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SillaJen Announces Completion of Jennerex, Inc. Acquisition

Union Creates Global Leader In Targeted Oncolytic Immunotherapy

BUSAN, South Korea and SAN FRANCISCO, March 17, 2014 /PRNewswire/ -- SillaJen, Inc., a privately-held biotherapeutics company focused on the development of targeted oncolytic immunotherapy products for cancer, announced today that it had completed the acquisition of San Francisco-based Jennerex, Inc. Privately-held Jennerex is a clinical-stage, biotherapeutics company recognized as a global leader in the development of best-in-class targeted oncolytic immunotherapies. SillaJen will continue the development of the late-stage product Pexa-Vec (JX-594), as well as products from both companies' pipelines.  Jennerex is now a wholly-owned subsidiary of SillaJen.

"We are very excited to achieve this defining moment in SillaJen's history," stated Dr. Eun-Sang Moon, Chief Executive Officer of SillaJen. "The strategic acquisition of Jennerex is a natural evolution of the long-standing collaboration between the two companies, solidifying SillaJen's position as a global leader in the emerging and exciting field of oncolytic immunotherapy."

Dr. David Kirn, founder of Jennerex and Chairman of the SillaJen board of directors commented, "SillaJen's acquisition of its long-standing research and development partner positions it as the world leader in oncolytic immunotherapy. Positive Pexa-Vec clinical data have recently been published in leading peer-reviewed journals, including Nature and Nature Medicine. The incredible potential of this emerging multi-mechanistic therapeutic class has also been validated by the demonstration of a survival benefit in front-line advanced cancer patients with both Pexavec and Amgen's T-Vec in randomized Phase 2 and 3 trials, respectively. We look forward to working with our global partners to bring Pexa-Vec into a Phase 3 pivotal trial for front-line treatment of patients with advanced liver cancer. Pexa-Vec has also demonstrated objective and durable tumor responses in other common cancer types, and these will be the focus of upcoming clinical trials. These trials will study Pexa-Vec as both a single agent and in combination with checkpoint inhibitor therapies."

Wedbush PacGrow Life Sciences, Korea Ratings, and Dong-Bu Securities, Co., Ltd. acted as financial advisors to SillaJen, while Latham & Watkins LLP served as legal advisor. Centerview Partners LLC and Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP advised Jennerex, Inc.

About Pexa-Vec
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 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.

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). 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 currently being evaluated in a Phase 2 clinical trial in patients with treatment-refractory colorectal cancer as monotherapy and in combination with irinotecan, and in a Phase 2 clinical trial in treatment-refractory kidney cancer patients.

Hepatocellular Carcinoma: A Global Unmet Need
Hepatocellular carcinoma (HCC) is the fifth most common cancer worldwide and the third leading cause of cancer death, with over 600,000 new cases diagnosed annually resulting in more than 90 percent mortality.i The annual incidence rate in the U.S., Europe, Japan and China are estimated to be 20,000, 55,000, 40,000 and 350,000 patients, respectivelyii. Currently, there is only one approved systemic treatment for advanced HCC patients that has demonstrated a survival benefit.

About SillaJen, Inc.
SillaJen, Inc., headquartered in Busan, South Korea with offices in San Francisco, California, is an R&D company specializing in the translational and clinical development of complex biologics.  Headquartered on the campus of Pusan National University, the company is comprised of dedicated in-house pre-clinical, bioanalytic, and clinical research teams that collaborate closely with a network of local hospitals and USA-based world-class scientists and physicians. 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 SillaJen operations are uniquely poised for rapid and efficient development of similar cutting-edge gene and viral therapies.  Additional information about SillaJen can be found at www.sillajen.com.

About Jennerex
Jennerex 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 in mid-stage clinical development for the treatment of advanced primary liver cancer, colorectal cancer, kidney cancer and ovarian cancer, and its next generation product candidate, JX-929, 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. 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. For more information about Jennerex, please visit www.jennerex.com.

SillaJen Contact: U.S.
David A. McDonald – Chief Business Officer
[email protected]

SillaJen Contacts: Korea
Dr. Eun-Sang Moon – Chief Executive Officer (Investors)
[email protected]  

Dr. Tae-Ho Hwang – Co-Founder and Chief Scientific Officer (Media)
[email protected]

i http://www.who.int/mediacentre/factsheets/fs297/en/

ii Ferlay J, Shin HR, Bray F, Forman D, Mathers C and Parkin DM.GLOBOCAN 2008 v2.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 10 [Internet]. Lyon, France: International Agency for Research on Cancer; 2010. Available from: http://globocan.iarc.fr

SOURCE SillaJen, Inc.

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