Rznomics Inc. Secures Fast Track Designation from the U.S. FDA for RZ-001

GBM is known as the most malignant tumor in Central Nervous system with high mortality rate but lacks effective therapies. RZ-001, the RNA replacement enzyme-based cancer gene therapy for the treatment of GBM, targets and cleaves hTERT mRNA and replaces the mRNA with the therapeutic gene RNA. This induces anti-cancer activity and cytotoxic effect by trans-ligating an HSVtk-encoding sequence into the reprogrammed hTERT mRNA. RZ-001 has demonstrated very promising responses in preclinical studies in which an enhanced anti-cancer efficacy and a higher survival rate was observed.

GBM is known as the most malignant tumor in Central Nervous system with high mortality rate but lacks effective therapies. RZ-001, the RNA replacement enzyme-based cancer gene therapy for the treatment of GBM, targets and cleaves hTERT mRNA and replaces the mRNA with the therapeutic gene RNA. This induces anti-cancer activity and cytotoxic effect by trans-ligating an HSVtk-encoding sequence into the reprogrammed hTERT mRNA. RZ-001 has demonstrated very promising responses in preclinical studies in which an enhanced anti-cancer efficacy and a higher survival rate was observed.

"We are proud to receive Fast Track Designation from the FDA," said Dr. Seong-Wook Lee, Chief Executive Officer of Rznomics. "This designation signifies an important milestone in developing a safe and effective treatment for patients with GBM who are in need of new therapeutic options."

Rznomics received Phase I/IIa IND approval for RZ-001 from the FDA and the South Korean Ministry of Food and Drug Safety (MFDS) in Glioblastoma and the clinical trial will investigate the safety, tolerability, and efficacy of RZ-001 in patients with GBM. Subjects will be treated with RZ-001 according to the planned dose escalation design.

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.

Rznomics' lead candidate (RZ-001) is a treatment for Hepatocellular Carcinoma & Glioblastoma (Phase 1/2a IND approval from both in South Korea and in the U.S.), with other treatments for Alzheimer's disease and hereditary retinal dystrophy (RD)

For more information, please visit https://www.rznomics.com/

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