Immunotherapy company CEL-SCI Corporation (NYSE American: CVM) on Tuesday announced the successful commissioning of its Multikine manufacturing facility, a crucial step toward filing a Biologics License Application with the FDA and other regulators for marketing approval.

Originally built for the world's largest Phase 3 trial in head and neck cancer, the facility underwent expansion and upgrades for regulatory approval and commercial scale manufacturing. The commissioning adhered to industry standards, ISPE guidelines, ICH and regulatory requirements.

Designed to enhance the immune system's targeting of tumours, Multikine is administered in newly diagnosed head and neck cancer patients before standard care. CEL-SCI's unique approach, administering Multikine first, demonstrated statistically significant survival benefits in the final target population. The company plans to submit a proposed study protocol to the FDA in Q1 2024, aiming for FDA endorsement for a confirmatory clinical trial and exploring accelerated approval pathways.

Multikine has received FDA Orphan Drug designation for neoadjuvant therapy in head and neck squamous cell carcinoma.

CEL-SCI operates in Vienna, Virginia, and near/in Baltimore, Maryland.