Shanghai, China/New York – July 21, 2020 – 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 with taletrectinib in a Phase 2 trial of Non-Small Cell Lung Cancer (NSCLC) with ROS1 fusion at Shanghai Pulmonary Hospital.
“We have laid out an ambitious timeline for the taletrectinib global clinical development program for TKI-naïve and -pretreated patients and have managed to remain on track with projections despite COVID-19 delays ,” said Bing Yan, MD, Co-founder and Chief Medical Officer of AnHeart. “We commend our investigators for this major milestone. We look forward to bringing taletrectinib to patients with ROS1 and NTRK mutations.”
This Phase 2 trial will enroll approximately 106 NSCLC patients with ROS1 fusion and is designed as an open-label, single-arm, multi-center study in China. Professor Caicun Zhou at Shanghai Pulmonary Hospital is the leading principal investigator of this trial in China. AnHeart aims to report the study topline readouts as early as in Q4 2021.
AnHeart also plans to start a second Phase 2 taletrectinib trial this year to enroll approximately 40 patients with locally advanced or metastatic solid tumors with NTRK fusions, and global Phase 2 taletrectinib trials in Japan, Korea, US, EU and the rest of world seeking its global registration for indications of NSCLC with ROS1 fusions and solid tumors with NTRK fusions.
The lead clinical candidate taletrectinib is a next-generation, 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. Two Phase 1 studies in the U.S. and Japan have been reported with promising safety and efficacy data. Taletrectinib inhibits both ROS1 fusion WT and crizotinib-resistant secondary mutations, including G2032R. There is no approved drug against resistant mutations like G2032R, which may lead to rapid penetration of taletrectinib in major global markets. The mutation rate of the oncogenic driver ROS1 fusion is about 2 to 3 percent in patients with advanced NSCLC, and the rate of NTRK fusion is about 0.5 percent in patients with various solid tumors. The estimated number of new patients diagnosed with advanced NSCLC each year is about 1.8 million worldwide.
The results of two Phase 1 studies in the US and Japan support the potential of taletrectinib to be a next generation ROS1/NTRK inhibitor with durable responses and activity in brain metastases. Based on a data cutoff date in March 2019 from two Phase 1 trials, the mPFS in TKI-naïve and 1 TKI-pretreated patients were 24.6 months and 18.4 months, respectively, with a generally acceptable safety profile. More information about the Phase 1 and ongoing phase 2 trials may be found at clinicaltrials.gov with NCT02279433, NCT02675491 and NCT04395677.
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 New York. Formed in November 2018, AnHeart is currently managed by biopharmaceuticals industry veterans (Pfizer, BMS, Merck, J&J, Novartis) and financially backed by a venture capital fund.
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