On January 4, 2023 Oncorus, Inc. (Nasdaq: ONCR), an RNA medicines company focused on developing intravenously administered, self-amplifying RNA to transform outcomes for cancer patients, and Daewoong Pharmaceutical Co., Ltd. (KRX: 069620), a leading South Korean pharmaceutical company, reported a research collaboration for the discovery and development of novel lipid nanoparticle (LNP) formulations for mRNA drug candidates (Press release, Oncorus, JAN 4, 2023, View Source [SID1234625817]).
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Under the terms of the collaboration, Oncorus and Daewoong will conduct joint research to identify and evaluate formulations of Daewoong’s mRNAs encapsulated in Oncorus’ proprietary LNPs. Oncorus will develop formulated drug candidates at its state-of-the-art manufacturing facility in Andover, Massachusetts. Subject to the parties’ satisfaction with the formulations and the achievement of certain study milestones specified in the research plan, Oncorus and Daewoong have agreed to commence negotiations of a potential future license and supply arrangement for the formulated product.
"This collaboration is important validation for our proprietary LNP platform, which is comprised of both novel ionizable amines and cleavable PEG lipids for both intravenous and intramuscular administration, and we are excited to develop novel LNP formulations for Daewoong’s RNA-based programs," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "With our optimized LNPs and manufacturing capabilities, Oncorus is uniquely positioned to partner with companies like Daewoong that are developing novel, RNA-based therapeutics that would benefit from optimized LNP formulations. We look forward to working closely with the Daewoong team on the first of hopefully many similar partnerships to come."
"mRNA is now known to be a powerful tool in our ability to fight many diseases," said Sengho Jeon, Chief Executive Officer of Daewoong. "Oncorus offers a robust solution to enabling mRNA delivery through the pairing of its proprietary LNP technology and in-house process development, with the capacity to manufacture a successful mRNA/LNP formulation on both clinical and commercial scales. We are excited to work with Oncorus to optimize our mRNA drug delivery as we work to improve the quality of life for patients around the world."
Oncorus’ LNP platform leverages proprietary ionizable and polyethylene glycol (PEG) lipids for multiple nucleic acid cargos and possesses other desirable physiochemical properties. In multiple preclinical models involving repeat intravenous (IV) dosing, Oncorus’ formulations have demonstrated improved tolerability, an enhanced therapeutic window and consistent pharmacokinetics compared to approved formulations. Similar studies incorporating Oncorus’ LNP formulations have demonstrated low immunogenicity along with other desirable attributes, including tunable pharmacokinetics with different compositions and stable pharmacokinetics following repeat dosing. The platform is designed to efficiently deliver nucleic acids, including large cargos up to 14 kilobases. This delivery strategy is intended to address many of the complications associated with anti-PEG antibodies interfering with the effective IV delivery of RNA and other nucleic acid-based medicines and can also be leveraged for vaccine applications.