via NewMediaWire -- GeoVax Labs,
Inc. (NasdaqCM: GOVX), a biotechnology company developing
immunotherapies and vaccines against cancers and infectious
diseases, announced today that the National Institute of Allergy
and Infectious Diseases (NIAID), part of the National Institutes of
Health (NIH), has awarded the Company a Small Business Innovative
Research (SBIR) grant in support of its development of a vaccine
against SARS-CoV-2, the virus that causes COVID-19.
The Phase 1 grant, titled, “Preclinical
Development of GV-MVA-VLP Vaccines Against COVID-19,” will support
the ongoing design, construction and preclinical testing of
GeoVax’s vaccine candidates in preparation for human clinical
trials. The efficacy testing will be performed in collaboration
with the University of Texas Medical Branch (UTMB).
GeoVax is leveraging its GV-MVA-VLP™
platform to address the global need for an effective and safe
SARS-CoV-2 vaccine. Unique among other vaccines under development,
the experimental GeoVax candidates are specifically designed to
provide a broader and more long-lived level of protective immunity
against SARS-CoV-2 while avoiding the potential side effects that
can limit vaccine utility and acceptance. GeoVax’s vaccine
candidates will be tested for antigen expression and genetic
stability under conditions designed to simulate those in
manufacturing, which will demonstrate the likely suitability of
each vaccine construct as a candidate for full-scale production and
clinical testing.
Mark Newman, Ph.D., GeoVax’s Chief Scientific
Officer, commented, “The first generation of SARS-CoV-2 vaccines
are based on the ‘Spike (S)’ protein and are designed to induce
antibodies that block infection of human cells, an effect referred
to as virus neutralization. The GV-MVA-VLP platform provides the
opportunity to design and test vaccine candidates that differ
significantly through the inclusion of multiple SARS-CoV-2 proteins
that are presented to the immune system as virus-like particles
(VLPs). Our goal is to safely increase vaccine potency and efficacy
by inducing both neutralizing antibody and cellular immune
responses to optimize the level of protection against existing and
potential new variants of COVID as well as establish immunological
memory to provide multi-year protection. Vaccines using the
GV-MVA-VLP platform developed for other pathogens have proven to be
efficacious with a single dose, having strong durability which
would be a significant advantage for SARS-CoV-2 global vaccination
campaigns.”
David Dodd, GeoVax’s Chairman & CEO, added,
“We are pleased to receive this Phase 1 SBIR funding award, which
will supplement the internal resources allocated to our COVID-19
vaccine program and accelerate our progress toward human clinical
trials. We appreciate and welcome this support from NIH/NIAID,
which follows our signing of a Patent and Biological Materials
License Agreement providing GeoVax with access to key NIAID patent
rights, and which provides GeoVax with nonexclusive rights to
develop, manufacture and commercialize our COVID-19 vaccine. While
we continue to advance our COVID-19 vaccine program, we remain in
discussions and negotiations related to additional funding support
that will further accelerate our progress into clinical testing and
supply chain preparation. We anticipate that additional
vaccines, such as ours will be necessary against COVID-19, as well
as potentially new strains and variants, requiring broader immune
response, strong durability, exquisite safety within various cohort
populations and minimal refrigeration for distribution and supply
throughout the world. These attributes represent the
focus of our overall ‘COVID-X’ vaccine program (think ‘COVID-20,
-21’, etc.).”
About COVID-19
Coronaviruses are common in many species of
animals, including bats and birds. These viruses can evolve to
cross the animal species and infect humans and quickly spread from
person to person resulting in lethal but rare respiratory
infections. Recent epidemics with SARS and MERS coronaviruses
resulted in 774 and 858 deaths, respectively. Since 2015 there have
not been any cases of SARS and MERS reported, but in January 2020,
World Health Organization (WHO) identified a novel coronavirus,
recently named SARS-CoV-2, in the city of Wuhan, China. On January
31, 2020, the WHO declared the novel coronavirus to be a global
health emergency, and on March 11, 2020 the WHO declared a global
pandemic. Worldwide, more than 85 million people have been infected
(over 20 million in the U.S.), with nearly 2 million deaths (over
350,000 in the U.S). The situation is fluid, with the infection and
death statistics changing significantly on a regular basis.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage
biotechnology company developing human vaccines against infectious
diseases and cancers using a novel patented Modified Vaccinia
Ankara-Virus Like Particle (MVA-VLP) based vaccine platform. On
this platform, MVA, a large virus capable of carrying multiple
vaccine antigens, expresses proteins that assemble into VLP
immunogens within (in vivo) the person receiving the vaccine. The
production of VLPs in the person being vaccinated mimics virus
production in a natural infection, stimulating both the humoral and
cellular arms of the immune system to recognize, prevent, and
control the target infection. The MVA-VLP derived vaccines have
been shown to elicit durable immune responses in the host similar
to a live-attenuated virus, while providing the safety
characteristics of a replication-defective vector. The goal of
the GeoVax technology (GV-MVA-VLP™) is to provide high efficacy in
a single dose, without the need for additional immune response
components (“adjuvants”), strong durability (“minimizing the need
for boosters”), the highly-validated safety of MVA, minimal
refrigeration requirements, and cost-effective manufacturing.
GeoVax’s current development programs are focused
on preventive vaccines against COVID-19, Zika Virus, hemorrhagic
fever viruses (Ebola, Lassa, Marburg and Sudan), HIV and malaria,
as well as therapeutic vaccines against multiple cancers. The
Company has successfully completed six human clinical trials
related to HIV, having designed a preventive HIV vaccine candidate
to fight against the subtype of HIV prevalent in the geographic
markets of the Americas, Western Europe, Japan, and Australia.
Human clinical trials for this program are managed by the HIV
Vaccine Trials Network (HVTN) with the support of the National
Institutes of Health (NIH). GeoVax’s HIV vaccine is also part of
two separate collaborative efforts to apply its innovative approach
toward a functional cure for HIV, addressing those already infected
with HIV.
Forward-Looking Statements
This press release contains forward-looking
statements regarding GeoVax’s business. The words “believe,” “may,”
“estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,”
“could,” “target,” “potential,” “is likely,” “will,” “expect” and
similar expressions, as they relate to us, are intended to identify
forward-looking statements. We have based these forward-looking
statements largely on our current plans and expectations about our
product development, future events and trends that we believe may
affect our financial condition, results of operations, business
strategy and financial needs. Actual results may differ
materially from those included in these statements due to a variety
of factors, including whether: GeoVax can develop and manufacture
its vaccines with the desired characteristics in a timely manner,
GeoVax’s vaccines will be safe for human use, GeoVax’s vaccines
will effectively prevent targeted infections in humans, GeoVax’s
vaccines will receive regulatory approvals necessary to be licensed
and marketed, GeoVax raises required capital to complete vaccine
development, there is development of competitive products that may
be more effective or easier to use than GeoVax’s products, GeoVax
will be able to enter into favorable manufacturing and distribution
agreements, the impact of the COVID-19 pandemic continues, and
other factors, over which GeoVax has no control.
Further information on our risk factors is
contained in our most recent Quarterly Report on Form 10-Q
that we have filed with the SEC. Any forward-looking statement
made by us herein speaks only as of the date on which it is made.
Factors or events that could cause our actual results to differ may
emerge from time to time, and it is not possible for us to predict
all of them. We undertake no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future developments or otherwise, except as may be required by
law.
GeoVax Labs,
Inc.678-384-7220investor@geovax.com
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