CEL-SCI
CEL-SCI is a biotechnology company focused on developing immunotherapy products for cancer, autoimmune, and infectious diseases, with its lead product, Multikine, showing promising results in a Phase III trial for head and neck cancer.
Company Overview
CEL-SCI is focused on developing immunotherapy products aimed at treating cancer, autoimmune, and infectious diseases. The company's research and development efforts are centered on novel approaches to mobilizing and enhancing the body's immune system to fight diseases.
Multikine Immunotherapy
Multikine is an investigational immunotherapy being developed by CEL-SCI for the potential treatment of advanced primary head and neck cancer. The product has received Orphan Drug designation from the FDA for its use as a neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck. Multikine has shown a significant 5-year overall survival benefit in a Phase III trial, which was the largest ever conducted for head and neck cancer, with 928 patients enrolled.
LEAPS Technology
CEL-SCI is developing LEAPS technology, which includes two investigational product candidates aimed at treating rheumatoid arthritis. LEAPS stands for Ligand Epitope Antigen Presentation System and represents a unique approach to immune system modulation, leveraging specific antigens to achieve targeted therapeutic effects in autoimmune diseases.
FDA Submission and Phase III Trial
Following promising results from a large-scale Phase III clinical trial for Multikine, CEL-SCI plans to submit a Biologics License Application (BLA) or New Drug Application (NDA) to the FDA. This pivotal trial enrolled 928 patients and demonstrated a significant 5-year overall survival benefit for those treated with Multikine.
Manufacturing Facility
CEL-SCI has a dedicated manufacturing facility located outside Baltimore, Maryland, where it produces Multikine. This facility is integral to the company's capabilities in scaling up production to meet future demand for their immunotherapy products.