R&D

Korean company Rznomics has announced that its gene therapy-based cancer drug candidate has been granted Fast Track designation (FTD) by the US Food and Drug Administration (FDA). It is indicated for use in hepatocellular carcinoma (HCC).

This marks the second FTD for RZ-001, which was designated for glioblastoma in November 2023. RZ-001 has been developed using the company’s RNA editing and correcting platform technology, Trans-splicing Ribozyme, which uses ribonucleic acid substitution enzymes. Rznomics is currently conducting phase 1b/2a trials for HCC and phase 1/2a trials for glioblastoma in Korea, with FDA approval to carry out these same trials in the US.

Seong-wook Lee, CEO of Rznomics, stated: “This FTD reaffirms the potential of RZ-001 as an innovative cancer treatment. We are committed to accelerating clinical development to provide effective treatment options for patients suffering from difficult-to-treat cancers.”

According to the National Institutes of Health, HCC is the fifth most common cause of cancer worldwide and occurs in approximately 85% of patients diagnosed with cirrhosis.