Jennerex, Inc., a private, clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class targeted oncolytic immunotherapies, presented Phase 2 clinical data of JX-594 delivered first intravenously and subsequently through intra-tumoral route demonstrating safety as well as disease control and tumor responses in patients with hepatocellular carcinoma (liver cancer, HCC). The data were presented in an oral presentation at the International Liver Cancer Association (ILCA) Annual Meeting in Berlin, Germany, by Mong Cho, M.D., from Pusan National University Yangsan Hospital, South Korea.
Twenty five Asian patients with advanced HCC, 20 of whom were refractory to sorafenib, were treated with an initial intravenous dose of JX-594, and the majority of patients then received sequential intra-tumoral doses of JX-594 at week one and three. The majority of patients subsequently received treatment with sorafenib.
The primary objective of this study was to determine the safety of JX-594 followed by sorafenib in patients with advanced HCC. The sequential treatment regimen was well tolerated with transient flu-like symptoms and transient leukopenia being the most common side effects related to JX-594. The sorafenib side effects observed were consistent with the expected toxicity profile of this product.
Secondary endpoints included the effect of the sequential treatment of JX-594 followed by sorafenib on disease control and tumor response. Evidence of antitumor activity was observed in both sorafenib-naive and sorafenib-refractory patients.
Importantly, this trial also demonstrated the feasibility of the systemic administration of the product (through intravenous injection).
"Our ability to deliver JX-594 intravenously to liver cancer tumors, further confirmed by these encouraging data, is a key attribute that sets it apart from other therapies in the class of oncolytic immunotherapies," stated David H. Kirn, M.D., founder, chief medical officer and president of R&D of Jennerex. "In the Phase 2 trial presented at ILCA, JX-594 demonstrated its ability to selectively target and destroy tumors following intravenous infusion. This finding confirms the ability of JX-594 to target both primary and metastatic, or distant, tumors which we believe is important in this HCC patient population and most cancers."
"We have treated more than 160 patients with JX-594 to date and are actively enrolling a multinational Phase 2b study in second line treatment of liver cancer patients, a Phase 2 all-IV trial in first line HCC patients, and a Phase 2 study in colorectal cancer. The data presented today build on the growing body of promising clinical data showing that JX-594 has a direct anti-tumor effect and can stimulate an immune response killing cancer cells," stated Laurent Fischer, M.D., president and chief executive officer of Jennerex. "We are excited with the progress we are making in our JX-594 program and believe it has the potential to advance patient care across multiple types of cancer."
The abstract (#2012-1304) entitled "Phase 2 Trial Of JX-594, A Targeted Multi-Mechanistic Oncolytic Vaccinia Virus, Followed By Sorafenib In Patients With Advanced Hepatocellular Carcinoma (HCC)" was presented at the International Liver Cancer Association Annual Meeting in Berlin.