to clarify that Augtyro is a next-generation NTRK/ROS1 inhibitor.
NEW YORK – Beijing Avistone Biotechnology said Thursday that it has received the US Food and Drug Administration's permission to begin a trial of its next-generation ROS1/NTRK inhibitor ANS03.
After receiving FDA clearance for an investigational new drug (IND) application, the Beijing-based firm said it will begin studying ANS03 in Q1 2025 in patients with locally advanced or metastatic tumors harboring a ROS1 or NTRK alteration.
ANS03 is designed to address acquired resistance to first-generation ROS1 and NTRK inhibitors, such as Pfizer's Xalkori (crizotinib), Genentech's Rozlytrek (entrectinib), Bayer's Vitrakvi (larotrectinib), and Bristol Myers Squibb's next-generation NTRK/ROS1 inhibitor Augtyro (repotrectinib). ANS03 is designed to inhibit a broader spectrum of ROS1 and NTRK activity by inhibiting both the ATP-bound pocket of the kinase and the adjacent allosteric pocket. This allows the drug to broadly inhibit ROS1/NTRK activity, including wild-type ROS1/NTRK fusion and numerous acquired drug-resistant mutations.
ANS03 is Avistone's fifth oncology candidate to enter clinical trials. The firm's lead product, c-MET inhibitor vebreltinib, has been approved in China for MET-altered non-small cell lung cancer and MET fusion-positive glioblastoma. Avistone's other candidates include EGFR inhibitor PLB1004 and another c-MET inhibitor ANS01.