Rznomics has announced that its anticancer drug asset, RZ-001, has received fast track designation from the US Food and Drug Administration (FDA) for treating hepatocellular carcinoma (HCC).
This is the second fast track designation for RZ-001. The first was granted in November 2023 for glioblastoma (GBM), a difficult-to-treat brain cancer.
The drug candidate is currently in Phase 1b/2a clinical trials for hepatocellular carcinoma (HCC) and Phase 1/2a trials for glioblastoma.
RZ-001 is being developed as an anticancer drug developed using trans-splicing ribozyme, which is Rznomics’ proprietary RNA editing platform. The platform is designed to edit target RNA through simultaneous destruction and repair to produce the desired therapeutic RNA.
The drug candidate has received investigational new drug (IND) approval from both South Korea’s Ministry of Food and Drug Safety (MFDS) and the FDA.
For GBM, RZ-001 has also been approved under the FDA’s Expanded Access Program (EAP), allowing compassionate use outside clinical trials. Presently, this programme is being conducted at Harvard University Hospital.
The FDA’s fast track programme speeds up drug development for serious diseases.
With this latest designation, RZ-001 will undergo an accelerated review and approval process. It also allows for more frequent communication with the FDA and a rolling review for each data section during the biologics license application (BLA) process.
Rznomics CEO Seong-Wook Lee said: “We believe this designation recognises the potential of RZ-001 as an innovative cancer therapy.
“We are committed to expediting its clinical development to provide effective treatment options for patients suffering from hard-to-treat cancers.”
Rznomics, founded in Professor Seong-Wook Lee’s lab at Dankook University’s Department of Bioconvergence Engineering, specialises in developing RNA-based gene therapies for cancer and other incurable diseases.
Last month, the RNA-based gene therapy developer raised around KRW20.3bn ($14m) in a pre-IPO funding round. With the pre-IPO round, Rznomics has raised a total of KRW60.9bn ($42m), including KRW81.2bn ($56m) from its Series C funding round in June 2022.
In November 2023, Rznomics signed a clinical trial collaboration and supply agreement with Roche to assess RZ-001 in combination with the latter’s atezolizumab, in patients with HCC.
