CEL-SCI Awarded Patent for LEAPS Vaccine in Treatment of Rheumatoid Arthritis
LEAPS Platform Technology is currently being developed as a therapeutic vaccine for rheumatoid arthritis with support of a NIAMS grant of the NIH
VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: CVM) today announced that the European Patent Office has issued CEL-SCI patent EP 2254588B1 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 LEAPS platform technology is currently being developed as a potential therapeutic vaccine for rheumatoid arthritis under a $1.5 million grant from National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) of the U.S. National Insitututes of Health (NIH). Upon completion of preclinical investigational new drug (IND) enabling studies for the LEAPS-based rheumatoid arthritis vaccine candidate, CEL-SCI intends to file an IND application with the U.S. Food and Drug Administration to allow the rheumatoid arthritis vaccine to be tested in humans to determine its safety and potential therapeutic usefulness.
“As we move the first LEAPS platform vaccine candidate towards potential human studies, we are pleased to have this important patent issued in Europe. This patent, and other patent applications currently being pursued around the world, expand and fortify our intellectual property coverage 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.
In animal challenge tests conducted in collaboration with the NIH, the US Navy, and several highly regarded universities, LEAPS platform technology has been shown to direct the immune response preferentially to a cellular (e.g. T-cell), humoral (antibody) or mixed pathway. It 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 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, CEL-SCI treats patients who are newly diagnosed with head and neck cancer with its lead investigational immunotherapy Multikine** (Leukocyte Interleukin, Injection), BEFORE they have received 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 being developed as a potential therapeutic vaccine for rheumatoid arthritis and is supported by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
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.
* LEAPS is the trademark that CEL-SCI has registered for this investigational technology, currently in preclinical development. LEAPS has not been licensed or approved for sale, barter or exchange anywhere in the world.
** 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.
Gavin de Windt, 703-506-9460
Source: CEL-SCI Corporation