Pharma Focus America

Carrick Therapeutics Receives U.S. FDA Approval for IND Application of CT7439, a Novel CDK12/13 Inhibitor

Friday, September 08, 2023

Carrick Therapeutics, a biopharmaceutical company specializing in oncology treatments, has announced that the U.S. Food and Drug Administration (FDA) has granted clearance for its Investigational New Drug (IND) application for CT7439, a groundbreaking inhibitor targeting cyclin-dependent kinase 12/13 (CDK12/13). The company is gearing up to initiate a Phase 1 clinical trial in the first half of 2024, with plans to enroll patients with advanced solid tumors, including breast, ovarian, and Ewing's Sarcoma.

Tim Pearson, the CEO of Carrick Therapeutics, expressed excitement about the FDA's approval of their IND application for CT7439, marking it as their second therapeutic candidate. He underscored the significance of this milestone in bolstering their oncology pipeline and the potential it holds for assessing how promising preclinical data translate into clinical benefits for patients with solid tumors.

The Phase 1 clinical trial follows a modular design, commencing with a dose escalation phase for the initial administration of CT7439 to patients. During this stage, the primary objectives are to evaluate safety and pharmacokinetics, with an opportunity for an early Proof of Principle through a blood-based pharmacodynamic assay related to the homologous recombination repair (HRR) pathway.

CT7439 functions as both a CDK12/13 inhibitor and a 'glue degrader' of Cyclin-K, an essential co-factor for CDK12/13. This dual mechanism enhances the compound's potency, leading to the transcriptional-level inhibition of DNA repair. CDK12/13 plays a pivotal role in regulating gene transcription through the activation of RNA Polymerase II. CT7439 holds promise for potential synergies with other agents targeting DNA damage response (DDR), including PARP inhibitors, across a range of cancer types such as breast, ovarian, and Ewing’s Sarcoma.

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