U.S. Patent Office Allows New CEL-SCI Patents for LEAPS Vaccine Platform Technology
June 08 2018 - 8:30AM
Business Wire
New LEAPS Patents aimed at Multiple
Infectious Diseases
CEL-SCI Corporation (NYSE American: CVM) today announced
the U.S. Patent and Trademark Office has allowed two new US patents
for the Company’s LEAPS platform technology. These patents are
titled “Method for Inducing an Immune Response and Formulations
Thereof” and " Method for Inducing an Immune Response against
avian, swine, Spanish, H1N1, H5N9 influenza viruses and
formulations". CEL-SCI’s patented inventions relate to methods for
diagnosing, preventing, and treating disease by generating or
modulating the immune response through the use of specific
peptides.
The LEAPS platform technology is currently being developed as a
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.
“As we move the first LEAPS platform vaccine candidate towards
potential human studies, we are pleased by this important extra
step forward. These patents expand and fortify the intellectual
property protection for our LEAPS technology platform,” said Dr.
Daniel Zimmerman, Senior Vice President of Research, Cellular
Immunology.
LEAPS is a patented, T-cell modulation, peptide epitope delivery
technology that enables CEL-SCI to design and synthesize
proprietary peptide immunogens. LEAPS compounds consist of a small
T-cell binding peptide ligand linked with a disease-associated
peptide antigen.
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 is a Phase 3 cancer immunotherapy company. When it comes
to cancer immunotherapy, CEL-SCI believes it is most logical to
boost the patient’s immune system while it is still intact in order
to have the greatest possible impact on survival. Therefore, the
pivotal Phase 3 study treats patients who are newly diagnosed with
advanced head and neck cancer with its lead investigational
immunotherapy Multikine* (Leukocyte Interleukin, Injection), BEFORE
they receive any other treatment, such as surgery, radiation and/or
chemotherapy. This approach is unique. Most other cancer
immunotherapies are used only after conventional therapies have
been tried and/or failed. Head and neck cancer represents about 6%
of all cancers. Multikine has received Orphan Drug designation from
the FDA for the treatment of head and neck cancer patients with
advanced squamous cell carcinoma.
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.
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, 2017. 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/20180608005165/en/
COMPANY:CEL-SCI CorporationGavin de Windt,
703-506-9460www.cel-sci.com
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