CEL-SCI Corporation (NYSE American: CVM) announces that
it has concluded animal experiments using its LEAPS COVID 19
conjugate that provide the basis for moving forward into animal
challenge studies with live virus SARS-CoV-2, the causative agent
of COVID 19, at the University of Georgia Vaccine Center. These
SARS-CoV-2 challenge studies seek to repeat the success of animal
challenge studies conducted previously at the NIH/NIAID emerging
diseases laboratory during the threatened H1N1 flu pandemic.
The LEAPS COVID 19 conjugate has been designed employing the
same concepts as were used to construct the LEAPS H1N1 conjugate
which was successfully employed in previous H1N1 pandemic flu
studies. In those prior studies reduced morbidity and mortality
were observed in H1N1 virus infected animals treated with the LEAPS
H1N1 construct. The LEAPS H1N1 conjugates were administered after
virus challenge as a therapeutic intervention. We believe these
results and the positive results achieved in studies with LEAPS
constructs in other diseases are strongly suggestive that the LEAPS
COVID 19 challenge studies at the University of Georgia Vaccine
Center may also be successful.
The recent animal experiments showed that LEAPS COVID 19
conjugates induced faster and much higher than expected antibody
responses against a non-mutating region of the virus that causes
COVID 19, after only one injection. It is important to note that
IgG antibodies response was generated within 10 days of a single
immunization. Generation of IgG requires activation of dendritic, T
and B cells in order to promote the class switch from IgM to IgG
antibody.
Daniel Zimmerman, Ph.D., Senior VP of Research Cellular
Immunology at CEL-SCI and discoverer of the LEAPS technology said;
“We now have the immunogenicity data showing that the LEAPS
technology may work against COVID 19. Similar results were obtained
with LEAPS-H1N1 conjugates, in animals that were infected with H1N1
virus and subsequently treated with LEAPS-H1N1 conjugates. Those
challenge studies resulted in a decrease in morbidity and mortality
against pandemic flu H1N1 in a mouse model study conducted at the
NIAID. These studies give us confidence that the challenge studies
we are now undertaking with live virus SARS-CoV-2 in an animal
model of COVID 19 at the University of Georgia Vaccine Center will
be successful.”
Background on LEAPS and its Relevance to COVID 19:
CEL-SCI’s goal is to develop an immunotherapy with the potential
to treat the COVID 19 coronavirus using its patented LEAPS peptide
technology. The LEAPS peptides utilize conserved regions of
coronavirus proteins to stimulate protective antibody and cell
mediated T cell responses and reduce viral load. The LEAPS peptide
technology can be used to construct immunotherapeutic peptides that
exhibit both antiviral and anti-inflammatory properties at the same
time. Consequently, these products not only target the virus
infection against which they are directed, but also elicit the
appropriate protective response(s) against it, without exacerbating
an overly active inflammation.
CEL-SCI’s studies are utilizing the LEAPS peptide approach which
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 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 LEAPS-COVID-19 peptide conjugates are directed towards
antigens within the NP protein of SARS-Cov-2 the causative agent of
COVID-19 that elicit cytolytic T cell responses to virus infected
cells. Unlike glycoprotein spike antigens which are important for
antibody-based vaccines, these 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.
Ligand Epitope Antigen 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 virus SARS-Cov-2, the
causative agent of COVID-19.
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 its global pivotal 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, including statements with respect to Multikine and the
Phase 3 clinical trial of Multikine in patients with advanced
primary squamous cell carcinoma of the head and neck. 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. Factors that could cause or
contribute to such differences include, an inability to duplicate
the clinical trials or nonclinical 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/20200724005064/en/
Gavin de Windt CEL-SCI Corporation (703) 506-9460
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