Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today
announced that the U.S. Food and Drug Administration (FDA) has
granted Fast Track designation for the investigation of
vepdegestrant (ARV-471) for monotherapy in the treatment of adults
with estrogen receptor (ER) positive/human growth epidermal growth
factor 2 (HER2) negative (ER+/HER2-) locally advanced or metastatic
breast cancer previously treated with endocrine-based therapy.
Vepdegestrant is a novel oral PROteolysis Targeting Chimera
(PROTAC®) ER degrader that is being jointly developed by Arvinas
and Pfizer.
As described by the FDA, Fast Track is a process designed to
facilitate the development and expedite the review of drugs to
treat serious conditions and fill an unmet medical need. The
purpose is to get important new drugs to patients earlier.
Vepdegestrant as a monotherapy is being studied in the ongoing
Phase 3 VERITAC-2 clinical trial, which is evaluating vepdegestrant
or fulvestrant in patients with locally advanced or metastatic
ER+/HER2- breast cancer who have been previously treated with an
endocrine-based therapy.
"We are focused on the persisting unmet needs of people with
ER+/HER2- breast cancer and doing all that we can to expedite the
development of vepdegestrant as a novel, oral ER-targeted potential
therapy for this patient community,” said John Houston, Ph.D.,
Arvinas Chairperson, Chief Executive Officer, and President. “We
are pleased the FDA has granted Fast Track designation for
vepdegestrant, and we continue to believe this investigational drug
has the potential to harness the body’s own natural protein
disposal system to selectively and efficiently degrade and remove
disease-causing proteins."
“The receipt of Fast Track designation reinforces the potential
of vepdegestrant to provide an important new therapeutic option for
people with ER+/HER2- breast cancer whose disease has progressed,”
said Roger Dansey, M.D., Chief Development Officer, Oncology,
Pfizer. “We are proud to continue our legacy of developing
innovative treatment options for people impacted by metastatic
breast cancer and look forward to working with the FDA as we
advance our development program for vepdegestrant.”
About Vepdegestrant (ARV-471) and its Clinical
TrialsVepdegestrant 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.
Vepdegestrant is currently being evaluated as a monotherapy in
the second-line setting in the ongoing Phase 3 VERITAC-2 clinical
trial and in the first-line setting in combination with palbociclib
in the ongoing study lead-in cohort of the Phase 3 VERITAC-3
clinical trial. Vepdegestrant is also being evaluated for potential
combination therapy with abemaciclib, ribociclib, samuraciclib,
everolimus, and with Pfizer’s investigational novel CDK4 inhibitor,
PF-07220060.
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: ARV-766
and bavdegalutamide 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), and the ability to realize the benefits from
vepdegestrant receiving Fast Track designation. 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: Fast Track designation may not result
in a more expedited development or regulatory review process, and
such a designation does not increase the likelihood that
vepdegestrant will receive marketing approval; Fast Track
designation does not change the standards for regulatory approval;
the FDA may later decide that vepdegestrant no longer meets the
conditions for qualification or decide that the time period for FDA
review or approval will not be shortened; 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 after
the date of this release.
About Pfizer OncologyAt Pfizer Oncology, we are
at the forefront of a new era in cancer care. Our industry-leading
portfolio and extensive pipeline includes game-changing mechanisms
of action to attack cancer from multiple angles, including
antibody-drug conjugates (ADCs), small molecules, bispecifics and
other immunotherapies. We are focused on delivering transformative
therapies in some of the world’s most common cancers, including
breast cancer, genitourinary cancer and hematologic malignancies,
as well as melanoma, gastrointestinal, gynecological and thoracic
cancers, which includes lung cancer. Driven by science, we are
committed to accelerating breakthroughs to extend and improve
patients’ lives.
Pfizer Disclosure NoticeThe information
contained in this release is as of February 6, 2024. 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 Pfizer
and Arvinas’ investigation of vepdegestrant (ARV-471) for
monotherapy in the treatment of adults with estrogen receptor (ER)
positive/human growth epidermal growth factor 2 (HER2) negative
(ER+/HER2-) locally advanced or metastatic breast cancer previously
treated with endocrine-based therapy, including its potential
benefits and its Phase 3 development program, 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 our 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 our clinical studies;
whether and when drug applications may be filed in any
jurisdictions for vepdegestrant; whether and when any such
applications may be approved by regulatory authorities, 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
vepdegestrant 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 vepdegestrant; 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:Kathleen Murphy, Arvinas
Communications760-622-3771Kathleen.Murphy@arvinas.com
Pfizer Contacts
Investor Contact:+1 (212)
733-4848IR@pfizer.com
Media Contact:+1 (212)
733-1226PfizerMediaRelations@pfizer.com
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