Arvinas Announces First-in-Human Dosing of ARV-102, an Investigational PROTAC® Protein Degrader for Neurodegenerative Disease
February 20 2024 - 7:00AM
Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology
company creating a new class of drugs based on targeted protein
degradation, today announced that the first subject was dosed in
its Phase 1 clinical trial of ARV-102, the Company’s first oral
PROTAC® (PROteolysis-TArgeting Chimera) protein degrader in
development to treat neurodegenerative diseases. In preclinical
studies, ARV-102 has been shown to cross the blood-brain barrier
and degrade leucine-rich repeat kinase 2 (LRRK2), which is a large
multidomain scaffolding kinase. Increased activity and expressions
of LRRK2 is genetically involved in the pathogenesis of
neurological diseases including Parkinson’s disease and progressive
supranuclear palsy.
In non-human primates, orally administered
ARV-102 has been shown to reach deep-brain regions and degrade
LRRK2 by nearly 90%. The Phase 1 clinical trial of ARV-102 is
enrolling healthy volunteers at the Centre for Human Drug Research
(CHDR) in Leiden, the Netherlands. The trial will evaluate the
safety, tolerability, pharmacokinetics, and pharmacodynamics of
ARV-102, including the evaluation of LRRK2 degradation and
exploratory LRRK2 pathway biomarkers.
“Parkinson’s disease and progressive
supranuclear palsy are devastating diseases and this important step
of dosing the first healthy volunteer with ARV-102 marks a
significant milestone in our commitment to develop transformative
therapies for patients living with neurodegenerative diseases,”
said Angela M. Cacace, Ph.D., Senior Vice President, Neuroscience
and Platform Biology. “There is a high unmet need in many
neurologic diseases, and unlike other therapeutic modalities
designed to inhibit LRRK2 activity, ARV-102 is an investigational
oral PROTAC degrader uniquely designed to cross the blood-brain
barrier and degrade the LRRK2 protein. As a pioneer in targeted
protein degradation, we believe that PROTAC degraders have great
potential to change the treatment paradigm for patients with
neurodegenerative diseases.”
John Houston, Ph.D., Chairperson, Chief
Executive Officer, and President, and Angela M. Cacace, Ph.D.,
Senior Vice President, Neuroscience and Platform Biology, provided
an update on recent progress with ARV-102, as well as Arvinas’
preclinical pipeline of PROTAC protein degraders directed towards
neurological disorders, in a webcast available on the Events &
Presentations section of the Investors and Media section of the
Company’s website.
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. Arvinas applies its platform to
develop treatments for diseases associated with historically
“undruggable” targets. In addition to its robust preclinical
pipeline of PROTAC protein degraders against validated and
“undruggable” targets, the company has four investigational
clinical-stage programs: vepdegestrant (ARV-471) for the treatment
of patients with locally advanced or metastatic ER+/HER2- breast
cancer; ARV-766 and bavdegalutamide for the treatment of men with
metastatic castration-resistant prostate cancer; and ARV-102 for
the treatment of patients with neurodegenerative disorders. 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 ARV-102, including the
potential for ARV-102 to change the treatment paradigm for patients
with neurodegenerative diseases, as well as plans and timing
related to the Phase 1 clinical trial of ARV-102. 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.
Arvinas may not actually achieve the plans,
intentions or expectations disclosed in these forward-looking
statements, and you should not place undue reliance on such
forward-looking statements. Actual results or events could differ
materially from the plans, intentions and expectations disclosed in
the forward-looking statements made as a result of various risks
and uncertainties, including but not limited to: whether Arvinas
will be able to successfully conduct and complete clinical
development forARV-102 on our current timelines or at all; Arvinas’
approach to the discovery and development of product candidates
based on its PROTAC technology platform is unproven, which makes it
difficult to predict the time, cost of development and likelihood
of successfully developing any products; Arvinas’ ability to
protect its intellectual property position; whether cash and cash
equivalent resources will be sufficient to fund Arvinas’
foreseeable and unforeseeable operating expenses and capital
expenditure requirements; and other important factors discussed in
the “Risk Factors” section of the company’s Annual Report on Form
10-K for the year ended December 31, 2022, and subsequent other
reports on file with the U.S. Securities and Exchange Commission.
The forward-looking statements contained in this press release
reflect current views with respect to future events, and Arvinas
assumes 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 Arvinas’ views
as of any date after the date of this release.
Arvinas Contacts
Investor Contact:Jeff Boyle,
Arvinas Investor Relations+1 (347)
247-5089Jeff.Boyle@arvinas.com
Media Contact:Kathleen Murphy,
Arvinas Communications+1 (760)
622-3771Kathleen.Murphy@arvinas.com
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