[Edaily Reporter KIM SAE-MI ] Olix Pharmaceuticals, Inc.(226950)is expanding its presence in the RNA technology sector by filing a U.S. patent application for its circular messenger RNA (mRNA) manufacturing platform.

Olix Pharmaceuticals, Inc. announced on the 1st that it has completed a patent application with the U.S. Patent and Trademark Office (USPTO) for its circular mRNA manufacturing platform technology through its U.S. subsidiary, “OliX US, Inc.”

This application covers manufacturing platform technology that can be applied to the expression of various antigens and therapeutic proteins, rather than specific therapeutic candidates. Olix Pharmaceuticals, Inc. plans to expand its RNA technology portfolio from existing RNA interference (RNAi)-based gene expression suppression technology to the field of protein expression.

Circular mRNA is a ring-shaped RNA with both ends connected. Because it lacks 5’ and 3’ free ends, it offers greater resistance to RNA-degrading enzymes and higher intracellular stability than conventional linear mRNA, and enables sustained protein expression over a longer period. It is being researched as a next-generation RNA platform in various fields, including cancer vaccines, therapeutic proteins, and gene editing.

Olix Pharmaceuticals, Inc. employed a manufacturing method that first produces kilobase (kb)-scale long-chain RNA precursors capable of circularization at the transcription stage, followed by the enzymatic ligation of the two ends of the RNA. The company explains that this approach reduces the post-transcriptional processing steps and minimizes the likelihood of generating unnecessary residual sequences or byproducts consisting of multiple linked RNA molecules in the final circular mRNA.

According to the company, its own initial process evaluation showed that the yield of long-chain RNA precursors was approximately 30% higher by mass than that of comparative mRNA produced under the same conditions. Anion-exchange high-performance liquid chromatography (HPLC) analysis immediately after circularization measured the circular mRNA ratio at up to approximately 72%.

Subsequently, following RNase R treatment to remove linear RNA and prior to separate chromatographic purification, a circular mRNA purity of approximately 94% was achieved. The process recovery rate relative to the input precursor RNA was approximately 34%.

In initial cell-based assays, circular mRNA and a control mRNA were introduced into cells at the same molar concentration, and protein expression was tracked for up to 6 days. The protein expression signal from the circular mRNA declined more gradually than that from the control mRNA. Circular mRNA modified with specific nucleic acid modifications also exhibited higher cumulative protein expression levels than the control group.

Olix Pharmaceuticals, Inc. plans to further refine the native mRNA purification process and evaluate protein expression persistence, in vivo distribution, immune responses, and safety in animal models. The company also plans to validate efficacy in disease models and expand the scope of application to include cancer vaccines and therapeutic proteins.

Lee Dong-ki, CEO of Olix Pharmaceuticals, Inc., stated, “This patent application marks the starting point for securing intellectual property rights for our native mRNA manufacturing platform and expanding our RNA technology into the field of protein expression,” adding, “We will enhance our technological competitiveness and commercialization potential by securing data from animal and disease models in the future.”