Vaxxinity’s Anti-PCSK9 Candidate Demonstrates Durable LDL Cholesterol Lowering in Non-Human Primates
02 August 2022 - 10:00PM
Vaxxinity, Inc. (Nasdaq: VAXX), a U.S. company pioneering the
development of a new class of immunotherapeutic vaccines, today
announced data demonstrating durable lowering of low-density
lipoprotein (LDL) cholesterol in non-human primates and the
selection of VXX-401 to pursue as its anti-PCSK9 vaccine candidate
to treat hypercholesterolemia. This study along with other
IND-enabling nonclinical studies will support progression of the
program into a Phase 1 first-in-human clinical trial in early 2023.
“Our mission is to develop vaccines that can transform and
expand the treatment of chronic disease with effective medicines
that are cheaper, safer, and more convenient for all,” said Mei Mei
Hu, Chief Executive Officer of Vaxxinity. “We’ve made significant
progress across our pipeline, successfully generating positive data
in multiple clinical trials and scaling our synthetic peptide
manufacturing to hundreds of millions of doses. Achieving
proof-of-concept in a well-validated target such as PCSK9 is
another meaningful milestone for Vaxxinity and brings us one step
closer to our vision of vaccinating the world against heart attack
and stroke.”
VXX-401 is a synthetic peptide vaccine that targets proprotein
convertase subtilisin/kexin type 9 serine protease (PCSK9) to lower
low-density lipoprotein (LDL) cholesterol, a mechanism proven to
reduce the risk of cardiovascular events. High LDL cholesterol is a
major risk factor for coronary heart disease, heart attack and
stroke, and atherosclerotic cardiovascular disease is the leading
cause of disease burden globally.1
"Targeting PCSK9 is a proven and effective approach for lowering
cholesterol and reducing the risk of heart attack and stroke, but
today’s approved therapies have access and administration
challenges that limit their use to a small subset of the full
population who could benefit,” said Ulo Palm, Chief Medical Officer
of Vaxxinity. “These results demonstrate the potent and durable
effects of our vaccine platform in a consistent and well-understood
biology, and further validate the technology and this approach as a
potential safe, convenient, and accessible vaccine for heart
disease.”
The new data in non-human primates demonstrate that VXX-401 is
well tolerated and provides long-lasting, significant LDL reduction
versus placebo. After a 6-week priming regimen with VXX-401, LDL
cholesterol progressively dropped to 40-50% of placebo values in
healthy monkeys. A steady-state reduction of LDL cholesterol was
observed for months and the magnitude of LDL reduction with VXX-401
was similar to that of a single dose of a comparator monoclonal
antibody. While LDL levels returned to baseline within 2-3 weeks
after a single dose of monoclonal antibody, a steady-state and
long-lasting reduction of LDL levels was observed after the last
dose of VXX-401. Levels of “good” high-density lipoprotein (HDL)
cholesterol were not affected by treatment and remained stable
during the course of the studies. These data will be submitted for
publication in a peer-reviewed journal.
Renowned cardiologist Professor Stephen Nicholls of Monash
University, who will serve as the inaugural clinical director of
Victorian Heart Hospital in Australia, said, “The prospect of a
vaccine to lower cholesterol is extremely exciting and could change
the game in cardiovascular health. Cardiovascular diseases are
still the leading causes of death in the world. A vaccine approach
affords a solution that other medicines cannot, so this would be
huge.”
About VXX-401
VXX-401 was designed using Vaxxinity’s proprietary synthetic
peptide vaccine platform and is being developed for the treatment
of hypercholesterolemia. The platform is designed to harness the
immune system to convert the body into its own natural “drug
factory,” stimulating the production of antibodies. VXX-401 is
designed to induce robust, long-acting antibodies against PCSK9 and
lower LDL cholesterol to treat coronary heart disease.
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 “vision,” “potential,”
“could,” “would,” “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
development of a new class of immunotherapeutic vaccines, the
innovation and efficacy of Vaxxinity’s product candidates, and the
anticipated outcomes from the studies we are conducting or will
conduct for our 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 Vaxxinity’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 Matone
benm@vaxxinity.com
Press ContactKaren
Chasemedia@vaxxinity.com __________________________________¹
World Health Organization. (2021, July). Cardiovascular diseases
(CVDs).
https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)
Vaxxinity (NASDAQ:VAXX)
Historical Stock Chart
From Apr 2024 to May 2024
Vaxxinity (NASDAQ:VAXX)
Historical Stock Chart
From May 2023 to May 2024