Country for PR: United Kingdom
Contributor: PR Newswire Europe
Tuesday, December 20 2022 - 02:24
Carrick Therapeutics and The Menarini Group Announce Clinical Trial Collaboration to Evaluate Samuraciclib and Elacestrant Combination
DUBLIN and FLORENCE, Italy, December 19, 2022 /PRNewswire-AsiaNet/--

Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering 
and developing highly differentiated therapies, and the Menarini Group 
("Menarini"), a privately-held, leading international pharmaceutical company, 
today announced a clinical trial collaboration and supply agreement.

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

"We are excited to initiate this collaboration with Menarini to explore the 
potential of samuraciclib in combination with elacestrant for the treatment of 
advanced breast cancer," said Tim Pearson, Chief Executive Officer of Carrick 
Therapeutics. "Our pre-clinical work and prior clinical studies have validated 
the biology for SERD combinations with CDK7, pointing to potential synergies 
when combining samuraciclib with Menarini's oral SERD, elacestrant. This 
collaboration represents a shared commitment to maximizing the potential of 
novel combination therapies to improve outcomes for people living with breast 

"This new clinical collaboration with Carrick Therapeutics is yet another step 
we are making to develop elacestrant in an extensive way to address unmet needs 
of patients resistant to CDK4/6 therapies in HR+, HER2- metastatic breast 
cancer," said Elcin Barker Ergun, Chief Executive Officer of Menarini. 
"Menarini will continue to pursue research collaborations that have the 
potential to improve patients' lives in breast cancer." 

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

About The Menarini Group

The Menarini Group is a leading international pharmaceutical and diagnostics 
company, with a turnover of over $4 billion and over 17,000 employees. Menarini 
is focused on therapeutic areas with high unmet needs with products for 
cardiology, oncology, pneumology, gastroenterology, infectious diseases, 
diabetology, inflammation, and analgesia. With 18 production sites and 9 
Research and Development centers, Menarini's products are available in 140 
countries worldwide. For further information, please visit

About Elacestrant (RAD1901) and the EMERALD Phase 3 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 EMERALD Phase 3 trial is a randomized, open 
label, active-controlled study evaluating elacestrant as second- or third-line 
monotherapy in ER+, HER2- advanced/metastatic breast cancer patients. The study 
enrolled 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 
randomized to receive either elacestrant or the investigator's choice of an 
approved hormonal agent. The primary endpoints of the study were 
progression-free survival (PFS) in the overall patient population and in 
patients with estrogen receptor 1 gene (ESR1) mutations. Secondary endpoints 
included evaluation 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 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 favorable safety profile and encouraging efficacy in early 
clinical studies. In addition to the above studies, it is currently being 
evaluated in prostate cancer with further potential in pancreatic, ovarian and 
colorectal cancers. Samuraciclib has been granted Fast Track designations from 
the U.S. Food and Drug Administration (FDA) for use in combination with 
fulvestrant for the treatment of CDK4/6i resistant HR+, HER2- advanced breast 
cancer. Carrick is also collaborating with Roche to evaluate a novel 
combination of samuraciclib and Roche's oral SERD giredestrant in CDK4/6i 
resistant HR+, HER2- metastatic breast cancer.  Carrick also intends to 
evaluate samuraciclib for the treatment of prostate cancer, where CDK7 has been 
shown to act as a regulator of transcription, the cell cycle and androgen 
receptor signalling.

About Carrick Therapeutics

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

For more information about Carrick Therapeutics, please visit 

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Source - Menarini Industrie Farmaceutiche Riunite