JX-594
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 reduction of the blood supply to tumors through vascular targeting and destruction, and 3) the stimulation of the body's immune response against cancer cells. JX-594 exploits a specific genetic feature in cancer cells to become activated and lyse the cells, including the EGFR-ras signaling pathway, the cell cycle activation and the loss of cellular interferon defenses. JX-594 is a Wyeth vaccinia virus with a disruption of the viral thymidine kinase (tk) gene and expression of the immunostimulatory cytokine, GM-CSF (granulocyte macrophage colony-stimulating factor).
Phase 1 and Phase 2 clinical trials in multiple cancer types have shown that JX-594, delivered either directly into tumors or intravenously, induces tumor shrinkage, 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. Importantly, JX-594 has also demonstrated an excellent tolerability profile to date in multiple clinical trials. Multiple JX-594-treated patients have survived for over one year and up to four years.
In November 2011, Jennerex presented final data from a randomized dose-ranging Phase 2 clinical trial of JX-594 in patients with advanced liver cancer showing a statistically significant benefit in overall survival for the high JX-594 dose group versus the low dose group. The final data from the HEP007 trial demonstrated that the risk of death for patients who received JX-594 at the high dose was markedly reduced (by nearly 60 percent; hazard ratio = 0.41) when compared to patients randomized to a low dose control (one-tenth of the high dose). The median overall survival for high and low dose groups was 13.8 months versus 6.7 months, respectively (p = 0.029 for superiority of the high dose). The percent of patients alive at one year was 66 percent versus 23 percent in high- and low-dose groups, respectively (Kaplan-Meier estimate). JX-594 was well-tolerated with patients experiencing transient flu-like symptoms that generally resolved within 24 hours. A Phase 2b multinational trial (TRAVERSE) is now underway and is designed to enroll 120 patients with advanced liver cancer who have failed sorafenib therapy. For more information about the trial, please visit www.clinicaltrials.gov.
Transgene (NYSE Euronext Paris: FR0005175080), a bio-pharmaceutical company specialized in the development of immunotherapeutic products, holds an exclusive license to develop and commercialize JX-594 in Europe and neighboring countries. Other regional licenses are held by Lee's Pharmaceutical Ltd. for China and Green Cross Corporation for South Korea. Jennerex has not licensed rights in the United States or Japan.
