Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today
announced they will present updated data related to vepdegestrant
(ARV-471) at the 2023 European Society for Medical Oncology (ESMO)
Breast Cancer Annual Congress. Vepdegestrant is a novel
investigational PROTAC® estrogen receptor (ER) protein degrader
that is being jointly developed by Arvinas and Pfizer 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. Four posters will be presented
during the poster session at the annual congress, which will be
held from May 11-13, 2023, in Berlin, Germany.
Poster session details are as follows:Date:
Friday, May 12, 2023Time: 12:15 – 1:00 p.m. CET/ 6:15 – 7:00 a.m.
ET
- VERITAC update: phase 2 study of ARV-471, a PROteolysis
TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader in
ER+/human epidermal growth factor receptor 2 (HER2)- advanced
breast cancer (Poster 205P)
- VERITAC-2: a global, randomized phase 3 study of ARV-471, a
PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER)
degrader, vs fulvestrant in ER+/human epidermal growth factor
receptor 2 (HER2)- advanced breast cancer (Poster 257TiP)
- TACTIVE-N: open-label, randomized, noncomparative neoadjuvant
phase 2 study of ARV-471, a PROteolysis TArgeting Chimera (PROTAC)
estrogen receptor (ER) degrader, or anastrozole in postmenopausal
women with ER+/human epidermal growth factor receptor 2 (HER2)-
localized breast cancer (Poster 154TiP)
- TACTIVE-E: phase 1b study of ARV-471, a PROteolysis TArgeting
Chimera (PROTAC) estrogen receptor (ER) degrader, in combination
with everolimus in ER+/human epidermal growth factor receptor 2
(HER2)- advanced breast cancer (Poster 256TiP)
For more information, visit the official ESMO Breast Cancer
Annual 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 in
development: 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 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.
Arvinas Forward-Looking StatementsThis press
release contains forward-looking statements that involve
substantial risks and uncertainties, including statements regarding
the potential benefits of our arrangements with our collaborative
partnership with Pfizer, the development and regulatory status of
our product candidates, such as statements with respect to our lead
product candidates, ARV-110, ARV-471 and ARV-766 and other
candidates in our pipeline, and the timing of clinical trials and
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 and therapeutic potential of our product
candidates, the potential commercialization of any of our product
candidates. All statements, other than statements of historical
facts, contained in this press release, including statements
regarding our strategy, future operations, 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: whether we and Pfizer will be able to
successfully conduct and complete clinical development for ARV-471,
whether we will be able to successfully conduct Phase 1/2 clinical
trials for ARV-110 and ARV-766, initiate and complete other
clinical trials for our product candidates, and receive results
from our clinical trials on our expected timelines, or at all and
other important factors discussed in the “Risk Factors” sections
contained in our quarterly and annual 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 May 8, 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 Media 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 Media Contacts
Investor Contact:+1 (212) 733-4848IR@pfizer.com
Media Contact:+1 (212)
733-1226PfizerMediaRelations@pfizer.com
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