SAN FRANCISCO, CA--(Marketwired - April 09, 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 presentation of research at the Annual Meeting of the American Association for Cancer Research (AACR) demonstrating the antivascular effect of its lead product candidate, Pexa-Vec (JX-594, pexastimogene devacirepvec).
Pexa-Vec is an investigational oncolytic immunotherapy designed to 1) rapidly de-bulk tumors via tumor cell lysis, 2) induce a durable immune response against tumors, and 3) activate an antivascular effect with rapid tumor vascular knockout. Pexa-Vec was derived from vaccinia, which has been used for decades as a vaccine in healthy individuals, and was engineered to selectively target cancer cells. 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 has been safely administered to over 200 patients and is currently in Phase 2b clinical development for the treatment of advanced liver cancer (HCC) and is also being evaluated in other solid tumor types including colon and kidney cancer.
The poster (Abstract # 2841), titled “Widespread endothelial cell infection and tumor cell apoptosis after intravenous injection of oncolytic vaccinia virus JX-594 into RIP-Tag2 mice,” provides additional evidence supporting Pexa-Vec-induced anti-vascular effects. In this study, mouse-adapted Pexa-Vec was infused intravenously into RIP-Tag2 transgenic mice bearing pancreatic neuroendocrine tumors. Tumors were examined at several timepoints post-infusion. Within six hours after intravenous infusion of Pexa-Vec, infection of tumor-associated vascular endothelial cells by Pexa-Vec was observed along with early evidence of apoptotic tumor cells. Five days post Pexa-Vec infusion, tumors exhibited a significant reduction in size which was accompanied by 1) a reduction of tumor vascularity, 2) a reduction in intratumoral oxygen levels (increased intratumoral hypoxia), as well as 3) widespread tumor cell death (apoptosis). Furthermore, most tumors had large areas of cells exhibiting evidence of direct Pexa-Vec infection; no evidence of Pexa-Vec infection was observed in the surrounding normal acinar pancreas.
“These data continue to validate and confirm this important mechanism-of-action of Pexa-Vec,” said Laurent Fischer, M.D., president and chief executive officer of Jennerex. “With its targeted and direct infection of tumor vascular endothelial cells and its ability to reduce tumor burden through cellular apoptosis or death, Pexa-Vec has the potential to be a powerful therapy for solid tumors.”
This research was conducted in collaboration with the laboratory of Donald M. McDonald, M.D., Ph.D., professor, Department of Anatomy, the University of California San Francisco. The funding for the study was supported by the University of California Discovery Grants Program in the field of biotechnology.
Pexa-Vec Clinical Development Program
Pexa-Vec (JX-594, pexastimogene devacirepvec) 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 in HCC patients 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.
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 200 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 resolve in 24 to 48 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.
About Jennerex
Jennerex Biotherapeutics, Inc. is a clinical-stage biotechnology company focused on the development and commercialization of first-in-class, breakthrough targeted oncolytic immunotherapy products for solid tumors. 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.
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