Press Release

AnHeart Therapeutics Announces Acceptance of Taletrectinib Phase 1 Data for Publication in Clinical Cancer Research

June 30, 2020

Hangzhou, China/New York, NY – June 26, 2020 – AnHeart Therapeutics, Co., Ltd. (“AnHeart”), a clinical stage oncology company focused on underserved patients in global markets, today announced that its Phase 1 taletrectinib data has been accepted for publication in Clinical Cancer Research, a prestigious oncology journal of the American Association for Cancer Research. The paper is entitled “US phase 1 first-in-human study of taletrectinib (DS-6051b/AB-106), a ROS1/TRK inhibitor, in patients with advanced solid tumors” and will be available online with open access.

“Taletrectinib is a promising oral tyrosine kinase inhibitor highly selective for ROS1/NTRK mutations with potent activity against ROS1 resistance mutations like G2032R” commented Dr. Sai-Hong Ignatius Ou, the corresponding author of the paper from University of California Irvine School of Medicine. “The drug had manageable toxicities at the maximum tolerated dose (MTD) of 800 mg daily and showed preliminary efficacy in crizotinib-refractory ROS1+ Non-Small Cell Lung Cancer (NSCLC) patients.”

“We are honored to have our study selected for publication in Clinical Cancer Research. There is a significant unmet need for next generation tyrosine kinase inhibitors to overcome resistance that develops to existing agents like crizotinib, and we are highly focused on developing taletrectinib for both first, and second-line use in global markets” said Dr. Bing Yan, Chief Medical Officer and Founder of AnHeart . “We are steadily making progress towards launching our Phase 2 trials (NCT04395677) in first-and second-line NSCLC patients with ROS1 mutations in the next few weeks.”

About Taletrectinib:

The lead clinical candidate taletrectinib is a next-generation novel, potent, highly selective ROS1 and NTRK inhibitor that can cross the blood-brain barrier. 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
(86) 137-0181-9470 (c)

Investor Relations Contact:
Irina Koffler
Managing Director
LifeSci Advisors, LLC
646-970-4681 (w)
917-734-7387 (c)

Info Source: