HANGZHOU, China & NEW YORK--(BUSINESS WIRE)-- AnHeart Therapeutics Co., Ltd (“AnHeart”), a clinical-stage biopharmaceutical company committed to developing novel first-in-class or best-in-class precision oncology therapeutics, together with 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, announced today interim clinical data from a Phase Ⅱ trial (TRUST) evaluating taletrectinib (AB-106), an investigational next-generation ROS1/NTRK inhibitor in ROS1-positive non-small cell lung cancer (NSCLC). The data was announced as a keynote presentation at the Chinese Society of Clinical Oncology (CSCO) 2021 Annual Meeting on September 25-29, 2021.

The scientific presentation entitled: “Taletrectinib (AB-106): Preliminary results from TRUST, Phase Ⅱ trial of a new generation of potent ROS1/NTRK inhibitors in ROS1-positive non-small cell lung cancer (NSCLC),” summarized preliminary data from an ongoing Phase Ⅱ trial of taletrectinib (NCT04395677).

As of June 16, 2021, 21 crizotinib treatment-naïve patients and 16 crizotinib pre-treated patients were confirmed to be ROS1 fusion-positive. The key results are as follows:

• In the crizotinib treatment-naïve patient group (n=21), the confirmed objective response rate (ORR) was 90.5% (19/21) and the disease control rate (DCR) was 90.5% (19/21).
• In the crizotinib pre-treated patient group (n=16), the confirmed ORR was 43.8% (7/16); and the DCR was 75.0% (12/16).
• Among the crizotinib pre-treated patient group (n=16), ROS1 G2032R resistant mutations were identified in three patients and all three patients experienced tumor regression, 2 patients reported a partial response (PR), and 1 patient stable disease (SD).
• In patients with assessable brain metastasis pre-enrollment, intracranial objective response rate (assessed by investigator) was 83.3% (5/6).
• Taletrectinib was well-tolerated and treatment-related adverse events primarily included gastrointestinal adverse events and reversible aspartate aminotransferase (AST) and alanine aminotransferase (ALT) increased.

“We are pleased with the interim Phase Ⅱ data, which have shown taletrectinib to be safe and tolerable, a very promising novel therapy for patients with ROS1 fusion positive lung cancer,” said Dr. Caicun Zhou, Director of the Department of Oncology, Shanghai Pulmonary Hospital. “Responses appear particularly impressive in crizotinib treatment-naïve patients, and while the number of crizotinib pre-treated patients is limited, so far, most patients continue to show benefit from the drug.”

“Our team is focused on completing patient enrollment for our Phase Ⅱ TRUST trial,” said Bing Yan, MD, Co-founder and Chief Medical Officer at AnHeart Therapeutics. “The interim data presented builds a strong foundation for our ongoing global pivotal taletrectinib clinical program. We sincerely thank the patients, their families and investigators in the TRUST trial and look forward to advancing development of taletrectinib for all ROS1 fusion positive patients with NSCLC, an area of significant unmet medical needs.”

“We are glad to see the interim Phase Ⅱ data of taletrectinib presented at the CSCO meeting, one of the most authoritative clinical oncology conferences in China,” said Dr. Hui Zhou, Senior Vice President of Innovent, “In China, ROS1-positive patients currently have limited treatment options. Novel therapies are urgently needed, and taletrectinib has good efficacy and safety results, which offers hope to patients with ROS1 fusion-positive NSCLC.”

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.

About AnHeart

AnHeart Therapeutics Co., Ltd. (“AnHeart”) is a clinical-stage biopharmaceutical company developing novel first-in-class or best-in-class precision oncology therapeutics. Its lead asset, taletrectinib, is a next-generation ROS1 and NTRK inhibitor currently in Phase Ⅱ trials for the first and second-line non-small cell lung cancer (NSCLC) . AnHeart is developing a broad pipeline of next-generation precision oncology therapeutics with high unmet medical need. For more information, please visit www.anhearttherapeutics.com.

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 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 this platform, the company has built a robust pipeline of 26 valuable assets in major therapeutic areas, with 5 products - TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection) , HALPRYZA® (rituximab biosimilar injection), and Pemazyre® (pemigatinib oral inhibitor) – officially approved for marketing, 1 asset’s NDA under NMPA review, sintilimab’s Biologics License Application (BLA) acceptance in the U.S., 5 assets in Phase 3 or pivotal clinical trials, and an additional 15 molecules in clinical studies.

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. For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/.

AnHeart Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance, or achievements to be materially different from those anticipated by such statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “intends,” or “continue,” or the negative of these terms or other comparable terminology. Forward-looking statements contained in this presentation include, but are not limited to, (i) statements regarding the timing of anticipated clinical trials for our product candidates and our research and development programs; (ii) the timing of receipt of clinical data for our product candidates; (iii) our expectations regarding the potential safety, efficacy, or clinical utility of our product candidates; (iv) the size of patient populations targeted by our product candidates and market adoption of our product candidates by physicians and patients; and (v) the timing or likelihood of regulatory filings and approvals. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. This Presentation discusses product candidates that are under clinical study and which have not yet been approved for marketing by the U.S. Food and Drug Administration or regulatory agencies in other countries. No representation is made as to the safety or effectiveness of these product candidates for the use for which such product candidates are being studied.

Innovent Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words “anticipate”, “believe”, “estimate”, “expect”, “intend” and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent’s control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent’s competitive environment and political, economic, legal and social conditions.

Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.

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