Carrick Therapeutics Announces Collaboration With Roche to Evaluate Novel Samuraciclib Combination to Treat HR+ Breast Cancer


Carrick Therapeutics recently announced a clinical collaboration with Roche to evaluate a novel combination of Carrick’s samuraciclib and Roche’s giredestrant in CDK4/6i resistant HR+, HER2- metastatic breast cancer. The collaboration will utilize Roche’s MORPHEUS Phase 1b/2 platform for rapid and efficient combination development, with upfront randomization versus a control group.

This new study expands Carrick’s portfolio of clinical trials with samuraciclib, which is also being evaluated in a Phase 2a study in combination with fulvestrant for CDK4/6i resistant HR+, HER2- metastatic breast cancer. Other ongoing studies include samuraciclib for the treatment of triple negative breast cancer (TNBC) and prostate cancer – all settings in which CDK7 has been shown to act as a regulator of transcription, the cell cycle and endocrine receptor signalling.

“We are excited to initiate this collaboration with Roche to explore the broad potential of samuraciclib in combination with giredestrant, a next-generation oral SERD,” said Tim Pearson, Chief Executive Officer of Carrick Therapeutics. “Carrick’s preclinical studies have shown strong synergy combining CDK7 inhibitors with endocrine therapies, including models of resistance to CDK4/6 inhibitors. This collaboration represents a shared commitment to maximize the potential of innovative combination treatment approaches and address significant unmet needs.”

Under the agreement, each company is supplying its respective anti-cancer agent to support the trial.

Samuraciclib is the most advanced oral CDK7 inhibitor in clinical development. Inhibiting CDK7 is a promising therapeutic strategy in cancer as CDK7 regulates the transcription of cancer-causing genes, promotes uncontrolled cell cycle progression and resistance to anti-hormone therapy. Samuraciclib has demonstrated a favourable safety profile and encouraging efficacy in early clinical studies.

The MORPHEUS platform consists of multiple, global, open-label, randomized, umbrella Phase 1b/2 trials designed to accelerate the development of combinations for several indications by identifying early signals and establishing proof-of-concept clinical data.

Carrick Therapeutics is an oncology-focused biopharmaceutical company leveraging its deep expertise to discover highly differentiated novel therapies that address significant unmet needs. Samuraciclib, the most advanced oral CDK7 inhibitor in clinical development, is currently being evaluated in Phase 2a studies targeting CDK4/6 inhibitor resistant second-line HR+, HER2- metastatic breast cancer. Samuraciclib is also being evaluated in triple negative breast cancer (TNBC) and prostate cancer with further potential in pancreatic, ovarian and colorectal cancers. Carrick is also developing a novel CDK12/13 inhibitor / Cyclin-K glue-degrader which has advanced into IND enabling toxicology studies. For more information, visit www.carricktherapeutics.com