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Hangzhou, China, June 6, 2021 (Global News Agency)- Anxin Treatment Co., Ltd. (“AnHeart”), a clinical-stage oncology company focused on underserved patients in the global market, and Innovent Biologics, Inc. (“Innovent”, HKEx code: 01801) today jointly released a report entitled “Preliminary results from Trust: A phase II clinical study of Taletrectinib in the treatment of ROS1-fusion-positive non-small cell lung cancer (NSCLC) patients”, summarizing the preliminary data of the ongoing taletrectinib (NCT04395677) trial of the American Society of Clinical Oncology (ASCO) at the 2021 annual meeting. As of the data deadline April 8, 2021, there are 15 patients who have not received crizotinib treatment and 5 patients who have received crizotinib treatment in advance. These patients have been confirmed to be ROS1 fusion positive and have been studied The personnel are evaluated at least twice. The results are as follows:
- Among patients who did not receive crizotinib treatment (n=15), the overall response rate (ORR) was 93% (14/15), and the disease control rate (DCR) was 93% (14/15);
- In crizotinib pretreated patients (n=5), ORR was 60% (3/5); and DCR was 100% (5/5).ROS1 G2032R resistance mutation was found in three of five patients, and all three patients experienced tumor regression; and
- Taletrectinib has shown a controllable safety profile, its main feature is gastrointestinal adverse events, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) reversible increase.
“These data on the safety and effectiveness of taletrectinib are very promising for ROS1 fusion-positive lung cancer patients,” said Dr. Zhou Caicun, director of the oncology department of Shanghai Pulmonary Hospital. “In patients who have not received crizotinib, the response seems to be particularly impressive. Although the number of patients who have received crizotinib is limited, so far, all 5 patients have continued to take the drug Benefit.”
“Our team is highly focused on completing patient registration for this Phase II TRUST trial in the third quarter of 2021,” said Bing Yan, MD, co-founder and chief medical officer of AnHeart. “These data from the TRUST trial lay a solid foundation for our upcoming global trial of taletrectinib and will support us in seeking regulatory approval for taletrectinib in China and globally. We sincerely thank the patients in the TRUST trial, their families and researchers, I look forward to bringing taletrectinib to all ROS1 fusion-positive patients in the near future after approval.”
“We are very pleased to see that taletrectinib’s research results can be presented at the most authoritative clinical oncology conference ASCO,” said Dr. Zhou Hui, senior vice president of clinical development at Cinda. The choices are limited, and clinical applications require more research and development of new drugs. Taletrectinib has shown good efficacy and safety, which brings hope to patients with ROS1 fusion-positive non-small cell lung cancer. “
About Taletrectinib
Taletrectinib is an investigative next-generation tyrosine kinase inhibitor (TKI), designed to effectively target the fusion mutation of ROS1 and NTRK, and has the potential to treat TKI-naïve or pretreated patients. It is estimated that approximately 2% to 3% of ROS1 rearrangements in patients with advanced NSCLC are carcinogenic drivers, and it is estimated that approximately 0.5% of NTRK rearrangements in patients with other advanced solid tumors are carcinogenic drivers. More information about ongoing trusts (TonAletinib resistanceOS1 Lyoung Yingshiudy) test and basket test in NTRK fusion-positive solid tumors of taletrectinib can be found by searching for clinical trial identifiers NCT04395677 and NCT04617054, respectively https://clinicaltrials.gov.
About Anxin
Anxin Treatment Co., Ltd.. (“AnHeart”) is a clinical-stage biopharmaceutical company that develops new tumor therapies. AnHeart is headquartered in Hangzhou, China, with offices in Beijing and Shanghai, and a subsidiary AnHeart Therapeutics Inc. in New York. Under the leadership of a management team with a record of successful clinical development, AnHeart is developing three clinical phases of oncology projects worldwide. For more information, please visit: https://anhearttherapeutics.com/.
About innovation
In the spirit of “being honest and seeking truth from facts”, Cinda’s mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that ordinary people can afford.
Founded in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative drugs for the treatment of cancer, autoimmune, metabolic diseases and other major diseases. On October 31, 2018, Cinda was listed on the main board of The Stock Exchange of Hong Kong Limited, stock code: 01801.HK.
Since its establishment, Cinda has developed a fully integrated multifunctional platform that includes R&D, CMC (Chemistry, Manufacturing and Control), clinical development and commercialization capabilities. Through this platform, the company has established a powerful pipeline of 24 valuable assets in the main therapeutic areas such as cancer, metabolism, and autoimmune diseases. Among them, 4 products have been officially approved for listing in China-TYVYT® (sintilimab injection) Solution), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection) and HALPRYZA® (rituximab biosimilar injection)-officially approved in Listed in China, the US FDA accepted a biologics license application (BLA), 6 assets are in phase 3 or key clinical trials, and another 14 molecules are in clinical trials. In 2019, TYVYT® (sintilimab injection) was the first PD-1 inhibitor listed in the National Medical Insurance List (NRDL), and it was also the only PD-1 inhibitor listed in the National Medical Insurance List that year.
Cinda Bio has built an international team with senior talents in the R&D and commercialization of high-end biopharmaceuticals and biopharmaceuticals, including many global experts. The company has also reached strategic cooperation with international partners such as Eli Lilly, Adimab, Incyte, MD Anderson Cancer Center, and South Korea. Innovent strives to cooperate with many partners to help promote the development of China’s biopharmaceutical industry, increase drug supply and improve the quality of life of patients. For more information, please visit: www.innoventbio.com .
AnHeart forward-looking statements
The 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, which may cause our or our industry’s actual results, activity levels, performance or achievements to be materially different from those expected by such statements. In some cases, you can identify forward-looking through terms such as “may”, “will”, “should”, “anticipate”, “plan”, “anticipate”, “believe”, “estimate”, “forecast”, etc. statement. “”Potential”, “intend” or “continue”, or the negative form of these terms or other similar terms. The forward-looking statements contained in this presentation include but are not limited to (i) about our product candidates and our R&D plans A statement of the expected clinical trial time; (ii) The time of receipt of the clinical data of our product candidates; (iii) Our expectations for the potential safety, effectiveness or clinical utility of the candidate product; (iv) Our candidate product The size of the patient population targeted and the market adoption of our candidate products by doctors and patients; (v) The timing or possibility of regulatory filing and approval. We are not obliged to publicly update these forward-looking statements, or update them, except as required by law. Reasons why actual results may differ materially from those expected in the forward-looking statements, even if new information becomes available in the future. This presentation discusses candidates who are undergoing clinical research and have not yet been approved for marketing by the US Food and Drug Administration or other national regulatory agencies Products: No statement is made regarding the safety or effectiveness of the use of these candidate products in the research.
Innovation forward-looking statements
This press release may contain certain forward-looking statements, the nature of which depends on significant risks and uncertainties. “Expects,” “believes,” “estimates,” “expects,” “intends,” and similar expressions related to Innovent are intended to identify certain such forward-looking statements. Innovent does not intend to update these forward-looking statements on a regular basis. These forward-looking statements are based on Innovent’s management’s current beliefs, assumptions, expectations, estimates, forecasts and understandings of future events at the time these statements are made. These statements are not guarantees for future development and are subject to risks, uncertainties and other factors, some of which are beyond Cinda’s control and are difficult to predict. Therefore, due to future changes or developments in our business, Innovent’s competitive environment, and political, economic, legal, and social conditions, actual results may differ materially from the information contained in forward-looking statements. Innovent, the directors and employees of Innovent undertake (a) have no obligation to correct or update the forward-looking statements contained in this website; (b) if any forward-looking statements are not realized or the results are incorrect, they shall not assume any responsibility.
Contact person
Anxin Media Contact:
pr@anhearttherapeutics.com
+86-21-6474 6017
Reassured investor contact information:
ir@anhearttherapeutics.com
+86-21-6474 6017
Innovative media contact:
pr@innoventbio.com
+86 512-6956 6088
Innovative investor contact information:
ir@innoventbio.com
+86 512-6956 6088
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