Positive Clinical Data from Phase 2 Trial of JX-594 in Sorafenib-Refractory Liver Cancer Patients

Jennerex Presents Positive Clinical Data from Phase 2 Trial of JX-594 in Sorafenib-Refractory Liver Cancer Patients

Key Clinical Endpoints Met: JX-594 can be Safely and Efficiently Delivered Through Systemic Route, and Standard-of-Care Sorafenib Can Be Safely Administered Sequentially After JX-594, Opening Door to New Clinical Perspectives

BERLIN, Sept. 17, 2012 /PRNewswire/ -- 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.

About this Trial:

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 intratumoral doses of JX-594 at week one and three. The majority of patients subsequently received treatment with sorafenib.

Following treatment with JX-594 alone at four weeks, 62 percent of patients had disease control as measured by modified RECIST (tumor burden measurement). Tumor biopsies of four patients following intravenous infusion showed four of four patients had local infection of JX-594 in tumor tissue while normal liver tissue was not affected, providing further evidence of JX-594's tumor selectivity and the ability to administer JX-594 intravenously. Furthermore, after six or 12 weeks, 59 percent of patients had disease control as measured by modified RECIST and 75 percent of patients had objective responses by Choi criteria. 85 percent of patients had disease control by mRECIST and /or Choi response.

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 2) the stimulation of an immune response against cancer cells, (i.e., active immunotherapy), and 3) the shutdown of the blood supply to tumors. 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 (over 160 patients 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, predictable and generally mild safety profile to date which includes flu-like symptoms that resolve in 24 to 48 hours.

JX-594 takes advantage of the natural attributes of poxviruses and was engineered to target and destroy solid tumors both systemically and locally. The vaccinia virus 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 and encode the immunogenic GM-CSF gene, to enhance the immune response against cancer cells.

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. The only treatment approved for HCC is sorafenib. There is no treatment approved for patients who fail sorafenib.

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 1/2 clinical trials 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 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. For studies evaluating JX-594 please visit www.clinicaltrials.gov.

SOURCE Jennerex, Inc.
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