Life Sciences

Life Sciences

Key Capital has agreement to license a promising and unique range of oral vaccine immunotherapies commencing in Central America, and initially in Guatemala and Costa Rica. The lead immunotherapy product has demonstrated breakthrough success in the treatment of liver cancer.

Key Capital has agreement to establish a Cancer Research and Treatment Center in association with and at Hospital Reina de Los Herreros in Antigua, Guatemala. It is expected that the Center will formally open at the hospital in Q1, 2020 with a focus on patients with advanced or terminal cancers. Guatemala and other Central American countries have a high incidence of cancer, with a large portion of their population having little to no treatment options, especially in late-stage and terminal liver and pancreatic cancer cases. Providing a treatment program to research and meet this unmet medical need will be a priority for the Center as it researches and trials the immunotherapeutic oral vaccine. In preparation for the establishment of the Cancer Research and Treatment Center a dedicated hospital wing has been renovated over the past six months and advanced diagnostic and screening facilities have been installed. As previously announced by Key Capital, the Immunitor hepcortespenlisimut-L oral vaccine has demonstrated highly promising results in late-stage liver cancer patients.

Phase II Trial

An open-label Phase II study of the hepcortespenlisimut-L immunotherapeutic vaccine conducted in 75 terminal stage patients with inoperable hepatocellular carcinoma (HCC) has shown that taking one Immunitor oral vaccine tablet per day is safe and highly effective as published in the open access Journal of Hepatocellular Carcinoma (https://www.dovepress.com/articles.php?article_id=32377).

The study demonstrated that after a median two months of treatment 50 out of 75 patients saw their hepatic tumor marker or alpha-fetoprotein (AFP) levels decline, indicating two thirds of the study population responded to immunotherapy as the decrease in AFP levels was correlated with tumor shrinkage. Those patients who saw their AFP range fall to normal levels experienced tumor clearance, implying that they were in remission.

In the study, there were 12 patients (16%) who had AFP levels below the 10 IU/ml threshold where the tumors were cleared. Further, over 90% of the patients were alive after median follow-up of 12 months as compared to a 10% overall survival rate in patients who received sorafenib, the first-line chemotherapy approved by the FDA in 2005. No adverse events or toxicity were observed at any time.

Based on the encouraging data in HCC patients, hepcortespenlisimut-L has received orphan drug designation from the U.S. FDA (Food and Drug Administration). The Cancer Research and Treatment Center in Guatemala will administer the Immunitor immunotherapy treatment and provide patient supervision and monitoring that is expected to lead to further patient data acquisition within a population where poverty and social conditions provide few alternative options.