First Patient Dosed in Phase II Basket Trial of Taletrectinib for Solid Tumors with NTRK Fusion
June 18, 2021
Hangzhou, Suzhou China/New York, USA – June 17, 2021 – AnHeart Therapeutics Co., Ltd. (“AnHeart”), a clinical stage oncology company focused on underserved patients in global markets, today announced that the first patient has been dosed in a Phase II basket trial of taletrectinib for solid tumors containing NTRK fusions (NCT04617054).
In June 2021, Innovent Biologics, Inc. (HKEX: 01801) (“Innovent”), a biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, entered into an exclusive agreement with AnHeart under which Innovent obtained exclusive rights to co-develop and commercialize taletrectinib in Greater China.
Building upon the promising preliminary results in the Phase II trial for non-small cell lung cancer (NSCLC) with ROS1 fusions, we are moving forward with the Phase II trial of taletrectinib for NTRK fusion-driven solid tumors, said Bing Yan, MD, Co-founder and Chief Medical Officer of AnHeart. “We plan to enroll approximately 40 patients in this open-label, single-arm, multi-center Phase II study in China.”
Dr. Hui Zhou, Senior Vice President of Clinical Development, Innovent Biologics, stated, “Many patients with rare conditions, like NTRK fusion-positive cancer have limited treatment options and poor access to targeted therapies. We are very pleased to see that our partner AnHeart is advancing the Phase II trial of taletrectinib in NTRK fusion-driven solid tumors. We will work closely with AnHeart to bring taletrectinib to patients in Greater China.”
Taletrectinib is an investigational next-generation TKI designed to effectively target ROS1 and NTRK with potential to treat TKI-naïve or pretreated patients. ROS1 rearrangement is estimated to be an oncogenic driver in approximately 2 to 3 percent of patients with advanced NSCLC, and NTRK fusion is estimated to be an oncogenic driver in approximately 0.5 percent of patients across multiple advanced solid tumors. There’s very limited approved therapy available for advanced ROS1-positive lung cancer patients and NTRK-positive cancer patients in Greater China. After treatment with existing therapies, most patients eventually acquire resistance for which there are significant unmet medical needs globally.
Taletrectinib is currently undergoing three Phase II clinical studies, including (i) the Phase II study for first line treatment of TKI-naive and second line treatment of TKI-pretreated ROS1-positive non-small cell lung cancer (NSCLC) in China, (ii) the Phase II study for NTRK-positive solid tumors in China, and (iii) the Phase II study for first line and second line treatment of ROS1-positive NSCLC globally.
More information about the ongoing TRUST (Taletrectinib ROS1 LUng STudy) trial in ROS1 fusion positive NSCLC and the ongoing basket trial in NTRK fusion positive solid tumors of taletrectinib may be found by searching clinical trial identifiers NCT04395677 and NCT04617054, respectively at https://clinicaltrials.gov.
AnHeart Therapeutics Co., Ltd. (“AnHeart”) is a clinical stage biopharmaceutical company developing novel oncology therapies. AnHeart is headquartered in Hangzhou, China with offices in Beijing, Shanghai and has a subsidiary AnHeart Therapeutics Inc. in New York. Led by a management team with a successful track record of clinical development, AnHeart is developing three clinical stage oncology programs globally. For more information, please visit: https://anhearttherapeutics.com/.
Inspired by the spirit of “Start with Integrity, Succeed through Action,” Innovent’s mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people.
Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune, metabolic diseases, and other major diseases therapeutic areas. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.
Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. By Leveraging the this platform, the company has built a robust pipeline of 24 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 4 products officially approved for marketing in China – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection) and HALPRYZA® (rituximab biosimilar injection), – officially approved for marketing in China, one Biologics License Application (BLA) submission for sintilimab accepted by the U.S. FDA, 6 assets in Phase 3 or pivotal clinical trials, and an additional 14 more molecules in clinical trials. In 2019, TYVYT® (sintilimab injection) was the first PD-1 inhibitor included in the National Reimbursement Drug List (NRDL) and the only PD-1 inhibitor included in the NRDL in that year.
Innovent has built an international team with advanced talented professionals in high-end biological drug biopharmaceutical development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with many collaborators to help advance China’s biopharmaceutical industry, improve drug availability and enhance the quality of the patients’ lives. For more information, please visit: www.innoventbio.com.
AnHeart 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.
Innovent Forward-Looking Statements
This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words “anticipate”, “believe”, “estimate”, “expect”, “intend” and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent’s control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent’s competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect.
AnHeart Media Contact:
AnHeart Investors Contact:
Innovent Media Contact:
+86 512-6956 6088
Innovent Investors Contact:
+86 512-6956 6088