Chinese Center for Drug Evaluation (CDE) Cleared Taletrectinib IND and Issued Clinical Trial Authorizations for Two Phase 2 Clinical Trials in China
March 30, 2020
HANGZHOU, China, March 23, 2020 – AnHeart Therapeutics, Co., Ltd. (“AnHeart”), a clinical stage oncology company focused on underserved patients in global markets, today announced that its new drug candidate taletrectinib has received IND clearance and Clinical Trial Authorization (CTA) for its two Phase 2 clinical trials from CDE, the Chinese drug evaluation agency.
“This is a major milestone for AnHeart. We have an experienced team who has successfully completed technology transfer and navigated through the local regulatory process to simultaneously gain clearance of our two Phase 2 taletrectinib trials, one of which is utilizing a relatively new basket design. We expect to initiate both trials in the next few months, in line with our current global clinical development strategy,” said Dr. Junyuan (Jerry) Wang, Chief Executive Officer.
The first Phase 2 trial will enroll first-and second-line Non-Small Cell Lung Cancer (NSCLC) patients with ROS1 mutations and is designed as an open-label, single-arm, multi-center study.
The second trial will enroll patients with locally advanced or metastatic solid tumors with NTRK mutations, and is designed as an open-label, multi-center basket trial.
AnHeart also plans to initiate one Phase 2 taletrectinib trial in Japan and another trial for rest of world (including USA). Trials in China and Japan will support the global development program for taletrectinib.
The lead clinical candidate taletrectinib is a next-generation novel, potent, highly selective ROS1 and NTRK inhibitor. AnHeart licensed the global rights to taletrectinib from Daiichi Sankyo Company Limited (“DS”). Two Phase 1 studies in the U.S. and Japan have been completed with promising safety and efficacy data. Taletrectinib inhibits both ROS1 WT and major crizotinib-resistant mutations, including G2032R. There is NO effective drug approved against resistant mutations like G2032R, which may lead to rapid penetration in major global markets.
AnHeart Therapeutics, Co., Ltd. (the “Company”) is a clinical stage biopharmaceutical company developing novel oncology therapies. The Company is headquartered in Hangzhou, China with offices in Beijing, Shanghai and New York. Formed in November 2018, the Company is currently managed by biopharmaceuticals industry veterans (Pfizer, BMS, Merck, J&J, Novartis) and financially backed by a venture capital fund.
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Info Source: https://www.globenewswire.com/news-release/2020/03/23/2004693/0/en/Chinese-Center-for-Drug-Evaluation-CDE-Cleared-Taletrectinib-IND-and-Issued-Clinical-Trial-Authorizations-for-Two-Phase-2-Clinical-Trials-in-China.html