Carrick Therapeutics Announces Clinical Trial Collaboration with Arvinas and Pfizer to Evaluate Samuraciclib and Vepdegestrant Combination
06 Luglio 2023 - 3:00PM
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 ArvinasArvinas 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’
LivesAt 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 TherapeuticsCarrick
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 TherapeuticsJenny Horsfield, Chief Business
Officerjenny.horsfield@carricktherapeutics.com
Investors and MediaKevin Lui, Real
Chemistryklui@realchemistry.com
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