FDA Approves IND for CT7439, a Novel CDK12/13 Inhibitor to Treat Multiple Types of Advanced Solid Tumors


The CDK12/13 inhibitor will be tested for efficacy and safety in patients with advanced solid tumors, such as breast, ovarian, and Ewing Sarcoma.

An investigational new drug (IND) application for CT7439 (Carrick Therapeutics), a novel cyclin dependent kinase 12/13 (CDK12/13) inhibitor, has been approved by the FDA. A phase 1 clinical trial to test safety and how the drug moves within the body is set to begin in the first half of 2024. The trial will enroll patients with advanced solid tumors (eg, breast, ovarian, and Ewing Sarcoma) who will then receive escalated doses of CT7439.

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CT7439 is an inhibitor of CDK12/13 and a ‘glue degrader’ of Cyclin-K, which is the obligate co-factor for CDK12/13; the mechanism of action of CT7439 gives it both first-in-class and best-in-class potential. The dual modality considerably increases the efficacy of the compound, leading to the inhibition of transcriptional-level DNA repair. Further, CDK12/13 helps regulate gene transcription through the initiation of RNA Polymerase II and has the potential to synergize with other agents targeting DNA damage response such as the PARP inhibitors in different types of cancers including breast, ovarian and Ewing Sarcoma.

“FDA clearance of our IND application for [CT7439] further strengthens our oncology pipeline and will allow us to evaluate how our promising preclinical data translate into clinical benefits in patients with solid tumors,” said Tim Pearson, chief executive officer of Carrick Therapeutics, in a press release.


Carrick Therapeutics Announces U.S. FDA Clearance of IND for CT7439, a First-In-Class Inhibitor of CDK12/13. News release. Dublin, Ireland: Carrick Therapeutics; September 7, 2023. Accessed September 11, 2023. https://www.carricktherapeutics.com/news-media/press-releases/detail/20/carrick-therapeutics-announces-u-s-fda-clearance-of-ind

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