NEW YORK – Clinical-stage oncology company AnHeart Therapeutics said on Monday that the Chinese drug evaluation agency has granted investigational new drug authorization to its lead candidate taletrectinib, allowing it to start two Phase II trials in the next few months.
Taletrectinib is a ROS1 and NTRK inhibitor that AnHeart licensed from Daiichi Sankyo. The drug inhibits both ROS1 wild-type and major crizotinib-resistant mutations, including G2032R. There are currently no approved drugs that are effective against resistant mutations like G2032R.
The first Phase II trial will enroll first- and second-line ROS1-mutated non-small cell lung cancer patients. It will be an open-label, single-arm study held at multiple centers.
The second Phase II trial will enroll patients with NTRK-mutated advanced or metastatic solid tumors. The trial will be an open-label basket trial held at multiple centers.
Trials in China and Japan will support the global development program for taletrectinib, according to Hangzhou, China-based AnHeart.
Currently, Pfizer, Novartis, Betta Pharmaceuticals, and Exelixis are developing drugs against ROS1-positive NSCLC. Bayer and Exelixis are also developing agents against TRK-positive solid tumors.