On August 31, 2020, TYK Medicines, Inc (hereinafter referred to as “TYK Medicines”), a biotechnology company focused on the development of the world’s leading small molecule anti-tumor drugs, and Livzon Pharmaceutical Group (hereinafter referred to as “Livzon Pharma”), signed a patent assignment and exclusive technology license agreement for TY-2136b in Greater China.

TY-2136b is a next-generation ROS1/NTRK/ALK multi-target small broad-spectrum tyrosine kinase inhibitor (TKI) developed by TYK Medicines at the PCC (preclinical candidate compound) stage. Preclinical studies have shown that TY-2136b has shown excellent efficacy against multiple ROS1/NTRK/ALK targets, while also effectively inhibiting drug-resistant mutations, effectively addressing many unmet medical needs.

Dr. Yusheng Wu, Chairman and CEO of TYK Medicines, said, “We are pleased to have the opportunity to collaborate with Livzon Pharma to accelerate the research, clinical development, and commercialization of TY-2136b. Despite its recent establishment, TYK Medicines has strong R&D capabilities. This successful collaboration with Livzon Pharma is also a demonstration of our team’s R&D capabilities.” Dr. Jun Li, CSO of TYK Medicines, said, ” TYK Medicines’ establishment criteria is to address unmet medical needs and to be the Best-in-Class in its class. The preclinical data show that TY-2136b shows similar or better inhibition of major resistance mutations in both ROS1/NTRK/ALK. Also, TY-2136b could penetrate the blood-brain barrier, which is potentially advantageous for patients with brain metastases.

Mr. Yanggang Tang, Executive Director and President of Livzon Pharma, said, “This collaboration with TYK Medicines can fully utilize our respective strengths to accelerate the development and launch of new drugs and further complement Livzon Pharma’s oncology product pipeline. For a long time, Livzon has been committed to the development of innovative oncology drugs, and Chinese oncology patients still need more and better therapeutic drugs. Based on the current excellent preclinical data of TY-2136b, we believe that the product will definitely benefit Chinese oncology patients when it is launched in the future.”

Lung cancer is reported to be one of the leading causes of cancer deaths worldwide. About 85% of them are patients with non-small cell lung cancer (NSCLC) [1], and an analysis of the prevalence of malignancies in China in 2015 showed that about 787,000 new lung cancer patients are diagnosed annually in China [2]. According to the classification of oncogenic driver genes, ROS1 positive accounts for about 2% of the number of NSCLC patients, and more than half of them will develop drug-resistant mutations such as G2032R and D2033N after receiving the existing targeted drug therapy [3]; the number of cancer patients caused by fusion mutations of NTRK gene accounts for about 0.5-1% of the number of NSCLC patients [4], in addition to the fusion of this gene can also cause a variety of cancers including appendiceal cancer, breast cancer, bile duct cancer, colorectal cancer, gastrointestinal mesenchymal tumor (GIST), and many other solid tumors in a totaling of 17 types. ALK-positive accounts for about 5-8% of the number of patients with NSCLC [5], and many G1202R resistance mutations arise after treatment with ALK inhibitors, especially second-generation ALK inhibitors.

About TYK Medicines, Inc.

TYK Medicines, Inc. was established in Nov. 2017 in Life Science Park Changxing Economic Development Zone with a fully functionalized 3,000 square meters world-class drug discovery R&D center; subsequently, the company set up the administrative headquarters, medical affairs, and business development in Shanghai. In Zhengzhou, the company has its small molecule drug screening platform.

The company focuses on the research and development of new drugs of anti-tumor small molecule Best-in-class/First-in-class and has established a high-efficiency small molecule new drug research and development platform. TYK has a highly experienced team with 10 returnees from the US with rich experience in the research and development of new drugs by well-known multinational pharmaceutical companies and led more than ten compounds into the clinical stage. In addition, the company has 3 clinical experts and has experience in dozens of innovative drug clinical projects.

About Livzon Pharmaceutical Group

Founded in 1985 with a registered capital of RMB 957 million, Livzon Pharmaceutical (000513.SZ, 1513.HK) is a comprehensive pharmaceutical group company integrating pharmaceutical R&D, manufacturing, and sales, with more than 8,000 employees. Livzon is dedicated to the R&D, production, and sales of APIs, small molecule drugs, biologics, and diagnostic reagents, and its key therapeutic areas cover anti-tumor, reproductive endocrine, digestive, anti-infection, psychiatric/neurological, endocrine, and other fields.

Reference

1. Herbst R S, Morgensztern D, Boshoff C . The biology and management of non-small cell lung cancer[J]. Nature, 2018, 553(7689): 446-454.
2. Zheng, RS, Sun, KX, Zhang, SW, et al. Analysis of the prevalence of malignant tumors in China in 2015. China J Oncol, 2019, 41 (1): 19-28. DOI: 10.3760/cma.j.issn.0253-3766.2019.01.005
3. Gainor JF, Tseng D, Yoda S, et al. Patterns of Metastatic Spread and Mechanisms of Resistance to Crizotinib in ROS1-Positive Non-Small-Cell Lung Cancer. JCO Precision Oncology. 2017;2017. DOI: 10.1200/po.17.00063.
4. Ricciuti, B., et al., Targeting NTRK fusion in non-small cell lung cancer: rationale and clinical evidence. Med Oncol, 2017. 34 (6): p. 105.
5. McCoach CE, Le AT, Gowan K, et al. Resistance Mechanisms to Targeted Therapies in ROS1+ and ALK+ Non-small Cell Lung Cancer. Clin Cancer Res. 2018; 24 (14):3334-3347. doi:10.1158/1078-0432.CCR-17-2452