Innovent Announces First Patient Dosed in the Phase II Basket Trial of Taletrectinib for Solid Tumors with NTRK Fusion

Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, announced that the first patient has been dosed in a Phase II basket trial of taletrectinib for solid tumors containing NTRK fusion (NCT04617054).

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 https://clinicaltrials.gov.

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, S.A.R., China, Macau, S.A.R., China and Taiwan, China.

About Innovent 

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 therapeutic areas. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong, S.A.R., China 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 this platform, the company has built a robust pipeline of 24 valuable assets in 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), one Biologics License Application (BLA) submission for sintilimab accepted by the U.S. FDA, six assets in Phase 3 or pivotal clinical trials, and 14 more molecules in clinical trials. TYVYT® (sintilimab injection) was included in the National Reimbursement Drug List (NRDL) in 2019 as the historically first PD-1 inhibitor entering in NRDL and the only PD-1 included in the list in that year.

Innovent has built an international team of advanced talented professionals in high-end biopharmaceutical development and commercialization, including many overseas 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 all relevant parties to help advance China's biopharmaceutical industry, improve drug availability to ordinary people and enhance the quality of the patients' lives.

About Anheart

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.