SAN FRANCISCO, CA--(Marketwired - May 15, 2013) - Jennerex Biotherapeutics, Inc., a private, clinical-stage biotechnology company focused on the development and commercialization of best-in-class targeted oncolytic immunotherapies for solid tumors, today announced the publication of data demonstrating the ability of its lead product-candidate, Pexa-Vec (JX-594, pexastimogene devacirepvec) to induce functional anti-cancer immunity, both in patients with diverse solid tumor types and in animal models.
This research, published in the May 15th, 2013 issue of the journal, Science Translational Medicine, covers findings from a Phase 1 study evaluating the safety and efficacy of Pexa-Vec after an intratumoral administration in patients with various tumor types. Antibody-mediated complement-dependent cytotoxicity (CDC) directed at cancer cells was observed in serum from Pexa-Vec treated patients. In addition, CDC induction was found to be cancer-selective with greater specificity for the same tumor tissue histology as the patients' tumor type.
"These findings represent the first demonstration of functional anti-cancer immunity induction by an oncolytic immunotherapy in humans and is an important validation of Pexa-Vec as an active immunotherapeutic agent," said Laurent Fischer, M.D., president and chief executive officer of Jennerex. "Furthermore, the association between the development of an immune response against a patient's own cancer and a patient's survival suggest that this activity has the potential to be clinically relevant. We look forward to validating the clinical potential of Pexa-Vec across our ongoing Phase 2 program in liver, colorectal and kidney cancers."
This research was funded and conducted by Jennerex, Green Cross Corporation, Pusan National University (PNU) and Sillajen, Inc.
Pexa-Vec (JX-594, pexastimogene devacirepvec) is an investigational oncolytic immunotherapy designed to 1) rapidly de-bulk tumors via direct killing of tumor cells, 2) induce a systemic anti-tumor immune response and 3) selectively target tumor vasculature resulting in a rapid reduction in tumor blood flow. Pexa-Vec was engineered from vaccinia vaccine, which has been used for decades as a vaccine in healthy individuals. Pexa-Vec was also engineered to express GM-CSF, a white blood cell growth factor, which activates a systemic immune response to kill tumor cells throughout the body. Pexa-Vec exploits the unique characteristics of vaccinia, including its stealth extracellular enveloped form, which allows the virus to survive in the bloodstream in the presence of neutralizing antibodies, leading to its ability to be administered both intravenously (IV) and intratumorally (IT). Unlike many targeted therapies that rely on a single target, Pexa-Vec is applicable to multiple solid tumor targets.
Pexa-Vec is currently being evaluated in an international, randomized Phase 2b clinical trial (TRAVERSE) in patients with advanced primary liver cancer who have failed sorafenib therapy. It is also being tested as monotherapy in sorafenib-naïve HCC patients and in combination with sorafenib. In addition, Pexa-Vec is being evaluated in a Phase 1-2 clinical trial in patients with treatment-refractory colorectal cancer as monotherapy and in combination with irinotecan, and in a Phase 2a clinical trial in treatment-refractory kidney cancer patients.
Phase 1 and Phase 2 clinical trials in multiple cancer types to date have shown that Pexa-Vec, delivered either directly into tumors or intravenously, induces tumor shrinkage and/or necrosis and is well-tolerated (over 250 patients treated to date). Objective tumor responses have been demonstrated in a variety of cancers including liver, colon, kidney, lung cancer and melanoma. Pexa-Vec has had a predictable and manageable safety profile to date which includes flu-like symptoms that typically resolve in 24 hours.
Pexa-Vec is the lead product candidate from Jennerex' SOLVE™ platform, a groundbreaking approach offering new therapeutic options for patients with life-threatening cancers that can be injected directly into tumor tissue or administered systemically by infusion.
Pexa-Vec is partnered in Europe with Transgene, a member of the Institute Merieux group, in South Korea with Green Cross Corporation and in China with Lee's Pharmaceutical Holdings.
Jennerex Biotherapeutics, Inc. is a clinical-stage biotechnology company focused on the development and commercialization of best-in-class, breakthrough targeted oncolytic immunotherapy products for cancer. The Company is focused on two main programs, lead product candidate, Pexa-Vec (JX-594), which is in mid-stage clinical development for the treatment of advanced primary liver cancer and colorectal cancer and JX-929 which is under investigation for a variety of other solid tumors. 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.