CEL-SCI Awarded European Patent for LEAPS Vaccine in Treatment of Rheumatoid Arthritis
September 18 2020 - 9:00AM
Business Wire
LEAPS Platform Technology being developed as
a therapeutic vaccine for rheumatoid arthritis with support of a
NIAMS grant of the NIH
CEL-SCI Corporation (NYSE American: CVM) today announced
that the European Patent Office has issued CEL-SCI patent: European
Patent 2989121 to be published on October 7, 2020, and titled
“Method of Preparation and Composition of Peptide Constructs for
Treatment of Rheumatoid Arthritis” for the Company’s LEAPS platform
technology. CEL-SCI’s LEAPS technology relates to peptide
constructs which may be useful in the treatment or prevention of
autoimmune diseases, particularly rheumatoid arthritis, asthma,
allergies, and host versus graft (or graft versus host)
rejection.
“The basic goal of this technology is to 'modulate' the immune
system of a patient with Rheumatoid Arthritis, and other autoimmune
diseases, away from the body attacking itself to a more normal
immune response where the body does not attack itself. This should
result in a decrease or elimination of the symptoms of the disease.
We are in the process of completing pre-IND studies for CEL-4000,
being developed against Rheumatoid Arthritis, and hope to start
human studies with CEL-4000 next year. LEAPS is also currently
being tested at the University of Georgia vaccine center against
COVID-19,” said Dr. Daniel Zimmerman, Senior Vice President of
Research, Cellular Immunology.
The LEAPS platform technology is being developed as a potential
therapeutic vaccine for rheumatoid arthritis under phase I and
phase II SBIR grants of over $1.7 million from National Institute
of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) of the
U.S. National Institutes of Health (NIH) which was used in part to
fund IND enabling studies in non-human primates.
In animal challenge tests conducted in arthritic diseased
animals using CEL-4000 as a therapeutic treatment in collaboration
with our Rush Universities Medical center collaborators and
co-inventors on this patent, LEAPS platform technology has been
shown to direct the immune response preferentially to a cellular
(e.g. T-cell) response, reducing pro inflammatory cytokines (IFNγ
and IL17A) and enhancing production of anti-inflammatory cytokines
(IL4 and IL10). Additional studies in other disease models have
shown either cellular, humoral (antibody) or mixed pathway immune
responses depending on the disease model and the desired type of
protection.
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. Usually given after the disease process is
initiated and underway. That is not being used as a preventative
agent or conventional preventative vaccine.
The LEAPS conjugates can potentially be utilized to treat
diseases for which antigenic epitope sequences have already been
identified, such as: a number of infectious diseases, some cancers,
autoimmune diseases (e.g., rheumatoid arthritis), 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 treated patients
who are newly diagnosed with advanced primary squamous cell
carcinoma of the head and neck with the investigational product
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 believes that this 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 of the head and neck were treated
with the Multikine treatment regimen first - for 3 weeks prior to
receiving the Standard of Care (SOC), which involves surgery,
radiation or concurrent radiochemotherapy. 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 be
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 to
attack the cancer. 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. This study milestone occurred in late April 2020. The study
is currently in the database lock and analysis phase.
The Company’s LEAPS technology is being developed for rheumatoid
arthritis and as a potential treatment of COVID-19 in hospitalized
and at-high-risk patients. The Company has operations in Vienna,
Virginia, and near/in 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 results demonstrated in clinical trials or nonclinical
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 amended 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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Gavin de Windt CEL-SCI Corporation (703) 506-1137
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