via NewMediaWire – A COVID-19 investigational vaccine, developed by
City of Hope scientists and now licensed to GeoVax Labs Inc.
(Nasdaq: GOVX), produced a robust neutralizing antibody and T cell
(an immune cell) response against SARS-CoV-2 with no significant
side effects in a Phase 1 clinical trial led by John Zaia, M.D.,
Aaron D. Miller and Edith Miller Chair for Gene Therapy, according
to a study published today in The Lancet Microbe.
COH04S1 is uniquely different than the many vaccines that have
been developed because it targets both the spike and nucleocapsid
proteins, in contrast to the current U.S. Food and Drug
Administration (FDA)-approved COVID-19 vaccines, which only target
the spike protein.
COH04S1 is being studied in a first-of-its-kind Phase 2 clinical
trial for immunocompromised cancer patients who have difficulty
producing antibodies and largely depend on T cells to protect
against the virus responsible for COVID-19. Likewise, COH04S1 is
also being evaluated in a Phase 2 vaccine booster trial format,
which is aimed at evaluating how COH04S1 can boost pre-existing
vaccine immunity to spike while also causing a strong immune
response to nucleocapsid.
COH04S1 elicited neutralizing antibodies against the virus’
spike protein, which interacts with the human cellular ACE2
receptor, allowing the virus to enter cells of the lung, heart and
other organs, resulting in damage and significant inflammation.
These neutralizing antibodies were effective against the original
SARS-CoV-2 and subsequent viral variants. T cells were produced
against the SARS-CoV-2 nucleocapsid protein, as well as its spike
protein, after just one dose of COH04S1.
“This data confirms the powerful dual action of our vaccine,”
said Don J. Diamond, Ph.D., professor in City of Hope’s Department
of Hematology & Hematopoietic Transplantation and the vaccine’s
lead developer. "Given the multiple mutations in spike, leading to
variants of concern and inconsistent protection from existing
FDA-approved vaccines, we are excited about our approach
incorporating two antigens in one vaccine. Should a new mutation
arise in the spike antigen that interferes with antibody
recognition, we believe a person vaccinated with our vaccine would
still have substantial T cell immunity against both the
nucleocapsid and spike antigens that would protect them from the
ravages of COVID-19.
“The T cell response is especially important for
immunocompromised cancer patients as they can readily lose the
ability to produce antibodies during and after chemotherapy or
other treatments that deplete antibody-producing cells,” he
added.
In November 2021, GeoVax licensed the vaccine for further
development and commercialization, including potentially as a
first-line COVID-19 vaccine. GeoVax has now designated the vaccine
as GEO-CM04S1.
“Our license of GEO-CM04S1 (formerly known as COH04S1)
represented a significant and exciting milestone for GeoVax, and
the data published today confirm the validity of the vaccine’s
approach against SARS-CoV-2,” said David Dodd, GeoVax president and
CEO. “We believe the vaccine, containing the two antigens, S and N,
along with the recognized antibody and cellular immune responses
resulting from the MVA approach, has the potential to offer a more
robust and durable booster protection than that from the current
vaccines in use, as well as provide a greater degree of protection
within immunocompromised patients.”
“We have developed a strong working relationship with Dr.
Diamond and his colleagues at City of Hope as we make plans to
accelerate the clinical advancement of this promising vaccine for
patients and look for opportunities for further collaboration in
other areas of vaccine and immunotherapy needs,” Dodd added.
For the Phase 1 trial at City of Hope, 58 healthy adult
volunteers participated and 34 participants received two doses of
COH04S1 28 days apart. Five received two placebo doses and 13
volunteers received a first dose of the vaccine and a second dose
of the placebo. Volunteers who received the placebo were informed
56 days after first injection — of either the vaccine or placebo —
that they didn’t receive one or both vaccine injections. They were
offered COH04S1 or one of the then-emergency use authorized
vaccines as a second dose.
T cells against the spike and nucleocapsid proteins were induced
following the first dose of COH04S1. Following the second dose,
given four weeks after the first, high amounts of neutralizing
antibodies were detected at the next monitoring period.
All vaccinated volunteers reached the primary immunological
endpoint, defined as a four-fold increase of antibodies against the
spike or nucleocapsid protein eight weeks after the first dose.
“Our vaccine could potentially be used as a first vaccination,
or a booster to previous vaccinations, as it would boost antibodies
to the spike protein and help generate T cells,” Diamond
added.
The Phase 2 clinical trial of COH04S1 is the first to
study the safety and effectiveness of an investigational vaccine in
patients with blood cancer who have received a bone marrow
transplant or chimeric antigen receptor (CAR) T therapy. The trial
is also the first to compare an investigational COVID-19 vaccine to
the Pfizer Cominarty vaccine in people who are immunocompromised
and receiving immunosuppressive therapy.
The Phase 2 booster study is for healthy individuals, 18 years
of age and older, who were previously vaccinated with one of the
FDA-approved mRNA vaccines or the FDA-authorized Johnson &
Johnson vaccine. The study is designed as a dose-escalation trial
to evaluate the safety profile and immune response of COH04S1 as a
booster shot. The immunological responses measured will include
both the level of neutralizing antibodies against SARS-CoV-2,
including omicron and T cell responses.
To produce the vaccine, a team led by Felix Wussow, Ph.D.,
and Flavia Chiuppesi, Ph.D., both City of Hope assistant
research professors in the Department of Hematology &
Hematopoietic Cell Transplantation, together with Diamond, first
developed a synthetic modified vaccinia ankara (MVA) virus platform
technology to house the genetic components that make up the vaccine
at a molecular level. The natural form of the MVA virus, currently
used in a smallpox vaccine, is approved by the FDA and has a record
of safety and efficacy, rapid immune response and lasting
protection in both healthy and immunocompromised patients. City of
Hope has experience using the natural virus for transplant-related
vaccines, such as the Triplex vaccine, which was used in a Phase 2
trial to prevent cytomegalovirus in immunocompromised stem cell
transplant recipients and an oncologic-based vaccine as a
therapeutic in breast, head and neck, ovarian, and other
cancers.
About City of HopeCity of Hope's mission
is to deliver the cures of tomorrow to the people who need them
today. Founded in 1913, City of Hope has grown into one of the
largest cancer research and treatment organizations in the U.S. and
one of the leading research centers for diabetes and other
life-threatening illnesses. As an independent,
National Cancer Institute-designated comprehensive cancer
center, City of Hope brings a uniquely integrated model to
patients, spanning cancer care, research and development, academics
and training, and innovation initiatives. Research and technology
developed at City of Hope has been the basis for numerous
breakthrough cancer medicines, as well as human synthetic insulin
and monoclonal antibodies. A leader in bone marrow
transplantation and immunotherapy, such as CAR T cell
therapy, City of Hope’s personalized treatment protocols help
advance cancer care throughout the world.
With a goal of expanding access to the latest discoveries and
leading-edge care to more patients, families and communities, City
of Hope’s growing national system includes its main Los Angeles
campus, a network of clinical care locations across Southern
California, a new cancer center in Orange County, California,
scheduled to open in 2022, and Cancer Treatment Centers of
America. City of Hope’s affiliated family of organizations
includes Translational Genomics Research
Institute and AccessHopeTM. For more information
about City of Hope, follow us
on Facebook, Twitter, YouTube, Instagram and LinkedIn.
About GeoVaxGeoVax 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
geovax.com.
Forward-Looking StatementsThis 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
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
City of HopeLetisia Marquezlemarquez@coh.org626-476-7593
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