Highlights from the review:
- T cell immunogens are Next Generation influenza vaccines and antigen specific rheumatoid arthritis (RA) therapy will target T cells.
- Immunomodulation rather than ablation may provide cure of rheumatoid arthritis.
Gavin de Windt
CEL-SCI Corporation (NYSE American: CVM) today announced that a review titled, “Lessons From Next Generation Influenza Vaccines For Inflammatory Disease Therapies” was published in the peer reviewed scientific Journal International Immunopharmacology. This review was authored by Dr. Zimmerman of CEL-SCI, Dr. Rosenthal of Northeast Ohio Medical University and Roseman University and two other CEL-SCI scientists. This review proposes a new approach to treating autoimmune and inflammatory diseases based on lessons from new generation influenza vaccines.
The authors propose that treating autoimmune and inflammatory diseases using a T cell approach, which targets the key drivers of the disease, ablation of potentially harmful cytokines, pathways or cells, offers advantages over the approach used currently, which focuses on stimulating protective antibodies only to specific surface proteins. T cell directed vaccines elicit broader antigenic responses and provide more universal protection.
The current licensed vaccines for influenza generate protective antibodies to specific coat proteins (surface antigens) of the influenza viruses from which they were prepared, and recipients of the vaccines are immunized only to those strains of virus. Because the influenza virus is constantly undergoing a process known as antigenic drift, new variants of the virus may emerge from year to year, and the vaccine which was protective during one influenza season may not be fully protective during the following year. As a result, annually the influenza virus vaccine composition must be reviewed and revised, if necessary. Several approaches to a universal T cell (Uni-Flu) vaccine in NIAID sponsored phase II studies were discussed. In another approach, the DC-LEAPS Uni-Flu anti-influenza vaccine targets dendritic cells which present the influenza antigens and direct the T cell responses towards protection and away from most inflammatory cytokines (i.e. cytokine storm).
Based on the results of the Uni-Flu experiments, the CEL-2000 and CEL-4000 LEAPS (Ligand Epitope Antigen Presentation System) therapeutic antigen specific vaccines were developed for treatment of rheumatoid arthritis. These vaccines can be readily customized to provide an antigen specific approach to modulating the disease driving immune response. In animal models of rheumatoid arthritis these vaccines stopped the progression of disease and promoted a return to a more balanced cytokine and immune cell response to the disease driving antigen. Other immune modulating therapeutic approaches were also mentioned.
The LEAPS platform technology is currently being utilized to develop an antigen specific 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.
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 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 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 thought to 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 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.
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.
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.
CEL-SCI’S scientific review on inflammatory disease therapies published in peer reviewed journal “International Immunopharmacology”