Carrick Therapeutic's lead program is the CDK7 inhibitor, samuraciclib. The primary indication for samuraciclib, is hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer. In addition, it has the potential to treat many other cancer types.
Cyclin dependent kinase 7 (CDK7) is a highly attractive cancer target due to its involvement in multiple oncogenic pathways. CDK7 regulates three primary pathways that can lead to tumor growth in certain cancer types.
View CDK7 Biology SchematicSamuraciclib is an orally available CDK7 inhibitor which is in Phase 2 clinical development.
The inhibition of CDK7 is a promising therapeutic strategy in cancer. CDK7 regulates the transcription of cancer-causing genes, promotes uncontrolled cell cycle progression and drives resistance to anti-hormone therapy.
Samuraciclib has demonstrated a favorable safety profile and encouraging efficacy in early clinical studies in breast cancer. In addition, it has shown signals of efficacy in prostate cancer and triple negative breast cancer (TNBC) and has potential in other opportunities, including pancreatic and small cell lung cancer.
Samuraciclib has been granted Fast Track designations from the U.S. Food and Drug Administration (FDA) for the treatment of CDK4/6 inhibitor HR+, HER2- advanced breast cancer and for the treatment of locally advanced or metastatic triple negative breast cancer (TNBC).
The lead indication for samuraciclib is hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) breast cancer. This is the most common type of breast cancer comprising of two thirds of all breast cancer cases. Patients with advanced/metastatic disease are typically treated with an endocrine (hormone) backbone treatment in combination with a CDK4/6 inhibitor. Approximately 20% of patients with advance disease do not respond and all eventually become resistant to the CDK4/6 inhibitor. The prognosis for these patients with resistant disease is poor and existing treatments are limited and have significant side effects. It is these CDK4/6 inhibitor resistant patients that Carrick is targeting using a combination of samuraciclib and an endocrine backbone treatment.
The typical endocrine treatment used in these cancer patients is fulvestrant. It is a selective estrogen receptor degrader (SERD) and is given by intramuscular (IM) injection. Breast cancer tumor cells require estrogen to grow, fulvestrant blocks this process. Carrick has generated clinical Phase 1b data which shows that the combination of samuraciclib and fulvetsrant provides significant benefit over fulvestrant alone in HR+, Her2- breast cancer patients. Carrick is collaborating with Pfizer who are providing global development capabilities and expertise to support a Phase 2 clinical study of samuraciclib in combination with fulvestrant
A number of Pharmaceutical companies are developing alternative SERDs which can be dosed orally. Carrick has generated pre-clinical data which indicates that the combination activity of samuraciclib with SERDs is agnostic to the SERD combination partner. Carrick has entered into clinical collaborations with Menarini, Arvinas and Roche who are developing oral SERD therapies.
Carrick is building an innovative portfolio of first-in-class treatments that target multiple mechanisms of the most aggressive forms of cancer. In doing so, we aim to have a major impact on the lives of patients with the greatest unmet need and transform the way cancer is treated.
At this time Carrick is conducting clinical trials to evaluate the safety and effectiveness of our investigational drug, Samuraciclib (CT7001). Once sufficient positive data is available from clinical trials, Carrick plans to submit the data to regulatory authorities (such as the FDA and EMA) to obtain marketing approval so that Samuraciclib can be made available to any patient who needs it.
At the current time, Carrick is making Samuraciclib available on a managed access basis (for example expanded access, compassionate use, named patient supply) only to clinical trial participants who have been treated with Samuraciclib in a clinical trial setting sponsored by Carrick. This is because the evaluation of the safety and effectiveness of Samuraciclib is still at an early stage of clinical development and until sufficient data is available, Carrick must exercise due care in making Samuraciclib available on any managed access basis.
Carrick continuously monitors emerging data from our clinical trials. When the data is advanced enough to enable an assessment of the potential benefit and risks of broadening the current criteria for managed access to Samuraciclib, Carrick will further consider at that time.
The most up to date information regarding our ongoing Samuraciclib (CT7001) clinical trials is available at www.clinicaltrials.gov by searching ‘CT7001’.