CEL-SCI concludes provides update on Multikine immunotherapy path to market

CEL-SCI announced it has concluded a productive meeting with the FDA regarding the path forward for bringing Multikine immunotherapy to market for the treatment of newly diagnosed locally advanced squamous cell carcinoma of the head and neck, or SCCHN. During the recent meeting, the FDA acknowledged the longstanding need for improved treatments for head and neck cancer. CEL-SCI believes the agency was collaborative and positive. Preliminary feedback from the FDA included that the selection criteria developed by CEL-SCI could be used to determine which patients should receive Multikine. Based on the feedback received at this recent meeting, CEL-SCI is preparing additional information about its development plan for the next meeting with the agency. CEL-SCI is expecting scientific advice meetings with the European Medicines Agency, or EMA, and the Medicines and Healthcare Products Regulatory Agency, or MHRA, in the UK in the fall of 2023. These are priority markets for CEL-SCI, as Europe has more than twice the number of head and neck cancer cases diagnosed each year as compared to the U.S. The company believes that it is even further along the regulatory path in Canada, as Health Canada already advised CEL-SCI earlier this year that it would be appropriate to request advance consideration for approval of Multikine under the Notice of Compliance with Conditions, or NOCC, policy. If Health Canada grants the NOCC, then it is possible that CEL-SCI could begin commercialization in Canada as early as 2024.