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Jennerex Announces First Patient Treated in Phase 2 Clinical Trial of Intravenous Delivery JX-594 In Patients with Advanced Liver Cancer
Date:7/25/2012

SAN FRANCISCO, July 25, 2012 /PRNewswire/ -- Jennerex, Inc., a private, clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class targeted oncolytic immunotherapies, today announced that the first patient has been treated in a Phase 2 clinical trial of intravenous treatment with JX-594 for patients with advanced hepatocellular carcinoma (HCC), or liver cancer, who have not received treatment with sorafenib—the current standard of care for this patient population.  This trial expands the development of the JX-594 program in HCC, which is currently being evaluated in a multi-national Phase 2b trial (TRAVERSE) in patients with advanced HCC who have failed prior sorafenib.

This Phase 2 trial is a multinational, single-arm, open-label study of JX-594 administered weekly by intravenous infusions in sorafenib-naive patients with advanced HCC. The primary objective of the study is to determine the radiographic response rate based on modified RECIST and modified Choi criteria.  Patients will subsequently be followed for progression-free survival and overall survival. The trial is being conducted at sites in South Korea, the United States, and Europe.  For more information about this trial as well as the Phase 2b TRAVERSE trial, please visit www.clinicaltrials.gov.

"We are pleased to have treated our first patient in this study, which will build on our experience with intravenous treatment with JX-594 and will allow us to assess anti-tumor activity of multiple intravenous infusions in the liver cancer patients specifically," said David H. Kirn, M.D., founder, chief medical officer and president of research and development.  "Unlike other treatments in the class, JX-594 can be administered intravenously, and we've shown that it has the ability to target tumors systemically—in addition to locally—and, therefore, has the potential to impact both metastatic and primary tumors. In our previously reported randomized Phase 2 dose-ranging study in HCC with intratumoral delivery, we showed a statistically significant benefit in overall survival in the high dose group, which we believe was due, in large part, to the systemic delivery of JX-594 at that dose level."

JX-594: A Multi-Mechanistic Approach To Targeting Cancer

JX-594 is a proprietary, engineered oncolytic immunotherapy designed to selectively target and destroy cancer cells 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 oncolytic immunotherapies 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.

Hepatocellular Carcinoma: A Global Unmet Need

Hepatocellular carcinoma is the fifth most common cancer worldwide and the third leading cause of cancer death, with over 600,000 new cases diagnosed annually resulting in more than 90 percent mortality.  The annual incidence rate in the U.S., Europe, Japan and China are estimated to be 20,000, 55,000, 40,000 and 350,000 patients, respectively.

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 immunotherapy 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 solid tumor types and trigger a potent immune response. 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 targeted 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 Busan, South Korea. For more information about Jennerex, please visit www.jennerex.com.


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