CEL-SCI Corporation is a late-stage biopharmaceutical company developing products for life-threatening diseases (such as cancer and infectious diseases). Its lead pipeline product – Multikine investigational immunotherapy (Leukocyte Interleukin, Injection) is a complex biological product containing a patented mixture of pro-inflammatory cytokines, lyphokines and chemokines. The aim of the Multikine immunotherapy treatment regimen is to break tumor-tolerance and up-end the tumor’s defense mechanisms by increasing tumor–specific infiltrating T-cells, NK cells and Neutrophils in the tumor and its microenvironment. The Multikine regimen is administered prior to any other therapy (immediately after diagnosis) when the immune system is thought to be most amenable to be activated against the tumor.
Clinical Need/ Opportunity
H&N Cancer is the 6th most common cancer world-wide with about 90% of patients’ cancer being SCC. About 2/3 of the patients have advanced primary disease at diagnosis (i.e., they have advanced disease which has never been treated at the time of diagnosis). In the US about 61,000 new H&N cancer cases are diagnosed annually and over 13,000 deaths result from the disease. The clinical outcome following current standard of care (SOC) treatment for advanced primary SCC patients is generally very poor, and their prognosis dire. The 3-5 year overall survival for these patients is estimated to be less than 50%. These patients, therefore, have a clear unmet medical need. An Orphan Drug Designation for Multikine for the treatment of patients with advanced primary squamous cell carcinoma of the head and neck was granted by US FDA.
US and European patent for Multikine; US patent for LEAPS Platform Technology.
CEL-SCI has six patent applications pending in the United States and one in Europe for LEAPS
CEL-SCI, a pioneer in immunotherapy and immuno-oncology, has been developing Multikine for more than 20 years. They have conducted multiple early (human phase 1 and 2) clinical studies to establish its safety profile, investigate and understand its mechanism of action and ascertain the potential benefit, unique to Multikine immunotherapy. Pathology studies conducted on the tumors removed from patients who participated in the Multikine phase 2 studies have confirmed that Multikine treatment affects tumor cell killing and leads to tumor necrosis. The results of these studies have been published in top-tier peer reviewed journals. The hope is that by administering Multikine treatment to SCC H&N cancer patients prior to their being given standard of care treatment the rate of recurrence will decrease and the overall survival will increase in this patient population, and the unmet medical need for head and neck cancer patients will finally be met.
December 2017: After review of clinical data, the IDMC finds no evidence of any significant safety questions and recommends the continuation of the study
December 2017: CEL-SCI announces confirmation that the study is fully enrolled and CEL-SCI is waiting for 298 deaths to occur in the 2 main groups of the study
$1.5M grant from the US Government (NIH)
Multikine is nearing the end of a global pivotal phase 3 study as a first-line therapy for patients with advanced primary squamous cell carcinoma (SCC) of the head and neck (H&N Cancer).