GeoVax Partners With ABL to Advance cGMP Production of Vaccine Candidates
2023年5月31日 - 10:00PM
via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a
biotechnology company developing immunotherapies and vaccines
against cancers and infectious diseases, today announced it has
executed a Master Services Agreement (MSA) with Advanced Bioscience
Laboratories, Inc. (ABL) to support current Good Manufacturing
Practices (cGMP) production of the company’s vaccine candidates,
including GEO-MVA and GEO-CM04S1.
ABL, a subsidiary of Institut Mérieux, is a pure-play contract
development and manufacturing organization (CDMO) specialized in
development and manufacturing of gene therapies, oncolytic viruses
and vaccine candidates. With cGMP facilities located in the U.S.
and Europe, ABL is well-positioned to support GeoVax’s global
development programs.
David Dodd, GeoVax’s Chairman and CEO, commented “In choosing to
collaborate with ABL to support the cGMP manufacturing of our
multiple vaccine candidates, we have selected a partner with a
strong technical and regulatory track record in process
development, scale-up and GMP manufacturing of oncolytic and
immunotherapeutic viral vectors. We believe ABL, as a
manufacturing partner, is highly capable of assisting us in
advancing our innovative product candidates, including GEO-CM04S1
and GEO-MVA, through late-stage development and towards eventual
commercialization.”
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A recent presentation of unpublished data from the open-label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 continues to advance in a second 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 GEO-MVA
In response to the global need to address the continued emerging
threat from Mpox, 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.
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 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.
Investor Relations Contact:Rich CockrellCG
Capital404-736-3838govx@cg.capital
GeoVax Labs (NASDAQ:GOVXW)
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から 5 2023 まで 5 2024