On June 17, 2021 Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported that the first patient has been dosed in a Phase II basket trial of taletrectinib for solid tumors containing NTRK fusion (NCT04617054) (Press release, Innovent Biologics, JUN 17, 2021, View Source [SID1234584145]).
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In June 2021, Innovent entered an exclusive agreement with AnHeart Therapeutics Co., Ltd. ("AnHeart"), a clinical stage oncology company focused on underserved patients in global markets, under which Innovent obtained exclusive rights to co-develop and commercialize taletrectinib in Greater 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."
"Building upon the promising preliminary results in the Phase II trials 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."
About Taletrectinib
Taletrectinib is an investigational next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and NTRK fusion mutations with potential to treat TKI-naïve or pre-treated patients. ROS1 rearrangement is estimated to be an oncogenic driver in approximately 2 to 3 percent of patients with advanced NSCLC, and NTRK rearrangement is estimated to be an oncogenic driver in approximately 0.5 percent of patients with other advanced solid tumors. More information about the ongoing TRUST (Taletrectinib ROS1 LUng STudy) trial and the basket trial in NTRK fusion positive solid tumors of taletrectinib may be found by searching clinical trial identifiers NCT04395677 and NCT04617054, respectively at View Source
On 1 June 2021, Innovent and Anheart announced an exclusive license agreement for the co-development and commercialization of AnHeart’s lead drug candidate, taletrectinib – a next-generation tyrosine kinase inhibitor (TKI) designed to effectively target ROS1 and NTRK – in Greater China, including mainland China, Hong Kong, Macau and Taiwan.