SOURCE: Jennerex

Jennerex

May 15, 2013 18:00 ET

Jennerex Presents Pexa-Vec Clinical Data at 2013 American Society of Clinical Oncology Annual Meeting

Jennerex Highlights Clinical Results From Its Liver Cancer and Colorectal Cancer Programs

CHICAGO, IL--(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 that data relating to the company's lead product, Pexa-Vec (JX-594; pexastimogene devacirepvec), was featured in three separate abstracts during the American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago, Illinois, May 31 to June 4, 2013. Details of the presentations follow:

Abstract #3608, Poster: Phase 1b Dose-Escalation Study of Pexa-Vec (pexastimogene devacirepvec; JX-594), an Oncolytic and Immunotherapeutic Vaccinia Virus, Administered by Intravenous (IV) Infusions in Patients with Metastatic Colorectal Carcinoma (mCRC). June 2, 2013 8:00 am, Location S Hall A2.

Abstract #4122, Poster: Phase 2 Trial of Pexa-Vec (pexastimogene devacirepvec; JX-594), an Oncolytic and Immunotherapeutic Vaccinia Virus, followed by Sorafenib in Patients with Advanced Hepatocellular Carcinoma (HCC). June 2, 2013 8:00 am, Location S Hall A2.

Abstract #TPS4161 (Trials in Progress), Poster: Phase 2b Randomized Trial of Pexa-Vec (pexastimogene devacirepvec; JX-594), a Targeted Oncolytic Vaccinia Virus, plus Best Supportive Care (BSC) Versus BSC Alone in Patients With Advanced Hepatocellular Carcinoma Who Have Failed Sorafenib Treatment (TRAVERSE). June 2, 2013 8:00 am, Location S Hall A2.

"We look forward to these presentations of our broadening clinical program, including the first presentation of Pexa-Vec in a multiple, all IV administration setting, a key differentiator from other oncolytic immunotherapies," said Laurent Fischer, M.D., president and chief executive officer of Jennerex. "The abstracts set the stage for an important year for Jennerex as we await final data from TRAVERSE, our randomized Phase 2b study in second-line liver cancer (HCC), and continue to show the potential of Pexa-Vec in the treatment of other tumor types, including colorectal cancer."

About Pexa-Vec
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 derived 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 types.

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(TM) 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.

About Jennerex
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.

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