Jennerex, a private clinical-stage biotherapeutics company, has treated the first patient in a Phase IIa clinical trial of JX-594, as a neoadjuvant therapy in patients who are undergoing surgery to treat colorectal cancer.
JX-594 is a proprietary, engineered oncolytic virus that will selectively target and destroy cancer cells through three mechanisms of action: lysis of cancer cells through viral replication, shutdown of the blood supply to tumours through vascular targeting and destruction, and stimulation of the body's immune response against cancer cells.
The study being led by Rebecca Auer, a surgical oncologist at The Ottawa Hospital, is funded by the Ontario Institute for Cancer Research.
The Phase IIa trial will enrol around 20 patients with colorectal cancer metastases to the liver, and will receive a single injection of JX-594 intravenously or intratumorally two weeks prior to surgical resection.
In the study, tumours will be evaluated for evidence of JX-594 replication and pathologic response, and then patients will be followed for progression-free survival and overall survival.
Jennerex president and chief medical officer David Kirn said the study will allow them to demonstrate the use of JX-594 in patients with surgically resectable disease, potentially expanding the role of the therapy in the treatment continuum.
"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 IIb study, called TRAVERSE, that is under way in patients with advanced hepatocellular carcinoma," Kirn added.
Ottawa Hospital Research Institute Cancer therapeutics senior scientist John Bell said that the trial also will help them to expand their analysis of the multi-mechanistic therapeutic activity of JX-594 through the examination of tumour specimens collected during surgery following JX-594 administration.
Earlier Phase I and Phase II clinical trials have showed that JX-594 induces tumour shrinkage and tumour necrosis, and is safe and well-tolerated by patients with only mild adverse events exhibited.