CEL-SCI’s vision is to change the way cancer is treated. We strive to develop novel immune-based therapies with the potential to utilize the body’s own immune defense system against the disease with the possibility of minimal toxicity to normal cells and organ systems.
CEL-SCI’s lead investigational therapy, Multikine® (Leukocyte Interleukin, Injection), is currently being developed as a potential therapeutic agent directed at enabling the immune system to use the body’s own anti-tumor immune response. Multikine (Leukocyte Interleukin, Injection) is the full name of this investigational therapy, which, for simplicity, is referred to in the remainder of this page as Multikine*. Multikine is being developed as a first-line therapy for cancer meaning that it is being studied for use before a patient receives any other therapy for their advanced primary head and neck cancer.
The goal was to demonstrate that this investigational therapy can help make a patient’s initial course of treatment more successful. Data from CEL-SCI’s pivotal Phase III randomized and controlled clinical study demonstrate that Multikine performs as intended based upon its meeting pre-specified protocol endpoints in the treatment arm that received surgery and radiation after Multikine treatment. It did not do so in the treatment arm that received chemoradiotherapy following surgery. The assumption is that the chemotherapy negated the beneficial immunological effect from Multikine. Should the FDA, after reviewing the totality of the manufacturing, preclinical, and clinical data and other information provided to them in a Biologics License Application (BLA), agree and see fit to issue a Biologics License, then the potential that Multikine could be administered to a large number of advanced primary head and neck cancer patients before they begin their first course of traditional therapy.
From the start we have had three core beliefs with respect to building CEL-SCI into a successful biotechnology company:
- Our immune system continuously fights off cancer. As we age, our immune system weakens, making us more likely to develop cancer with each passing year. That is why cancer generally occurs more frequently in older people. We believe that we have the potential to enhance a weakened immune system to fight cancer.
- We believe in creating genuinely new and innovative therapies that have the potential to meet unmet medical needs, as opposed to minor innovations to existing therapies or ‘me-too’ products.
- We believe that it is possible to create a safe and non-toxic cancer drug. In fact, the Phase 3 data suggests that we have done so.
The last FDA approval for advanced primary head and neck cancer was many decades ago. Between 2019 and 2021 six large pharmaceutical companies reported failed studies in head and neck cancer. Consequently, the disease represents a true unmet medical need. Multikine has been granted orphan drug designation for this disease.
Based on the results of our Phase 3 clinical trial, we plan to apply for FDA approval for Multikine use in the treatment of patients who receive Multikine treatment regimen followed by surgery and radiation therapy. The population of patients globally who could benefit from this therapeutic regimen comprise at least 210,000 per year.
* Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with our future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or by any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from clinical trials data summarized on this page or elsewhere on this website involving the investigational therapy Multikine (Leukocyte Interleukin, Injection).