After years in development, CEL-SCI’s Multikine has moved one more step closer to regulatory approval, as the company announced plans to run another Phase III study for head and neck cancer patients following discussions with the US Food and Drug Administration (FDA). Multikine has been in development for a while, and CEL SCI has released Phase III data with the therapy from the IT-MATTERS trial (NCT01265849) through several updates in the last few years. However, last year, the FDA said the company would need to run another confirmatory trial that uses certain selection criteria that rely on methods like PET-CT/MRI screening, to be eligible for approval.

The recent announcement states the FDA has approved a plan for a Phase III study with specific inclusion criteria. The study will accrue 212 patients who will be identified before they undergo surgery, which is when Multikine is administered. As per the company, these will be newly diagnosed advanced primary head and neck cancer patients who could see the greatest survival benefit when treated with Multikine.

Half of the cohort will receive Multikine plus standard of care, with the other half receiving standard of care alone. Standard care is surgery followed by radiotherapy or concurrent radiochemotherapy. According to a report on GlobalData’s Pharma Intelligence Center, the head and neck squamous cell carcinomas (HNSCC) market is forecast to generate $3.4bn in the eight major markets (UK, US, Spain, France, Italy, Germany, Japan, and China) by 2031. GlobalData is the parent company of Clinical Trials Arena. While the company has received an approval to conduct such a study in the US, it has also pursued regulatory approvals in other countries. In October 2023, the company said it would discuss a path for approval with the UK Medicines and Healthcare Products Regulatory Agency (MHRA), and later said it expects a meeting with the regulatory in H1 2024.

Recently in the HNSCC space, Transgene and Japanese NEC Corporation announced plans to start a Phase II extension for its individualised cancer vaccine, TG4050. The companies released follow-up data from the Phase I trial (NCT04183166) of the vaccine in April 2024 which demonstrated that all 16 patients in the TG4050 treatment group were disease-free while three out of the 16 patients in the control observation arm relapsed after 18.6 months.

Announcing the latest plans for the Phase III trial, CEL-SCI’s CEO Geert Kersten said: “Through this discussion and agreement with the FDA, we have achieved a tremendous milestone for people who are newly diagnosed with head and neck cancer. ”

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