OLDWICK, N.J. and TAMPERE, Finland, May
18, 2020 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq:
PRVB), a clinical-stage biopharmaceutical company dedicated to
intercepting and preventing immune-mediated disease and its
licensor, Vactech Oy (Vactech), a Finnish biotechnology company
focused on development of vaccines for Type 1 Diabetes (T1D) and
other immune mediated diseases, today announced the publication of
results demonstrating that a preclinical prototype of Provention's
polyvalent coxsackievirus B (CVB) vaccine, PRV-101, is
well-tolerated, immunogenic and highly protective in relevant
animal models. Provention is developing PRV-101 as a potential
vaccine for acute coxsackievirus infection and for the potential
prevention of T1D.
![(PRNewsfoto/Provention Bio, Inc.) (PRNewsfoto/Provention Bio, Inc.)](https://mma.prnewswire.com/media/720849/Provention_Bio_Logo.jpg)
The paper, published in the peer-reviewed journal of Science
Advances and titled "A Hexavalent Coxsackievirus B vaccine is
Highly Immunogenic and has a Strong Protective Capacity in Mice and
Nonhuman Primates," evaluated the immunogenicity and safety of the
prototype vaccine. The study was carried out in collaboration with
Tampere University in Finland and Karolinska
Institute in Sweden and
supported by Vactech material, know-how and intellectual property
rights.
"Our results provide a solid scientific basis for human trials
with Provention's PRV-101 vaccine. Our observation showing
that this prototype works in macaques is highly important since
their immune system closely resembles the immune system of humans,"
said Heikki Hyöty, Professor of Virology at Tampere University, co-founder of Vactech, and an
author on the study.
In addition to immunogenicity and safety in non-human primates,
the prototype vaccine was efficacious in three relevant murine
species. In non-obese diabetic (NOD) mice, which are genetically at
risk to develop diabetes, the prototype vaccine did not trigger or
accelerate diabetes. In SOCS-1-tg mice, a murine model for
virus-induced type 1 diabetes (T1D) in which the
insulin-producing beta cells are highly susceptible to CVB-induced
destruction, the prototype prevented both infection by CVB and the
development of CVB-induced diabetes. In BALB/c mice, a common
wild-type murine strain, the prototype vaccine prevented infections
known to cause CVB-induced myocarditis (heart infection), a serious
complication of acute CVB infection in humans.
"We congratulate the investigators at Karolinska Institute and their collaborators at
Tampere University for their compelling
research, highly supportive of our PRV-101 vaccine program to
prevent acute infection by CVB and the development of CVB-triggered
complications such as T1D, celiac disease and myocarditis," said
Francisco Leon, M.D., Ph.D.,
Co-founder and Chief Scientific Officer of Provention Bio. "The
published data shows that the vaccine is well tolerated, with no
side effects noted in the pancreas or other organs, and effective
in preventing acute infections. Importantly, the published results
demonstrate the vaccine was effective in preventing the development
of diabetes in a relevant mouse model, further validating
Provention's mission to intercept or prevent T1D."
Professor Hyöty added, "In addition to preventing the onset of
T1D, Provention's PRV-101 vaccine program has potential for other
applications and indications. We are encouraged by our published
results demonstrating the prevention of infection by CVB strains
known to cause myocarditis in humans, one of the most
well-documented CVB-related diseases. Myocarditis can lead to
dilated cardiomyopathy, a common cause of sudden cardiac deaths in
young adults. CVB infection is the most commonly identified cause
of this heart disease in developed countries."
The senior authors of the article, Professor Heikki Hyöty and Professor Malin Flodström-Tullberg (Karolinska Institute, Sweden, are members of Provention's PRV-101
scientific advisory board. Professor Hyöty is also a co-founder of
Vactech. Provention has licensed the exclusive worldwide rights to
Vactech's enterovirus vaccine platform targeting the prevention of
CVB infections leading to the onset of T1D and celiac disease.
About Provention Bio, Inc.
Provention Bio, Inc.
(Nasdaq: PRVB) is a clinical-stage biopharmaceutical company
leveraging a transformational drug development strategy focused on
the prevention or interception of immune-mediated disease.
Provention's mission is to source, transform and develop
therapeutic candidates targeting the high morbidity, mortality and
escalating costs of autoimmune diseases. Provention's diversified
portfolio includes PRV-031 (teplizumab), a pre-commercial-stage
candidate that has been shown to delay the onset of end-stage type
one diabetes (T1D) in at-risk individuals with pre-symptomatic
disease. The Company's portfolio includes additional
clinical-stage product development candidates that have
demonstrated proof-of-mechanism and/or proof-of-concept
in other autoimmune diseases, including celiac disease and
lupus.
About Vactech
Vactech develops and licenses vaccines
and novel technologies for vaccines and diagnostics with a pipeline
of early stage product candidates focused on Type 1 Diabetes,
Celiac Disease, Asthma & Allergy and diagnostics.
Vactech's flagship project is a patented enterovirus based
preventive Type 1 Diabetes (T1D) vaccine, similar to the widely
used enterovirus vaccine against polio. The vaccine is a
traditional inactivated vaccine and it has been proved to be safe
and effective in mice. In addition, Vactech's IMAVAC™ product line
uses Virus Like Particle (VLP) technology which is essential for
other vaccines, immunomodulators and diagnostic applications.
Vactech is a privately owned company. We have a track record of
collaboration with both industrial and academic partners. Vactech
has engaged in strategic partnership with Provention Bio Inc.
especially in the field of preventive Type 1 Diabetes vaccine and
related applications.
Forward Looking Statements:
Certain statements in this
press release are forward-looking within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements may be
identified by the use of forward-looking words such as
"anticipate," "believe," "forecast," "estimate," "expect," and
"intend," among others. These forward-looking statements are based
on Provention's current expectations and actual results could
differ materially. There are a number of factors that could cause
actual events to differ materially from those indicated by such
forward-looking statements. These factors include, but are not
limited to, the risks listed under "Risk factors" in our annual
report on Form 10-K for the year ended December 31,
2019 and any subsequent filings with the Securities and
Exchange Commission (SEC). As with any pharmaceutical under
development, there are significant risks in the development,
regulatory approval and commercialization of new products.
Provention does not undertake an obligation to update or revise any
forward-looking statement. The information set forth herein speaks
only as of the date hereof.
Investors:
Sam Martin, Argot Partners
sam@argotpartners.com
212-600-1902
Media:
Lori Rosen, LDR
Communications
lori@ldrcommunications.com
917-553-6808
Vactech Information:
www.vactech.fi
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SOURCE Provention Bio, Inc.