CEL-SCI Awarded European Patent for LEAPS Vaccine in Treatment of Rheumatoid Arthritis

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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