CDMO partnership to provide adenoviral vector production enabling initiation of clinical trials
WILMINGTON, Mass.–(BUSINESS WIRE)–Charles River Laboratories International, Inc. (NYSE: CRL) and Rznomics Inc., a South Korea-based biopharmaceutical company specialized in the development of RNA-based gene therapeutics, today announced a viral vector contract development and manufacturing organization (CDMO) partnership. Rznomics will leverage Charles River’s viral vector CDMO experience to initiate clinical development of its RNA-based anticancer gene therapy in liver cancer patients.
RZ-001 is the first ribozyme-based RNA reprogramming approach approved by the US Food and Drug Administration (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 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 in October, allowing the initiation of an international clinical study in HCC patients. Early-phase trials have also commenced in Korea following IND approval for RZ-001 from the South Korean Ministry of Food and Drug Safety (MFDS), formerly the Korea Food & Drug Administration (KFDA) in June.
Adenoviral Vector Manufacturing Services
Charles River has standardized protocols for cell culture, transfection, and downstream purification, as well as a validated platform process with a proven track record. These high-yield, optimized methods increase speed to clinical manufacturing by reducing process development time and costs while ensuring the highest quality production.
Expanding its comprehensive cell and gene therapy portfolio to span viral vector, plasmid DNA, and cell therapy production, through the acquisitions of Vigene Biosciences, Cobra Biologics, and Cognate BioServices in 2021, Charles River offers end-to-end support and supply chain simplification for advanced therapy medical product (ATMP) developers.
- “This collaboration with Rznomics will tap into our industry-leading CDMO capabilities and we are thrilled that our expertise will help to bring RZ-001, a potentially curative therapy, to HCC patients.” – Birgit Girshick, Corporate Executive Vice President and Chief Operating Officer, Charles River
- “We are proud to have achieved FDA approval to begin Phase I/IIa trials and excited to take this next step with Charles River. A reliable and experienced manufacturing partner is of utmost importance, and we are keen to continue building this relationship to enable us to bring our leading pipeline, RZ-001, into clinical development.” – Seong-wook Lee, President and Chief Executive Officer, Rznomics
About Charles River
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com.
As a biopharmaceutical company founded in the laboratory of Professor Seong-wook Lee, Dankook University Department of Bio-convergence Engineering, Rznomics is researching with the goal of developing new biologic drugs for cancer and incurable diseases through gene therapy development. Rznomics’ core platform technology is based on an RNA replacement enzyme, known as a trans–splicing ribozyme, which can edit target RNA through simultaneous destruction and repair (and/or reprograming) to yield the desired therapeutic RNA, thus selectively inducing therapeutic gene activity in cells expressing the target RNA. Rznomics’ lead candidate is a treatment for hepatocellular carcinoma (HCC), with other treatments for glioblastoma, Alzheimer’s disease, and hereditary retinal dystrophy (RD) also under development. For more information, please visit www.rznomics.com.
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