Progress on GeoVax’s Universal Coronavirus Vaccine Candidate, GEO-CM02, Presented at Vaccines Summit 2023
2023年11月14日 - 11:00PM
via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a
biotechnology company developing immunotherapies and vaccines
against cancers and infectious diseases, today announced the
presentation of preclinical vaccine efficacy data for GEO-CM02, a
multi-antigen investigational SARS-CoV-2 vaccine. The data were
presented during the Vaccines Summit 2023 conference, being held in
Boston, MA on November 13-15, 2023. The presentation, titled
“MVA-vectored multi-antigen COVID-19 vaccines induce protective
immunity against SARS-CoV-2 variants spanning Alpha to Omicron in
preclinical animal models,” was delivered by Mukesh Kumar, PhD,
Associate Professor, Department of Biology, Georgia State
University.
“We are thrilled to continue to demonstrate the robust efficacy
profile of GEO-CM02 with the presentation of preclinical data at
this year’s Vaccine Summit,” said David Dodd, GeoVax’s Chairman and
CEO. “Together, these data indicate that immunization with the
multi-antigen GEO-CM02 vaccine can protect against severe disease
and death induced by SARS-CoV-2 infection and regardless of the
variant. Along with a demonstrated safety profile, we believe
GEO-CM02 has potential as a transformative universal coronavirus
vaccine.”
First-generation SARS-CoV-2 vaccines based on the spike (S)
protein have demonstrated that they induce neutralizing antibodies,
providing effective, albeit short-term levels of immune protection.
Unfortunately, with the existing authorized vaccines, efficacy is
disrupted by emerging variants that contribute to neutralizing
antibody evasion, requiring continuous updating and booster doses.
To address this limitation, GeoVax is currently evaluating its dual
antigen COVID-19 vaccine, GEO-CM04S1 in three Phase 2 clinical
trials. 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. Moreover,
GEO-CM04S1 is being developed specifically as a COVID-19 vaccine in
support of patients with compromised immune systems, for whom the
current authorized vaccines appear inadequate in providing
protective immunity.
GEO-CM02 is a multi-antigen SARS-CoV-2 vaccine, based on the S,
membrane (M), and envelope (E) proteins, which are designed to also
engage both the humoral (antibody) and cellular (T-cell) arms of
the immune system and to broaden both the function and specificity,
potentially as a universal coronavirus vaccine. Efficacy of this
investigational vaccine was tested using the industry standard,
lethal hACE2 transgenic mouse model.
Data highlights from the Vaccine Summit 2023 presentation are as
follows:
- The GEO-CM02 vaccine induced immune responses that were
efficacious against the original Wuhan strain and BA.1 Omicron
variant with a single dose.
- Animals were protected prior to the detection of neutralizing
antibodies, likely indicating a critical T-cell contribution.
- GEO-CM02 significantly reduced or eliminated inflammation and
immunopathology in the lungs of vaccinated animals.
The data generated in the GEO-CM02 studies validate GeoVax’s
hypothesis that vaccines designed to induce both antibodies and
T-cells to multiple viral structural proteins can address the issue
of viral variation and escape from the immune system. GEO-CM02 is
based on GeoVax’s MVA viral vector platform, which supports the
presentation of multiple vaccine antigens to the immune system in a
single dose.
GeoVax’s more advanced, next-generation COVID-19 vaccine,
GEO-CM04S1, is being evaluated in three ongoing Phase 2 clinical
trials:
- As a primary vaccine in immunocompromised patients (with
hematologic cancers receiving cell transplants or CAR-T therapy).
ClinicalTrials.gov Identifier: NCT04977024. GeoVax recently
announced clinical site expansion for this trial.
- As a booster vaccine in immunocompromised patients with chronic
lymphocytic leukemia (CLL), a recognized high-risk group for whom
current mRNA vaccines and monoclonal antibody (MAb) therapies
appear inadequate relative to providing protective immunity.
ClinicalTrials.gov Identifier: NCT05672355.
- As a booster vaccine for healthy patients who have previously
received the Pfizer or Moderna mRNA vaccine. ClinicalTrials.gov
Identifier: NCT04639466. GeoVax recently announced that this trial
has fully enrolled.
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.
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GeoVax Labs (NASDAQ:GOVXW)
過去 株価チャート
から 8 2024 まで 9 2024
GeoVax Labs (NASDAQ:GOVXW)
過去 株価チャート
から 9 2023 まで 9 2024