Immunitor unveils Phase II trial of hepcortespenlisimut-L at the Society of Immunotherapy of Cancer

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Commercial stage biotech company, Immunitor Inc., presents results of an open-label Phase II trial (NCT02256514) of its lead cancer vaccine at the Cutting-Edge Clinical Trials session (poster #212) of the Society of Immunotherapy of Cancer, National Harbor, MD. The study involved 75 patients, most in advanced stage of HCC, who received daily pill of the vaccine for a median of two months and were followed for an average of 13 months.

This is the first time ever a treatment has been shown to cure liver cancer and offered overwhelming survival advantage to HCC patients

Hepcortespenlisimut-L is an allogeneic vaccine derived from patients’ blood, which is formulated into convenient, once-per-day tablet according to proprietary technology developed by Immunitor founders including Mr. Vichai Jirathitikal. The immunotherapy resulted in 93.3% overall survival rate after one year of follow-up. Complete tumor resolution along with partial responses and stable disease were observed in two out of three patients as presented at the 30th annual conference of the Society of Immunotherapy of Cancer (SITC), National Harbor, MD, November 4-8.

Each year, 780,000 people are diagnosed with liver cancer, with 740,000 people dying from it. Hepatocellular carcinoma (HCC) ranks 6th among all cancer types, but occupies 2nd place in fatality. Doctors have nothing to offer people whose liver cancers are diagnosed at an advanced stage. In the U.S. and Europe about 40% of liver cancers are diagnosed at a late stage; elsewhere in the world, e.g., Mongolia – the main site of the study - the figure stands at 80% or more. Current standard in HCC therapy is sorafenib (Nexavar), which produces a 2% partial response and prolongs life by 3 months. In the past decade many other drugs were tested against HCC, but so far all of them have failed.

“This is the first time ever a treatment has been shown to cure liver cancer and offered overwhelming survival advantage to HCC patients,” said Dr. Aldar Bourinbaiar, CEO of Immunitor LLC - immuno-oncology specialist by training. “Typically, people diagnosed with advanced liver cancer have only a few months to live, but in this trial over 90% of patients were still alive after one year. What is remarkable is that those who had their tumor marker, alpha-fetoprotein (AFP), go back to normal levels had also seen their tumors cleared regardless of the size and number of lesions.”

The mechanism of action of hepcortespenlisimut-L remains to be established, but from preliminary investigations it appears that vaccine works by eliciting powerful immune response of anti-inflammatory nature, which wipes out malignant cells. So far, no adverse side effects have been observed. Contrary, patients, the majority of whom had chronic hepatitis B or C virus infections, often with cirrhosis, have benefited from the immunotherapy by showing improved liver function as demonstrated by normalization of ALT, AST, bilirubin and alkaline phosphatase.

“Immunotherapy is now regarded as the most promising solution in a wide range of diseases and, in my opinion, is the best way to treat cancer as well. This is very promising therapeutic intervention that will potentially save many lives or at least postpone the imminent death," said Dr. Galyna Kutsyna, world-renowned immunotherapy specialist with over 20 published clinical trials to her credit. "This is very exciting. I do not want to be overly optimistic, but it will certainly change the paradigm in the management of liver cancer. We have found that the tumors shrank in as short as one month when we checked patients with a CT scan,” Kutsyna said. “Patients who lost their weight from the cancer started regaining their strength. It is exhilarating to see patients recovering from wasting and enjoying again the life they used to know," she said.

"This is an important milestone as we continue to develop hepcortespenlisimut for this very difficult to treat malignancy that ranks second after lung cancer on the list of global death rates," said Allen Bain, Ph.D., director of Immunitor Inc., in Vancouver, Canada. "We welcome all HCC patients, especially those who have been turned down as incurable, to take part in the trial. There is a hope and immediate opportunity to receive cutting edge therapy," he said. "There is no reason why this would not work with other hepatic tumors as we have seen spectacular responses in some but not all patients with cholangiocarcinoma, fibrolamellar HCC, liver metastases and even in individuals with pancreatic cancer. Though 75 patients may not sound like much, now for the first time, we have a drug that may become the standard of care in terminal liver cancer. The planned price tag is modest, starting from $500 a month, and due to a dearth of other options this will be not a barrier even in low-income countries in Africa and Asia with heavy HCC burden. For example, China alone accounts for half of liver cancers”, he added.

Orphan Drug Designation
Hepcortespenlisimut-L has been designated by the U.S. Food and Drug Administration (FDA) as an orphan drug (#457714) in December of 2014. The orphan designation is assigned for rare diseases like hepatocellular carcinoma, which is diagnosed in about 30,000 people each year in the U.S. The designation creates incentives for pharmaceutical companies, which otherwise would be reluctant to invest time and money into products that will have limited market. Recently, several immunotherapeutics have been proven effective in more common cancers affecting the lung, skin, colon, breast and prostate. But so far none has been approved for liver cancer. Hepcortespenlisimut is now half-way through the pivotal Phase III clinical trial (NCT02232490) and researchers expect to continue enrolling new patients through the first quarter of 2016. The trial is designed for patients who have failed all conventional treatment options. It will document the efficacy and safety of Immunitor’s vaccine and will ultimately lay the ground for the FDA approval.

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Aldar BourinbaIar

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