Immunotherapy Trial Started in Patients with Inoperable Pancreatic Cancer

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Immunitor Inc., is announcing the launch of Phase II, open-label, immunotherapy trial in patients with pancreatic cancer.

We are glad to have opportunity to offer the most advanced immunotherapy available today for patients with pancreatic cancer

At least 30 patients with inoperable and chemotherapy-failed pancreatic cancer are expected to be recruited for a 3-month trial (NCT03165591). The main inclusion criteria are higher than normal baseline levels of CA 19.9 tumor antigen. Based on preliminary evidence the immunotherapy-induced decrease of this surrogate marker is correlated with tumor shrinkage and prolonged survival.

Pancreatic cancer is the deadliest form of cancer. It is estimated that in 2017, 53,670 Americans will be diagnosed with pancreatic cancer and 43,090 will die from the disease. Globally, up to 418,000 new cases will be diagnosed annually by 2020. While surgery offers the best chance for survival, fewer than 20 percent of pancreatic cancer cases are diagnosed early enough for surgical intervention. Even with surgery, the disease recurs in approximately 80 percent of these patients. Chemotherapy offers very limited benefit. The U.S. Food and Drug Administration (FDA) approved drugs such as gemcitabine (Gemzar®), erlotinib (Tarceva®), paclitaxel (Abraxane®), irinotecan (Onivyde™), and FOLFIRINOX can improve survival, but produces no cure - the vast majority of patients die within first year. According to the American Society of Clinical Oncology, a six-month course of gemcitabine, the chemotherapy drug typically prescribed for advanced pancreatic cancer, costs about $23,500. Adding erlotinib, which might increase survival time slightly, adds another $16,500, for a total of more than $40,000. For patients without health insurance, pancreatic cancer treatment typically costs about $50,000-$200,000 or more, depending on the type and length of treatment. Despite all these efforts only about 1 in 4 patients survive more than one year and less than 5% survive after five years.

The main endpoint in the planned immunotherapy study are changes in tumor marker CA 19.9 and correlation with tumor burden by CT scans. Additional endpoints will include measuring blood glucose and bilirubin levels that are usually higher than norm in pancreatic cancer. Trial is designed for those who have inoperable form of cancer and are free of concomitant chemotherapy.

“We are glad to have opportunity to offer the most advanced immunotherapy available today for patients with pancreatic cancer. Having successfully developed similar immunotherapies for patients with hepatocellular carcinoma, now in Phase III trial, and cholangiocarcinoma, now in Phase II stage, we are confident that our latest vaccine will be as cost-effective and safe intervention”, said Dr. Allen Bain – director of Vancouver-based Immunitor Inc. Dr. Aldar Bourinbaiar, CEO of Mongolia-based Immunitor LLC, commented: “We are deeply satisfied by our progress in developing portfolio of products designed to address the unmet need in patients with hepato-pancreato-biliary- or HPB diseases that affect the liver, pancreas, gallbladder, and the bile ducts. Our V3-P is yet another proof-of-concept for our oral vaccines platform designed to target tumor and counteract cancer-associated inflammation through induction of immune tolerance. Such an approach has been shown by us to cure cancer, but without any evidence of toxicity”. “Now, we have filled the need for each of HPB diseases, our next frontier is gastrointestinal and colorectal space”, concluded Mr. Vichai Jirathitikal – pharmacist and co-founder of Immunitor.

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, Hong Kong, 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. Hepko-V5 designed to treat hepatocellular carcinoma (HCC) the most common form of liver cancer is now in Phase III trial stage. Based on encouraging preliminary data, 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. A Phase II trial in patients with cholangiocarcinoma – second most common form of liver cancer affecting bile ducts - has been initiated recently. This month another immunotherapy is deployed with intent to treat pancreatic cancer, which has the worst prognosis out of all forms of cancer.

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Aldar Bourinbaiar
Immunitor
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