Rznomics Approves Phase 1 and 2a Clinical Trials for Glioblastoma Permission granted in South Korea following the U.S.

Rznomics announced on the 25th that it received approval from the U.S. Food and Drug Administration (FDA) for phase 1 and 2a clinical trials for glioblastoma patients of "RZ-001" on the 6th of this month, and the same clinical trial plan was approved by the Ministry of Food and Drug Safety.
Glioblastoma is an intractable disease with a 5-year survival rate of less than 3%, and no clear treatment. Immuno-cancer drugs are also not showing any effect, so a new mechanism of treatment is needed. Rznomics has a platform technology that can remove targeted RNA and express the desired gene using a trans-splicing ribozyme. RZ-001 applied with this technology targets telomerase (hTERT) RNA, which is specifically expressed in cancer cells, and expresses a gene that induces anticancer action. It explained that in this process, immune cells in the body are also induced.
Telomerase targeted by RZ-001 is expressed in most cancer cells. Therefore, it is expected to be applicable to various carcinomas. Last year, clinical trials for hepatocellular cancer patients were approved by the Ministry of Food and Drug Safety and the FDA. Starting with glioblastoma, it is pushing to expand its indication to other intractable carcinomas.In addition to anticancer drugs, it is developing treatments in various areas such as Alzheimer's, hereditary retinal biological degeneration, and retinal syndrome using platform technology.
"As RZ001 has been approved by Korean and U.S. regulators for various indications, we will make all-out efforts to produce optimal clinical results," said Sung-woo Hong, head of Rznomics' development division.
Seong-wook Lee, CEO of Rznomics, said, "It is encouraging to lay the foundation for glioblastoma to enter multinational clinical trials following liver cancer," adding, "We will do our best to provide new treatment opportunities to patients as soon as possible."

Rznomics attracted 37.2 billion won worth of Series C investment last year. In the second half of this year, it is planning to attract pre-IPO investment and evaluate technology.