GeoVax Update: Clinical and Operational Progress Toward Transformative Opportunities
24 Ottobre 2023 - 3:00PM
via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a
biotechnology company developing immunotherapies and vaccines
against cancers and infectious diseases, today announced an update
on key strategic initiatives.
“The third quarter marked advancements in our
next-generation COVID-19 vaccine clinical programs and our cancer
therapy program, along with advanced manufacturing developments,
and new patents issued for our Ebola, Marburg, Malaria, and HIV
vaccines. I look forward to sharing more details about these
developments during our upcoming investor/analyst earnings call on
November 8,” said David Dodd, GeoVax’s Chairman and CEO.
“We believe this is a defining moment for the
Company, as we expand the full potential of a next-generation
COVID-19 vaccine (GEO-CM04S1) currently in three Phase 2 clinical
trials and the broad application of Gedeptin® against solid tumors.
We are gearing up to announce initial data readouts from two of
these trials, along with updates from our Gedeptin clinical trial
against advanced head and neck cancer as well as other important
corporate developments. We believe that these upcoming catalysts
will have a profound impact on patients in need and all our
stakeholders.”
Recent Company Highlights
GEO-CM04S1
- Investigator-Initiated Clinical
Trial Begins, “Randomized Observer-Blinded Phase 2 Trial of
COVID-19 Booster with GEO-CM04S1 or Pfizer-BioNtech Bivalent
Vaccine in Patients with Chronic Lymphocytic Leukemia.”
- Trial is rapidly enrolling
patients, progressing towards an interim data review.
- Enrollment Target Completed for
Phase 2 Clinical Trial Evaluating GEO-CM04S1 as a Booster for
Healthy Patients Who Have Previously Received the Pfizer or Moderna
mRNA Vaccine.
- Initial data readout is expected
soon.
- GeoVax Next-Generation COVID-19
Vaccine (GEO-CM04S1) Demonstrated Potent Antibody and Cellular
Immunity in Immunocompromised Patients.
- The journal, Vaccines, publishes
data (GEO-CM04S1 Publication) from GeoVax’s Phase 2 clinical trial
evaluating the safety and immunogenicity of GEO-CM04S1
next-generation COVID-19 vaccine, compared to either the
Pfizer/BioNTech or Moderna mRNA-based vaccine in patients who have
previously received an allogeneic hematopoietic cell transplant, an
autologous hematopoietic cell transplant or CAR-T cell
therapy.
- GeoVax Universal COVID-19 Vaccine
Data Presented at Keystone Symposia Conference.
- Abstract Title: MVA-vector
multi-antigen COVID-19 vaccines induce protective immunity against
SARS-CoV-2 variants spanning Alpha to Omicron in preclinical animal
modes.
- Data revealed: GEO-CM02 vaccine
induced immune responses that were efficacious against the original
Wuhan strain and BA.1 Omicron variant with a single dose.
Gedeptin®
- Gedeptin® Clinical Data presented
at the AACR-AHNS Head and Neck Cancer Conference
- Abstract Title: Phase 1/2 study of
Ad/PNB with Fludarabine for the Treatment of Head and Neck Squamous
Cell Carcinoma (HNSCC).
- Data revealed: FDA-funded study
reveals that administration of Gedeptin® is safe and feasible.
Advanced Vaccine Manufacturing
Process
- GeoVax and ProBioGen announced the
signing of a landmark commercial license agreement for ProBioGen’s
groundbreaking AGE1.CR.pIX® suspension cell line. The agreement
empowers GeoVax to enhance the manufacturing capabilities of its
entire Modified Vaccinia Ankara (MVA)-based vaccine portfolio.
Intellectual Property
Developments
- GeoVax announced that the U.S.
Patent and Trademark Office has issued a Notice of Allowance for
Patent Application No. 17/584,231 titled patent titled “Replication
Deficient Modified Vaccina Ankara (MVA) Expressing Marburg Virus
Glycoprotein (GP) and Matrix Protein (VP40).”
- GeoVax announced that the U.S
Patent and Trademark Office has issued a Notice of Allowance for
Patent Application No. 17/409,574 titled “Multivalent HIV Vaccine
Boost Compositions and Methods of Use.”
- GeoVax announced that the U.S.
Patent and Trademark Office has issued a Notice of Allowance for
Patent Application No. 17/726,254 titled “Compositions and Methods
for Generating an Immune Response to Treat or Prevent
Malaria.”
- GeoVax announced that the U.S.
Patent and Trademark Office has issued Patent No. 11,701,418 B2 to
GeoVax, pursuant to the Company’s patent application No. 15/543,139
titled “Replication-Deficient Modified Vaccinia Ankara (MVA) and
Matrix Protein (VP40).”
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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