CEL-SCI advances Multikine study for head and neck cancer

VIENNA, Va. - CEL-SCI Corporation (NYSE American: CVM), whose stock has surged over 26% in the past week according to InvestingPro data, is set to commence its Confirmatory Registration Study for Multikine in the treatment of head and neck cancer, following the submission of the final clinical protocol to the FDA in December 2024. With analyst price targets ranging from $6 to $10, the market is closely watching this study intended to confirm prior Phase 3 findings, which showed a significant increase in 5-year survival rates for patients treated with Multikine compared to those who received standard care.

The study will target a specific patient group: those with newly diagnosed resectable stage 3 and 4 head and neck cancer, no lymph node involvement, and low PD-L1 tumor expression. The previous Phase 3 trial indicated a survival rate boost to 73% from 45% for control patients, with Multikine treatment extending median overall survival by nearly 4 years.

Enrollment for the 212-patient trial is expected to be complete by Q2 2026. Early tumor response data, which has been correlated with long-term survival outcomes, will be used to seek accelerated approval. The FDA has agreed with the study’s design, which was developed based on feedback from agency reviewers.

CEL-SCI CEO Geert Kersten expressed confidence in the study’s prospects, citing the positive responses from head and neck cancer physicians and the potential for Multikine to set a new standard of care. While InvestingPro data shows the company currently operates with negative EBITDA of $24.6M and faces profitability challenges, the company has been advised by a biostatistician that the study has over a 95% chance of success, given the selection of the target population that benefited the most in the prior study. Investors can access more detailed financial analysis and 8 additional ProTips through InvestingPro’s comprehensive platform.

The study, titled "A Phase III, Open Label, Randomized, Controlled, Multi-Center Study of the Effects of Neoadjuvant Leukocyte Interleukin, Injection (LI) Plus Standard of Care Versus Standard of Care Only in Treatment Naïve Adults With Resectable Locally Advanced Primary Squamous Cell Carcinoma of the Head and Neck," will commence with clinical sites opening in four countries across three continents, with the first site expected in the United States.

CEL-SCI emphasizes the importance of boosting the immune system before surgery and other treatments, which is the approach Multikine takes. The treatment has been administered to over 740 patients and has received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck. With the next earnings report expected on May 13, 2025, investors will be watching closely for updates on the company’s progress and financial position.

This announcement is based on a press release statement from CEL-SCI Corporation.

In other recent news, CEL-SCI Corporation has completed a stock offering, raising approximately $5 million. The offering involved 16,130,000 shares of common stock, priced at $0.31 per share. Proceeds from this offering are intended to support the development of CEL-SCI’s treatment, Multikine, as well as general corporate purposes and working capital. ThinkEquity acted as the sole placement agent for this transaction. Multikine is an investigational therapy aimed at enhancing the immune system’s response to cancer and has been administered to over 740 patients. The treatment holds Orphan Drug designation from the FDA for use in patients with squamous cell carcinoma of the head and neck. CEL-SCI plans a confirmatory Registration Study to further evaluate Multikine, with an enrollment target of 212 patients. The company notes that boosting a patient’s immune system early in the disease process may improve survival outcomes.

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