Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today
announced they will present updated Phase 1/2 data for
vepdegestrant (ARV-471) at the 2023 European Society for Medical
Oncology (ESMO) Annual Congress. Vepdegestrant is a novel oral
PROTAC® estrogen receptor (ER) degrader that is being jointly
developed by Arvinas and Pfizer for the treatment of patients with
locally advanced or metastatic ER positive/human epidermal growth
factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer. This
update will be presented during a poster session at the annual
congress being held from October 20-24, 2023, in Madrid, Spain.
Poster session details are as follows:
Date: Saturday, October 21, 2023Time: 12:00 – 1:00 p.m. CEST /
6:00 – 7:00 a.m. EDTPresentation Number: 390PSpeaker: Erika P.
Hamilton, M.D.
- Vepdegestrant, a PROteolysis TArgeting Chimera (PROTAC)
estrogen receptor (ER) degrader, in ER+/human epidermal growth
factor receptor 2 (HER2)- advanced breast cancer: update of dose
escalation results from a phase 1/2 trial
For more information, visit the official ESMO Congress website
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 robust 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 StatementsThis 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 vepdegestrant
(ARV-471), as well as other statements with respect to
vepdegestrant, including the presentation and/or publication of
data from vepdegestrant trials. All statements, other than
statements of historical facts, contained in this press release are
forward-looking statements. The words “believe,” “expect,” “may,”
“plan,” “potential,” “will,” “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 and obtain marketing approval for and commercialize
vepdegestrant 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 on Form 10-K for
the year ended December 31, 2022 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 October 15, 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 Contacts
Investor Contact:Jeff Boyle, Arvinas Investor
Relations347-247-5089Jeff.Boyle@arvinas.com
Media Contact:Kirsten Owens, Arvinas
Communications203-584-0307Kirsten.Owens@arvinas.com
Pfizer Contacts
Investor Contact:+1 (212)
733-4848IR@pfizer.com
Media Contact:+1 (212)
733-1226PfizerMediaRelations@pfizer.com
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