On November 10, 2023 Rznomics Inc., a South Korea based biopharmaceutical company specialized in the development of RNA-based gene therapeutics, reported that it has entered into a clinical collaboration agreement with F. Hoffmann-La Roche Ltd (Roche) to study RZ-001, a gene therapy approach utilizing the company’s proprietary trans-splicing ribozyme-based RNA reprogramming and editing technology, in combination with Roche’s atezolizumab, in patients with hepatocellular carcinoma (HCC) (Press release, Rznomics, NOV 10, 2023, View Source [SID1234637471]). Under the terms of the agreement, Roche will provide atezolizumab to be used in combination with RZ-001 for the planned Phase 1b/2a study.
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RZ-001, the RNA replacement enzyme based cancer gene therapy, targets and cleaves hTERT mRNA and replaces the mRNA with the therapeutic gene RNA. Specifically, RZ-001 induces anti-HCC activity by suppressing hTERT expression selectively in cancer cells, which express hTERT, and simultaneously inducing a cytotoxic effect by trans-ligating an HSVtk-encoding sequence into the reprogrammed hTERT mRNA. It also induces effective immune cell infiltration into treated tumors and reduces VEGF expression in the tumors, which leads to the anti-cancer efficacy and transformation of tumor microenvironment to be more responsive to immunotherapy.
RZ-001 has demonstrated therapeutic activity in preclinical studies and significant improvement in anti-cancer efficacy in a dose dependent manner in combination with atezolizumab. The clinical study will evaluate the safety and efficacy in liver cancer patients and it is anticipated that the combination of RZ-001 with atezolizumab may enhance response rate and anti-cancer efficacy that could benefit patients with HCC.
"We are excited to initiate collaboration with longstanding oncology leader, Roche, to further explore the potential benefits of combining checkpoint blockade with RZ-001," said Dr. Seong-Wook Lee, Chief Executive Officer of RZNOMICS. "We look forward to having this collaboration, evaluating combination therapy and continuing our mission to offer innovative therapies for patients in need."
About RZ-001
RZ-001 is the first Group I intron based trans-splicing ribozyme-based RNA reprogramming approach approved by the FDA for evaluation in patients. The treatment was developed utilizing Rznomics’ proprietary RNA reprogramming and editing technology and takes the form of an adenoviral vector that expresses an hTERT targeting trans-splicing ribozyme to treat hepatocellular carcinoma (HCC) patients. HCC is the most common type of primary liver cancer, accounting for 80 percent of cases worldwide.
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 HCC and Glioblastoma as well.