On January 22, 2018 SillaJen, Inc., (KOSDAQ:215600), a clinical-stage, biotherapeutics company focused on the development of oncolytic immunotherapy products for cancer, and ABL Europe, an ABL, Inc. company providing dedicated viral vector GMP services for gene therapy, oncolytic products and vaccines for all stages of clinical supply, reported that thay have expanded their strategic manufacturing collaboration (Press release, Advanced BioScience Laboratories, JAN 22, 2018, View Source [SID1234565002]). Under the current agreement, ABL is currently manufacturing Pexa-Vec (formerly JX-594) for SillaJen’s multinational, randomized Phase 3, open-label study of Pexa-Vec in patients with advanced liver cancer. Under the expanded agreement, ABL will also provide development, manufacturing & QC release testing services for SillaJen’s pipeline product, JX-970.
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"Based on SillaJen’s established partnership with ABL, we are pleased to further expand our agreement to include another exciting product in our pipeline," stated Georg Roth, Ph.D, Senior Vice President, Technical Operations at SillaJen. "ABL has significant experience in virus manufacturing, and we are glad to be able to utilize their expertise in order to continue to expedite the development of these important oncolytic virus therapies."
"We are excited about the significant potential of SillaJen’s oncolytic immunotherapy products and are pleased to further expand our agreement with an additional product," stated Patrick Mahieux, Ph.D., General Manager of ABL Europe. "Our primary focus is ultimately to safely help patients in need, and so we look forward to applying our twenty-plus years of experience in virus manufacturing to these exciting oncolytic products."
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: View Source
About JX-970
JX-970 is an oncolytic virus that is derived from a Western Reserve strain vaccinia virus, and its tumor selectivity has been optimized through deletion of thymidine kinase (TK) and vaccinia growth factor (VGF). In addition, it expresses GM-CSF to stimulate immune responses. In nonclinical studies, the JX-970 backbone exerted a tumor debulking effect and at the same time demonstrated a selective preference for tumor tissues.