Jennerex Inc, a private clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class targeted oncolytic products for cancer, and Transgene, a bio-pharmaceutical company specialized in the development of immunotherapeutic products, have announced that enrollment and treatment of patients in a Phase 1b clinical trial has been initiated to evaluate JX-594 in patients with advanced metastatic, refractory colorectal cancer (CRC).
The study will be performed in Korea, where Green Cross Corporation holds market rights for JX-594.
“The initiation of this study marks an important step forward in the development of JX-594 for a second major oncology indication. With a significant and growing population of colorectal cancer patients who have failed existing therapies or for whom existing therapies are not appropriate, we believe JX-594, with its unique mechanisms of action and demonstrated tumour response in preclinical models of CRC, may provide an important new therapeutic modality for patients around the world suffering from this devastating cancer,” said David H Kirn, MD, president and chief executive officer of Jennerex.
“The study design for this trial builds on our joint experience and positive clinical results using JX-594 to treat liver cancer and represents an important milestone which is our ability to administer multiple doses intravenously,” added Philippe Archinard, chairman and chief executive officer of Transgene.
The intravenous, open-label, multi-dose-escalation study is being conducted at Samsung Cancer Center in Seoul, South Korea. The study will enroll up to 15 patients with metastatic colorectal cancer that have failed both oxaliplatin-based and irinotecan-based chemotherapy regimens, and whose tumors harbor ras mutations and/ or are refractory to Erbitux therapy. Patients enrolled in the trial will receive biweekly intravenous infusions of JX-594 at one of three dose levels to evaluate the safety, tolerability and maximum tolerated dose of JX-594 for the treatment of CRC.
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: the lysis of cancer cells through viral replication, the reduction of the blood supply to tumors through vascular targeting and destruction, and the stimulation of the body's immune response against cancer cells.
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. Objective tumor response has been demonstrated in a variety of cancers including liver, colon, kidney, lung and melanoma. Transgene holds an exclusive license to develop and commercialize JX-594 in Europe and neighboring countries. Green Cross Corporation, a leading company in the development, manufacturing, and commercialization of viral vaccines and other biological products, holds an exclusive license to develop and commercialize JX-594 in South Korea, and Lee's Pharmaceutical Ltd. holds an exclusive license to develop and commercialize JX-594 in China.
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 exactcause 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.