CEL-SCI Presents New Data for Its LEAPS Vaccine in the Treatment of Rheumatoid Arthritis at the American Association of Immun...
13 May 2019 - 11:00PM
Business Wire
- Newly discovered LEAPS conjugate
vaccine acts alone and can complement CEL-4000 therapeutically when
administered in combination to an animal model of Rheumatoid
Arthritis
- This new LEAPS conjugate appears to act
on T cell pathways by a new mechanism that is different from the
pathways used by the CEL-4000 vaccine.
CEL-SCI Corporation (NYSE American: CVM) announced today
that Daniel Zimmerman, Ph.D., its Senior Vice President of
Research, Cellular Immunology, presented new LEAPS data at the
American Association of Immunologists 103th Annual Meeting
(Immunology 2019) in San Diego, California on Saturday, May 11,
2019. The title of his presentation is “Therapeutic vaccination by
two DerG LEAPS conjugates incorporating different PG (aggrecan)
epitopes protect by different immune mechanisms in the PG G1 domain
induced mouse model of rheumatoid arthritis”.
The work was performed in conjunction with researchers at Rush
University Medical Center, Chicago, Illinois. CEL-4000 and a newly
discovered LEAPS conjugate, DerG-PG275Cit, were evaluated alone and
in combination in the sister model of proteoglycan [PG] induced
arthritis (PGIA) called recombinant PG G1 domain-induced arthritis
(GIA), an autoimmune mouse model of rheumatoid arthritis (RA).
Dr. Zimmerman commented, "Both CEL-4000 (DerG-PG70) and
DerG-PG275Cit LEAPS vaccines are therapeutic in the GIA model of RA
with high efficacy, although it appears that they act by different
T helper 2/regulatory T cell (Th2/Treg)-associated protective
mechanisms. In addition, these vaccines incorporate distinct
epitopes that are located in distant regions of the PG molecule
involved in arthritis induction. Thus, a combination vaccine
containing both LEAPS conjugates CEL-4000 (DerG-PG70) and
DerG-PG275Cit, could offer advantages, in case one epitope or
another was missing in the disease inducing situation."
The LEAPS platform technology is currently being utilized to
develop a therapeutic antigen-specific treatment for RA under a
$1.5 million grant from the National Institute of Arthritis and
Musculoskeletal and Skin Diseases (NIAMS), part of the National
Institutes of Health (NIH). Upon completion of preclinical and
Investigational New Drug (IND) enabling studies for the
antigen-specific LEAPS vaccine treatment of RA, 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 protective 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 the 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 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 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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Gavin de WindtCEL-SCI Corporation(703) 506-1137
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