CEL-SCI to Present New Multikine® Data at ESMO 2024

CEL-SCI Corporation has announced that it will present new findings from its Phase 3 study of Multikine (Leukocyte Interleukin, Injection) at the European Society for Medical Oncology (ESMO) 2024 Congress. The congress will be held from September 13 to 17, 2024, in Barcelona, Spain. The presentation will be in the form of a poster titled “Prognostic significance of diagnostic staging in treatment naïve, resectable locally advanced primary oral cavity squamous cell carcinoma for neoadjuvant Leukocyte Interleukin Injection immunotherapy.” This poster will be presented by Dr. József Tímár, a well-regarded pathologist.

The U.S. Food and Drug Administration (FDA) has greenlit CEL-SCI to start a confirmatory Registration Study for Multikine in head and neck cancer treatment. This approval is based on the positive safety and efficacy results from the completed Phase 3 IT-MATTERS study. Dr. Tímár, who is a professor at Semmelweis University in Budapest, Hungary, played a significant role in this study by serving as the Director of the Central Pathology Laboratory. He has published 174 peer-reviewed studies and is an editor or board member for four oncology journals. His contributions to cancer research have earned him numerous honors and awards.

CEL-SCI Corporation focuses on enhancing a patient’s immune system while it is still mostly intact, thereby maximizing its potential to combat cancer. Multikine is designed to aid the immune system in targeting tumors effectively. This therapy has been administered to over 740 patients and has received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with head and neck squamous cell carcinoma.

In the target patient group, Multikine has shown impressive results, extending the survival rate to 73% compared to 45% for those who did not receive the treatment, five years post-treatment. Given this robust data, the FDA has given CEL-SCI the approval to proceed with a small, focused confirmatory Registration Study. This study aims to enroll 212 newly diagnosed patients with locally advanced primary head and neck cancer who have no lymph node involvement and low PD-L1 tumor expression. Globally, this patient profile represents over 100,000 individuals annually.

CEL-SCI operates out of Vienna, Virginia, with additional facilities near Baltimore, Maryland.

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