SillaJen Announces Collaboration with the National Cancer Institute for Development of Combination Therapy with SillaJen's pexastimogene devacirepvec (Pexa-Vec) Oncolytic Immunotherapy

SAN FRANCISCO and SEOUL, Korea, Aug. 16, 2017 /PRNewswire/ -- SillaJen, Inc., (KOSDAQ:215600), a clinical-stage, biotherapeutics company focused on the development of oncolytic immunotherapy products for cancer, today announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), for the development of a combination therapy for colorectal cancer (CRC).  Under the CRADA, SillaJen will collaborate with Tim Greten, M.D., to evaluate the combination of SillaJen's lead clinical candidate, pexastimogene devacirepvec (Pexa-Vec), with anti-PDL1 and anti-CTLA4 antibodies in an early phase clinical trial in patients with advanced stage CRC. 

"We welcome the opportunity to collaborate with Dr. Greten in the development of this promising combination therapy," said Eun Sang Moon, chief executive officer of SillaJen.

Dr. Greten is Senior Investigator in the Thoracic and Gastrointestinal Oncology Branch of NCI's Center for Cancer research and an expert in GI Oncology and tumor immunology.  Dr. Greten received his training in Medical Oncology, Gastroenterology and Hepatology in Germany and has been performing basic and translational research studies in tumor immunology for more than 20 years. He is currently studying novel immune based approaches to treat patients with primary hepatobiliary tumors and patients with tumors of the GI tract metastasizing into the liver.

"Treatment options for advanced colorectal cancer are a significant unmet medical need globally.  To date, there has been no approval for checkpoint inhibitor therapy for the vast majority of patients with CRC," stated James Burke, M.D, Chief Medical Officer of SillaJen. "Therefore, investigation of the potential for Pexa-Vec to "prime" or sensitize CRC to check point inhibitor therapy is an exciting opportunity to further extend immunotherapy to this substantial number of patients without curative or immunotherapeutic options.  We believe this trial being conducted in collaboration with Dr. Greten and the NCI will provide an excellent opportunity to assess this potential."

Under the terms of CRADA, Dr. Greten will recruit and treat patients at the NCI on the jointly developed protocol, and NCI will handle the management of this trial. SillaJen will supply Pexa-Vec for the clinical trial while PD-L1 and CTLA-4 antibodies will be provided by a third party to NCI under a separate CRADA.  Further, in depth assessment of tumor biopsies and other collected patient samples will be conducted to assess the immune modulating potential of Pexa-Vec given concurrently with checkpoint inhibitor therapy. This CRADA will provide SillaJen access to NCI's scientific and clinical expertise to facilitate development of Pexa-Vec for the benefit of public health.

For Patients
Patients interested in enrolling please contact NCI's toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY:  1-800-332-8615) and/or the Web site:  https://trials.cancer.gov

About Pexa-Vec and the SOLVE Platform
Pexa-Vec is the most advanced product candidate from SillaJen's proprietary SOLVE™ (Selective Oncolytic Vaccinia Engineering) platform. The vaccinia strain backbone of Pexa-Vec has been used safely in millions of people as part of a worldwide vaccination program, and over 300 cancer patients have been treated with Pexa-Vec to date. Pexa-Vec was engineered to target common genetic defects in cancer cells by deleting its thymidine kinase (TK) gene, thus making Pexa-Vec dependent on the cellular TK expressed at persistently high levels in cancer cells. Pexa-Vec is also engineered to express GM-CSF protein. GM-CSF complements the cancer cell lysis of the product candidate, leading to a cascade of events resulting in tumor necrosis, tumor vasculature shutdown and sustained anti-tumoral immune attack. Pexa-Vec has been shown to be effective when delivered both intratumorally and systemically by intravenous administration. Pexastimogene devacirepvec (Pexa-Vec) is currently being evaluated in a worldwide Phase 3 clinical trial for advanced primary liver cancer, and more information can be found at: http://www.pexavectrials.com.

About SillaJen's Regional Partners for Pexa-Vec

About Transgene
Transgene S.A. (Euronext: TNG), part of Institut Mérieux, is a publicly traded French biopharmaceutical company focused on discovering and developing targeted immunotherapies for the treatment of cancer and infectious diseases. Transgene's programs utilize viral vector technology with the goal of indirectly or directly killing infected or cancerous cells. The Company's two lead clinical-stage programs are: TG4010 for non-small cell lung cancer and Pexa-Vec for liver cancer. The Company has several other programs in clinical and pre-clinical development. Transgene is based in Strasbourg, France, and has additional operations in Lyon, as well as satellite offices in China and the U.S.  Additional information about Transgene is available at www.transgene.fr.

About Lee's Pharma
Lee's Pharmaceutical Holdings Limited is a research-based biopharmaceutical company listed in Hong Kong with over 20 years operation in China's pharmaceutical industry. It is fully integrated with strong infrastructures in drug development, manufacturing, sales and marketing. It has established extensive partnership with over 20 international companies and currently has 14 products in the market place. Lee's focuses on several key disease areas such as cardiovascular, oncology, gynecology, dermatology and ophthalmology. Lee's development program is lauded with 47 products stemming from both internal R&D efforts and collaborations with US, European and Japanese companies and aspiring to combat diseases such as liver cancer and pulmonary hypertension. The mission of Lee's is to become a successful biopharmaceutical group in Asia providing innovative products to fight diseases and improve health and quality of life. Additional information about Lee's Pharmaceutical is available at www.leespharm.com.

About SillaJen

SillaJen, Inc. is a South Korean based biotechnology company headquartered in Busan South Korea, with satellite offices in Seoul, South Korea and San Francisco, CA.  The company is focused on the development and commercialization of oncolytic immunotherapy products using the SOLVE^TM platform, including its lead product Pexa-Vec, which is currently in Phase 3 trials for the treatment of advanced primary liver cancer. Additional information about SillaJen is available at www.sillajen.com.

Disclaimer Language:
This press release contains certain forward-looking statements regarding, among other things, statements relating to goals, plans and projections regarding the Company's financial position, results of operations, market position, product development and business strategy. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and SillaJen undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

SOURCE SillaJen, Inc.

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