GeoVax Retains CATO SMS to Manage Two Phase 2 COVID-19 Vaccine Clinical Trials
March 14 2022 - 9:00AM
via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a
biotechnology company specializing in developing human vaccines and
cancer immunotherapies, today announced the engagement of
CATO SMS to manage GeoVax’s two ongoing Phase 2 clinical trials
of its vaccine candidate, GEO-CM04S1, against SARS-CoV-2.
GEO-CM04S1 is a synthetic, non-replicating modified vaccinia
Ankara (MVA) vaccine vector, developed as a double recombinant
vectored vaccine to stimulate potent humoral and cellular immune
responses against both the spike (S) and nucleocapsid (N) proteins
of the SARS-CoV-2 virus. Upon immunization, the vaccine vector
infects cells at the local injection site, leading to the
expression of the SARS-CoV-2 antigens that are visible to the
immune system. GeoVax believes GEO-CM04S1 will provide additional
recognition elements to the immune system over a homologous boost
from mRNA vaccines alone, such as those developed by Moderna or
Pfizer/BioNTech, which are directed only toward the S protein. The
GEO-CM04S1 vaccine’s MVA backbone may also be more effective at
inducing COVID-19 immunity since MVA is known to strongly induce T
cell responses even in a background of immunosuppression. In
addition, GEO-CM04S1 targeting of both S and N antigens may offer
greater protection and durability against the significant sequence
variation observed with the S antigen among variants of concern
such as Omicron.
GEO-CM04S1 for Immunocompromised Patients – GEO-CM04S1 is
being studied in an ongoing Phase 2 clinical trial (NCT04977024) to
evaluate its safety and immunogenicity, compared to the
Pfizer/BioNTech mRNA-based vaccine, in patients who have previously
received either an allogeneic hematopoietic cell transplant, an
autologous hematopoietic cell transplant or chimeric antigen
receptor (CAR) T cell therapy. GEO-CM04S1 is the only COVID-19
vaccine that includes both SARS-CoV-2 spike and nucleocapsid
proteins to advance to a Phase 2 trial in cancer patients. Such
vaccines tend to produce an immune response quickly – in less than
14 days – with only mild side effects. The trial is also the first
to compare an investigational multi-antigenic COVID-19 vaccine to
the current Food and Drug Administration (FDA)-approved mRNA
vaccine from Pfizer/BioNTech in people who are immunocompromised.
Such patients have often shown a weak antibody response after
receiving currently available COVID-19 vaccines.
GEO-CM04S1 as a Booster Vaccine – In December 2021,
patient enrollment began for the Phase 2 portion of a Phase 1/2
trial (NCT04639466) of GEO-CM04S1, evaluating its use as a
universal booster vaccine to current FDA-approved two-shot mRNA
vaccines from Pfizer/BioNTech and Moderna. The Phase 1 portion of
the trial is completed and was designed as a dose-escalation safety
study in healthy individuals who had not been previously infected
with SARS-CoV-2. The Phase 2 booster study, for which vaccination
is ongoing, includes healthy individuals who were previously fully
vaccinated with either the Pfizer/BioNTech or Moderna vaccine. The
study is designed as a dose-escalation trial to specifically
evaluate the safety profile and immunogenicity of COH04S1 as a
booster. The immunological responses measured throughout the study
will include the level of SARS-CoV-2 neutralizing antibodies
against SARS-CoV-2 variants of concern (VOC), including the newly
identified Omicron VOC, as well as specific T-cell responses.
David Dodd, GeoVax President and CEO, commented, “We are excited
to have engaged CATO SMS as our CRO partner for our advancing
clinical studies of GEO-CM04S1. CATO SMS brings deep experience in
the area of infectious disease including managing COVID-19 clinical
trials. We previously announced the engagement of CATO to manage
our Phase1/2 trial of Gedeptin® therapy in patients with recurrent
head and neck squamous cell carcinoma (HNSCC), and now look forward
to working with them for our COVID-19 vaccine trials as well to
achieve important clinical milestones including the expansion of
clinical sites and acceleration of patient enrollment and
evaluation.”
About CATO SMS
CATO SMS is a global provider of clinical research solutions,
including strategic consulting, full-service clinical trial
operations, biometrics, and clinical pharmacology. With more than
30 years of experience focusing on the needs of small and emerging
biopharmaceutical companies, CATO SMS effectively designs and
executes studies — from strategy to approval — in complex
indications and modalities across a variety of therapeutic areas
with a proven center of excellence in oncology. CATO SMS’
regulatory, therapeutic and operational expertise enables the
company to meet goals and exceed expectations. Visit CATO-SMS.com
for more information.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company
developing human vaccines and immunotherapies against infectious
diseases and cancer using novel proprietary platforms. GeoVax’s
product pipeline includes two ongoing Phase 2 clinical trials of
GEO-CM04S1 (formerly COH04S1) for COVID-19 as a universal booster
vaccine to mRNA vaccines authorized by the U.S. Food and Drug
Administration (FDA) and as a primary vaccine for use in
immunocompromised patients. In addition to GEO-CM04S1 for COVID-19,
GeoVax is developing GEO-CM02 as a pan-coronavirus vaccine. The
Company is also conducting a Phase 1/2 clinical trial of Gedeptin®
for treatment of head and neck cancer. Gedeptin® has been granted
orphan drug status by the FDA. Additional research and development
programs include preventive vaccines against Zika Virus,
hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa) and
malaria, as well as immunotherapies for multiple solid tumors. The
Company’s portfolio of wholly owned, co-owned, and in-licensed
intellectual property stands at over 70 granted or pending patent
applications spread over 20 patent families.
For additional information about GeoVax, 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 preventive 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 preventive vaccines
with the desired characteristics in a timely manner, GeoVax’s
immuno-oncology products and preventive vaccines will be safe for
human use, GeoVax’s vaccines will effectively prevent targeted
infections in humans, GeoVax’s immuno-oncology products and
preventive 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 registration statement on Form S-1 and the
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 U.S.
federal securities law.
Contact:GeoVax Labs,
Inc.investor@geovax.com 678-384-7220
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