Rznomics Inc. has recently entered into a contract manufacturing agreement with a global CDMO, Vigene Biosciences, Inc., for its leading pipeline product, RZ-001. RZ-001 is a gene therapy for advanced hepatocellular carcinoma (HCC) that Rznomics has developed using its RNA replacement enzyme platform technology.
The agreement between Rznomics and Vigene aims at process confirmation and GMP production for Rznomics’s new drug candidate, RZ-001. This partnership represents a significant step closer to entering the clinical trial of RZ-001 by securing a global partner for manufacturing its candidates.
“Rznomics aims to escalate the development of new biopharmaceuticals that can enter the global market based on our innovative RNA technology. This agreement with Vigene, a leading CDMO for GMP viral vector manufacturing, is a necessary step for the progress of the global clinical trial, and Rznomics will do our best for the approval in a timely manner and successful completion of the clinical trial through multi-faceted cooperation with Vigene,” CEO Seong-Wook Lee said.
“Prior to this agreement for the GMP production for RZ-001, we completed research to select the most effective producer cell line and chose the global CDMO with an optimum platform for mass production based on the research result,” Sungwoo Hong, Chief Development Officer at Rznomics, added.
“Vigene is honored to be selected as the partner for RZ-001 manufacturing.” Zairen Sun, Ph.D., President and CEO of Vigene, said. “Vigene is well experienced and equipped with the RZ-001 production to meet the timeline and quality requirements. We will leverage on our state-of-the-art GMP facility, experienced team, strong track record of GMP viral vector production for the successful delivery of RZ-001 to the client”
RZ-001 is an RNA replacement enzyme expressed through viral vector that targets telomerase reverse transcriptase (TERT) RNA, cleaves the target site and then ligates suicide gene RNA to the cleaved region specifically for HCC. It is multi-functional as it can suppress TERT expression and simultaneously induce cell death specifically for TERT expressed HCC.
The company also explained, through a combination study of RZ-001 and immune checkpoint inhibitors (ICI), Rznomics found that the combination therapy has a synergistic anti-cancer efficacy compared to the monotherapy, and expect that the low response rate of ICI caused by its resistance can be overcome through the mechanism of RZ-001.
Rznomics plans to enter the clinical trial of RZ-001 in 2H21 and has other promising candidates in pipelines targeting intractable diseases such as glioblastoma, Alzheimer’s disease and Retinitis Pigmentosa.
Rznomics is a biopharmaceutical company dedicated to development of gene therapies for cancers, genetic disorders, and Alzheimer’s disease using viral vectors. Our team of industry veterans in gene therapy development and world-class academic and biopharmaceutical partnerships are potentiating our gene therapy capabilities. To learn more about Rznomics, please visit http://rznomics.com/.
Vigene Biosciences is an award winning world leader in plasmid and viral vector development and manufacturing. Vigene features integrated plasmid and viral vector production and analytical service offerings from its 71,000 sq ft of state-of-the-art facility with 10 GMP cleanroom suites. Vigene’s mission is to make gene therapy affordable. On basic research side, Vigene is developing, manufacturing, and distributing state-of-the-art AAV, lentivirus, retrovirus, adenovirus and plasmid-based reagents including HHMI/Janelia Research Campus AAV Biosensors. On the cGMP clinical production side, Vigene combines the proven production technologies with rigorous regulatory compliant cGMP production to meet the needs and expectations of clinical and commercial clients. Vigene offers FDA and EMA compliant cGMP production for AAV, lentivirus, adenovirus, retrovirus, and plasmids to global pharmaceutical and biotech companies, governmental agencies and non-profit organizations.
Jeffrey Hung, Ph.D.
Chief Commercial Officer