BUSAN, South Korea and SAN FRANCISCO, June 19, 2014 /PRNewswire/ -- SillaJen, Inc., a privately-held biotherapeutics company focused on the development of targeted oncolytic immunotherapy products for cancer, announced today that it has completed its name change to SillaJen Biotherapeutics following its acquisition of Jennerex Biotherapeutics. SillaJen's lead product Pexa-Vec (formerly JX-594) demonstrated an overall survival benefit in a randomized dose-finding Phase 2 trial for liver cancer, and plans are underway to enter Phase 3 in first-line hepatocellular carcinoma patients in 2015.
"We are thrilled that this long-standing partnership between SillaJen and Jennerex resulted in a merger that has married strong funding and scientific expertise from SillaJen and a dedicated team from Jennerex committed to continuing the development of its best-in-class oncolytic immunotherapies which are continuously building with successes in the field," stated Dr. Eun-San Moon, chief executive officer of SillaJen. "
"SillaJen's oncolytic viruses have several unique attributes that give them significant treatment advantages including that they are multi-modality, meaning that they induce direct oncolysis (killing) of tumor cells while also spurring anti-cancer immunity," stated David Kirn, M.D., executive chairman and co-founder. "Further, our immunotherapy can be delivered intravenously, as opposed to just intratumorally, which allows our oncolytic therapies to target metastases systemically."
"Completing our name change to SillaJen Biotherapeutics solidifies the merger of these two exciting companies and helps unite us as one company with one mission, which is to develop groundbreaking therapeutics that offer new hope for patients with life-threatening cancers," stated David McDonald, chief business officer of SillaJen.
Pexa-Vec (JX-594, pexastimogene devacirepvec) is derived from vaccinia, which has been used for decades as a vaccine in healthy individuals, and is engineered to selectively target cancer cells. Pexa-Vec is 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 the 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.
Phase 1 and Phase 2 clinical trials in multiple cancer types have shown that Pexa-Vec, delivered either directly into tumors or intravenously, induces tumor shrinkage and/or necrosis and has been well-tolerated in over 250 patients treated to date (Breitbach et al., Nature, 2011, Heo et al. Nature Medicine 2013). Pexa-Vec is currently being evaluated in a Phase 2 clinical trial in patients with treatment-refractory colorectal cancer and in a Phase 2 clinical trial in treatment-refractory kidney cancer patients.
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 SillaJen, Inc.
SillaJen, Inc., is a clinical-stage biotechnology company focused on the development and commercialization of groundbreaking oncolytic immunotherapies for patients with life-threatening cancers. The company's lead product candidate, Pexa-Vec (JX-594), is entering late-stage clinical development for the treatment of advanced primary liver cancer (Pexa-Vec described in Nature Reviews Cancer, Kirn et al 2009). High-dose Pexa-Vec treatment was associated with an overall survival benefit in a randomized Phase 2 trial in patients with 1st-line liver cancer (Nature Medicine, 2013). Pexa-Vec also demonstrated unique IV delivery to solid tumors, and objective tumor responses, as reported in Nature (2011). Pexa-Vec is in mid-stage development for kidney cancer and other solid tumors. The company is also developing a robust pipeline of oncolytic immunotherapy products with multiple complementary mechanisms-of-action.
Born from a desire to revolutionize therapeutic approaches for patients with serious unmet medical needs, and honed through years of pioneering experience guiding oncolytic vaccinia through clinical trials in Korea, the U.S. and around the world, SillaJen is uniquely poised for rapid and efficient clinical development of cutting-edge gene and viral therapies. SillaJen acquired Jennerex Inc (San Francisco, California) in 2014. SillaJen is headquartered in Busan, South Korea with labs in Busan and offices in San Francisco, California. Additional information about SillaJen can be found at www.sillajen.com.
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