SAN FRANCISCO, CA--(Marketwired - May 23, 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 it has completed a successful private placement financing of $21.6 million.
Proceeds from this financing will be used to advance the clinical development of Jennerex's lead product candidate, Pexa-Vec (JX-594, pexastimogene devacirepvec), for the potential treatment of liver, colorectal and kidney cancers. Pexa-Vec is an investigational oncolytic immunotherapy designed to 1) rapidly de-bulk tumors via tumor cell lysis, 2) induce a systemic anti-tumor immune response, and 3) selectively target tumor vasculature resulting in a rapid reduction in tumor blood flow. Jennerex plans to initiate a Phase 3 study in advanced primary liver cancer (hepatocellular carcinoma, HCC) in 2014.
"This financing will enable us to expand our efforts to develop Pexa-Vec as a novel therapeutic option for liver cancer, our lead program, which represents the third most deadly cancer in the world," stated Laurent Fischer, M.D., president and chief executive officer of Jennerex. "The strong participation in this financing by our existing investors provides important validation of Pexa-Vec's clinical potential and their belief in our targeted oncolytic immunotherapy platform. We look forward to sharing data from the TRAVERSE Phase 2b study that completed enrollment earlier this week."
Pexa-Vec is currently being evaluated in an international, randomized Phase 2b study (TRAVERSE) for the treatment of HCC in patients who failed prior therapy with sorafenib (Nexavar®). Enrollment of over 120 subjects at approximately 40 sites was completed earlier this month. The primary objective of TRAVERSE is to determine the overall survival of patients receiving Pexa-Vec with best supportive care, compared to those receiving best supportive care alone. Pexa-Vec is also being evaluated in Phase 2 clinical studies for colorectal and kidney cancer.
Pexa-Vec (JX-594, pexastimogene devacirepvec) 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 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.
In addition to TRAVERSE, Pexa-Vec is currently being evaluated as monotherapy in sorafenib-naïve HCC patients and in combination with sorafenib. Pexa-Vec is also being evaluated in a Phase 1-2 clinical study in patients with treatment-refractory colorectal cancer as monotherapy and in combination with irinotecan, and in a Phase 2a clinical study in treatment-refractory kidney cancer patients.
Phase 1 and Phase 2 clinical studies 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 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 South Korea. For more information about Jennerex, please visit www.jennerex.com.