PR99264

DUBLIN and FLORENCE, Italy, December 19, 2022 /PRNewswire=KYODO JBN/--

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

cancer."

"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

Symposium.

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 www.menarini.com.

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

www.carricktherapeutics.com　

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Source - Menarini Industrie Farmaceutiche Riunite