CEL-SCI’s LEAPS Vaccine Offers Promising New Paradigm to Treat Rheumatoid Arthritis: Published in Frontiers in Immunology

CEL-4000 may deliver safe and effective therapy for RA by rebalancing the inflammatory response, without weakening important immune defense mechanisms, risking infections or cancer, as current treatments may

CEL-SCI Corporation (NYSE American: CVM) today announced the peer reviewed scientific journal Frontiers in Immunology published an article regarding CEL-SCI’s Ligand Epitope Antigen Presentation System (LEAPS) technology in the treatment of rheumatoid arthritis (RA) titled: “Current status of immunological therapies for rheumatoid arthritis with a focus on antigen-specific therapeutic vaccines”. CEL-SCI’s LEAPS team, along with outside collaborators from U.S. and Europe, reviewed published/presented results from pre-clinical animal model of antigen-specific LEAPS therapeutic vaccines, such as CEL-4000 and CEL-5000, made specific for the treatment of RA, and compared these findings with published results of other RA-therapies that either suppress or alter the immune response in order to treat RA.

In the article, the authors note that the currently available therapeutic arsenal for the treatment of RA consists mainly of immunosuppressive or ablative drugs, which may carry the potential risk of facilitating recurrent or primary infectious diseases or cancer.

They also underscore that a therapeutic vaccine that can rebalance the inflammatory disease process, promoting antigen-specific disease-directed T cell immune responses, is highly desirable. CEL-4000, an antigen specific immunomodulating vaccine, is provided as a new treatment paradigm that should deliver therapy for RA without weakening important immune defense mechanisms against microbial infections or cancer.

The authors also emphasized that the most appropriate way to advance the LEAPS vaccines to the clinic would be an adaptive study design for clinical trials, enrollment of patients with early-stage RA, and using the Bayesian optimal design model, currently used in oncology studies, as well as the use of disease-related biomarkers to ascertain responsiveness to treatment and introduce additional tools to assess outcome at the disease level.

“At CEL-SCI, we focus on utilizing a healthy immune system to overcome disease safely and with minimal side effects. Our LEAPS platform, and CEL-4000 specifically approaches the treatment of auto immune diseases like rheumatoid arthritis in a completely different way. By rebalancing the immune system to its original healthy state, CEL-4000 could protect patients from the risk of cancer and infection,” stated CEL-SCI CEO, Geert Kersten. “The growing body of preclinical data on LEAPS supports the advancement of this asset into human studies.”

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. Multikine* (Leukocyte Interleukin, Injection) is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. In a Phase 3 study, CEL-SCI studied patients who were newly diagnosed with locally advanced primary squamous cell carcinoma of the head and neck (oral cavity and soft-palate) with the investigational product Multikine administered first, before they received the standard of care, which involved surgery followed by either radiation or chemoradiation. The Phase 3 study enrolled 928 patients. Our approach is unique because most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed.

After analyzing data from the Phase 3 study, we have better defined the target head and neck cancer population for Multikine, which is advanced primary head and neck cancer patients with no lymph node involvement and with low PD-L1 tumor expression. In the Phase 3 study, we observed statistically significant survival data in the final target population, showing that Multikine cut the risk of death in half at five years vs control. We plan to submit the proposed study protocol to the FDA in Q1 2024, with the goal to get FDA buy-in for a confirmatory clinical trial, and also to discuss potential accelerated approval pathways.

Multikine (Leukocyte Interleukin, Injection) received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.

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. 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, 2023. 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. 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.


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