SEONGNAM, South Korea, Aug. 5, 2024 -- SK pharmteco, a prominent global contract development, manufacturing, and analytical testing organization, has entered into a memorandum of understanding (MOU) with Rznomics Inc., a South Korean biopharmaceutical company specializing in RNA-based gene therapeutics. This MOU is set to establish a long-term contract development and manufacturing partnership between the two firms.
The collaboration aims to leverage SK pharmteco's technical capabilities and resources to facilitate the development and commercialization of multiple gene therapy products developed by Rznomics. With SK pharmteco's support, Rznomics will transition its innovative RNA-based biopharmaceutical products from clinical trials to full-scale commercial manufacturing.
Andy Fenny, Chief Commercial Officer of SK pharmteco, expressed enthusiasm about the collaboration, highlighting the synergy between SK pharmteco's gene therapy manufacturing expertise and Rznomics' innovative RNA-based therapeutic approach. He believes that this partnership has the potential to expedite the delivery of life-changing treatments to patients in need.
Seong-Wook Lee, President and Chief Executive Officer of Rznomics, echoed this sentiment, emphasizing that the partnership will enable the late-stage development and manufacturing of their gene therapy pipeline. This collaboration will pave the way for Phase II and later stage clinical trials, as well as potential commercialization of their products. Lee expressed eagerness to work closely with SK pharmteco on these initiatives.
SK pharmteco, a subsidiary of SK Inc., operates as a global contract development and manufacturing organization (CDMO) with 13 offices and manufacturing facilities across the U.S., Europe, and Korea. The company partners with biopharmaceutical companies to manufacture Active Pharmaceutical Ingredients (API), intermediates, cell and gene therapy technologies, registered starting materials, and analytical services for the global biopharmaceutical industry. SK Inc. is the strategic investment company for SK Group, South Korea's second-largest conglomerate.
Rznomics, an innovative RNA biopharmaceutical company based in South Korea, is focused on developing treatments for various intractable diseases. The company has several pipelines in development, including RZ-001 for Hepatocellular Carcinoma and Glioblastoma, which has received Phase I/IIa IND approvals from the FDA in 2022 and 2023, respectively. The FDA has also granted Fast Track Designation for Glioblastoma in November 2023 and Orphan Drug Designation for Hepatocellular Carcinoma in January 2024.
Early-phase trials for RZ-001 have commenced in Korea, following IND approval from the Ministry of Food and Drug Safety (MFDS). Additionally, Rznomics has received IND approval from the MFDS for the combination of RZ-001 and immunotherapy in December 2023.
Overall, this partnership between SK pharmteco and Rznomics represents a significant step forward in the development and commercialization of RNA-based gene therapeutics, with the potential to bring innovative treatments to patients worldwide.
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