Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today
announced that the U.K. Innovative Licensing and Access Pathway
Steering Group, which consists of The All Wales Therapeutics and
Toxicology Centre (AWTTC), The Medicines and Healthcare products
Regulatory Agency (MHRA), the National Institute for Health and
Care Excellence (NICE), and the Scottish Medicines Consortium
(SMC), has awarded an Innovation Passport to vepdegestrant
(ARV-471), an investigational PROTAC® ER degrader, for the
treatment of patients with estrogen receptor (ER)+/ human epidermal
growth factor receptor (HER)2- locally-advanced breast cancer or
metastatic breast cancer.
The Innovation Passport is the entry point for the Innovative
Licensing and Access Pathway (ILAP). The goal of ILAP is to
accelerate the time to market facilitating patient access to
medicines in the U.K. The Innovation Passport application is the
first step in the ILAP process, which activates the Medicines and
Healthcare products Regulatory Agency (MHRA) and its partner
agencies, including the National Institute for Health and Care
Excellence (NICE), and the Scottish Medicines Consortium (SMC) and
to develop a roadmap for regulatory and development milestones.
“This esteemed acknowledgment underscores our commitment to
advancing medicine and delivering transformative solutions for
patients,” said John Houston, Ph.D., president and chief executive
officer at Arvinas. “Arvinas is hopeful our investigational PROTAC®
ER degrader, vepdegestrant, will have the potential to be an
endocrine therapy backbone for ER+/HER2-breast cancer."
“The Innovation Passport designation opens the door for Pfizer
and Arvinas to discuss access considerations for potential future
indications for vepdegestrant,” said Chris Boshoff, M.D., Ph.D.,
chief oncology research and development officer and executive vice
president at Pfizer. “We look forward to an ongoing dialogue with
regulators, health technology assessment agencies and other
partners, supporting a timely review as we aim to bring this
potential medicine to patients as quickly as possible.”
Multiple Phase 1, 2, and 3 studies with vepdegestrant are
enrolling globally, including the VERITAC-2 Phase 3 2L/3L clinical
trial of vepdegestrant as a monotherapy for the treatment of
patients with ER+/HER2- metastatic breast cancer, which is
anticipated to complete enrollment in 2024. Arvinas and Pfizer
recently initiated the study lead-in of the VERITAC-3 Phase 3 trial
of vepdegestrant and palbociclib as a first-line treatment in
patients with ER+/HER2- locally advanced or metastatic breast
cancer. The study lead-in will identify the dose of palbociclib for
the randomized portion of the study. The companies also plan to
submit additional data from the Phase 1b combination trial with
palbociclib at a medical congress during the second half of
2023.
About ILAPThe U.K. Medicines and Healthcare
products Regulatory Agency (MHRA) launched ILAP at the start of
2021 in order to accelerate the development and access to promising
medicines in the early stages of development. The pathway, part of
the UK’s plan to attract life sciences development in the
post-Brexit era, features enhanced input and interactions with MHRA
and other stakeholders. Other benefits of ILAP include access to a
range of development tools, such as the potential for a 150-day
accelerated Marketing Authorization Application (MAA) assessment,
rolling review and a continuous benefit risk assessment. More
information about ILAP can be found here.
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 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.
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 preclinical pipeline
of PROTAC protein degraders against validated and
“undruggable” targets, the company has three investigational
clinical-stage programs: bavdegalutamide 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.
Arvinas 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 advantages and therapeutic benefits of
bavdegalutamide (ARV-110), vepdegestrant (ARV-471), and ARV-766 and
our other discovery programs, the development and regulatory status
of our product candidates, such as statements with respect to the
potential of our lead product candidates bavdegalutamide,
vepdegestrant, ARV-766 and other candidates in our pipeline, and,
including the initiation of and timing of the timing of clinical
trials, including the timing to complete enrollment, as well as the
presentation and/or publication of data from those trials and plans
for registration for our product candidates, and
our discovery programs that may lead to our development
of additional product candidates, the potential utility of our
technology, our plans with respect to submission of investigational
new drug/clinical trial authorization applications, the potential
commercialization of any of our product candidates, and the
sufficiency of our cash resources. All statements, other than
statements of historical facts, contained in this press release,
including statements regarding our strategy, future operations,
future financial position, future revenues, projected costs,
prospects, plans and objectives of management, are forward-looking
statements. The words “anticipate,” “believe,” “estimate,”
“expect,” “intend,” “may,” “might,” “plan,” “predict,” “project,”
“target,” “potential,” “will,” “would,” “could,” “should,”
“continue,” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words.
We may not actually achieve the plans, intentions or
expectations disclosed in our forward-looking statements, and you
should not place undue reliance on our forward-looking statements.
Actual results or events could differ materially from the plans,
intentions and expectations disclosed in the forward-looking
statements we make as a result of various risks and uncertainties,
including but not limited to: our and Pfizer, Inc.’s (“Pfizer”)
performance of our respective obligations with respect to our
collaboration with Pfizer; whether we and Pfizer will be able to
successfully conduct and complete clinical development for
vepdegestrant; whether we will be able to successfully conduct and
complete development for bavdegalutamide, ARV-766 and
our other product candidates, including whether we initiate
and complete clinical trials for our product candidates and receive
results from our clinical trials on our expected timelines or at
all; obtain marketing approval for and commercialize vepdegestrant,
bavdegalutamide, ARV-766 and our other product candidates on our
current timelines or at all; whether our cash and cash
equivalent resources will be sufficient to fund our foreseeable and
unforeseeable operating expenses and capital expenditure
requirements; and other important factors discussed in the “Risk
Factors” section of our Annual Report of Form 10-K for the year
ended December 31, 2021 and subsequent other reports on file with
the Securities and Exchange Commission. The forward-looking
statements contained in this press release reflect our current
views with respect to future events, and we assume no obligation to
update any forward-looking statements except as required by
applicable law. These forward-looking statements should not be
relied upon as representing our views as of any date subsequent to
the date of this release.
About Pfizer OncologyAt Pfizer Oncology, we are
committed to advancing medicines wherever we believe we can make a
meaningful difference in the lives of people living with cancer.
Today, we have an industry-leading portfolio of 24 approved
innovative cancer medicines and biosimilars across more than 30
indications, including breast, genitourinary, colorectal, blood and
lung cancers, as well as melanoma.
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.
Pfizer Disclosure Notice:The information
contained in this release is as of July 31, 2023. Pfizer assumes no
obligation to update forward-looking statements contained in this
release as the result of new information or future events or
developments.
This release contains forward-looking information about
vepdegestrant (ARV-471) and a global collaboration between Pfizer
and Arvinas to develop and commercialize ARV-471, including their
potential benefits, that involves substantial risks and
uncertainties that could cause actual results to differ materially
from those expressed or implied by such statements. Risks and
uncertainties include, among other things, the uncertainties
inherent in research and development, including the ability to meet
anticipated clinical endpoints, commencement and/or completion
dates for clinical trials, regulatory submission dates, regulatory
approval dates and/or launch dates, as well as the possibility of
unfavorable new clinical data and further analyses of existing
clinical data; the risk that clinical trial data are subject to
differing interpretations and assessments by regulatory
authorities; whether regulatory authorities will be satisfied with
the design of and results from the clinical studies; whether and
when any applications may be filed for ARV-471 for any potential
indications in any jurisdictions; whether and when regulatory
authorities may approve any potential applications that may be
filed for ARV-471 in any jurisdictions, which will depend on myriad
factors, including making a determination as to whether the
product’s benefits outweigh its known risks and determination of
the product’s efficacy and, if approved, whether ARV-471 will be
commercially successful; decisions by regulatory authorities
impacting labeling, manufacturing processes, safety and/or other
matters that could affect the availability or commercial potential
of ARV-471; whether the collaboration between Pfizer and Arvinas
will be successful; uncertainties regarding the impact of COVID-19
on Pfizer’s business, operations and financial results; and
competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2022 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
Arvinas ContactsInvestor Contact:Jeff Boyle+1
(347) 247-5089Jeff.Boyle@arvinas.com
Media Contact:Kirsten Owens+1 (203)
584-0307Kirsten.Owens@arvinas.com
Pfizer ContactsInvestor Contact:+1 (212)
733-4848IR@pfizer.com
Media Contact:+1 (212)
733-1226PfizerMediaRelations@pfizer.com
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