SK pharmteco and Rznomics sign MoU to develop gene therapies

SK pharmteco has entered a memorandum of understanding (MoU) with South Korea-based Rznomics for the development and manufacturing of RNA-based gene therapies.

The strategic collaboration aims to bring multiple gene therapy products to the market.

The multi-year deal will leverage SK pharmteco’s technical expertise and resources, including facilities and skilled personnel, to facilitate the transition from clinical to commercial-scale manufacturing for Rznomics’ RNA-based biopharmaceuticals.

Rznomics has been focusing on a diverse pipeline of RNA editing platform technologies, including RZ-001 for hepatocellular carcinoma and glioblastoma, RZ-003 for Alzheimer’s disease, RZ-004 to treat retinitis pigmentosa and RZ-005 targeting neurodegenerative disorder, alongside its Circular RNA platform.

For RZ-001, the company has secured investigational new drug (IND) approvals from the US Food and Drug Administration (FDA) for Phase I/IIa trials for hepatocellular carcinoma in 2022 and glioblastoma in 2023.

The FDA awarded fast track designation for glioblastoma in November 2023 and orphan drug designation for hepatocellular carcinoma in January 2024.

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Clinical trials for RZ-001 have also commenced in Korea following IND approval from the Ministry of Food and Drug Safety (MFDS).

In December 2023, Rznomics received further IND approval from the MFDS for a combination therapy involving RZ-001 and immunotherapy.

SK pharmteco chief commercial officer Andy Fenny stated: “We are thrilled about the opportunity to partner with Rznomics on their groundbreaking initiatives.

“By combining our significant expertise in gene therapy manufacturing with Rznomics’ innovative RNA-based therapeutic approach, we believe this collaboration has the potential to deliver life-changing treatments to patients in need quickly.”

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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