- Initial studies with COVID-19 corona virus aim to replicate
prior successful preclinical experiments of LEAPS against
H1N1pandemic flu in mice conducted with National Institutes for
Allergies and Infectious Diseases (NIAID)
- Treatment targeted for patients who are at highest risk of
dying from COVID-19 due to tissue damage from infection to the
lungs
- Principal Investigator for the COVID-19 study Dr. Ted Ross is
world renowned researcher and key opinion leader in infectious
disease and vaccine development
CEL-SCI Corporation (NYSE American: CVM) announced today
it has signed a collaboration agreement with the University of
Georgia’s Center for Vaccines and Immunology to develop LEAPS
COVID-19 immunotherapy. CEL-SCI’s immunotherapy candidate aims to
treat patients at highest risk of dying from COVID-19. The
collaboration will commence with pre-clinical studies based on the
experiments previously conducted with LEAPS immunotherapy in
collaboration with the National Institutes for Allergies and
Infectious Diseases (NIAID) against another respiratory virus,
H1N1, involved in the 2009 H1N1 flu pandemic. Those successful
studies demonstrated that LEAPS peptides, given after virus
infection has occurred, reduced morbidity and mortality in mice
infected with H1N1.
It is suggested, based on studies with H1N1, that a LEAPS
coronavirus - SARS-CoV-2 immunotherapy may reduce or arrest the
progression of the SARS-CoV-2 virus infection and prevent tissue
damage from inflammation resulting from lung infection by the
virus. By stimulating the correct immune responses to the
COVID-19-causing virus without producing unwanted inflammatory
responses associated with lung tissue damage, LEAPS immunotherapy
may be particularly beneficial in those patients who are at highest
risk of dying from COVID-19.
“We are eager to commence these studies, which if successful,
may lead to clinical trials in humans to address the immediate and
critical need to treat COVID-19 in the most vulnerable patients. We
are very pleased and honored to partner with Dr. Ted M. Ross and
his team and the University of Georgia Center for Vaccines and
Immunology. Their world-renowned expertise and world-class
facilities will accelerate the development of LEAPS COVID-19
immunotherapy,” stated CEL-SCI CEO Geert Kersten.
The University of Georgia (UGA) Center for Vaccines and
Immunology (CVI) brings together a diverse, world-renowned team of
experts in the areas of infectious disease, veterinary medicine,
ecology and public health. The university’s world-class
biocontainment research resources are coupled with the expertise of
CVI investigators who focus on translational studies to test and
assess the efficacy of vaccines and immunotherapies in development
by industry, governmental and academic institutions. CEL-SCI’s
COVID-19 studies at UGA will be led by Principal Investigator Ted
M. Ross, PhD, Director of the Center for Vaccines and Immunology,
Georgia Research Alliance Eminent Scholar, and Professor of
Infectious Diseases at the University of Georgia. Dr. Ross is a
world renowned key opinion leader in new vaccine technologies
intended to protect against all strains for influenza and life
threatening viruses. Dr. Ross has published more than 160 papers
and book chapters on infectious disease and vaccine development. He
has been an invited speaker at more than 130 national and
international conferences, and he participates in several vaccine
working groups, including at the U.S. National Institutes of
Health, U.S. Centers for Disease Control and Prevention and the
World Health Organization.
Dr. Ross commented, “LEAPS has the potential to be a powerful
tool against SARS-CoV-2, the causative agent of COVID-19, based on
its dual anti-viral and anti-inflammatory properties. Combining the
prior pre-clinical data of LEAPS against H1N1 with our advancing
knowledge of COVID-19, we aim to rapidly evaluate this technology’s
potential to meet the urgent need to treat patients at greatest
risk of dying from this global pandemic. The University of
Georgia’s biocontainment labs at the Center for Vaccines and
Immunology are ideally suited for these studies, and will serve as
critical assets in this collaboration with CEL-SCI.”
CEL-SCI’s studies will utilize the LEAPS peptide approach that
is unique in its proven ability in animals to elicit both a cell
mediated antiviral response and an anti-inflammatory
immunomodulating response by activating CD8 T lymphocytes. Previous
studies showed that LEAPS immunogens can prevent lethal infection
by herpes simplex virus (HSV) and influenza A (H1N1) and stop the
inflammatory disease progression of rheumatoid arthritis in animal
models. LEAPS peptides against HSV demonstrated that the T cell
response was sufficient to prevent viral disease, and if there was
residual virus production, anti-viral antibody was generated to
further control the spread of the virus.
The proposed LEAPS peptides for the COVID-19 study are directed
towards antigens within the NP protein of SARS-Cov-2 virus that
elicit cytolytic T cell responses. Unlike the viral glycoprotein
“spike” antigens which are important for antibody-based vaccines,
these NP-antigens are less variable between viral strains and less
likely to change in response to antibodies elicited by prior
infection or other vaccines. Cytolytic T cell responses attack the
virus infected cellular “factories” within the infected host in
order to eliminate the source of virus and help subdue the
infection.
About LEAPS
The Ligand Antigen Epitope Presentation System (LEAPS) platform
technology has demonstrated in several animal models the ability to
design antigen-specific immunotherapeutic peptides that
preferentially direct the immune response to a cellular (e.g.,
T-cell), humoral (antibody) or mixed response and are also capable
of enhancing important T-regulatory (Treg) responses. Therefore,
the LEAPS technology provides the opportunity to develop
immunotherapeutic products for diseases for which disease
associated antigenic peptide(s) sequences have already been
identified, such as: a number of infectious diseases, some cancers,
autoimmune diseases (e.g., RA), allergic asthma and allergy, select
CNS diseases (e.g., Alzheimer's) and the COVID-19 associated
virus.
The Company's LEAPS technology is currently also being developed
as a therapeutic vaccine for rheumatoid arthritis and is supported
by $1.5 million grant for IND enabling studies from the National
Institute of Arthritis and Musculoskeletal and Skin Diseases.
About CEL-SCI Corporation
CEL-SCI believes that boosting a patient's immune system while
it is still intact should provide the greatest possible impact on
survival. Therefore, in the Phase 3 study CEL-SCI treated patients
who are newly diagnosed with advanced primary squamous cell
carcinoma of the head and neck with Multikine* first, BEFORE they
received surgery, radiation and/or chemotherapy. This approach is
unique. Most other cancer immunotherapies are administered only
after conventional therapies have been tried and/or failed.
Multikine (Leukocyte Interleukin, Injection), has received Orphan
Drug designation from the FDA for neoadjuvant therapy in patients
with squamous cell carcinoma (cancer) of the head and neck.
CEL-SCI's Phase 3 study is the largest Phase 3 study in the
world for the treatment of head and neck cancer. Per the study's
protocol, newly diagnosed patients with advanced primary squamous
cell carcinoma are treated with the Multikine treatment regimen for
3 weeks prior to the Standard of Care (SOC) which involves surgery,
chemotherapy and/or radiation. Multikine is designed to help the
immune system "see" the tumor at a time when the immune system is
still relatively intact and thereby thought to better able to mount
an attack on the tumor. The aim of treatment with Multikine is to
boost the body's immune system prior to SOC. The Phase 3 study is
fully enrolled with 928 patients and the last patient was treated
in September 2016. To prove an overall survival benefit, the study
requires CEL-SCI to wait until 298 events have occurred among the
two main comparator groups.
The Company has operations in Vienna, Virginia, and in/near
Baltimore, Maryland.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. When used in this press release, the words "intends,"
"believes," "anticipated," "plans" and "expects," and similar
expressions, are intended to identify forward-looking statements.
Such statements are subject to risks and uncertainties that could
cause actual results to differ materially from those projected.
Such statements include, but are not limited to, statements about
the terms, expected proceeds, use of proceeds and closing of the
offering. Factors that could cause or contribute to such
differences include, an inability to duplicate the clinical results
demonstrated in clinical studies, timely development of any
potential products that can be shown to be safe and effective,
receiving necessary regulatory approvals, difficulties in
manufacturing any of the Company's potential products, inability to
raise the necessary capital and the risk factors set forth from
time to time in CEL-SCI's filings with the Securities and Exchange
Commission, including but not limited to its report on Form 10-K/A
for the year ended September 30, 2019. The Company undertakes no
obligation to publicly release the result of any revision to these
forward-looking statements which may be made to reflect the events
or circumstances after the date hereof or to reflect the occurrence
of unanticipated events.
* Multikine (Leukocyte Interleukin, Injection) is the trademark
that CEL-SCI has registered for this investigational therapy, and
this proprietary name is subject to FDA review in connection with
the Company's future anticipated regulatory submission for
approval. Multikine has not been licensed or approved for sale,
barter or exchange by the FDA or any other regulatory agency.
Similarly, its safety or efficacy has not been established for any
use. Moreover, no definitive conclusions can be drawn from the
early-phase, clinical-trials data involving the investigational
therapy Multikine. Further research is required, and early-phase
clinical trial results must be confirmed in the Phase 3 clinical
trial of this investigational therapy that is in progress.
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version on businesswire.com: https://www.businesswire.com/news/home/20200323005336/en/
Gavin de Windt CEL-SCI Corporation (703) 506-9460
www.cel-sci.com
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