- Immunotherapy using LEAPS peptide technology may be able to
reduce COVID-19 viral load and tissue damage resulting from
infection in the lungs.
- Studies conducted in collaboration with NIAID showed LEAPS
peptides reduced morbidity and mortality in mice with another
respiratory virus, pandemic influenza (H1N1).
CEL-SCI Corporation (NYSE American: CVM) announces that
it is developing an immunotherapy with the potential to treat the
COVID-19 coronavirus using its patented LEAPS peptide technology.
The LEAPS peptides will utilize conserved regions of coronavirus
proteins to stimulate protective 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. Consequently, these products not
only target the virus infection against which they are directed,
but also elicit the appropriate protective response(s) against
it.
Predictions of success using the LEAPS peptides against COVID-19
coronavirus are based on previous studies conducted in
collaboration with the National Institutes for Allergies and
Infectious Diseases (NIAID) with another respiratory virus,
pandemic influenza (H1N1). In those studies, LEAPS peptides
elicited protection of mice from morbidity and mortality after the
introduction of infection by activating appropriate T cell
responses rather than an inflammatory response.
Although individuals of all ages are susceptible to COVID-19
coronavirus infection, the elderly and individuals with compromised
lung function or immunosuppression are at highest risk for severe
morbidity and mortality. It is believed that, in most cases, onset
of symptoms takes between 2 and 14 days post infection, a period of
time that may allow intervention for those at highest risk and with
a known exposure.
Daniel Zimmerman, Ph.D. Senior VP of Research, Cellular
Immunology at CEL-SCI Corporation, said, ”We believe that a LEAPS
COVID 19 coronavirus peptide will reduce or arrest the progression
of the virus infection and prevent tissue damage from inflammation
resulting from lung infection by the virus. In short, we believe
that we can stimulate the correct immune responses to the virus
without producing unwanted inflammatory responses associated with
lung tissue damage. That should be particularly important in the
older population who is at highest risk of dying from this
virus.”
CEL-SCI CEO Geert Kersten added, “CEL-SCI is currently in
discussion with multiple health care partners to expeditiously move
this critically important work forward. We look forward to
combining the LEAPS technology, experience and expertise of CEL-SCI
with the expertise of various partners to promote the rapid
development of a LEAPS/COVID-19 product to help particularly those
patients who are at very high risk from COVID-19 infection.”
COVID-19 is a member of the coronavirus family which “jumped” to
humans from an animal reservoir. Unlike human coronaviruses, which
include the second most common cause of the common cold, COVID-19,
like its cousins SARS and MERS coronaviruses, can replicate at the
higher temperatures within the human lungs and, as a result, can
cause highly morbid/mortal disease. It is thought that the
morbidity and mortality in the at-risk population is due to lung
damage resulting from inflammatory immune responses to the
virus.
CEL-SCI’s studies will utilize 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 influenza A, 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 are directed towards antigens within
the NP protein of COVID-19 that elicit cytolytic T cell responses.
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.
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 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/20200309005285/en/
Gavin de Windt CEL-SCI Corporation (703) 506-9460
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