CEL-SCI Corporation is a clinical-stage biotechnology companyfocused on developing immunotherapy products and technologiesto treat cancer and infectious diseases that address significant unmet medical needs. The Company aims to develop novel therapies with the potential to activate and utilize the body’s own immune system against the disease.
The Company is focused on developing product candidates based on two innovative technologies: (1) Multikine® (Leukocyte Interleukin, Injection), a next-generation, comprehensive immunotherapy; and (2) L.E.A.P.S.™ (Ligand Epitope Antigen Presentation System or LEAPS™), an immunotherapy vaccine technology platform.
CEL-SCI’s lead product candidate, Multikine®, is an investigational immunotherapy in Phase 3 studiesfor patients with squamous cell carcinoma of the head and neck (advanced primary head and neck cancer), for which the Company has received Orphan Drug Status from the FDA. CEL-SCI intends to demonstrate that Multikine® could become an integral first-line component of the current standard of care (SOC) regimen due to its effectiveness and safety profile. Multikine® is also being studied for the treatment of cervical dysplasia in human immunodeficiency virus (HIV) and human papillomavirus (HPV) co-infected patients.
Multikine® modulates the body’s immune system through a dual mechanism of action: eliciting the direct killing of tumor cells and micrometastasis (limiting the possibility of recurrence), while generating a sustainable anti-tumor response, and possibly rendering tumor cells more susceptible to subsequent radiation and chemotherapy.
Multikine® is being developed as a first-line treatment for advanced primary head and neck cancer, to be given as a neoadjuvant, prior to other therapy options (chemotherapy and radiation therapy). Multikine® augments/stimulates the immune system before it is weakened by both the toxic therapies and the cancer itself. According to CEL-SCI, Multikine® would be the world’s first cancer immunotherapy drug to be administered prior to surgery.
In its most recent Phase 2 clinical trial for Multikine®, CEL-SCI reported a 10.5% complete response rate (no clinical or pathology evidence of any remaining cancer) and a 33% improvement in overall survival. Most importantly, there has been no severe adverse events associated with the use of Multikine®.
Multikine® is currently in a pivotal Phase 3 clinical trial (IT-MATTER), the largest head and neck cancer study ever conducted. In May 2020, CEL-SCI announced that it had reached the required number of events for the completion of its Phase 3 trial. The Company is proceeding with the analysis of the data and expects to file for regulatory approval in 2021.
CEL-SCI’s second proprietary technology platform, LEAPS™, is a vaccine technology platform designed to stimulate the immune system to fight bacterial, viral, and parasitic infections more effectively, as well as autoimmune conditions, transplant rejection, and cancer. Research for the development of the LEAPS™ technology as a treatment for RA has been funded in part via two Small Business Innovation Research (SBIR) grants from the National Institutes of Health totaling $1.725 million.
The LEAPS™ technology is being used to develop therapeutic agents for rheumatoid arthritis (RA) as the lead indication, as well as for COVID-19 in collaboration with the University of Georgia’s Center for Vaccines and Immunology.
The inflammatory response driving RA may be different in different individuals, with failure of some patients to respond to certain therapies reflecting these differences. The LEAPS™ platform can be designed to produce a specific natural immune response depending on the type of construct used. Thus, once the nature of the inflammatory response has been identified, the patient can be treated with the appropriate LEAPS™ vaccine.
CEL-SCI operates a dedicated state-of-the art manufacturing facility with over 73,000 sq. ft. of manufacturing and research and development (R&D) space. The Phase 3 trial was supplied from this facility, reducing regulatory risks at time of approval.
As of March 31, 2020, CEL-SCI’s cash position was $14.3 million. The Company has no debt, no convertible notes, and a clean balance sheet.