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- Second keynote invitation follows recent peer reviewed publications and growing international recognition of CEL-SCI's Multikine Phase 3 research
- Multikine neoadjuvant immunotherapy is the first pre-surgery treatment to significantly increase overall survival (OS) of resectable locally advanced head and neck (oral/soft palate) squamous cell carcinoma patients in decades
- Biomarker-based patient selection method that identifies target patient population who can achieve OS benefit is being used in CEL-SCI's 212-patient Registration Study
- Multikine increased the 5-year survival rate in this 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% in the now completed Phase 3 study
CEL-SCI Corporation (NYSE American: CVM) today announced that the Company's Chief Scientific Officer and Multikine® (Leukocyte Interleukin, Injection)* inventor and developer, Dr. Eyal Talor, has received his second invitation to deliver a keynote address at an international head and neck cancer conference. Dr. Talor has been invited to speak at the 3 rd Global Congress on Otolaryngology, Head and Neck Surgery which will take place on June 9-10, 2027 in Lisbon, Portugal.
Dr. Talor's presentation, titled "Disease/Tumor Biomarkers Prognosticate Overall Survival Benefit in Oral Squamous Cell Carcinoma: A Novel Neoadjuvant Cancer Immunotherapy" will address findings from CEL-SCI's Phase 3 study of Multikine and the Company's work using tumor and disease biomarkers to identify patients most likely to benefit from Multikine treatment before surgery.
This follows Dr. Talor's recent keynote speech at the 6th World Congress on Otology, Rhinology and Laryngology in Rome on October 26. Both invitations came after recent peer-reviewed publications of CEL-SCI's IT-MATTERS Phase 3 research. The series of scientific publications and keynote invitations is expanding the visibility of CEL-SCI's biomarker-based approach among specialists who diagnose and treat head and neck cancer.
"We believe these keynote invitations reflect growing scientific interest in what we have demonstrated with Multikine: the first overall survival advantage for a neoadjuvant treatment in this patient population in many decades, and a biomarker-based method that can identify at diagnosis the patients most likely to achieve this substantial survival benefit," said CEL-SCI CEO Geert Kersten. "This combination is what makes our findings potentially groundbreaking for head and neck cancer patients. We are now applying this patient selection method prospectively in our Registration Study of 212 patients."
CEL-SCI's completed 928-patient IT-MATTERS Phase 3 study identified disease and tumor biomarkers which can be applied at diagnosis to select previously untreated, locally advanced head and neck cancer patients most likely to benefit from neoadjuvant Multikine administration, a pre-surgery treatment. CEL-SCI is applying these biomarkers prospectively as patient selection criteria in its 212-patient Registration Study, which is designed with approximately 97% statistical power to detect the survival effect previously observed in this population.
Surgeons, healthcare professionals, academic scholars and researchers from around the world are expected to participate in the 3rd Global Congress on Otolaryngology, Head and Neck Surgery in Lisbon. The Congress provides a forum for scientific research, surgical advances and clinical developments in otolaryngology and head and neck surgery. The theme of the 2027 Congress is "Transforming ENT Care through Research, Innovation, and Clinical Excellence."
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, resectable 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%. The results of the IT-MATTERS global Phase 3 study represent the first overall survival advantage for a neoadjuvant treatment, in the treatment naïve resectable locally advanced head and neck squamous cell carcinoma (cancer) patients, in many decades.
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
