Press Release

AnHeart Therapeutics Announces Presentation at the European Lung Cancer Congress (ELCC) 2022

NEW YORK, NY – AnHeart Therapeutics (“AnHeart”), a clinical-stage global biopharmaceutical company committed to developing novel precision oncology therapeutics, today announced a poster presentation for ROS1 inhibitor taletrectinib at the European Lung Cancer Congress 2022, held in Prague, Czech Republic, and virtually, March 30-April 2, 2022. 

Details of the poster presentation are below:

Poster Presentation Title: TRUST-II: A Global Phase II Study for Taletrectinib in ROS1 fusion Positive Lung Cancer and other solid tumors. 

Presenter: Misako Nagasaka, M.D. Ph.D., University of California (UC) Irvine, School of Medicine

Date/Time: The e-Posters will be available on the virtual platform of the ELCC website, in the e-Posters section, as of 29 March at 12:00 CEST.

“Taletrectinib is a next-generation, brain-penetrant, ROS1 inhibitor, and there is a high unmet medical need for lung cancer patients with this specific type of ROS1 fusions," said Dr. Misako Nagasaka, Associate Clinical Professor and Thoracic Oncologist, UC Irvine. "The results from the Phase 2 trial evaluating taletrectinib in patients with ROS1 fusions, in particular the compound’s ability to penetrate the blood-brain barrier is impressive and I look forward to participating in this program.”

“We’re excited to present the poster at ELCC 2022, a major medical conference, and look forward to sharing additional data from the ongoing Phase 2 trial and bringing hope to patients with ROS1 fusion-positive NSCLC,” said CEO Junyuan (Jerry) Wang, Ph.D., CEO & Co-Founder, AnHeart Therapeutics.

About TRUST-II Study

TRUST-II study (NCT04919811) is a phase 2, global, multicenter, open-label, single-arm multi-cohort study evaluating the efficacy and safety of taletrectinib for ROS1 fusion-positive advanced metastatic NSCLC and other solid tumors. Taletrectinib will be given at 600 mg once daily in 21-day cycle. The patients with ROS1 fusions detected by local tests are eligible to enroll with retrospective confirmation by a central laboratory. The study consists of four cohorts: cohort 1: systemic chemotherapy naïve or ≤ one prior line and ROS1 TKI naïve NSCLC (N=53); cohort 2: previously treated with one ROS1 TKI (crizotinib or entrectinib) and with progression who are either chemotherapy naïve or ≤ one line of platinum and/or pemetrexed based therapy for NSCLC (N=46); cohort 3: ≤ 2 prior ROS1 TKIs and with progression who are either chemotherapy naïve or ≤ 2 lines of platinum and/or pemetrexed based therapy for NSCLC (N=10); and cohort 4: systemic chemotherapy naïve or ≤ 2 prior lines of chemotherapy, but ROS1-TKI naïve ROS1 positive solid tumor other than NSCLC (N=10). The primary endpoint is objective response rate (ORR) (RECIST v1.1) by independent review committee (IRC) assessment for cohorts 1 and 2. Key secondary endpoints include IRC-assessed duration of response, IRC-assessed intra-cranial ORR, progression free survival (PFS), overall survival (OS), and safety. This study is currently recruiting in Japan, Republic of Korea, and USA. Additional accrual is planned in Canada, China, and European Union.

About Taletrectinib

Taletrectinib is a novel best-in-class next-generation ROS1 inhibitor designed to effectively target ROS1 fusions with potential to treat both TKI-naïve and pre-treated patients. ROS1 rearrangement is estimated to be an oncogenic driver in approximately 1 to 2 percent of patients with NSCLC. ROS1 fusions are also observed in several other cancers such as cholangiocarcinoma, glioblastoma, ovarian, gastric, and colorectal cancers. Taletrectinib has demonstrated excellent potency against crizotinib resistance, good brain penetration and intracranial antitumor activity, and favorable safety profiles in ROS1 fusion-positive NSCLC patients. In these patients, few neurological adverse effects were observed, which likely benefits from the selective inhibition of ROS1 over TRKB by taletrectinib. More information about the ongoing China TRUST (Taletrectinib ROS1 LUng STudy) phase 2 trial and the global TRUST-II phase 2 trial may be found by searching clinical trial identifiers NCT04395677 and NCT04919811, respectively at https://clinicaltrials.gov. For questions about the ongoing trials, please contact trials@anhearttherapeutics.com.

About AnHeart Therapeutics

AnHeart Therapeutics (“AnHeart”), a Cayman Islands entity (registered name AnBio Therapeutics Ltd.), is a clinical-stage global biopharmaceutical group company developing a broad pipeline of novel or next-generation precision oncology therapeutics with high unmet medical needs. Its lead asset, taletrectinib, is a best-in-class next-generation ROS1 inhibitor currently in Phase 2 trials for the first-line TKI-naïve and second-line TKI-pre-treated patients with ROS1 fusion-positive non-small cell lung cancer (NSCLC). The Company’s pipeline also includes AB-218, a mIDH1 inhibitor in Phase 2 trials with good brain penetration for multiple solid tumors with mIDH1 mutations and AB-329, an AXL inhibitor in Phase 1 studies to be used in combination with checkpoint inhibitor or chemotherapies in NSCLC or other solid tumors. The Company operates from offices in the US and China. For more information, please visit https://www.anhearttherapeutics.com/.

Contacts

AnHeart Media Contact:
Kimberly Ha
KKH Advisors
917-291-5744
kimberly.ha@kkhadvisors.com

AnHeart Investor Contact:
Weiqing Wang, PhD
ir@anhearttherapeutics.com
212-466-6378