CVM - CEL-SCI receives FDA feedback on lead asset Multikine

2023-07-14 10:34:58 ET

CEL-SCI Corporation ( NYSE: CVM ) lost ~7% in early trading on on Friday after the company announced the outcome of a recent meeting with the FDA regarding Multikine, an immunotherapy targeted at newly diagnosed squamous cell carcinoma of the head and neck (SCCHN).

The Vienna, Virginia-based biotech said that based on the agency’s comments, it is preparing additional data for the company’s next meeting with the FDA regarding its development plan for the experimental therapy.

However, CEO Geert Kersten noted an FDA requirement to conduct a confirmatory trial to target Multikine for the intended patient population.

CEL-SCI ( CVM ) has already completed a Phase 3 trial for the candidate, indicating a five-year statistically significant benefit of 14.1% in a group of patients who received Multikine followed by surgery and radiation.

"We will collaborate closely with the FDA to design a clinical protocol that will allow us to generate, as expeditiously as possible, the confirmatory data they require for approval of Multikine," Kersten added.

The company expects to file for conditional approval for Multikine in Canada later this year/early next year.

CEL-SCI ( CVM ) expects to commercialize the therapy in early 2024 if Health Canada clears its request for approval under its Notice of Compliance with Conditions (NOCC) policy. The company is looking forward to meetings with European and British regulators on Multikine in the fall of 2023.

More on Multikine

• CEL-SCI spikes after data presentation on lead asset Multikine
• Cel-Sci: Stuck On Its First Next Step

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