GeoVax Achieves Milestone in Transition to Commercially Validated Manufacturing System
March 06 2024 - 9:00AM
via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a
biotechnology company developing immunotherapies and vaccines
against cancers and infectious diseases, today announced a
significant milestone toward implementation of a validated chicken
embryonic fibroblast (CEF) based production system for the
company’s MVA-based vaccines, with the release of its first lot of
GEO-CM04S1 (next-generation Covid-19 vaccine) produced with a
commercial manufacturing platform. This milestone marks the
successful completion of the transfer and scale-up of manufacturing
from the research-focused Center for Biomedicine & Genetics at
City of Hope (Duarte, CA) to the experienced CDMO ABL Europe (a
subsidiary of Oxford Biomedica), the Company’s cGMP (current Good
Manufacturing Procedures) manufacturing partner.
David Dodd, GeoVax President and CEO, commented, “The successful
establishment of cGMP production at ABL Europe represents great
progress for GeoVax and the CM04S1 program. This latest
manufacturing milestone also validates our choice of ABL Europe as
our partner for cGMP production of our MVA-based vaccine
candidates. This gives us a high degree of confidence in our
manufacturing process as we move into late-stage clinical
development for CM04S1, addressing a critically important unmet
medical need for immunocompromised populations.”
Dodd continued, “While we continue the use of CEF-based
production for our CM04S1 clinical programs, it is important to
also recognize the significant advancements made in our
commercial-scale production capabilities. Our multi-product license
of ProBioGen’s AGE1.CR.PIX® suspension cell line enhances our
capacity to produce MVA-based vaccines (including CM04S1 and
GEO-MVA) and immunotherapies at an unprecedented scale. These
developments signify GeoVax's commitment to improving vaccine
accessibility through cost-effective and scalable manufacturing
processes.”
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 continually emerging variants of
Covid-19. Results released during 2023 demonstrated the safety and
efficacy of CM04S1 and emphasize the role it will play in
protecting immunocompromised patients from greater risk of severe
disease, hospitalization and death from SARS-CoV-2 infection.
About GEO-MVA
In response to the global need to address the continued emerging
threat from Mpox (monkeypox), GeoVax previously announced having
secured rights from the National Institutes of Health (NIH)
covering preclinical, clinical and commercial uses of the NIH-MVA
as a vaccine against Mpox or smallpox. The Company is
currently pursuing different regulatory pathways toward achievement
of an expedited approval and intends to become the first U.S.-based
supplier of the MVA vaccine to prevent Mpox and smallpox.
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: |
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Investor Relations Contact: |
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Media Contact: |
info@geovax.com |
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paige.kelly@sternir.com |
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sr@roberts-communications.com |
678-384-7220 |
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212-698-8699 |
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202-779-0929 |
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