SillaJen, Inc., (KOSDAQ:215600), a clinical-stage, biotherapeutics company focused on the development of oncolytic immunotherapy products for cancer, announced the first patient has been enrolled in REN026, the Phase 1b clinical trial of Pexa-Vec (pexastimogene devacirepvec) in combination with cemiplimab (REGN2810) for the treatment of renal cell cancer (RCC). The first patient was enrolled in the United States, with expansion to sites in South Korea 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 cemiplimab, an anti-PD1 monoclonal antibody. 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.
"Given the initial activity seen with Pexa-Vec monotherapy and the potential of oncolytic viruses to enhance anti-tumor immunity, combining Pexa-Vec with cemiplimab is quite rational and has the promise to build upon the activity of checkpoint inhibitor therapy alone in RCC. This trial will not only assess the clinical activity of the two agents but allow us to assess in more depth the changes elicited in anti-tumor immunity following treatment by examining peripheral blood and tumor samples. This will give us proof of concept data that will help us expand this approach to other tumor types," stated James Burke, M.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 http://www.pexavectrials.com.