via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a
biotechnology company developing immunotherapies and vaccines
against cancers and infectious diseases, today
announced the presentation of data from the active development
program for its next-generation COVID-19 vaccine (GEO-CM04S1),
including Phase 2 clinical trial data. The data include some of
which was recently published in the
journal Vaccines and can be accessed
here: GEO-CM04S1 Publication.
The data were presented during the World Vaccine Congress, West
Coast conference, being held in Santa Clara, CA from November
27-30, 2023. The presentation, titled “COVID-19 Vaccines for
Immunocompromised Patients,” was delivered by Don Diamond, PhD,
Professor, Department of Hematology and Hematopoietic Cell
Transplantation, City of Hope Comprehensive Cancer Center.
David Dodd, GeoVax Chairman and CEO, commented, “Safeguarding
individuals at the highest risk in our society requires the
development of next-generation COVID-19 vaccines. Ideally, these
vaccines should induce enhanced immune responses after the first
dose, provide long-lasting protection, and effectively address the
ongoing emergence of new variants. Current mRNA vaccines and
monoclonal antibody therapies often fall short in quickly
delivering sufficient protective immunity to immunocompromised
patients. Given the persistent evolution of variants, the public
health community faces a continuous challenge to mitigate the
impact of infections, ultimately minimizing the risks of severe
illness, hospitalizations, and mortality. Vaccines like GEO-CM04S1,
designed to be "variant-agnostic," are becoming increasingly vital
in addressing these risks, protecting the most vulnerable
populations, and bolstering our ability to combat infectious
threats effectively.”
In his presentation, Dr. Diamond described the immune response
analyses conducted on the open-label portion of the Phase 2 trial,
indicating that GEO-CM04S1 is highly immunogenic in these
immunocompromised patients, inducing potent humoral (antibody) and
cellular (T cell) responses, including neutralizing antibodies
against SARS-CoV-2 ancestral virus and variants of concern and the
highly immune-evasive Omicron XBB 1.5 variant.
The Phase 2 clinical trial (ClinicalTrials.gov
Identifier: NCT04977024) is evaluating the safety and
immunogenicity of GEO-CM04S1, compared to either the
Pfizer/BioNTech or Moderna mRNA-based vaccine, in patients who have
previously received either an allogeneic hematopoietic cell
transplant, an autologous hematopoietic cell transplant or chimeric
antigen receptor (CAR) T cell therapy. These patients have
significantly compromised immune system function as the result of
their treatment and are at exceptionally high risk for COVID. They
must be re-vaccinated and will benefit greatly from the types of
immune responses induced by the GEO-CM04S1 vaccine, both the
antibodies and T cells.
About GEO-CM04S1
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.
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 can be inadequate in providing
protective immunity.
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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