Carrick Therapeutics Announces Clinical Trial Collaboration with Arvinas and Pfizer to Evaluate Samuraciclib and Vepdegestrant Combination

Collaboration expands Carrick’s clinical-stage Oncology program

DUBLIN, Ireland and BOSTON, July 06, 2023 (GLOBE NEWSWIRE) — Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, today announced a clinical trial collaboration and supply agreement with Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE).

This agreement covers the execution of a Phase 1b/2 clinical trial to evaluate the novel combination of Carrick’s samuraciclib (CT7001), an oral and first-in-class inhibitor of CDK7, and Arvinas’ vepdegestrant (ARV-471), an investigational oral PROTAC^® (PROteolysis TArgeting Chimera) estrogen receptor protein degrader being developed in collaboration with Pfizer, in patients who have received prior CDK4/6i, with ER+, HER2- metastatic breast cancer.

“We’re pleased to announce our collaboration with Arvinas and Pfizer to explore the potential of samuraciclib in combination with vepdegestrant for the treatment of advanced breast cancer,” said Tim Pearson, Chief Executive Officer of Carrick Therapeutics. “Despite the significant progress made in oncology in recent years, the treatment of HR+ breast cancer continues to have considerable unmet needs. We are encouraged by the initial clinical trial data from vepdegestrant and believe there could be potential synergies when combining it with samuraciclib.”

Under the terms of the agreement, Arvinas will be the regulatory sponsor of the study in the U.S. and Pfizer will be the acting sponsor for the study conducted in the U.S., as well as the regulatory and acting sponsor of the study outside of the U.S. The three parties will collaborate through a Joint Development Committee. It is anticipated that the Phase 1b/2 trial will be initiated in the second half of 2023.

About vepdegestrant (ARV-471)
Vepdegestrant is an investigational, orally-bioavailable PROTAC® protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of patients with early and locally advanced or metastatic ER positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. Use of vepdegestrant in the ongoing and planned clinical trials will continue to monitor and evaluate patient safety and anti-tumor activity.

In preclinical studies, vepdegestrant demonstrated up to 97% ER degradation in tumor cells, induced tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed increased anti-tumor activity when compared to a standard of care agent, fulvestrant, both as a single agent and in combination with a CDK4/6 inhibitor. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will equally share worldwide development costs, commercialization expenses, and profits.

About Arvinas
Arvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body’s own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and “undruggable” targets, the company has three investigational clinical-stage programs: bavdegalutamide (ARV-110) and ARV-766 for the treatment of men with metastatic castration-resistant prostate cancer; and vepdegestrant (ARV-471) for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer. For more information, visit www.arvinas.com.

About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

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 promotes 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, samuraciclib has further potential in prostate, 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 collaborating with Roche and Menarini Group to evaluate novel combinations of samuraciclib with Roche’s oral SERD giredestrant and Menarini Group’s oral SERD elacestrant in CDK4/6i resistant HR+, HER2- metastatic breast cancer.

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

Carrick Contacts

Carrick Therapeutics
Jenny Horsfield, Chief Business Officer
jenny.horsfield@carricktherapeutics.com

Investors and Media
Kevin Lui, Real Chemistry
klui@realchemistry.com