On February 15, 2023, TYK Medicines announced that its independently developed, highly selective and effective oral next-generation Cyclin-dependent kinase7 (CDK7) inhibitor TY-2699a received the official letter (Study May Proceed Letter) from the U.S. Food and Drug Administration (FDA) approving to conduct clinical trials. This is the third innovative drug of TYK Medicines to receive FDA approval for clinical trials.
TY-2699a is China’s first CDK7 inhibitor to be approved for clinical studies by the FDA. There are currently no CDK7 inhibitors with marketing authorization , and only four agents in early-stage clinical trials (all in Phase I/II), with no investigational drugs in domestic clinical development, leaving a considerable clinical demand unmet.
Meanwhile, TYK Medicines held a Pre-IND communication meeting of TY-2699a with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) and is scheduled to submit an IND application in near future, and is expected to get a notification of clinical trial permission from the NMPA in May 2023.
About TY-2699a
TY-2699a is a novel, highly effective, and selective small-molecule inhibitor of CDK7, independently developed by TYK Medicines, Inc, aiming for various advanced tumors, such as breast cancer, ovarian cancer, prostate cancer, pancreatic cancer, small cell lung cancer (SCLC), and blood tumor etc. TY-2699a has demonstrated the marked sensitivity of many cancer types to selective CDK7 inhibition via preclinical animal models, as well as high tolerance and safety, laying a solid foundation for future clinical practice. In addition, TY-2699a showed great performance in breast cancer models with acquired resistance to CDK4/6 inhibitors, implying that TY-2699a may be a viable choice for dealing with drug resistance following CDK4/6 targeted therapy.
About CDK7
CDK7 is a member of the cyclin-dependent kinases (CDK) family and a subunit of the multi-protein transcription factor, TFIIH, playing key roles in both transcription and regulation of the cell cycle, emerging as an attractive and promising target for anti-cancer therapeutics. In the cell cycle, CDK7 forms the CDK-activating kinase (CAK) with cyclin H and MAT1 and controls cell cycle progression, particularly in malignant cells, by activating other CDK family kinases (CDK1/2/4/6). Concerning transcription, the CAK module is a component of TFIIH, a multi-protein complex essential for transcription and regulation. CDK7 has been implicated in multiple tumor types driven by aberrant transcriptional control (e.g., MYC-, ESR1-activation) and/or aberrant cell cycle control (e.g., RB1, CCNE1, CDKN2A alterations). Multiple tumors, including but not limited to triple-negative breast cancer (TNBC), relapsed or refractory ovarian cancer (OC), pancreatic ductal adenocarcinoma (PDAC), and blood cancers, have been demonstrated to be highly dependent on CDK7. CDK7 inhibitors are expected to be a promising treatment for such cancers.
About TYK Medicines
TYK Medicines, Inc. was established in November 2017 in Life Science Park Changxing Economic Development Zone with a fully functionalized 30,000 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. In addition to the current scope, the company is building DP plants in Changxing, Zhejiang Province, and Songjiang District, Shanghai. Thus, the company is capable of a whole industry chain of innovative drug discoveries, as well as drug manufacturing, which makes the company the first-tier innovative biotechnology company in China.
References
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