South Korean biotechnology company SillaJen has enrolled the first patient in the REN026 trial in the US.
REN026 is a Phase lb clinical trial of Pexa-Vec (pexastimogene devacirepvec) in combination with cemiplimab (REGN2810) to treat renal cell cancer (RCC).
The trial is designed to investigate the safety and efficacy of the combination in patients with unresectable or metastatic RCC.
It also aims to evaluate the immune modulating potential of Pexa-Vec given simultaneously with checkpoint inhibitor therapy by analysing multiple blood and tissue biomarkers.
SillaJen plans to expand the clinical trial sites in South Korea and Australia over the next few weeks.
The company has also partnered with Regeneron to use its anti-PD1 monoclonal antibody cemiplimab in the trial.
SillaJen chief medical officer James Burke said: “Given the initial activity seen with Pexa-Vec monotherapy and the potential of oncolytic viruses to enhance anti-tumour 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-tumour immunity following treatment by examining peripheral blood and tumour samples.
“This will give us proof of concept data that will help us expand this approach to other tumour types.”
SillaJen has used its Selective Oncolytic Vaccinia Engineering (SOLVE) platform to develop the Pexa-Vec solution, which is designed to target common genetic defects in cancer cells by deleting their thymidine kinase (TK) gene.