Jennerex Publishes Clinical Data in Journal, Nature, Demonstrating Intravenous Delivery of Multi-Mechanistic Cancer-Targeted Oncolytic Poxvirus JX-594 to Tumors

SAN FRANCISCO, Aug. 31, 2011 /PRNewswire/ -- Jennerex, Inc., a private clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class targeted oncolytic virus products for cancer, today announced the publication of clinical data on its lead product JX-594 in the journal Nature. For the first time in humans, an oncolytic virus was shown to reproducibly infect, replicate and express transgene products within cancer tissue after intravenous infusion.  Normal tissues were not significantly affected clinically, underscoring the designed selectivity of JX594 for malignant tissue and safety of the product.

"Our platform technology opens up the possibility of selectively expressing multiple transgene products with complementary mechanisms of action at high concentration in tumors systemically. This is a first in medical history," said David Kirn, M.D., president and chief executive officer of Jennerex. "We believe it will take truly innovative, multi-mechanistic approaches to significantly prolong survival, and to potentially cure patients with metastatic solid tumors. JX-594, with its ability to reach tumors systemically after IV infusion, coupled with its three complementary mechanisms of action, represents a bold new approach to the treatment of metastatic cancers."

Dr. Kirn continued, "We look forward to working with our partners on the clinical development of JX-594 in liver, colorectal and other cancer types. We're particularly excited about the TRAVERSE trial, a global, randomized, controlled Phase 2b clinical trial of JX-594 in patients with hepatocellular carcinoma (liver cancer) having failed sorafenib (Nexavar®) treatment, which we plan to initiate this year."

JX-594 replication and engineered transgene expression within solid tumors was evaluated on a Phase 1 dose-escalation trial of intravenous infusion of JX-594. Twenty-three patients with advanced, treatment-refractory solid tumors were enrolled in one of six cohorts.  Safety, antitumor activity and pharmacokinetic parameters were also evaluated.  JX-594 was generally well-tolerated, and dose escalation proceeded without dose-limiting toxicities.  The most common treatment-related adverse events consisted of Grade 1-2 flu-like symptoms lasting up to 24 hours. Cancer-selective and dose-related JX-594 delivery and replication in tumors were demonstrated in biopsies obtained eight to 10 days following infusion.  In patients receiving higher doses whose tumor biopsies were evaluable for analysis, 87 percent exhibited JX-594 positivity, whereas JX-594 was not detected in biopsies collected from patients receiving lower doses.

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 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, 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 100 treated to date). Objective tumor responses have been demonstrated in a variety of cancers including liver, colon, kidney, lung and melanoma. JX-594 has a favorable safety profile with predictable and generally mild side effects that typically include flu-like symptoms that resolve in 48 to 72 hours.

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 GM-CSF protein. GM-CSF complements the cancer cell lysis work of the product candidate, leading to a cascade of events resulting in tumor necrosis, tumor vasculature shutdown and an anti-tumoral immune attack.

About Jennerex's Partners for JX-594

Transgene (NYSE Euronext Paris: FR0005175080), a biopharmaceutical company specialized in the development of immunotherapeutic products, 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.

Transgene, a member of the Institut Merieux Group, is a publicly traded French biopharmaceutical company dedicated to the development of therapeutic vaccines and immunotherapeutic products in oncology and infectious diseases, and has five compounds in clinical development: TG4010 and JX-594 (TG6006) having completed initial phase II trials, TG4001 in phase IIb trial, TG4040 in phase II trial and TG4023 in phase I trial. Transgene has concluded strategic agreements for the development of two of its immunotherapy products, an option agreement with Novartis for the development of TG4010 to treat various cancers, and an in-licensing agreement with U.S.-based Jennerex Biotherapeutics, Inc., to develop and market JX-594 (TG6006), an oncolytic product. Transgene has bio-manufacturing capacities for viral-based products. Additional information about Transgene is available on the internet at www.transgene.fr

Green Cross Corp. is a publicly traded and leading Korean biopharmaceutical company specialized in development and commercialization of vaccines, plasma-derivatives, recombinant proteins and therapeutic antibodies in oncology and infectious diseases. Green Cross Corp. has been collaborating with Jennerex in Korea since 2006 to jointly conduct the Phase 1 and 2 clinical trials in patients with liver cancer. Additional information about Green Cross Corp. is available on the internet at www.greencross.com.

Lee's Pharmaceutical Holdings Limited is a public biopharmaceutical company with over 16 years operation in China's pharmaceutical industry. It is fully integrated with solid infrastructures in drug development, clinical development, regulatory, manufacturing, sales and marketing in China with global perspectives and currently markets nine products. Lee's Pharma focuses on several different areas such as cardiovascular and infectious diseases, dermatology, oncology, gynecology and others. It has more than 30 products under different development stages stemming from both internal R&D as well as from the recent acquisition of licensing and distribution rights from various U.S. and European companies. The mission of Lee's is to become a successful biopharmaceutical group in Asia providing innovative products to fight diseases and improve health and quality of life. Additional information about Lee's Pharma is available on the internet at www.leespharm.com.

About Jennerex

Jennerex, Inc. is a clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class, breakthrough targeted oncolytic products for cancer. The Company's lead product JX-594 is currently in two Phase 2 clinical trials in patients with primary liver cancer—an international, randomized, Phase 2 clinical trial, and a Phase 2 study of JX-594 in combination with sorafenib. Published studies designed to establish optimal dose levels and the safety profile of JX-594 have shown its ability to selectively target and cause destruction of a variety of common cancer types. JX-594 and other product candidates under development are designed to attack cancer tumors through three diverse mechanisms of action: the lysis of cancer cells through viral replication, the ablation of the blood supply to tumors through vascular targeting and destruction and the stimulation of the body's immune response against the cancer. Jennerex is headquartered in San Francisco and has related research and development operations in Ottawa, Canada and Pusan, South Korea. For more information about Jennerex, please visit www.jennerex.com.

SOURCE Jennerex, Inc.