CEL-SCI’s Scientific Review on Inflammatory Disease Therapies Published in Peer Reviewed Journal “International Immunopha...
July 23 2019 - 9:30AM
Business Wire
Highlights from the review:
- T cell immunogens are Next Generation influenza vaccines and
antigen specific rheumatoid arthritis (RA) therapy will target T
cells.
- Immunomodulation rather than ablation may provide cure of
rheumatoid arthritis.
CEL-SCI Corporation (NYSE American: CVM) today announced
that a review titled, “Lessons From Next Generation Influenza
Vaccines For Inflammatory Disease Therapies” was published in the
peer reviewed scientific Journal International Immunopharmacology.
This review was authored by Dr. Zimmerman of CEL-SCI, Dr. Rosenthal
of Northeast Ohio Medical University and Roseman University and two
other CEL-SCI scientists. This review proposes a new approach to
treating autoimmune and inflammatory diseases based on lessons from
new generation influenza vaccines.
The authors propose that treating autoimmune and inflammatory
diseases using a T cell approach, which targets the key drivers of
the disease, ablation of potentially harmful cytokines, pathways or
cells, offers advantages over the approach used currently, which
focuses on stimulating protective antibodies only to specific
surface proteins. T cell directed vaccines elicit broader antigenic
responses and provide more universal protection.
The current licensed vaccines for influenza generate protective
antibodies to specific coat proteins (surface antigens) of the
influenza viruses from which they were prepared, and recipients of
the vaccines are immunized only to those strains of virus. Because
the influenza virus is constantly undergoing a process known as
antigenic drift, new variants of the virus may emerge from year to
year, and the vaccine which was protective during one influenza
season may not be fully protective during the following year. As a
result, annually the influenza virus vaccine composition must be
reviewed and revised, if necessary. Several approaches to a
universal T cell (Uni-Flu) vaccine in NIAID sponsored phase II
studies were discussed. In another approach, the DC-LEAPS Uni-Flu
anti-influenza vaccine targets dendritic cells which present the
influenza antigens and direct the T cell responses towards
protection and away from most inflammatory cytokines (i.e. cytokine
storm).
Based on the results of the Uni-Flu experiments, the CEL-2000
and CEL-4000 LEAPS (Ligand Epitope Antigen Presentation System)
therapeutic antigen specific vaccines were developed for treatment
of rheumatoid arthritis. These vaccines can be readily customized
to provide an antigen specific approach to modulating the disease
driving immune response. In animal models of rheumatoid arthritis
these vaccines stopped the progression of disease and promoted a
return to a more balanced cytokine and immune cell response to the
disease driving antigen. Other immune modulating therapeutic
approaches were also mentioned.
The LEAPS platform technology is currently being utilized to
develop an antigen specific therapeutic vaccine for rheumatoid
arthritis (RA) under a $1.5 million grant from the U.S. National
Institutes of Health (NIH). Upon completion of preclinical and
Investigational New Drug (IND) enabling studies for the LEAPS-based
rheumatoid arthritis vaccine candidate CEL-4000, CEL-SCI intends to
file an IND application with the U.S. Food and Drug
Administration.
About LEAPS
This platform technology has been shown in several animal models
to preferentially direct the immune response to a cellular (e.g.
T-cell), humoral (antibody) or mixed pathway and has been shown to
involve upregulation of T-regulatory (Treg) cells in some animal
models. It has the potential to be utilized in diseases for which
antigenic epitope sequences have already been identified, such as:
a number of infectious diseases, some cancers, autoimmune diseases
(e.g., RA), allergic asthma and allergy, and select CNS diseases
(e.g., Alzheimer's).
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 treats patients
who are newly diagnosed with advanced primary squamous cell
carcinoma of the head and neck with Multikine* first, BEFORE they
receive 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's LEAPS technology is currently being developed as a
therapeutic vaccine for rheumatoid arthritis and is supported by
grants from the National Institutes of Health. 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
for the year ended September 30, 2018. 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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COMPANY CONTACT: Gavin de Windt CEL-SCI Corporation (703)
506-9460 www.cel-sci.com
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