GeoVax Presents Gedeptin® Clinical Data at the AACR-AHNS Head and Neck Cancer Conference
July 10 2023 - 8:00AM
via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a
biotechnology company developing immunotherapies and vaccines
against cancers and infectious diseases, announced
today the presentation of Phase 1/2 clinical trial data for
GeoVax’s gene therapy candidate, Gedeptin® at the American
Association for Cancer Research (AACR) and the American Head and
Neck Society (AHNS) joint Head and Neck Cancer Conference in
Montréal, QC, Canada. The presentation, titled “Phase 1/ 2 study of
Ad/PNP with fludarabine for the treatment of head neck squamous
cell carcinoma (HNSCC)”, describes the evaluation of Gedeptin as an
experimental therapy for refractory solid tumors.
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 highly 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
daily 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 poster presentation (viewed here), highlighted the
following data:
- 8 patients have been enrolled in the study to date.
- No dose limiting toxicities or serious adverse events (SAEs)
are definitively attributable to treatment. Additionally, no
adverse events above grade 3 severity have been reported.
- Up to 5 cycles of Gedeptin treatment have been administered
without limiting sequelae. Intratumoral expression of the PNP
transgene by RT-PCR has been established in treated tumors studied
to date.
- Impairment of tumor growth (i.e., "stable disease" using RECIST
1.1 evaluation criteria) in targeted lesions was seen in 5 of 7
patients; tumor response assessment in one patient remains under
study.
Kelly T. McKee, M.D., GeoVax’s Chief Medical Officer and
presenting author, commented, “This clinical trial is ongoing, but
from our interim analysis, we can conclude that administration of
Gedeptin is safe and feasible. The strategy is also being
considered for earlier-stage HNSCC with less tumor burden,
including a role similar to neoadjuvant or cytoreductive
radiotherapy in combination with checkpoint blockade inhibition. A
multi-center trial is planned to define the maximum tolerable dose
and feasibility in smaller tumors.”
The current study is being funded in part by the U.S. Food and
Drug Administration (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 the 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 monotherapy and combination therapy in
conjunction with other therapies to potentially include immune
checkpoint inhibitors, angiogenesis inhibitors, radiation,
chemotherapy, etc.)
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
Media Contact:Susan
Robertssr@roberts-communications.com202-779-0929
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