GeoVax Commences Site Expansion for Phase 2 Trial of Next-Generation COVID-19 Vaccine
30 Outubro 2023 - 10:00AM
via NewMediaWire -- GeoVax Labs, Inc. (Nasdaq: GOVX), a
biotechnology company developing immunotherapies and vaccines
against cancers and infectious diseases, today announced that it
has commenced the planned site expansion for the Phase 2 clinical
trial investigating its next-generation SARS-CoV-2 vaccine,
GEO-CM04S1, as a primary vaccine in immunocompromised patients. In
addition to study enrollments completed at the City of Hope Medical
Center (Duarte, California), the trial will be initiating
enrollment of eligible patients at Wake Forest Baptist Medical
Center (Winston Salem, North Carolina), the University of
Massachusetts Medical Center (Worcester, Massachusetts), and Fred
Hutchinson Cancer Research Center (Seattle, Washington).
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 with hematologic malignancies who
have received either an allogeneic hematopoietic stem cell
transplant, an autologous hematopoietic stem cell transplant or
chimeric antigen receptor (CAR) T cell therapy. Such patients often
have difficulty mounting an adequate protective antibody response
after receiving currently available COVID-19 vaccines.
David Dodd, GeoVax Chairman and CEO, commented, “We are pleased
with these site activations to expand the scope and reach of this
trial, which we expect will accelerate patient enrollment for this
important study in one of the highest at-risk patient populations,
currently underserved by available vaccines. We believe the unique
properties of GEO-CM04S1 potentially offer a more robust, durable
degree of protection than the current authorized COVID-19 vaccines,
not only as a vaccine for highly vulnerable immunocompromised
patients for whom the currently authorized mRNA vaccines may be
inadequate, but also potentially for healthy patients as a
universal booster vaccine to the mRNA vaccines. In the U.S., there
are approximately 15 million individuals who, as a result of their
compromised immune systems, often do not adequately respond to the
current authorized vaccines. Worldwide, there are an estimated 240+
million such patients. Our hope is that GEO-CM04S1 provides robust,
durable immune protection for such patients, while also providing a
critically important alternative to COVID-19 booster vaccines for
healthy individuals.”
A recent publication in Vaccines
(https://doi.org/10.3390/vaccines11091492) from the open-label
portion of the trial indicates that GEO-CM04S1 is highly
immunogenic in these patients, inducing both antibody responses,
including neutralizing antibodies, and T cell responses against
ancestral as well as recently evolved SARS-CoV-2 virus strains.
These data support the progression of the Phase 2 clinical study,
which includes a direct comparison to currently approved mRNA
vaccines.
About GEO-CM04S1
GEO-CM04S1 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. 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.
In addition to this ongoing study, GEO-CM04S1 is being evaluated
in two other Phase 2 clinical trials:
- 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.
- 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.
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.
Company Contact: |
|
Investor Relations Contact: |
|
Media Contact: |
info@geovax.com |
|
paige.kelly@sternir.com |
|
sr@roberts-communications.com |
678-384-7220 |
|
212-698-8699 |
|
202-779-0929 |
GeoVax Labs (NASDAQ:GOVX)
Gráfico Histórico do Ativo
De Ago 2024 até Set 2024
GeoVax Labs (NASDAQ:GOVX)
Gráfico Histórico do Ativo
De Set 2023 até Set 2024