GeoVax Announces Gedeptin® Presentation at the AACR-AHNS Head and Neck Cancer Conference
28 Juni 2023 - 3:00PM
via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a
biotechnology company developing immunotherapies and vaccines
against cancers and infectious diseases, today announced that an
abstract regarding GeoVax’s gene therapy candidate, Gedeptin®, has
been selected for poster presentation at the American Association
for Cancer Research (AACR) and the American Head and Neck Society
(AHNS) joint Head and Neck Cancer Conference, being held from July
7-8, 2023 at the Palais des congrès de Montréal in Montréal, QC,
Canada.
Presentation Details:
Abstract Title: |
Phase 1/ 2 study of
Ad/PNP with fludarabine for the treatment of head neck squamous
cell carcinoma (HNSCC) |
Abstract
Authors: |
A. Dimitrios
Colevas1, Eric J. Sorscher2, William Parker3, Roan Courtney
Raymundo1, Jeong S. Hong2, Regina Rab2, Camilo Henao4, Nikki
Schmitt2, Madison Stallings2, Kelly T. McKee, Jr.5, Eben
Rosenthal6, Joseph Curry4 |
|
1Stanford Cancer
Institute, Stanford University2Emory University School of
Medicine3PNP Therapeutics, Inc.4Thomas Jefferson University5GeoVax
Labs, Inc.6Vanderbilt University |
Date and Time: |
Friday, July 7, 4:30
p.m.-6:00 p.m. ET |
Presenting
Author: |
Kelly T. McKee, Jr.,
M.D., MPH, Chief Medical Officer, GeoVax |
About Gedeptin®
Gedeptin is a novel patented product/technology
for the treatment of solid tumors through a gene therapy strategy
known as Gene-Directed Enzyme Prodrug Therapy (GDEPT). In GDEPT, a
vector is used to selectively transduce tumor cells with a nonhuman
gene, which expresses an enzyme that can convert a nontoxic prodrug
into a very toxic antitumor compound in situ.
The ongoing Phase 1/2 trial (ClinicalTrials.gov
Identifier: NCT03754933) is evaluating the safety and efficacy of
repeat cycles of Gedeptin therapy in patients with recurrent head
and neck squamous cell carcinoma (HNSCC), with tumor(s) accessible
for injection and no curable treatment options. The protocol
entails up to five treatment cycles, each consisting of three
intra-tumoral injections of Gedeptin over two days followed by
infusion of a prodrug, fludarabine phosphate, once a day for three
days. A completed Phase 1 dose-ranging study demonstrated that
treating a tumor with a single cycle of Gedeptin, followed by
fludarabine infusions, was well tolerated, with evidence of a
reduction in tumor size in patients with solid tumors.
The current study is being funded in part by the
FDA pursuant to its Orphan Products Clinical Trials Grants Program.
The FDA has also granted Gedeptin orphan drug status for the
intra-tumoral treatment of anatomically accessible oral and
pharyngeal cancers, including cancers of the lip, tongue, gum,
floor of mouth, salivary gland, and other oral cavities. GeoVax
anticipates completion of the current trial by year-end 2023, after
which expanded development of Gedeptin is anticipated, both as
mono-therapy and as potential combination therapy in conjunction
with Immune Checkpoint Inhibitors.
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
Capital404-736-3838 govx@cg.capital
Media Contact:Susan
Robertssr@roberts-communications.com202-779-0929
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