SillaJen Announces First Patient Enrolled in the NCI-Sponsored Trial Evaluating Combination Therapy in Colorectal Cancer with SillaJen's Pexa-Vec Oncolytic Immunotherapy

SAN FRANCISCO and SEOUL, Korea, Jan. 29, 2018 /PRNewswire/ -- SillaJen, Inc., (KOSDAQ:215600), a clinical-stage, biotherapeutics company focused on the development of oncolytic immunotherapy products for cancer, announced the initiation of a Phase 1/2 clinical trial of pexastimogene devacirepvec (Pexa-Vec) in combination with checkpoint inhibitor therapy for the treatment of metastatic colon cancer.  The study, led by Dr. Tim Greten at the National Cancer Institute (NCI), is being conducted as part of a Cooperative Research and Development Agreement (CRADA) with the NCI, part of the National Institutes of Health (NIH). 

Under the CRADA, SillaJen will collaborate with Dr. Greten to evaluate the combination of SillaJen's lead clinical candidate, Pexa-Vec in combination with durvalumab (anti-PDL1 antibody) and, in a separate treatment group, with both durvalumab and tremelimumab (anti-CTLA4 antibody) in patients with refractory metastatic CRC. The aim of the trial will be to test if the combination of oncolytic virus and immune checkpoint inhibitor therapy can activate the immune system to fight cancer and overcome self-tolerance to colon cancer. 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.

"We are pleased to be working with Dr. Greten at the NCI. He is a leading researcher in the area of cancer immunotherapy.  Obviously, we hope this collaboration can improve the treatment options for patients with incurable colon cancer," said Eun Sang Moon, chief executive officer of SillaJen.

Dr. Greten is a Senior Investigator in the Thoracic and Gastrointestinal Oncology Branch of NCI's Center for Cancer Research and a recognized 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 gastrointestinal tumors.

"We are excited that this clinical trial has started.  Cancer immunotherapy is significantly impacting multiple cancer types, and we hope this trial will provide further understanding about how our immunotherapy might help patients with CRC, particularly given the limited treatment options available to this patient population," stated James Burke, M.D., chief medical officer at SillaJen.

Under the terms of the CRADA, Dr. Greten will recruit and treat patients at the NCI on the jointly developed protocol, and NCI will handle the operational aspects of this trial. SillaJen will supply Pexa-Vec for the clinical trial, while tremelimumab and durvalumab will be provided by a third party to NCI under a separate CRADA.  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://ccr.cancer.gov/thoracic-and-gastrointestinal-oncology-branch/tim-f-greten

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 their 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® 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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