Under the partnership, Rznomics will use Charles River’s viral vector CDMO knowledge to begin clinical development of its RNA-based anticancer gene therapy in liver cancer patients
Charles River and Rznomics sign viral vector CDMO partnership. (Credit: National Cancer Institute on Unsplash)
US-based Charles River Laboratories has signed a viral vector contract development and manufacturing organisation (CDMO) partnership with South Korea-based biopharmaceutical company Rznomics.
Under the partnership, Rznomics will use Charles River’s viral vector CDMO knowledge to begin clinical development of its RNA-based anticancer gene therapy in liver cancer patients.
RZ-001 is said to be the first ribozyme-based RNA reprogramming technique cleared by the US Food and Drug Administration (FDA) for patient evaluation.
The treatment is an adenoviral vector that expresses an hTERT targeting ribozyme to treat patients with hepatocellular carcinoma (HCC). It was created using Rznomics’ patented RNA reprogramming and editing technique.
Charles River corporate executive vice president and chief operating officer Birgit Girshick said: “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.”
The FDA granted Rznomics Phase I/IIa IND permission for RZ-001 in October, enabling the start of a global clinical investigation in HCC patients.
Following the South Korean Ministry of Food and Drug Safety (MFDS), acceptance of RZ-001’s IND in June, early-phase trials have also started there, the US-based pharmaceutical company added.
Rznomics president and chief executive officer Seong-wook Lee said: “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.”
Charles River provides end-to-end support and supply chain simplification for developers of advanced therapy medical products (ATMPs).
The firm acquired Vigene Biosciences, Cobra Biologics, and Cognate BioServices in 2021 to expand in the viral vector, plasmid DNA, and cell therapy production.
In April last year, Charles River and Valo Health unveiled a new AI-powered drug solution Logica. It translates clients’ biological insights into optimised preclinical assets.