Groundbreaking Immunotherapy Trial in Advanced Liver Cancer

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Immunitor Inc., is pleased to report publication of a first ever successful trial in the oncoimmunology field showing that the once-daily tablet of oral immunotherapeutic vaccine, hepcortespenlisimut-L (Hepko-V5), was safe and highly effective in treating patients with advanced liver cancer - inoperable hepatocellular carcinoma (HCC). The open-label Phase II study conducted in 75 patients with late-stage HCC appeared in open access Journal of Hepatocellular Carcinoma (https://www.dovepress.com/articles.php?article_id=32377

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We are deeply satisfied by outcome of this study, which has all the signs of long-awaited breakthrough in liver cancer

The overall survival observed in the published study was outstanding – over 90% of patients were alive after median 12 months of follow up – by comparison only about 10% survive after one year of treatment with sorafenib. This study has also shown that after median 2 months of treatment 50 out 75 patients had their hepatic tumor marker, alpha-fetoprotein or AFP, declined, which indicates that two thirds (66.7%) of studied population responded to immunotherapy, since the decrease in AFP was correlated with tumor shrinkage. Those who had AFP down to normal levels experienced tumor clearance, implying that they were cured. There were 12 patients (16%) in the study who ended up with normalized AFP below 10 IU/ml. No adverse events or toxicity were observed at any time – an observation in line with the experience in over 10,000 people who took V5 for the past 15 years in more than 30 countries for clinical indications such as liver cirrhosis and hepatitis. Considering that no validated immunotherapy for liver cancer has emerged after 20 years of research efforts, these results are highly promising. An ongoing Phase III study at the Mongolian National Cancer Center is aimed to confirm the potential of hepcortespenlisimut-L in placebo-controlled, randomized setting.

HCC is the second most common cause of death from cancer, estimated to be responsible for 788,000 deaths or 9.1% of total cancer fatalities in 2015. Aside from surgery, the only available option is the FDA-approved chemotherapy, sorafenib (NEXAVAR), which prolongs life by 2.8 months, results in 2% of partial clinical response, but no cure. According to the American Cancer Society 40,710 new cases of HCC and intrahepatic bile duct cancer will be diagnosed in 2017 in the United States. “While HCC rates have tripled since 1980, they are still relatively low in North America and most of Europe, but it is a major cause of death in developing countries”, said Dr. Allen Bain – director of Vancouver-based Immunitor Inc. “Half of liver cancer patients are in mainland China”, added Mr. Alan Reid – head of Hong Kong-registered Immunitor China Ltd – a company set up to address the unmet need of Asian market. “Africa has the remaining share of burden”, joined Mr. Paul Heslop - the company manager in Johannesburg, South Africa. Mr. Valeryi Kalashnikov – representative in Moscow, Russia – noted: “Eastern Europe and Russian Federation are additional target countries with high prevalence of hepatitis, cirrhosis and liver cancer”. Dr. Aldar Bourinbaiar, CEO of Mongolia-based Immunitor LLC, commented: “The results of this trial are good news to patients with HCC, who now have life-saving option. We are deeply satisfied by outcome of this study, which has all the signs of long-awaited breakthrough in liver cancer. This trial is yet another proof-of-concept for our oral vaccines platform designed to counteract cancer-associated inflammation through induction of immune tolerance, explaining why our vaccine can cure cancer, but without any evidence of toxicity”. The co-founder of the company, Mr. Vichai Jirathitikal, concluded: “Hepko can control HCC the same way as V5 has shown for hepatitis and cirrhosis”.

About Immunitor

Immunitor Inc. is a privately held, commercial stage biopharmaceutical company with headquarters in Vancouver, Canada (http://www.immunitor.com) and offices in Beijing, Johannesburg, Moscow and Ulaanbaatar. Immunitor’s strength resides in its proprietary oral vaccine platform validated by numerous clinical trials conducted over the past 15 years. Immunitor makes several immunotherapy products addressing major health problems, i.e., in infectious diseases area: HIV, HBV, HCV, influenza, malaria, fungal and microbial infections including tuberculosis; in the area of autoimmune and metabolic diseases: i.e., renal failure, thyroiditis, Alzheimer disease, hypertension, atherosclerosis, obesity and diabetes; and recently in oncology space, with several candidates currently being investigated. The immediate goal of Immunitor is to address the unmet need in a wide range of liver-related diseases. A Phase II trial in patients with cholangiocarcinoma – second most common form of liver cancer affecting bile ducts - has been initiated last month. Soon, another immunotherapy will be deployed with intent to treat pancreatic cancer, which has the worst prognosis out of all forms of cancer. Based on encouraging preliminary data in HCC patients, hepcortespenlisimut-L has received orphan drug designation from the U.S. Food and Drug Administration (FDA), which clears the path toward approval in US market.

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Aldar Bourinbaiar
Immunitor
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Aldar Bourinbayar
Immunitor Inc
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since: 02/2017
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