GeoVax Reports Positive Interim Data From Phase 2 Clinical Trial of GEO-CM04S1 as a Universal Covid-19 Vaccine Booster
February 06 2024 - 8:00AM
via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a
biotechnology company developing immunotherapies and vaccines
against cancers and infectious diseases, today announced
positive initial safety and immune response findings from its Phase
2 clinical trial at one month following administration of its
Covid-19 vaccine, GEO-CM04S1. The trial, evaluating GEO-CM04S1 as a
heterologous booster in 63 healthy adults who had previously
received the Pfizer or Moderna mRNA vaccine (ClinicalTrials.gov
Identifier: NCT04639466), was fully enrolled at the end of
Sept 2023.
The study is designed to evaluate the safety and immunogenicity
of two GEO-CM04S1 dose levels. The trial remains blinded to dose of
vaccine received, with study subjects being followed for a total of
one year. To date, there have been no serious adverse events, and
adverse events were in line with other routine vaccinations. The
immunological responses measured throughout the study period
include both neutralizing antibodies against SARS-CoV-2 variants
and specific T-cell responses. Consolidated data from all subjects
tested one-month post-vaccination, documented statistically
significant increases in neutralizing antibody responses against
multiple SARS-CoV-2 variants, ranging from the original Wuhan
strain through Delta and Omicron XBB 1.5; additional testing
against the JN.1 variant is underway.
GEO-CM04S1 is a next-generation Covid-19 vaccine based on
GeoVax’s MVA viral vector platform, which supports the presentation
of multiple vaccine antigens to the immune system in a single dose.
GEO-CM04S1 encodes for both the spike (S) and nucleocapsid (N)
antigens of SARS-CoV-2 and is specifically designed to induce both
antibody and T-cell responses to those parts of the virus less
likely to mutate over time. The more broadly functional engagement
of the immune system is designed to protect against severe disease
caused by continually emerging variants of Covid-19. Vaccines of
this format should not require frequent and repeated modification
or updating. These latest findings lend support to previously
published findings in cell transplant patients of the ability of
GEO-CM04S1 to stimulate functional antibody responses against a
broad array of evolving SARS-CoV-2 virus variants (Chiuppesi et
al, Vaccines, Sept 2023).
Kelly McKee, Jr., MD, MPH, GeoVax Chief Medical Officer, stated,
“There is a critical need to address the recognized shortcomings of
currently approved SARS-CoV-2 vaccines. Annual (or even more
frequent) vaccination in a seemingly never-ending race to keep pace
with this rapidly evolving virus is an unsustainable strategy.
GEO-CM04S1 continues to demonstrate the ability to elicit broadly
reactive functional antibodies in conjunction with robust and
durable T-cell responses, offering the prospect of a
next-generation solution to address these shortcomings.”
“We are thrilled by these data and our investigational vaccine
designed to protect against severe disease caused by emerging
variants of Covid-19,” said David Dodd, GeoVax Chairman and CEO.
“These interim data reinforce our resolve to bring our expertise in
the development of innovative vaccines to address critical public
health needs using new approaches and technologies. We look forward
to providing further updates regarding the successful progress of
the clinical development of GEO-CM04S1.”
About GeoVaxGeoVax 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 StatementsThis 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.
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