RELEASE: Carrick Therapeutics and Menarini Group Announce Collaboration on Clinical Trial

(Information sent by the signatory company).

RELEASE: Carrick Therapeutics and Menarini Group Announce Collaboration on Clinical Trial

(Information sent by the signatory company)

-Carrick Therapeutics and Menarini Group announce collaboration on clinical trial to evaluate the combination of samuraciclib and elacestrant

Carrick will conduct a Phase 2 clinical trial in patients with CDK4/6i-resistant HR , HER2-resistant metastatic breast cancer

DUBLIN and FLORENCE, Italy, Dec. 20, 2022 /PRNewswire/ -- Carrick Therapeutics, an oncology-focused biopharmaceutical company that discovers and develops highly differentiated therapies, and Menarini Group ("Menarini"), a leading international private pharmaceutical company, have today announced a clinical trial supply and collaboration agreement.

This agreement covers the execution of a Phase 2 clinical trial to evaluate the novel combination of Carrick's samuraciclib (CT7001), a first-in-class oral CDK7 inhibitor, and Menarini's oral selective estrogen receptor degrader (SERD). , elacestrant, in patients with HR, HER2-resistant to CDK4/6i-resistant metastatic breast cancer. Menarini and Carrick will jointly sponsor the clinical trial.

"We are delighted to enter into this collaboration with Menarini to explore the potential of samuraciclib in combination with elacestrant for the treatment of advanced breast cancer," said Tim Pearson, CEO of Carrick Therapeutics. "Our preclinical work and previous clinical studies have validated the biology of SERD-CDK7 combinations, pointing to potential synergies when combining samuraciclib with elacestrant, Menarini's oral SERD. This collaboration represents a shared commitment to maximize the potential of novel combination therapies to improve outcomes for people with breast cancer."

"This new clinical collaboration with Carrick Therapeutics is another step we are taking to develop elacestrant extensively to address the unmet needs of patients resistant to CDK4/6 therapies in HR, HER2- metastatic breast cancer." said Elcin Barker Ergun, CEO of Menarini. "Menarini will continue to seek research collaborations that have the potential to improve the lives of breast cancer patients."

Carrick plans to start the Phase 2 clinical trial in 2023. This new study will expand Carrick's ongoing clinical trial portfolio with samuraciclib. The company presented encouraging results from a clinical study combining samuraciclib with fulvestrant at the 2021 San Antonio Breast Cancer Symposium.

About Menarini Group

Menarini Group is a leading international pharmaceutical and diagnostics company with more than $4 billion in turnover and more than 17,000 employees. Menarini focuses on therapeutic areas with high unmet needs with products for cardiology, oncology, pulmonology, gastroenterology, infectious diseases, diabetology, inflammation and analgesia. With 18 production plants and 9 research and development centers, Menarini products are available in 140 countries around the world. For more information, visit

About Elacestrant (RAD1901) and the Phase 3 EMERALD Study

Elacestrant is an investigational selective estrogen receptor degrader (SERD). In 2018, elacestrant received Fast Track designation from the FDA. Preclinical studies completed prior to EMERALD indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer. The Phase 3 EMERALD trial is a randomized, open-label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in patients with ER , HER2- advanced/metastatic breast cancer. The study included 478 patients who had received prior treatment with one or two lines of endocrine therapy, including a CDK 4/6 inhibitor. Patients in the study were randomly assigned to receive elacestrant or the approved hormonal agent chosen by the investigator. The primary endpoints of the study were progression-free survival (PFS) in the general patient population and in patients with estrogen receptor 1 (ESR1) gene mutations. Secondary endpoints included assessment of overall survival (OS), objective response rate (ORR), and duration of response (DOR), and safety.

About Samuraciclib (CT7001)

Samuraciclib is the most advanced CDK7 inhibitor in the clinical development phase. CDK7 inhibition is a promising therapeutic strategy in cancer, as CDK7 regulates the transcription of cancer genes, promotes uncontrolled cell cycle progression and resistance to antihormonal therapy. Samuraciclib has demonstrated a favorable safety profile and encouraging efficacy in early clinical studies. In addition to the studies mentioned, it is currently being evaluated in prostate cancer, with additional potential in pancreatic, ovarian, and colorectal cancers. The US Food and Drug Administration (FDA) has granted samuraciclib "fast track" designation for use in combination with fulvestrant in the treatment of HER2-, HR- and CDK4/6i-resistant advanced breast cancer . Carrick is also collaborating with Roche to evaluate a new combination of samuraciclib and giredestrant, Roche's oral SERD, in HR, HER2-resistant CDK4/6i-resistant metastatic breast cancer. Carrick also plans to evaluate samuraciclib for the treatment of prostate cancer, in which CDK7 has been shown to act as a regulator of transcription, cell cycle, and androgen receptor signaling.

About Carrick Therapeutics

Carrick Therapeutics is an oncology-focused biopharmaceutical company that draws on its deep expertise to identify and develop new, highly differentiated therapies that address important unmet needs. In addition to samuraciclib, Carrick is also developing a new CDK12/13 inhibitor/Cyclin-K degrader that has advanced IND-enabling toxicology studies.

For more information on Carrick Therapeutics, visit

Logo -

View original content: