Jennerex Announces First Patient Treated In Phase 2a Clinical Trial Of JX-594 As A Neoadjuvant Therapy In Colorectal Cancer

Main Category: Colorectal Cancer
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 01 Jan 2012 - 0:00 PST

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Jennerex, Inc., a private clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class targeted oncolytic virus products for cancer, announced that the first patient has been treated in a Phase 2a clinical trial of JX-594 as a neoadjuvant therapy in patients who are undergoing surgery to treat colorectal cancer that has spread to the liver.

The study is being led by Rebecca Auer, M.D., surgical oncologist at The Ottawa Hospital, associate scientist at the Ottawa Hospital Research Institute and assistant professor of surgery at the University of Ottawa in Ottawa, Canada. The clinical trial is being supported by funding from the Ontario Institute for Cancer Research­.

"This trial will allow us to evaluate the use of JX-594 in patients with surgically resectable disease, potentially expanding the role of this therapy in the treatment continuum," said David H. Kirn, M.D., president and chief medical officer of Jennerex. "We continue to believe that JX-594 could play an integral role in the treatment of cancers and look forward to the results of this trial along with data from the larger Phase 2b study, called TRAVERSE, that is under way in patients with advanced hepatocellular carcinoma."

"In addition, this study will allow us to expand our analysis of the multi-mechanistic therapeutic activity of JX-594 through the examination of tumor specimens collected during surgery following JX-594 administration," said John C. Bell, Ph.D., senior scientist, cancer therapeutics, Ottawa Hospital Research Institute, and professor of medicine, University of Ottawa. Dr. Bell is also the program leader of the Ontario Institute for Cancer Research's Immuno- and Bio-therapies Program.

This Phase 2a clinical trial will enroll approximately 20 patients with colorectal cancer metastases to the liver. Patients will receive a single injection of JX-594 intravenously or intratumorally two weeks prior to surgical resection. Tumors will be evaluated for evidence of JX-594 replication and pathologic response. Patients will subsequently be followed for progression-free survival and overall survival.

JX-594: A Multi-Mechanistic Approach To Targeting Cancer

JX-594 is a proprietary, engineered oncolytic virus that is designed to selectively target and destroy cancer cells. JX-594 is designed to attack cancer through three diverse mechanisms of action: 1) the lysis of cancer cells through viral replication, 2) the shutdown of the blood supply to tumors through vascular targeting and destruction, and 3) the stimulation of the body's immune response against cancer cells, i.e., active immunotherapy. Phase 1 and Phase 2 clinical trials in multiple cancer types to date have shown that JX-594, delivered either directly into tumors or systemically, induces tumor shrinkage and/or necrosis and is well-tolerated by patients (over 120 treated to date). Objective tumor responses have been demonstrated in a variety of cancers including liver, colon, kidney, lung cancer and melanoma. JX-594 has had a favorable safety profile to date with predictable and generally mild side effects that typically include flu-like symptoms that resolve in 24 to 48 hours.

JX-594 is the most advanced product candidate from Jennerex's proprietary SOLVE™ (Selective Oncolytic Vaccinia Engineering) platform. SOLVE takes advantage of the natural attributes of poxviruses as well as their ability to be genetically engineered to produce safe, therapeutic viruses that can infect solid tumors both systemically and locally. The vaccinia poxvirus strain backbone of JX-594 has been used safely in millions of people as part of a worldwide vaccination program. This strain naturally targets cancer cells due to common genetic defects in cancer cells. JX-594 was engineered to enhance this natural safety and cancer-selectivity by deleting its thymidine kinase (TK) gene, thus making it dependent on the cellular TK expressed at persistently high levels in cancer cells. To enhance product efficacy, JX-594 is also engineered to express the immunogenic GM-CSF protein. GM-CSF complements the cancer cell lysis of the product candidate, leading to a cascade of events resulting in tumor necrosis, tumor vasculature shutdown and sustained anti-tumoral immune attack.

About Colorectal Cancer

Colorectal cancer is the second leading cause of cancer-related deaths in the United States and according to the World Health Organization, it accounts for approximately 639,000 deaths worldwide each year. Approximately one in 20 people in the United States will develop CRC during their lifetime, with the risk increasing with age. Ninety percent of all CRC cases are diagnosed in people over the age of 50. The exact cause of colorectal cancer is not known, although there are certain known risk factors that increase the chance of developing colorectal cancer. These risk factors include inflammatory bowel disease, family history of CRC, certain genetic syndromes, smoking, low fruit and vegetable intake and a sedentary lifestyle.

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