FDA Clears IND Application for First-in-Class CDK12/13 Inhibitor

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A planned phase 1 trial will examine CDK12/13 inhibitor CT7439 in patients with several types of solid tumors, including breast and ovarian cancer, as well as Ewing’s sarcoma.

In addition to examining CT7439 as a single-agent treatment, investigators are assessing the compound in combination with a PARP inhibitor, as well as in combination with a checkpoint inhibitor.

In addition to examining CT7439 as a single-agent treatment, investigators are assessing the compound in combination with a PARP inhibitor, as well as in combination with a checkpoint inhibitor.

The FDA has given clearance to an investigational new drug (IND) application for CDK12/13 inhibitor CT7439, according to a press release from Carrick Therapeutics.1

Investigators have planned a phase 1 study in the first half of 2024 assessing CT7439 in a population of patients with advanced solid malignancies such as breast cancer, ovarian cancer, and Ewing sarcoma. The early-stage, dose-escalation study has a modular design. The goal of the study is to determine safety and pharmacokinetics. Moreover, investigators may assess the potential of using a blood-based pharmacodynamic assay of the homologous recombination repair pathway.

“FDA clearance of our IND application for CT7439, Carrick’s second therapeutic candidate, 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,” Tim Pearson, chief executive officer at Carrick Therapeutics, said in the press release.

The compound is a “glue degrader” of Cyclin-K, a known obligate co-factor of CDK12/13; this introduces the possibility of the agent having both first-in-class and best-in-class potential. Such a modality may result in better potency and result in DNA repair inhibition at a transcriptional level. Moreover, the compound may have synergy with agents targeted to DNA damage response including PARP inhibitors. This may prove to be effective in the aforementioned disease types being assessed in the phase 1 study.2

In addition to examining CT7439 as a single-agent treatment, investigators are assessing the compound in combination with a PARP inhibitor, as well as in combination with a checkpoint inhibitor.3

References

  1. Carrick Therapeutics announces U.S. FDA clearance of IND for CT7439, a first-in-class inhibitor of CDK12/13. News release. Carrick Therapeutics. September 7, 2023. Accessed September 7, 2023. https://bit.ly/3Z9GoN9
  2. CT7439: CDK12/13 inhibitor/Cyclin-K Degrader. Carrick Therapeutics. Accessed September 7, 2023. https://bit.ly/3P6SL7X
  3. Pipeline. Carrick Therapeutics. Accessed September 7, 2023. https://bit.ly/3RdaTj7
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