GeoVax Expands Rights Under NIH COVID-19 License to Include Mpox and Smallpox
19 Dezembro 2023 - 11:00AM
via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a
biotechnology company developing immunotherapies and vaccines
against cancers and infectious diseases, today announced that it
has amended a previously executed Patent and Biological Materials
License Agreement (the “License Agreement”) with the National
Institute of Allergy and Infectious Diseases (NIAID), part of the
National Institutes of Health (NIH), in support of GeoVax’s
development of a vaccine against SARS-CoV-2 (COVID-19). The
amendment expands GeoVax’s commercial license to include Mpox and
smallpox as additional indications.
The License Agreement, as amended, allows GeoVax to use these
materials and patent rights owned by agencies of the United States
Department of Health and Human Services (HHS) in combination with
the Company’s proprietary technology for the creation of preventive
Modified Vaccinia Ankara Virus-Virus Like Particle (MVA-VLP)
vaccines that prime and/or boost the immune system against
SARS-CoV-2 (the virus that causes COVID-19) as well as Mpox and/or
smallpox. Financial terms of the License Agreement were not
disclosed.
Potential Benefit of the Additional Indications
Modified Vaccinia Ankara (MVA) is the vaccine currently used and
stockpiled in the U.S. Strategic National Stockpile for
immunization against the Mpox and smallpox viruses. GeoVax
previously demonstrated that an experimental HIV vaccine, utilizing
MVA as the vaccine vector, protected non-human primates challenged
with a lethal dose of the Mpox virus (publication accessible here).
Further, in August 2022, researchers at the City of Hope National
Medical Center (COH) published results demonstrating that both
their proprietary sMVA (synthetic MVA) and GEO-CM04S1 (publication
accessible here) elicited robust orthopoxvirus-specific binding and
neutralizing antibody responses.
GeoVax’s COVID-19 vaccine candidates, which can induce strong
antibody and T cell responses against the variants of the
SARS-CoV-2 virus, also offers the possibility of protection against
Mpox and smallpox diseases, further differentiating GEO-CM04S1 as
compared to current mRNA-based COVID-19 vaccines. Such attributes
may be especially important in vulnerable patient populations, such
as the immune-compromised, as well as in geographic areas where
both diseases are endemic. Such a vaccine may offer a simplified
vaccine regimen for protection against diseases associated with
SARS-CoV-2 and orthopoxviruses.
David Dodd, GeoVax President and CEO, commented, “We are
delighted to have secured these expanded rights to the NIH MVA
technology for further development and commercial use together with
our ongoing COVID-19 vaccine program. The addition of the Mpox and
smallpox indications to our NIAID License Agreement complements
GeoVax’s license agreement with COH for GEO-CM04S1, which we also
recently amended to obtain development and commercialization rights
against orthopoxviruses in addition to SARS-CoV-2. Orthopoxviruses
include Mpox, smallpox, and other viruses that cause disease in
humans.”
Mr. Dodd continued, “We anticipate that the addition of the
Mpox/Smallpox indication to an MVA-vectored COVID-19 vaccine is a
viable regulatory pathway and may be an important product
differentiator from other competitors. For those
regions/populations where Mpox and/or smallpox may be of a concern,
we believe our COVID-19 vaccine will be a better choice.”
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company
developing novel therapies and vaccines for solid tumor cancers and
many of the world’s most threatening infectious diseases. The
company’s lead program in oncology is a novel oncolytic solid tumor
gene-directed therapy, Gedeptin®, presently in a multicenter Phase
1/2 clinical trial for advanced head and neck cancers. GeoVax’s
lead infectious disease candidate is GEO-CM04S1, a next-generation
COVID-19 vaccine targeting high-risk immunocompromised patient
populations. Currently in three Phase 2 clinical trials, GEO-CM04S1
is being evaluated as a primary vaccine for immunocompromised
patients such as those suffering from hematologic cancers and other
patient populations for whom the current authorized COVID-19
vaccines are insufficient, and as a booster vaccine in patients
with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is
in a Phase 2 clinical trial evaluating the vaccine as a more
robust, durable COVID-19 booster among healthy patients who
previously received the mRNA vaccines. GeoVax has a leadership team
who have driven significant value creation across multiple life
science companies over the past several decades. For more
information, visit our website: www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding
GeoVax’s business plans. The words “believe,” “look forward to,”
“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
expectations and projections about future events and financial
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
is able to obtain acceptable results from ongoing or future
clinical trials of its investigational products, GeoVax’s
immuno-oncology products and preventative vaccines can provoke the
desired responses, and those products or vaccines can be used
effectively, GeoVax’s viral vector technology adequately amplifies
immune responses to cancer antigens, GeoVax can develop and
manufacture its immuno-oncology products and preventative vaccines
with the desired characteristics in a timely manner, GeoVax’s
immuno-oncology products and preventative vaccines will be safe for
human use, GeoVax’s vaccines will effectively prevent targeted
infections in humans, GeoVax’s immuno-oncology products and
preventative vaccines will receive regulatory approvals necessary
to be licensed and marketed, GeoVax raises required capital to
complete 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, and other factors, over which GeoVax has
no control.
Further information on our risk factors is contained in our
periodic reports on Form 10-Q and Form 10-K that we have filed and
will file 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.
Company Contact: |
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Investor Relations Contact: |
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Media Contact: |
info@geovax.com |
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paige.kelly@sternir.com |
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sr@roberts-communications.com |
678-384-7220 |
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