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Jennerex, Inc. Presents JX-594 Clinical Data at 2012 American Society of Clinical Oncology Annual Meeting  
6/4/2012 10:24:37 AM

CHICAGO, June 4, 2012 /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 that data relating to the company's oncolytic virus therapy for cancer was featured in three separate abstracts during the American Society of Clinical Oncology (ASCO) Annual Meeting currently taking place in Chicago, Illinois.

Abstract #TPS4152: Jennerex presented an overview of TRAVERSE, a multinational, randomized Phase 2b trial evaluating JX-594 in patients with advanced liver cancer, or hepatocellular carcinoma (HCC), who have failed prior therapy with sorafenib. The study is ongoing with approximately 120 patients expected to be enrolled. In the study, patients are randomized 2:1 to receive JX-594 plus best supportive care versus best supportive care alone. Patients randomized to the JX-594 group receive an initial intravenous dose of JX-594 followed by five intratumoral injections of JX-594 over an 18-week treatment period. The primary objective of the trial is to determine and compare overall survival for patients receiving JX-594 plus best supportive care versus best supportive care alone. Secondary endpoints include safety and objective tumor response. For more information about the trial, please visit www.clinicaltrials.gov.

Additional abstracts relating to JX-594 clinical trials at ASCO include:

  • Abstract #e14566: Results from 20 advanced, sorafenib-refractory, HCC patients, treated with JX-594 in a Phase 2 clinical trial. In the single arm trial, patients received JX-594 by intravenous infusion and intratumoral injection prior to re-initiation of standard sorafenib therapy. Objectives of this study included determination of safety of JX-594 followed by sorafenib in patients with advanced HCC, and anti-tumor activity of JX-594 alone and in combination with sorafenib. Treatment with JX-594 was shown to be well-tolerated and demonstrated antitumor effects. Subsequent treatment with sorafenib was associated with the expected toxicity profile.

  • Abstract #e13044: A Phase 1b dose escalation study of JX-594 in patients with metastatic colorectal carcinoma refractory to chemotherapy and cetuximab. This study is designed to determine the maximum tolerated dose (MTD) of JX-594 administered intravenously every other week (four total treatments). Secondary endpoints include assessment of anti-tumor activity. JX-594 was shown to be well-tolerated, and no dose-limiting toxicities were reported. Enrollment is continuing in an expansion cohort at the MTD. For more information about the trial, please visit www.clinicaltrials.gov.

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 shutdown 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 intravenously, induces tumor shrinkage and/or necrosis and is well-tolerated by patients (over 130 treated to date). Objective tumor responses have been demonstrated in a variety of cancers including liver, colon, kidney, lung cancer and melanoma. JX-594 has had a favorable safety profile to date with predictable and generally mild side effects that typically include flu-like symptoms that resolve in 24 to 48 hours.

JX-594 is the most advanced product candidate from Jennerex's proprietary SOLVE (Selective Oncolytic Vaccinia Engineering) platform. SOLVE takes advantage of the natural attributes of poxviruses as well as their potential to be engineered to produce therapeutic viruses that can target and destroy solid tumors both systemically and locally. 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 abnormalities in cancer cells. JX-594 was engineered to enhance this cancer-selectivity by inactivating 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 immunogenic GM-CSF protein. GM-CSF complements the cancer cell lysis of the product candidate, leading to a cascade of events resulting in tumor necrosis, tumor vasculature shutdown and sustained anti-tumoral immune attack.

About Jennerex's Partners for JX-594
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. 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 an international, randomized Phase 2b clinical trial (TRAVERSE) in patients with advanced primary liver cancer who have failed sorafenib therapy. In addition, JX-594 is being tested in the same patient population in combination with sorafenib. JX-594 is also in a Phase 1 clinical trial in patients with treatment-refractory colorectal cancer. 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.


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