CEL-SCI Corporation announced that it has been granted a European patent on Multikine (Leukocyte Interleukin injection), its investigational phase 3 cancer immunotherapy. The patent, number EP 1 753 452 B, is entitled, “A method for altering the Cd4/Cd8 ratio and the mononuclear cellular infiltrate into a tumour”.

The patent is important because it recites a mechanism of action of Multikine by which Multikine changes the type of T cells that enter the tumour microenvironment. This change results in the tumour becoming "visible" to the immune system, resulting in a robust and sustainable anti-tumour immune response.

Positive results with Multikine in earlier clinical studies confirmed by pathology were published. An ongoing phase 3 clinical trial against advanced primary (not yet treated) head and neck cancer is progressing rapidly. The study is ongoing in 24 countries and so far has enrolled over 600 patients. In October 2015 the clinical research organisation that runs the study added $2 million to its co-development investment in the phase 3 study. Their investment of $12 million will only be repaid from a successful drug.

The Multikine phase 3 study is enrolling patients with advanced primary squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care (SOC) vs. subjects who are treated with SOC only.

Multikine (Leukocyte Interleukin injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal phase 3 clinical trial as a potential first-line treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body's natural immune system in the fight against tumours.

Multikine is also being tested in a phase 1 study under a Cooperative Research and Development Agreement (CRADA) with the US Naval Medical Center, San Diego, and at University of California, San Francisco (UCSF), as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. Dr. Joel Palefsky, a world renowned scientist and key opinion leader (KOL) in human papilloma virus (HPV) research and the prevention of anal cancer, is the principal investigator at UCSF, which was added to the study in July 2015.

CEL-SCI has also entered into two additional co-development agreements for up to $3 million each with Ergomed Clinical Research Limited to further the development of Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.