CEL-SCI (US:CVM)2020-02-11 18:19Multikine Clinical Trial and Regulatory Status - Multikine is an investigational therapy for head and neck cancer, not yet licensed or approved by the FDA or any other regulatory agency[7] - CEL-SCI is conducting a Phase 3 clinical trial of Multikine in advanced primary head and neck cancer patients, with full enrollment completed in September 2016, involving 928 patients[21] - The Phase 3 study is event-driven, requiring 298 events (deaths) to occur among the two main groups to assess the primary endpoint of a 10% improvement in overall survival[21, 45, 52] - The FDA has granted Orphan Drug designation to Multikine for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck, potentially providing 7 years of market exclusivity upon approval[43, 62] Multikine Mechanism and Clinical Data - Multikine is designed to be administered before surgery, radiation, and chemotherapy to stimulate the immune system[9, 21, 61] - A Phase 2 study showed that 10.5% of evaluable patients had no remaining cancer cells after 3 weeks of Multikine alone, and the remaining treated patients had about a 50% average reduction in cancer cells[31, 32] - The Phase 2 study also showed a 33.1% improvement in overall survival at 3.3 years with Multikine plus standard of care compared to standard of care alone[34, 62] Market and Competitive Landscape - The worldwide market for head and neck cancer involves approximately 650,000 new patients diagnosed per year[27, 62, 63] - Unlike other immunotherapies like Keytruda, Opdivo, and CAR-T, Multikine is intended for use in newly diagnosed patients before standard of care, not in recurrent or metastatic cases[10, 22, 62, 64] Manufacturing and Intellectual Property - CEL-SCI has a state-of-the-art manufacturing facility for Multikine, with over 73,000 ft2 of space, including about 35,000 ft2 fully developed[42] - Multikine has composition of matter patent protection until 2024, including US Patent 6,896,879 and European Patent 1,773,395[43]