Leukocyte interleukin (CEL-SCI)

VIENNA, Va.--( BUSINESS WIRE )-- CEL-SCI Corporation (NYSE American: CVM) today announced that in a recent meeting the U.S. Food and Drug Administration (FDA) concurred with the Company’s approach to patient selection using low PD-L1 tumor expression in its confirmatory Registration Study for Multikine® (Leukocyte Interleukin, Injection)*. This study will focus on the treatment of newly diagnosed locally advanced primary head and neck cancer patients with no lymph node involvement and low (TPS <10) PD-L1 tumor expression. This Registration Study, slated to commence in the first quarter of 2025, will enroll approximately 212 patients and prospectively confirm the favorable safety profile and the very favorable efficacy results demonstrated in the target population in CEL-SCI’s prior Phase 3 randomized study of 928 patients. PD-L1 is a widely used biomarker for cancer patient selection for checkpoint inhibitors, a class of cancer drugs representing a $48 billion global market in 2023, led by pembrolizumab (Keytruda) which is the top selling drug in the world with $27 billion in estimated 2024 sales. While checkpoint inhibitors such as nivolumab (Opdivo) and Keytruda appear to work best for patients with high PD-L1 expression, CEL-SCI’s Multikine has been shown to be more effective in patients with low PD-L1 expression, thereby uniquely positioning Multikine as potentially a more effective drug for head and neck patients, in whom about 70% have been shown to have low PD-L1 expression. Since PD-L1 acts as a brake on the immune system, Multikine can activate the immune system to fight cancer better without the interference of PD-L1. “To our knowledge, Multikine is the only neoadjuvant immunotherapy that has shown overall survival benefit in the low and negative PD-L1 head and neck cancer population. This underscores the critical importance of having reached an agreement with the FDA on the method for identifying and selecting patients with low PD-L1 tumor expression for our upcoming confirmatory Registration study,” stated CEL-SCI CEO Geert Kersten. “Patient selection based on low PD-L1 as a biomarker can boost the success of our upcoming confirmatory trial, further enhancing our confidence based on the retrospective data from our Phase 3 study. We appreciate the ongoing dialog, exchange of ideas and information with the FDA in support of CEL-SCI’s groundbreaking work as we aim to treat an unmet need in cancer patients with low PD-L1 expression.” 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 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), a true first-line cancer therapy, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Based on the very strong data from the completed randomized controlled Phase 3 study, the FDA concurred with CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a small, focused, confirmatory Registration Study which will enroll 212 patients. CEL-SCI will enroll newly diagnosed locally advanced primary treatment naïve resectable head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing about 100,000 patients annually. 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 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.