Rznomics gets approves U.S. FDA For anticancer Candidate Based On Gene Therapy

RZ001+T-Sentric + Avastin

Approved Phase 1b/2a clinical trial for hepatocellular carcinoma patients

Rznomics, a gene therapy drug-based anticancer drug developer, will start clinical trials in the United States that use its candidate and immune anticancer drugs in combination.

Rznomics announced on the 19th that it has received approval from the U.S. Food and Drug Administration (FDA) for its phase 1b/2a clinical trial in which the anticancer drug candidate "RZ-001" and immuno-cancer drugs are combined.

The plan is to evaluate both effectiveness and safety by co-administering RZ-001 together with the first standard treatment (Tscentrick + Avastin) to about 50 patients diagnosed with hepatocellular carcinoma.

RZ-001 is an anticancer drug candidate that is being developed by applying the RNA editing platform technologies owned by Rznomics. It targets telomerase (hTERT) RNA, which is specifically expressed in cancer cells, by delivering RNA enzymes with adenovirus as a vector.

Normal cells become shorter in telomeres, and when there is not much time left, they perceive themselves to be 'old' and die without further dividing. However, in cancer cells, telomerase, an enzyme that increases the length of telomeres that is decreasing again, is overactive, and telomeres may continue to lengthen. This is the cause of cancer cells continuing to divide without dying.

RZ-001 removes hTERT RNA from hepatocytes that have become cancerous cells so that telomerase is not expressed. It induces apoptosis by making telomeres shorten normally. HSV-TK is also expressed at the cut hTERT site. Antiviral drugs (balgancyclover) administered with RZ-001 selectively attack only cancerous cells in response to this gene.

It is a dual mechanism that removes the telomerase gene that causes infinite proliferation of cancer cells and inserts virus-derived genes to cause antiviral drugs to attack cancer cells.

The FDA-approved clinical trial was combined with ticentric + avastin, which is the most widely used first-line treatment for hepatocellular carcinoma. If differentiated safety and efficacy are demonstrated compared to existing treatments, it could open the way for them to enter the largest market of first-line treatments.

Rznomics plans to collaborate with large domestic and international pharmaceutical companies for this clinical trial. Among the clinical drugs, atetzolizumab has been contracted to receive supply from Roche and bevacizumab from Celltrion.

Seong-wook Lee, CEO of Rznomics, said, "As many researchers and institutions cooperate in RZ-001 clinical development, we will do our best to succeed as an innovative anticancer drug."