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SEOUL, South Korea, BUSAN, South Korea and SAN FRANCISCO, July 10, 2014 /PRNewswire/ -- SillaJen, Inc., a privately-held biotherapeutics company focused on the development of targeted oncolytic immunotherapy products for cancer, announced today a publication that reviews data from the company's oncolytic immunotherapy program, including its lead product Pexa-Vec. Additionally, the publication outlines the rationale for combination therapy with other cancer immunotherapies, such as immune checkpoint inhibitors, which could lead to improved survival for cancer patients. The review article entitled "Going viral with cancer immunotherapy" was published in Nature Reviews Cancer. Together with its partners Transgene and Lee's Pharmaceuticals, SillaJen plans to lead a global Phase 3 trial with Pexa-Vec in first-line advanced liver cancer in the first half of 2015.
"Our oncolytic immunotherapies are truly novel and, importantly, are multi-mechanistic allowing for a three-pronged approach to target cancer cells. SillaJen oncolytic viruses, which uniquely can be delivered both intravenously and intratumorally, are well-tolerated, cause acute direct tumor cell lysis and subsequently induce durable anti-cancer immunity," stated David Kirn, MD, executive chairman of SillaJen Inc. "Oncolytic immunotherapeutic virotherapy with Pexa-Vec, SillaJen's lead product, has the potential to be safely combined with immune checkpoint inhibitors and adoptive cell therapy to prolong the survival of cancer patients," said Dr. Eun-Sang Moon, chief executive officer of SillaJen.
"As is pointed out in this review paper, our oncolytic immunotherapies may be used as either a monotherapy or in combination with other therapies, as they may have the added benefit of sensitizing patients to other active immunotherapies," stated Caroline Breitbach, PhD, vice president, clinical and translational research of SillaJen.
About SillaJen's Oncolytic Immunotherapies
Targeted oncolytic poxviruses for cancer hold significant commercial and medical potential and represent a breakthrough technology for cancer. The primary reasons are their enhanced tolerability and efficacy versus currently available treatments such as chemotherapy. First, these products are highly selective for cancer and therefore have minimal side effects (flu-like symptoms). In addition, their efficacy is driven by three, novel mechanisms of action: 1) Rapid de-bulking of tumors via direct killing of tumor cells (oncolysis), 2) Activation of an acute anti-vascular effect, and 3) Induction of a durable adaptive immune response. Of note, these mechanisms are non-cross resistant with other approved available therapies. Therefore, these products have the potential to treat tumors that have failed other available therapies. In addition, given their novel mechanisms of action, these products can also be combined with other complementary therapies, and in particular immune checkpoint inhibitors, in order to activate a broad array of immunostimulatory mechanisms.
Over 250 patients with advanced cancers have received the company's lead oncolytic virus, Pexa-Vec. Treatment has been well-tolerated, generally with only transient (several hours) flu-like symptoms. Pexa-Vec was the first engineered oncolytic virus to cause partial and complete tumor responses, intravenous delivery to tumors (Nature 2012, Breitbach, Hwang, D.Kirn et al), induction of cancer targeting antibodies (Science Translational Medicine 2013, TH Hwang, D.Kirn et al) and improved survival in a randomized trial (Nature Medicine 2013, Heo et al). In a randomized dose-finding Phase 2 trial in patients with advanced liver cancer, high dose Pexa-Vec was associated with significantly improved survival (p=0.02; median survival duration 14.1 mo vs 6.7 mo), (Nature Medicine 2013 Heo, Hwang, Kirn et al).
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 Seoul and incorporated in Busan, South Korea, with labs in Busan and R & D offices in San Francisco, California. Additional information about SillaJen can be found at www.sillajen.com.
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