On June 6, 2019 SillaJen, Inc., (KOSDAQ:215600), a clinical-stage, biotherapeutics company focused on the development of oncolytic immunotherapy products for cancer, reported the first patient has been enrolled in Part 2 of JX594-REN026, a Phase 1b clinical trial of Pexa-Vec (pexastimogene devacirepvec) in combination with Libtayo(cemiplimab-rwlc), for the treatment of renal cell cancer (RCC) (Press release, SillaJen, JUN 6, 2019, View Source [SID1234536937]). Enrollment of Part 1 (dose-escalation phase) of the trial was completed in March 2019 without significant safety concerns, and the first seven patients in Part 2 were enrolled in South Korea, with expansion to sites in the United States and Australia anticipated over the coming weeks.
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SillaJen is collaborating with Regeneron to evaluate Pexa-Vec, SillaJen’s lead clinical candidate, in combination with Regeneron’s Libtayo, an anti-PD1 monoclonal antibody Regeneron is developing in collaboration with Sanofi. The aim of the trial is to assess the safety and efficacy of the combination in patients with unresectable or metastatic renal cell carcinoma. The study will also investigate the immune modulating potential of Pexa-Vec given concurrently with checkpoint inhibitor therapy by evaluating multiple blood and tissue biomarkers.
"We are encouraged to see positive safety data from the dose escalation phase of the REN026 study. Part 2 of this study is designed to reinforce the rationale of Pexa-Vec in combination with Libtayo," stated Francis Hyukchan Kwon, M.D, Ph.D., chief medical officer at Sillajen.
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 granulocyte-macrophage colony stimulating factor (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: View Source