HANGZHOU, China, March 23, 2020 (GLOBE NEWSWIRE) -- 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 techn
HANGZHOU, China, March 23, 2020 (GLOBE NEWSWIRE) -- 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.
About 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.
About AnHeart:
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.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance, or achievements to be materially different from those anticipated by such statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “intends,” or “continue,” or the negative of these terms or other comparable terminology. Forward-looking statements contained in this presentation include, but are not limited to, (i) statements regarding the timing of anticipated clinical trials for our product candidates and our research and development programs; (ii) the timing of receipt of clinical data for our product candidates; (iii) our expectations regarding the potential safety, efficacy, or clinical utility of our product candidates; (iv) the size of patient populations targeted by our product candidates and market adoption of our product candidates by physicians and patients; and (v) the timing or likelihood of regulatory filings and approvals. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. This Presentation discusses product candidates that are under clinical study and which have not yet been approved for marketing by the U.S. Food and Drug Administration or regulatory agencies in other countries. No representation is made as to the safety or effectiveness of these product candidates for the use for which such product candidates are being studied.
Company Contact:
Akira Jing Liu, MD
Director of Business Development
ajliu@anhearttherapeutics.com
Investor Relations Contact:
Irina Koffler
Managing Director
LifeSci Advisors, LLC
646-970-4681 (w)
917-734-7387 (c)
ikoffler@lifesciadvisors.com
