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Carrick Therapeutics are currently progressing CT7001, their first-in-class oral therapy that leads in the emerging field of CDK7 (Cyclin-dependent kinase 7) inhibition, through Phase 1b trials. CT7001 seeks to address a large unmet medical need across a range of tumours, including hormone receptor positive breast cancer and triple negative breast cancer.

Charnwood Molecular were involved in the chemistry development programme for this exciting new therapy. After the medicinal chemistry route had been pushed to its limits for production of the first appreciable quantities of material, the development programme designed and implemented new routes whilst still facilitating material supply. Charnwood Molecular provided a robust, scalable route to support initial toxicity studies and which enabled the GMP production of first kg quantities of compound for clinical studies. Concurrently, a second, improved route was developed by Charnwood. This more concise, efficient and cost-effective route is being used to manufacture hundreds of kgs of API to support formulation development and for Phase III supplies.

Along with API route evolution, Charnwood Molecular also provided complimentary activities such as chirality tracking/analysis, synthesis of impurities and isotopically labelled materials and technology transfer to GMP manufacturers. Charnwood Molecular continue to support Carrick Therapeutics with CT7001 back-up and with new programmes.

“Our development team enjoyed working with Carrick Therapeutics on an exciting project, assisting them as they continue to help cancer patients worldwide. It was very satisfying for our chemists to design and implement a plan, to deliver a process and material in a timely fashion and ultimately, to see that chemical route used at manufacturing scale”, said Dr. Mike McKenzie, Director of Operations and Chemical Development Charnwood Molecular.

Paul McGee, VP CMC Manufacturing at Carrick Therapeutics: “The expert route scouting and process development skills of the Charnwood chemists, alongside detailed reporting and collaborative sharing of ideas, enabled Carrick to progress the CT7001 programme rapidly into clinical studies.  Continued support of the programme has enabled efficient technical transfer of the process to larger scale, GMP vendors to meet the growing API needs of the programme as we progress into later Phase clinical development.”

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