Arvinas Receives Authorization to Proceed for ARV-471, a PROTAC® Protein Degrader to Treat Patients with Locally Advanced or...
June 25 2019 - 7:00AM
Arvinas, Inc. (Nasdaq: ARVN), a biotechnology company creating a
new class of drugs based on targeted protein degradation, today
announced that the U.S. Food and Drug Administration (FDA) has
cleared the company’s Investigational New Drug application (IND)
for ARV-471, an oral estrogen receptor (ER) PROTAC® protein
degrader, designed to selectively target ER for the treatment of
patients with locally advanced or metastatic ER positive / HER2
negative breast cancer. Arvinas expects to initiate a Phase 1
clinical trial for ARV-471 in the third quarter of 2019.
“ARV-471 is our second program in six months to receive IND
clearance, and we are pleased to be advancing it into the clinic
and progressing Arvinas’ portfolio of PROTAC® protein
degraders for the treatment of patients with cancer and other
life-threatening diseases,” said John Houston, Ph.D., President and
CEO of Arvinas. “We hope the activity ARV-471 demonstrated
preclinically will translate into a new, beneficial treatment for
patients with locally advanced or metastatic ER positive/HER2
negative breast cancer.”
In the United States, breast cancer is the second most common
cancer and the second leading cause of cancer death in women.
The American Cancer Society estimates that in 2019, there will be
approximately 268,000 women diagnosed with invasive breast cancer
in the United States. Metastatic breast cancer accounts for
approximately 6% of newly diagnosed cases. Approximately 80% of
newly diagnosed breast cancers are ER positive, with many patients
developing resistance to current treatment options over time.
ARV-471 is a PROTAC® protein degrader specifically designed to
target and degrade ER. The Phase 1 trial will assess the safety,
tolerability, and pharmacokinetics of ARV-471, and will also
include measures of anti-tumor activity and pharmacodynamic
readouts as secondary endpoints.
In preclinical studies, ARV-471 demonstrated near-complete ER
degradation in tumor cells, induced robust tumor shrinkage when
dosed as a single agent in multiple ER-driven xenograft models, and
showed superior anti-tumor activity as a single agent and in
combination with a CDK4/6 inhibitor when compared to a standard of
care agent, fulvestrant, dosed as single agent or in combination
with a CDK4/6 inhibitor. Arvinas believes the differentiated
pharmacology of ARV-471, including its iterative degradation
activity, has the potential to translate into meaningful clinical
benefit for patients.
About Arvinas Arvinas is a
clinical-stage biopharmaceutical 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 technology
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. The company’s lead
program, ARV-110 for the treatment of patients with metastatic
castrate-resistant prostate cancer, began a Phase 1 clinical trial
in the first quarter of 2019. For more information,
visit www.arvinas.com.
Forward-Looking Statements This press release
contains forward-looking statements that involve substantial risks
and uncertainties, including statements regarding the development
and regulatory status of our product candidates, including the
timing of our clinical trial for ARV-471, and preliminary data from
our clinical trial for ARV-471 and the potential advantages and
therapeutic potential 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 will be able to
successfully initiate and conduct a Phase 1 clinical trial for
ARV-471, and complete our clinical trials for our product
candidates on our expected timelines, or at all, whether our cash
resources will be sufficient to fund our foreseeable and
unforeseeable operating expenses and capital expenditure
requirements on our expected timeline 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.
Contacts for Arvinas
InvestorsWill O’Connor, Stern Investor
Relationsir@arvinas.com
MediaCory Tromblee,
ScientPRpr@arvinas.com
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