Vaxxinity Announces First Subjects Dosed in Phase 1 Clinical Trial of UB-313 for Preventive Treatment of Migraine
September 13 2022 - 8:00AM
Vaxxinity, Inc. (Nasdaq: VAXX), a U.S. company pioneering the
development of a new class of immunotherapeutic vaccines, today
announced that the first subjects have been dosed in a Phase 1
clinical trial of UB-313, a vaccine targeting calcitonin
gene-related peptide (CGRP), for the preventive treatment of
migraine.
“Initiating this first-in-human study of UB-313
represents another milestone for Vaxxinity as we continue to expand
our clinical pipeline into chronic conditions using our unique
peptide vaccine platform,” said Mei Mei Hu, Chief Executive Officer
of Vaxxinity. “An anti-CGRP vaccine has the potential to disrupt
the migraine paradigm by offering longer-lasting relief, more
convenient administration, and affordable access. Our vision is to
help migraine patients worldwide reclaim their lives with
UB-313.”
Jan de Hoon, M.D., Professor in Pharmacology and
Clinical Pharmacology, KU Leuven in Belgium, and principal
investigator, commented: “Therapeutics targeting the CGRP pathway
have been identified as an effective treatment option for chronic
and episodic migraines. Following the success of monoclonal
antibodies for the prevention of migraine and small molecule
CGRP-receptor antagonists for migraine prevention and acute
treatment, an immunotherapeutic vaccine could bring about a
transformational third wave of options for patients.”
The Phase 1 randomized, placebo-controlled, double-blind,
multidose trial will enroll approximately 40 healthy volunteers at
the Center for Clinical Pharmacology, UZ Leuven in Belgium. The
objectives of the trial are to evaluate safety, tolerability, and
immunogenicity. Immunogenicity will be measured by serum anti-CGRP
antibody titers. Pharmacodynamics of the immune response will be
measured by the inhibition of capsaicin-induced increase in dermal
blood flow, an established model of target engagement in
migraine.
More information about the trial is available at
clinicaltrials.gov using Identifier NCT05477095.
About UB-313
UB-313 is a novel immunotherapeutic vaccine candidate targeting
calcitonin gene-related peptide (CGRP) for the preventive treatment
of migraine. CGRP causes vasodilation and neurogenic inflammation,
and is known to play an important role in migraine pathophysiology.
UB-313 is designed to trigger the production of antibodies that
inhibit CGRP in patients with chronic and episodic migraine in
order to reduce migraine frequency and severity. Preclinically,
UB-313 has shown strong immunogenicity across species, inducing
anti-CGRP antibodies with similar properties as approved comparator
monoclonal antibodies, as well as a favorable safety and
tolerability profile. This trial was granted approval by the
Federal Agency for Medicines and Health Products (FAMHP) in
Belgium.
About Migraine
Migraine is a chronic and debilitating disorder
often characterized by a unilateral headache accompanied by a
cluster of autonomic and neurologic symptoms. It has been
identified as the sixth most prevalent disorder and one of the main
causes of disability worldwide, often occurring in young adults and
middle-aged women.¹ The pathophysiology of migraine is
complex, including changes in the vasculature, central and
peripheral pain processing, and inflammation. CGRP is known to play
an important role in migraine pathophysiology. Raised levels of
CGRP are observed both peripherally and centrally in migraine
patients. Multiple CGRP-targeting therapies have been approved for
the treatment and prevention of migraine.
About Vaxxinity
Vaxxinity, Inc. is a purpose-driven
biotechnology company committed to democratizing healthcare across
the globe. The company is pioneering a new class of synthetic,
peptide-based immunotherapeutic vaccines aimed at disrupting the
existing treatment paradigm for chronic disease, increasingly
dominated by monoclonal antibodies, which suffer from prohibitive
costs and cumbersome administration. The company’s proprietary
technology platform has enabled the innovation of novel pipeline
candidates designed to bring the efficiency of vaccines to the
treatment of chronic diseases, including Alzheimer’s, Parkinson’s,
migraine, and hypercholesterolemia. The technology is also
implemented as part of a COVID-19 vaccine program. Vaxxinity has
optimized its pipeline to achieve a potentially historic, global
impact on human health.
For more information about Vaxxinity, Inc.,
visit http://www.vaxxinity.com and follow us on social media
@vaxxinity.
Forward-looking Statement
This press release includes forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. The use of certain words, including
"potential," “vision,” “may,” “could,” "will" and similar
expressions, are intended to identify forward-looking statements.
These forward-looking statements involve substantial risks and
uncertainties, and are based on the current expectations and
assumptions of Vaxxinity’s management. Forward-looking statements
include statements about the future development of
immunotherapeutic vaccines and the innovation and efficacy of
Vaxxinity’s product candidates. Various important factors could
cause actual results or events to differ materially from those that
may be expressed or implied by our forward-looking statements.
Additional important factors to be considered in connection with
forward-looking statements are described in the "Risk Factors"
section of the Company's Annual Report on Form 10-K filed with the
Securities and Exchange Commission on March 24, 2022 and other
reports we file with the Securities and Exchange Commission. The
forward-looking statements are made as of this date and Vaxxinity
does not undertake any obligation to update any forward-looking
statements, whether as a result of new information, future events
or otherwise, except as required by law.
Investor ContactBen
Matonebenm@vaxxinity.com
Press ContactKaren
Chasemedia@vaxxinity.com
¹ World Health Organization. (2016, April 8). Headache
disorders.
https://www.who.int/news-room/fact-sheets/detail/headache-disorders
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