-
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.
VIENNA, Va.–(BUSINESS WIRE)–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.
Contacts
Gavin de Windt
CEL-SCI Corporation
(703) 506-1137