Jennerex, Inc., a private clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class targeted oncolytic products for cancer, announced that positive results from a proof-of-concept clinical trial using JX-594 to treat patients with metastatic melanoma were published in the peer-reviewed journal Molecular Therapy.

“This clinical trial in metastatic melanoma provides additional key information for our JX-594 programme and complements the ongoing clinical development of JX-594, which is expected to enter a randomized phase II b trial in advanced liver cancer later this year,” said David Kirn, MD, president and chief executive officer of Jennerex. “Specifically, JX-594 replication was observed following multiple rounds of intratumoral JX-594 therapy, providing proof-of-concept data for the potential benefit of chronic administration regimens of the product.”

The mechanistic proof-of-concept study enrolled 10 treatment-refractory Stage IV melanoma patients, eight of whom completed the study. All patients received up to nine weekly intratumoral injections of JX-594 at a low dose (less than 10 percent of the dose given in other JX-594 trials). Evidence of JX-594 activity was assessed in blood samples and tumour biopsies. Blood samples collected over the course of treatment demonstrated JX-594 replication after repeated dosing as well as the expression and functionality of JX-594 encoded transgenes. Tumour biopsies showed tumour cell necrosis (death) and immune cell recruitment into tumours. JX-594 was safe and well-tolerated, with flu-like symptoms as the most common side effect for patients.

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: the lysis of cancer cells through viral replication, the reduction of the blood supply to tumours through vascular targeting and destruction, and the stimulation of the body's immune response against cancer cells, i.e., active immunotherapy. Phase I and II clinical trials in multiple cancer types to date have shown that JX-594, delivered either directly into tumours or systemically, induces tumour shrinkage and/or necrosis and is well-tolerated by patients (over 100 treated to date). Objective tumour responses have been demonstrated in a variety of cancers including liver, colon, kidney, lung and melanoma. JX-594 has a favourable safety profile with predictable and generally mild side effects that typically include flu-like symptoms that resolve in 48 to 72 hours.

The poxvirus strain backbone of JX-594 has been used safely in millions of people as part of a worldwide vaccination programme. 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 tumour necrosis, tumour vasculature shutdown and an anti-tumoural immune attack.

Transgene a bio-pharmaceutical company specialized in the development of immunotherapeutic products, holds an exclusive license to develop and commercialize JX-594 in Europe and neighbouring 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 US-based Jennerex Biotherapeutics, Inc., to develop and market JX-594 (TG6006), an oncolytic product.

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.

Lee's Pharmaceutical Holdings Limited is a public biopharmaceutical company focuses on several different areas such as cardiovascular and infectious diseases, dermatology, oncology, gynaecology and others.