SillaJen is rolling up its sleeves to develop a biomarker for an investigational immunotherapy JX-970, sources said Tuesday.
The biotech firm is planning to conduct a phase-1 clinical trial in the first half of next year at the latest, they said.
Biomarkers indicate changes in the body, using proteins, DNA, RNA, and metabolites. They are now used to diagnose severe or incurable diseases such as cancer, stroke, and dementia.
One of the representative biomarkers in the immunotherapy sector is PD-L1 (programmed death-ligand 1), a protein located on the surface of cancer cells. The higher the PD-L1 expression, the more effective the immunotherapy is.
Keytruda, an immunotherapy, had 19.4 percent objective response rate (ORR) but a patient with more than 50 percent PD-L1 expression showed high OOR at 45.5 percent.
However, PD-L1 expression can change depending on the progression of cancer and its location inside the body. Even if the PD-L1 expression is negative or low, some patients still respond to immunotherapies.
To solve this problem, SillaJen aims to discover a new biomarker for JX-970 and boost the therapeutic efficacy of the immunotherapy.
JX-970 is a genetically recombined substance derived from Western Reserve vaccinia virus strain, which selectively kills tumors by removing TK (thymidine kinase) enzyme and VGF (vaccinia growth factor).
By analyzing proteome mutation, gene mutation, epigenomics studies, and comparing immunity profiles, SillaJen will seek to find a biomarker that distinguishes patients who respond to JX-970 and those who don’t.
“We aim to discover the right biomarker and secure the market of immunotherapies that do not respond to immune checkpoint inhibitors,” a SillaJen official said.