GeoVax and EmVenio Announce Collaboration to Expand Phase 2 COVID-19 Booster Vaccine Clinical Trial
February 15 2023 - 9:00AM
via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a
biotechnology company developing immunotherapies and vaccines
against cancers and infectious diseases, and EmVenio Research, a
patient-focused decentralized trial global organization, today
announced a collaboration to deploy a mobile clinical facility in
the Claremont, California area to expand GeoVax’s ongoing Phase 2
clinical trial evaluating GEO-CM04S1 as a COVID-19 booster vaccine
in healthy patients.
“This unique initiative will extend the reach of our COVID-19
vaccine booster trial by leveraging EmVenio Research’s localized
clinical trial model. As we continue to advance and explore the
potential of GEO-CM04S1 as a more robust and durable COVID-19
booster than currently approved vaccine boosters, this
collaboration will help reduce the burden of patient recruitment as
it brings clinical research to diverse populations directly in
their communities,” said David Dodd, GeoVax Chairman and CEO.
GEO-CM04S1 is a synthetic attenuated modified vaccinia Ankara
(sMVA) vector vaccine that expresses spike and nucleocapsid
antigens of the SARS-CoV-2 (COVID-19) virus. It is being researched
in two Phase 2 clinical trials, with this trial as a COVID-19
booster for patients who have already received an mRNA vaccine
approved by the U.S. Food and Drug Administration (FDA)
(ClinicalTrials.gov Identifier: NCT04639466). This trial will
include 60 healthy individuals, 18 years of age or older, and is
designed to specifically evaluate the safety profile and
immunogenicity of 2 dose levels of GEO-CM04S1 as a booster shot.
The immunological responses measured throughout the study will
include both the level of SARS-CoV-2 neutralizing antibodies and
specific T-cell responses. GEO-CM04S1 is also being studied as the
first vaccine comparing an investigational multi-antigenic COVID-19
vaccine to current FDA-approved mRNA vaccines in people who are
immunocompromised (ClinicalTrials.gov Identifier: NCT04977024).
“EmVenio Research has a passion for creating avenues to engage
local communities unfamiliar with research to participate in
clinical trials through our mobile Community Research Sites. These
sites can move closer into the neighborhoods and communities of
urban and rural communities alike to increase access to studies,”
said Thad Wolfram, President of EmVenio. “Community volunteers have
made this type of research successful, and we are excited to
partner with GeoVax on this Phase 2 clinical trial to deliver a
potential option for COVID prevention designed by local researchers
at City of Hope in Duarte, CA.”
About EmVenio
EmVenio Research delivers localized trial access to diverse and
underserved communities. We empower patients and embrace
communities on their terms. Our research solutions cultivate a
sustainable local ecosystem that benefits all stakeholders.
Removing barriers and unlocking doors to innovation reduces risk
and time associated with clinical research, while improving ROI.
EmVenio Research’s global network of skilled clinicians, principal
investigators, and state of the art Community Research sites
enables us to provide services via home visits, onsite support at
medical facilities, virtual visits, and mobile sites. Visit
https://emvenio.com/ to learn more.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company
developing novel therapies and vaccines for 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 two Phase 2 clinical trials, GEO-CM04S1 is being
evaluated as a COVID-19 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. 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.
GeoVax Media Relations Contact:Nancy
Turett914-434-0311nmturett@geovax.com
GeoVax Investor Relations Contact:Rich CockrellCG
Capital404-736-3838govx@cg.capital
EmVenio Media
Contact:302-740-0766Katy.Keating@EmVenio.com
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