Proprietary Synthetic Polynucleotide Platform Accelerates Non-Viral, Footprint-Free Induced Pluripotent Stem Cell Generation Amid Surging Commercialization of iPSC Therapies in Japan
SEATTLE, June 16, 2026 (GLOBE NEWSWIRE) -- Pluristyx, a leading provider of advanced induced pluripotent stem cell (iPSC) technologies and proprietary, genetically engineered solutions, today announced the Japanese Patent Office (JPO) issued a Notice of Allowance for Patent Application No. 2023-552219. The licensed patent, titled "Engineered Expression Constructs to Increase Protein Expression from Synthetic Ribonucleic Acid (RNA)" (nationalization of International Application No. PCT/US2022/017880), represents a critical expansion of Pluristyx’s intellectual property portfolio. These unique synthetic mRNA constructs stabilize mRNA and increase protein expression without need for modified nucleosides, microRNA sites, or immune-evading factors.
This allowance comes at a pivotal moment for regenerative medicine in Japan. A global leader in induced pluripotent stem cell (iPSC) research, Japan established an accelerated regulatory framework for iPSC-derived products in 2015. More than 11 years later, the first two landmark commercial iPSC-derived cell therapies have been approved. Pluristyx is addressing this critical industry bottleneck in the transition from R&D to commercial use by applying its unique synthetic mRNA technology to rapidly generate safe, clinical-grade iPSCs able to be manufactured at large commercial scale.
By optimizing expression kinetics of synthetic RNA with a multiplex of key pluripotency transcription factors, the Pluristyx platform streamlines reprogramming, enabling bulk processing and eliminating current obligatory manual clonal selection, thereby reducing line generation time to less than 30 days from the 90 plus days required by current methods. Additionally, by using synthetic RNA transcripts containing all natural nucleosides, Pluristyx mitigates innate cellular immune responses triggered by viral, DNA, and other mRNA-based methods, all the while reducing mutagenetic process. These improvements increase genomic stability while also providing thousands of selectable clones from a single cell line, addressing multiple safety criteria for commercial manufacturers specified by regulatory bodies like Japan's Pharmaceuticals and Medical Devices Agency (PMDA).
“Japan has consistently led the world in pioneering the clinical translation of iPSC-derived therapies and is now transitioning from development to commercialization. In order for the next wave of approvals to come in a timely manner, and succeed outside Japan, ensuring safety, purity, and scaling efficiency of iPSC is needed,” said Dr. Benjamin Fryer, Co-Founder and CEO of Pluristyx. “This patent allowance validates our unique approach using engineering synthetic mRNA to directly supporting our mission to quickly and efficiently provide the highest quality foundational cell lines to enable the next generation of regenerative medicine.”
“Reprogramming is one of the most demanding tests of synthetic mRNA, because it requires expressing a multiplex of pluripotency transcription factors at precisely the right relative levels, not just expressing a single protein. We designed this technology to give tunable control without modified nucleosides, and we're proud to see it validated in Japan and applied by Pluristyx to accelerate the next generation of regenerative medicine.” said Dr. Kambiz Mousavi, Founder and CEO of Riboz, LLC, from whom the foundational mRNA technology was licensed and then built upon by Pluristyx.
Pluristyx will leverage this newly protected IP to further expand its high-value partnering programs, granting therapeutic developers access to its clinical-grade, immune-cloaked, and gene-edited iPSC lines, establishing a fully streamlined, regulatory compliant pipeline from initial non-viral reprogramming to clinical delivery.
About Pluristyx
Pluristyx is the leading provider of advanced induced pluripotent stem cell (iPSC)-based solutions for the cell and gene therapy industry, delivering a comprehensive platform designed to accelerate therapeutic development with unmatched speed, safety, and scalability. Leveraging proprietary mRNA bulk reprogramming and a polyclonal iPSC approach, Pluristyx produces genetically younger, more stable, and highly expandable cells. The company's portfolio spans off-the-shelf, clinical-grade iPSC lines, custom gene editing and engineering, and innovative safety and immune-evasion technologies, including the FailSafe® safety switch and iACT™ immune cloaking system. Beyond cell sourcing, Pluristyx supports the entire development continuum, from concept to organoid-based disease modeling, high-throughput drug screening, and GMP-scale manufacturing, empowering therapeutic developers to streamline workflows, reduce risk, and accelerate the path to clinic.
Media Contact
Dr. Priya Baraniak
Chief Commercial and Development Officer
priya@pluristyx.com
