Charles River and Rznomics Partner on RNA-based Anticancer Gene Therapy Manufacturing

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Charles River Laboratories and Rznomics, a South Korea-based biopharmaceutical company specializing in the development of RNA-based gene therapeutics, entered into a viral vector contract development and manufacturing organization (CDMO) partnership. Rznomics will leverage Charles River’s viral vector CDMO experience to begin clinical development of its RNA-based anticancer gene therapy in liver cancer patients.

RZ-001 reportedly is the first ribozyme-based RNA reprogramming approach approved by the  FDA for evaluation in patients. The treatment was developed utilizing Rznomics’ 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% of cases worldwide.

Rznomics received Phase I/IIa IND approval for RZ-001 from the FDA in October, allowing the start of an international clinical study in HCC patients. Early-phase trials have also begun 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.

“This collaboration with Rznomics will tap into our CDMO capabilities and we are thrilled that our expertise will help to bring RZ-001, a potentially curative therapy, to HCC patients,” said Birgit Girshick, corporate executive vice president and COO, 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,” added Seong-Wook Lee, PhD, president and CEO, Rznomics.