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- Keynote presentation at leading head and neck cancer conference will include new findings from CEL-SCI's landmark Phase 3 study, the largest in the world for its indication
- CEL-SCI's patient selection method is a potential breakthrough advancement in head and neck cancer diagnosis and treatment
- Biomarker-based patient selection strategy is being used prospectively in CEL-SCI's upcoming 212-patient U.S. Confirmatory Registration Study
CEL-SCI Corporation (NYSE American: CVM) today announced that the Company's Chief Scientific Officer, Dr. Eyal Talor, has been invited to deliver a keynote presentation at the 6th World Congress on Otology, Rhinology and Laryngology ( Otorhinolaryngology 2026 ), being held October 26–27, 2026 at the Occidental Aran Park in Rome, Italy.
Dr. Talor's keynote presentation, titled "Disease/Tumor Biomarkers in Oral Squamous Cell Carcinoma Prognosticate Overall Survival Benefit for Novel Neoadjuvant Cancer Immunotherapy," will present findings from CEL-SCI's Phase 3 study of Multikine ® (Leukocyte Interleukin, Injection)*, including new analyses that have not previously been presented by CEL-SCI.
The presentation will further explore CEL-SCI's groundbreaking use of disease and tumor biomarkers to identify, before treatment, the head and neck cancer patients most likely to achieve a survival benefit from Multikine neoadjuvant immunotherapy. This biomarker-based patient selection strategy forms the foundation of CEL-SCI's upcoming 212-patient U.S. Confirmatory Registration Study.
"Being invited to deliver a keynote address at this very important international congress attended by specialists who diagnose and treat head and neck cancer is an important milestone for Multikine and points to the scientific and medical field's recognition of our work," said CEL-SCI CEO Geert Kersten. "Dr. Talor will present findings that expand our understanding of Multikine and its impact on tumors beyond what we have previously reported. We believe these findings not only further strengthen the scientific rationale for our biomarker-based patient selection strategy for our Confirmatory Registration Study, but they will also advance the approach of diagnosis and treatment of locally advanced head and neck cancer patients."
CEL-SCI has determined specific tumor and immune biomarkers that when applied as selection criteria at diagnosis, identify previously untreated locally advanced disease patients where the tumor defenses are less robust and the local immune system is mostly intact; this then allows Multikine to be more effective as a first-treatment (neoadjuvant) and increase its potential to extend the overall survival of treated patients versus control. The upcoming Confirmatory Registration Study will prospectively select patients based on these biomarkers and is designed with approximately 97% statistical power to detect the survival benefit observed in this population in the now completed Phase 3 study.
About Multikine
Multikine is a novel cancer immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated locally advanced head and neck cancer. Its goal is to activate a person's immune system to fight cancer before the ravages of surgery, radiation and chemotherapy have weakened the immune system. In the world's largest locally advanced head and neck cancer Phase 3 study, Multikine increased the 5-year survival rate of the target patient population to 73% vs 45% in patients treated with standard of care alone and halved the risk of death from 55% to 27%.
About Cel-Sci Corporation
CEL-SCI believes that boosting a patient's immune system before surgery, radiotherapy and chemotherapy have damaged it, should provide the greatest possible impact on survival. Multikine 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.
Multikine (Leukocyte Interleukin, Injection), given right after diagnosis and before surgery, has been administered to over 740 patients and has an excellent safety profile compared to other cancer drugs. It has 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. 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, inability to finalize a partnering agreement 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, 2025. 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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Gavin de Windt
Cel-Sci Corporation
(703) 506-9460
