Carrick Therapeutics Announces First Patient Dosed in Phase 1b/2 Clinical Trial of Samuraciclib in Combination with Vepdegestrant in Patients with Advanced Breast Cancer
14 Februar 2024 - 2:00PM
Carrick Therapeutics, an oncology-focused biopharmaceutical company
discovering and developing highly differentiated therapies, today
announced that the first patient has been dosed in its Phase 1b/2
clinical trial evaluating the combination of samuraciclib (CT7001),
an investigational oral and first-in-class inhibitor of CDK7, and
vepdegestrant (ARV-471), an investigational oral PROTAC®
(PROteolysis TArgeting Chimera) estrogen receptor (ER) degrader,
being jointly developed by Arvinas (Nasdaq: ARVN) and Pfizer (NYSE:
PFE) in women with ER+, HER2- metastatic breast cancer who have
previously received a CDK4/6 inhibitor.
“We’re excited to expand clinical development of
samuraciclib with our Phase 1b/2 clinical trial evaluating the
combination of samuraciclib and vepdegestrant, another step forward
in addressing an important need for patients with advanced breast
cancer,” said Tim Pearson, Chief Executive Officer of Carrick
Therapeutics. “We believe there is great potential for this
combination treatment, based on the encouraging initial clinical
trial data for vepdegestrant and Pfizer’s deep expertise in
developing treatments for breast cancer.”
The Phase 1b/2 clinical trial has two parts. In
Phase 1b, escalating doses of samuraciclib and vepdegestrant will
be tested to determine appropriate doses of each therapy to be used
in combination. In Phase 2, additional patients will be enrolled to
further explore the safety and efficacy of the selected doses.
This clinical trial evaluating the novel
combination of samuraciclib and vepdegestrant is being conducted as
part of the TACTIVE-U study in collaboration with Arvinas and
Pfizer under a clinical trial collaboration and supply agreement.
Clinical trial details can also be found on www.clinicaltrials.gov
under study ID: NCT06125522. For additional information on the
clinical trial, please contact hello@carricktherapeutics.com.
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 ER positive (ER+)/human epidermal growth factor
receptor 2 (HER2) negative (ER+/HER2-) breast cancer. In
preclinical studies, vepdegestrant demonstrated up to 97% ER
degradation in tumor cells, induced robust 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. Ongoing and planned clinical trials will
continue to monitor and evaluate the safety and anti-tumor activity
of vepdegestrant.
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
designation 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, Menarini Group and Arvinas/Pfizer to
evaluate novel combinations of samuraciclib with Roche’s oral SERD
giredestrant, Menarini Group’s oral SERD elacestrant, and
Arvinas/Pfizer’s proteolysis targeting chimera (PROTAC) Estrogen
Receptor degrader vepdegestrant (ARV-471) in late-stage CDK4/6i
resistant HR+, HER2- metastatic breast cancer.
About Carrick TherapeuticsCarrick
Therapeutics is an oncology-focused biopharmaceutical company
developing highly differentiated novel therapies that address
significant unmet needs. The Company’s lead program, samuraciclib,
is a novel CDK7 inhibitor currently in Phase 2 clinical trials for
HR+ breast cancer. Additionally, Carrick is developing CT7439, a
novel CDK12/13 inhibitor / Cyclin-K glue-degrader, which is
expected to enter a Phase 1 clinical trial in mid-2024.
For more information about Carrick Therapeutics,
please visit www.carricktherapeutics.com
Carrick Contacts
Carrick TherapeuticsJenny Horsfield, Chief Business
Officerjenny.horsfield@carricktherapeutics.com
Investors and MediaLuke Heagle, Real
Chemistrylheagle@realchemistry.com
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