SAN FRANCISCO and STRASBOURG, France, May 16, 2016 /PRNewswire/ -- SillaJen, Inc., a private, clinical-stage, biotherapeutics company focused on the development of oncolytic immunotherapy products for cancer, and ABL Europe, an ABL, Inc. company providing GMP production services for virus vaccine, gene therapy and oncolytic products, have entered into a commercial manufacturing agreement for SillaJen's lead product candidate, Pexa-Vec (formerly JX-594). SillaJen is currently conducting a multinational, randomized, Phase 3, open-label study of Pexa-Vec in patients with advanced liver cancer.
"We are happy to enter into a long-term relationship with ABL Europe for commercial supply of our breakthrough oncolytic virus, Pexa-Vec," stated Georg Roth, Ph.D., Senior Vice President, Technical Operations at SillaJen Biotherapeutics. "This agreement will secure supply for our ongoing Phase 3 clinical trial as well as for commercial market demand worldwide."
"ABL Europe is extremely pleased to collaborate with SillaJen on this critical program," stated Patrick Mahieux, Ph.D., General Manager of ABL Europe. "Pexa-Vec is a ground-breaking oncolytic product with significant potential in the treatment of HCC, and we are excited to apply our 20 years of expertise in virus manufacturing to help bring this promising treatment to patients."
Pexa-Vec Clinical Development Program and 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. This strain naturally targets cancer cells due to common genetic defects in cancer cells; Pexa-Vec was engineered to enhance this by deleting its thymidine kinase (TK) gene, thus making it dependent on the cellular TK expressed at persistently high levels in cancer cells. Pexa-Vec is also engineered to express the immunogenic 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.
The ongoing Phase 3 study, named the PHOCUS trial, is designed to enroll 600 patients who have not received prior systemic treatment for their cancer. To learn more about the trial, please visit: http://www.pexavectrials.com/.
About ABL Europe
ABL Europe, a wholly-owned subsidiary of ABL, Inc., offers clinical and commercial scale manufacturing for virus-based vaccines, gene therapies, oncolytic products and other biologics. From its state-of-the-art GMP facility located in Strasbourg, France, ABL Europe's multiple production platforms including bioreactors, large-scale cell stack technologies, and an isolator-based automated fill line for aseptic filling of live virus, provides optimal flexibility for the development of scalable GMP manufacturing processes and GMP production.
About ABL, Inc.
ABL, Inc. (ABL) is a Maryland-based biomedical contract research and manufacturing organization dedicated to advancing vaccines, therapeutics and other biologic products. ABL has extensive experience working with diverse organizations, including government and academic entities and commercial bio/pharmaceutical companies. Notable services include basic research, product design, process and assay development, preclinical studies, clinical immunomonitoring and immunogenicity testing, and Phase I/II cGMP biologics manufacturing. Since 2001, ABL has been a part of the Institut Mérieux, a group of companies dedicated to developing translational science for better patient care globally. For more information on ABL and our services, please visit our website at www.ablinc.com.
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 SOLVETM 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.
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SOURCE SillaJen, Inc.