- Anticancer drug utilizing Trans-splicing Ribozyme
technology
- Second Fast Track Designation following brain cancer
approval
SEONGNAM, South Korea, Feb. 18,
2025 /PRNewswire/ -- Rznomics announced on the 14th
that its anticancer drug, RZ-001, has received Fast Track
Designation from the U.S. Food and Drug Administration (FDA) for
the treatment of Hepatocellular Carcinoma (HCC).
This marks the second Fast Track Designation for RZ-001,
following its designation in November
2023 for Glioblastoma (GBM), a hard-to-treat brain
cancer.
The Fast Track program, established by the FDA, supports the
development of drugs for serious or life-threatening diseases by
expediting the approval process. Once a drug is designated and if
relevant criteria are met, it benefits from accelerated review and
approval, as well as more frequent and flexible communication with
the FDA. Additionally, during the Biologics License Application
review, a rolling review can be conducted for each data section,
providing an advantage in the evaluation process.
RZ-001 is an anticancer drug developed using Trans-splicing
Ribozyme, Rznomics' proprietary RNA editing platform technology. It
has received Investigational New Drug (IND) approval from both
South Korea's Ministry of Food and
Drug Safety (MFDS) and the U.S. FDA. Currently, it is in Phase
1b/2a clinical trials for
Hepatocellular Carcinoma (HCC) and Phase 1/2a trials for
Glioblastoma (GBM).
Furthermore, for Glioblastoma (GBM), RZ-001 has been approved
under the FDA's Expanded Access Program (EAP), which allows
compassionate use of investigational treatments outside clinical
trials. The program is currently being conducted at Harvard University Hospital.
Dr. Seong-Wook Lee, CEO of Rznomics, stated, "We believe this
designation recognizes 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."
About RZNOMICS
As a biopharmaceutical company founded in the laboratory of
Professor Seong-Wook Lee, Dankook University Department of
Bioconvergence Engineering, Rznomics is researching with the goal
of developing new RNA-based gene therapeutic bio-drugs for cancer
and incurable diseases. Rznomics' core platform technology is based
on an RNA replacement enzyme, known as trans-splicing ribozyme,
which can edit target RNA through simultaneous destruction and
repair (and/or reprogramming) to yield the desired therapeutic RNA,
thus, selectively inducing therapeutic gene activity in cells
expressing the target RNA.
For more information, please visit www.rznomics.com
Contact
Yonsoo Jeong
Business Development / Associate Manager
Email: ysjeong@rznomics.com
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