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.
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