via NewMediaWire - GeoVax Labs, Inc. (Nasdaq: GOVX), a
biotechnology company developing immunotherapies and vaccines
against cancers and infectious diseases, today announced
the start of an investigator-initiated clinical trial
(ClinicalTrials.gov Identifier: NCT05672355), titled
“Randomized observer-blinded phase 2 trial of COVID-19 booster with
GEO-CM04S1 or Pfizer-BioNTech Bivalent vaccine in patients with
chronic lymphocytic leukemia,” at City of Hope National Medical
Center, led by Alexey Danilov, M.D., PhD as principal investigator.
GEO-CM04S1, a multi-antigenic SARS-CoV-2 vaccine that targets the
spike (S) and nucleocapsid (N) proteins of SARS-CoV-2, is actively
under clinical study by GeoVax in severely immunocompromised
individuals, as well as in healthy adults for use as a universal
heterologous booster.
Despite a high vaccination rate, chronic
lymphocytic leukemia (CLL) patients may be at high risk for lethal
COVID-19 infection due to poor immune response to COVID-19
infections or vaccination. The GEO-CM04S1 vaccine uses a modified
vaccinia virus (MVA) backbone that may be more effective at
inducing COVID-19 immunity in patients with poor humoral immune
responses since MVA strongly induces T cell expansion even in the
background of immunosuppression. Targeting both the spike and
nucleocapsid protein antigens broaden the specificity of the immune
responses and protects against the loss of efficacy associated with
the significant sequence variation observed with the spike
antigen.
The study will examine the use of two injections
of GEO-CM04S1 three months apart to assess immune responses in
these vulnerable patients, with the Pfizer-BioNTech Bivalent
vaccine as the control arm. Participants will be randomized 1:1 to
receive two boosters with either the GEO-CM04S1 or the control
vaccine. The primary immune response outcome will be 56 days
following the first booster injection. Up to 40 participants will
be treated in each arm, with immune responses evaluated at the
interim and final analyses in each arm.
Brian Koffman, M.D.C.M., FCFP DABFP (retired) MS
Ed, Executive Vice President and Chief Medical Officer of the CLL
Society, a nonprofit dedicated to the unmet needs of those
diagnosed with CLL/small lymphocytic lymphoma (SLL), commented,
“Despite the current authorized COVID-19 vaccines providing
protective immunity among the majority of patient populations,
individuals with CLL/SLL, regardless of their treatment status,
have had less predictable and often insufficient immune responses
to the currently authorized vaccines. Within the CLL/SLL patient
population, more robust and durable protective immunity is needed,
especially next-generation vaccines that could induce stronger T
cell and antibody responses. This trial leverages past success with
a similar type of vaccine used for protection against a different
viral infection in the immunocompromised to develop a vaccine
intended to provide enhanced and more durable protection against
COVID-19 infections in the high-risk CLL/SLL population. The CLL
Society and the CLL/SLL community welcome this study and look
forward to the results.”
Kelly McKee, M.D., GeoVax Chief Medical Officer,
commented, “Unpublished clinical data recently presented at several
medical conferences confirmed our earlier findings in healthy
adults that GEO-CM04S1 stimulated a robust, durable, and
broad-based humoral and cellular immune response against multiple
SARS-CoV-2 variants, and by extension, to immunocompromised
patients. Validation of these findings in additional patients with
hematologic malignancies, who have received CAR-T and stem cell
transplants, is underway as we seek to provide a vaccine solution
to those individuals unable to mount adequate protective responses
with currently available COVID-19 vaccines. We expect the CLL trial
will further confirm the potential benefit of CM04S1 in another
population of immunocompromised individuals.”
David Dodd, GeoVax President, and CEO, added, “We
are excited to begin this third important study for CM04S1 and look
forward to sharing progress reports as we advance. We believe the
CM04S1 vaccine, containing the two antigens, S and N, along with
the recognized antibody and cellular immune responses resulting
from the MVA approach, has the potential to offer greater booster
protection than that from the current vaccines in use, as well as
provide a greater degree of protection within immunocompromised
patients.”
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. CM04S1 presents both the spike and nucleocapsid
antigens of SARS-CoV-2 and is specifically designed to induce both
antibody and T cell responses to non-variable parts of the virus.
The more broadly specific and functional engagement of the immune
system is designed to protect against the new and continually
emerging variants of COVID-19. Based on data from animal models and
a completed Phase 1 clinical study, vaccine-induced immune
responses were shown to recognize both early and later variants of
SARS-CoV-2, including the Omicron variant. Vaccines of this format
should not require repeated modification and updating.
A recent presentation of unpublished data from the
open-label portion of the Phase 2 trial of CM04S1
(ClinicalTrials.gov Identifier: NCT04977024) in patients
undergoing hematological cancer treatment (i.e., patients who
have reduced immune system function as a result of treatment)
indicates that CM04S1 is highly immunogenic in these patients,
inducing both antibody responses, including neutralizing
antibodies, and T cell responses. These data support the planned
progression of the Phase 2 clinical study, which will include a
direct comparison to currently approved mRNA vaccines. CM04S1 also
continues to advance in another Phase 2 clinical trial as a booster
for healthy patients who have previously received the Pfizer or
Moderna mRNA vaccine (ClinicalTrials.gov
Identifier: NCT04639466). Data from these studies will form
the basis for comparing vaccine potential in unique patient groups
as well as the general population.
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 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 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.
Investor Relations Contact:Rich CockrellCG
Capital404-736-3838govx@cg.capital
Media Contact:Susan
Robertssr@roberts-communications.com202-779-0929
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