Carrick Therapeutics Begins Phase 1 Trial Dosing for CT7439

BOSTON, Sept. 23, 2024 - Carrick Therapeutics Inc., a biopharmaceutical company with a focus on oncology, has commenced a Phase 1 clinical trial for CT7439, a novel inhibitor targeting cyclin dependent kinase 12/13 (CDK12/13) and functioning as a Cyclin-K glue-degrader. CDK12/13 plays a crucial role in various types of cancer since these kinases are involved in transcription elongation, RNA splicing, cleavage, and polyadenylation. The inactivation of CDK12/13 notably suppresses DNA damage response genes. This trial is recruiting participants with advanced solid tumors, such as ovarian, breast, and Ewing's Sarcoma.

Tim Pearson, CEO of Carrick Therapeutics, remarked on the initiation of the trial as a significant milestone, signifying the company's progress in bringing a second therapeutic option to clinical settings for aggressive and treatment-resistant cancers. Pearson highlighted that CT7439 is the pioneering CDK12/13 inhibitor to reach clinical trials and expressed optimism regarding its potential efficacy as either a standalone therapy or in combination with other treatments across various tumor types.

The Phase 1 trial employs a modular design, starting with a dose escalation phase where CT7439 is administered to patients. The primary objectives at this initial stage are to assess safety and pharmacokinetics. Furthermore, there will be an opportunity to obtain early Proof of Principle through a blood-based pharmacodynamic assay of the homologous recombination repair (HRR) pathway.

CT7439 is distinct in being both an inhibitor of CDK12/13 and a 'glue degrader' of Cyclin-K, the crucial co-factor for CDK12/13. This dual functionality provides CT7439 with potentially superior efficacy, as it enhances the compound's potency and blocks DNA repair at the transcriptional level. CDK12/13 influences gene transcription by activating RNA Polymerase II. Additionally, CT7439 may work synergistically with other DNA damage response agents, such as PARP inhibitors, in various cancer types including breast, ovarian, and Ewing’s Sarcoma.

Carrick Therapeutics is dedicated to developing innovative, highly differentiated cancer therapies that address significant unmet medical needs. The company’s leading program, samuraciclib, is a pioneering oral inhibitor of CDK7 currently undergoing multiple Phase 2 clinical trials for metastatic HR+ breast cancer. Carrick is also partnering with Roche, Menarini Group, and Arvinas/Pfizer to explore novel combinations of samuraciclib with oral SERD endocrine therapies. In addition to samuraciclib, Carrick is advancing CT7439, now in a Phase 1 clinical trial, further demonstrating their commitment to combating hard-to-treat cancers with innovative solutions.