Immunitor publishes interim results from Phase III trial of oral immunotherapy for liver cancer

The Immunitor study is published in January issue of Hepatoma Research ( Identifier: NCT02232490).

Liver cancer, called hepatocellular carcinoma (HCC), occurs each year in more than 800,000 people around the world and about 700,000 die from the disease. HCC is the 5th most common cancer and the 2nd leading cause of cancer deaths. Mongolia firmly occupies the first place among all countries when it comes to incidence of HCC, while China has half of all patients suffering from liver cancer. The incidence of HCC is expected to rise in the United States and across the world, given the increasing prevalence of hepatitis C and B infections, alcohol consumption, NASH, diabetes, toxin exposure and obesity. By the time diagnosis of HCC is made, various surgical interventions or liver transplantation are often not feasible. Conventional systemic chemotherapy such as sorafenib, regorafenib, lenvatinib, and cabozantinib are seldom effective and quite toxic. The FDA has recently approved three antibody-based drugs for HCC indication: nivolumab, pembrolizumab, and ramucirumab. Additional immune interventions from the checkpoint inhibitor family, i.e., durvalumab, atezolizumab, and bevacizumab, as well as tremelimumab, which belongs to the anti-CTLA4 class, are being investigated. Experience has shown that none of the currently approved or experimental HCC drugs are free from adverse side effects and have limited effect in shrinking tumors. While we have witnessed a surge of systemic therapies in recent years, the need for safer and truly effective treatment remains.

The Immunitor study is published in January issue of Hepatoma Research( Identifier: NCT02232490). Easy-to-use, once-per-day oral tableted therapeutic vaccine called hepcortespenlisimut-L (V5 or Hepko-V5) was developed by Vancouver-based Immunitor Inc in collaboration with medical team at the National Cancer Center in Mongolia and investigators in the USA, China and Thailand. This trial is continuation of successful 75-patient Phase II trial published in 2017 in the Journal of Hepatocellular Carcinoma. Anti-HCC property of V5 was discovered accidentally ten years ago during clinical use for original primary indications, which are chronic viral hepatitis and liver cirrhosis. V5 has been used by over 30,000 individuals since 2002 and has never been reported of causing any serious adverse reactions. The US FDA granted Hepko-V5 orphan drug designation status in 2014. V5 inherently incorporates all circulating antigens from pooled blood of HCC patients, including tumor unrelated immunogens such as viral hepatitis antigens, microbial antigens such as Mycobacterium TB, and alloantigens, which are not necessarily pathogenic. A version of V5 also known as Tubimod is approved by US FDA for immunotherapy of tuberculosis – most prevalent infectious disease in the world.

“What makes this investigation standing apart from current immunotherapeutic approaches in oncology is that it attacks the problem from a new angle that has not been attempted before. Our goal is to demonstrate that oral allogeneic vaccine delivery induces both the immune activation and at the same time the tolerance, which is the counterintuitive approach against paradigm dominating the field of immuno-oncology,” said Dr Aldar Bourinbaiar – the CEO of Immunitor. “We firmly believe that our approach makes sense since we see drastically higher response rate and unprecedented safety unlike anything published in in the past. Our investigation of hepcortespenlisimut-L is in its early stage and we are sure we will make more surprising discoveries down the road. Besides the profound influence on the immune response, which is expected from cancer vaccines, we see very clear clinical benefits in terms of improved liver function and decrease in tumor marker alphafetoprotein (AFP), which we have shown to be correlated with tumor regression. Indeed, when AFP levels in a patient are back to normal levels the tumor disappears.”

About Immunitor 
Canada-based Immunitor is a private biopharmaceutical company with affiliations in USA, Russia, China, Hong Kong, Ukraine, Mongolia and South Africa. Immunitor has developed unique oral delivery platform and is among the top ten leading oral vaccine companies globally. Company has an extensive pipeline of 22 oral immunotherapy products at various stages of development, including many already commercialized. Immunitor’s therapeutic vaccines are made as ordinary appearing tablets or pills stable at room temperature for years. They are broadly split into three clinical categories: infectious diseases, metabolic/ inflammatory/autoimmune disorders and oncology indications (cancers affecting lungs, breast, liver, pancreas, gallbladder ducts, GI tract, kidneys, ovaries, cervix, brain, sarcoma, multiple myeloma, etc. For more information, please write at [email protected].

What makes this investigation standing apart from immunotherapeutic approaches in oncology is that it attacks the problem from a new angle not attempted before