NEW
HAVEN, Conn. and SAN
FRANCISCO, May 2, 2023 /PRNewswire/ -- Arvinas, Inc.
(Nasdaq: ARVN) and Quantum Leap Healthcare Collaborative™ today
announced that Arvinas' vepdegestrant (ARV-471), a novel
PROTAC® estrogen receptor (ER) protein degrader being co-developed
with Pfizer Inc. will be evaluated in the ongoing I-SPY TRIAL
endocrine program sponsored by Quantum Leap. This study targets
patients with newly diagnosed ER positive invasive cancer.
Vepdegestrant is in Phase 3 clinical development for the
treatment of patients with locally advanced or metastatic ER
positive/human epidermal growth factor receptor 2 (HER2) negative
(ER+/HER2-) breast cancer.
The I-SPY-2 Endocrine Optimization Platform (EOP) study
(NCT01042379) will include a vepdegestrant monotherapy arm and
a vepdegestrant in combination with letrozole arm. This study
is focused on patients with clinically high-risk (stage 2/3)
ER+/HER2- breast cancer, but molecularly low risk (MammaPrint low
risk signature), a subset of patients with substantial risk for
late recurrence.
Quantum Leap opened the EOP program in 2021 to specifically
assess treatment options for this subset of patients, and work to
find an early endpoint to measure the success of therapy. EOP is a
sub-study within the main I-SPY-2 clinical trial utilizing
neoadjuvant endocrine therapy in patients whose tumors are
predicted to be sensitive to endocrine therapy but for whom
chemotherapy is expected to provide little or no benefit.
"I-SPY TRIALs focus on high-impact experimental treatments that
may benefit patients, providers, and researchers, and Arvinas is
thrilled to be part of this innovative I-SPY-2 clinical trial,"
said John Houston, Ph.D., president
and chief executive officer at Arvinas. "There is an unmet medical
need for novel agents in life-threatening diseases and this
research is vital to advancing patient outcomes. In all of our
investigational research, our commitment is to patient safety and
care, and we are excited by vepdegestrant's potential to
become a new standard of care for patients with ER+/HER2- breast
cancer."
"The heart of the I-SPY TRIALs is to change how new breast
cancer treatments are developed, to find treatments that are
more personalized, effective, and less toxic, faster. We are
excited to be partnering with Arvinas and investigating the
potential positive benefits of vepdegestrant. Women need better and
more tolerable options for extended endocrine therapy. We hope this
will be one of them." said Dr. Laura
Esserman, co-principal investigator of the I-SPY TRIAL and
founder of Quantum Leap.
Arvinas will provide vepdegestrant and financial support to
Quantum Leap for this investigational study. Quantum Leap is the
sponsor of the I-SPY program, which includes 41 open sites. All
I-SPY sites have the EOP program open.
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 early and locally
advanced or metastatic ER positive/human epidermal growth factor
receptor 2 (HER2) negative (ER+/HER2-) breast cancer. For more
information, visit www.arvinas.com.
About Quantum Leap Healthcare Collaborative
Quantum
Leap Healthcare Collaborative is a 501c(3) charitable organization
established in 2005 as a collaboration between medical researchers
at University of California, San
Francisco and Silicon Valley entrepreneurs. Our Quantum
Leap's mission is to integrate care and research, and to foster
high-impact trials with embedded clinical processes and systems
technology and improved data management, greater access to clinical
trial matching, and greater benefit to patients, providers, and
researchers. Quantum Leap's goal is to improve and save lives.
Quantum Leap provides operational, financial, and regulatory
oversight to I-SPY. For more information, visit
https://www.quantumleaphealth.org/.
About the I-SPY TRIALs
The I-SPY TRIAL (Investigation
of Serial studies to Predict Your Therapeutic Response with Imaging
And moLecular analysis 2) (I-SPY 2 TRIAL) was designed to rapidly
screen promising experimental treatments and identify those most
effective in specific patient subgroups based on molecular
characteristics (biomarker signatures). The Endocrine Optimization
Pilot (EOP) is developing better endpoints and new endocrine
targeted agents for stage 2/3 molecularly low risk breast cancer.
The trial is a unique collaborative effort by a consortium that
includes the Food and Drug Administration (FDA), industry, patient
advocates, philanthropic sponsors, and clinicians from 30 major
U.S. cancer research centers. Under the terms of the collaboration
agreement, Quantum Leap Healthcare Collaborative is the trial
sponsor and manages all study operations. For more information,
visit www.ispytrials.org.
Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995
that involve substantial risks and uncertainties, including
statements regarding the potential of the I-SPY endocrine program,
the potential for vepdegestrant (ARV-471) to become the standard of
care for patients with ER+/HER2- breast cancer, and the potential
and therapeutic benefits of our clinical programs, vepdegestrant
(ARV-471), bavdegalutamide (ARV-110), and ARV-766. The terms
"expect," "potential," "will," "intend," "believe," and "plan,"
derivatives of these words, and similar references are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Actual
results, performance or experience may differ materially from those
expressed or implied by any forward-looking statement as a result
of various risks, uncertainties and other factors, including, but
not limited to, risks associated with the successful conduct and
completion of clinical trials and development for Arvinas'
investigational clinical candidates, including vepdegestrant
(ARV-471). Other risks and uncertainties include those identified
under the heading "Risk Factors" in Arvinas' Annual Report on Form
10-K for the year ended December 31,
2022, and other filings that Arvinas may make with the U.S.
Securities and Exchange Commission in the future. These
forward-looking statements (except as otherwise noted) speak only
as of the date of this press release, and, except as required by
law, Arvinas does not undertake, and specifically disclaims, any
obligation to update any forward-looking statements contained in
this press release.
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SOURCE Quantum Leap Healthcare Collaborative