CEL-SCI Files Request with UK Regulator for Approval Pathway of Multikine Immunotherapy for Head and Neck Cancer Treatment

CEL-SCI Corporation, a biotechnology company, has announced that it has filed a request with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) to discuss the approval pathway for its immunotherapy treatment, Multikine, for newly diagnosed head and neck cancer. The company plans to present new results to the MHRA, demonstrating superior pre-surgical response rates and overall survival advantages compared to previous data.

The improved selection algorithm used in the study, based on feedback from regulators and consultants, has allowed CEL-SCI to more accurately identify patients who would benefit most from Multikine therapy. The statistical validation of outcomes in the new target population, based on Phase 3 study data, will be presented at the Conference of the European Society for Medical Oncology (ESMO) in Madrid, Spain.

CEL-SCI aims to obtain marketing authorization for Multikine in the UK as soon as possible, leveraging the data already generated. The company recently submitted a similar request to the European Medicines Agency (EMA). CEL-SCI’s CEO, Geert Kersten, expressed excitement about the results seen in the newly defined Multikine target population.

The pivotal Phase 3 study of Multikine involved newly diagnosed locally advanced head and neck cancer patients. The study revealed a nearly 4-year median overall survival benefit for Multikine-treated patients who underwent surgery and radiotherapy compared to the control group. The medical community recognizes the urgent need for a new and effective treatment for this type of cancer.

CEL-SCI believes that boosting a patient’s immune system while it is still intact can have a significant impact on survival. Unlike other cancer immunotherapies, Multikine is administered before conventional therapies, allowing the immune system to target the tumor more effectively. The Phase 3 study enrolled 928 patients.

Multikine has already received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck. CEL-SCI operates in Vienna, Virginia, and near/in Baltimore, Maryland.