On January 7, 2025 Pluristyx, a leading provider of Good Manufacturing Practices (GMP), cutting-edge, induced pluripotent stem cell (iPSC) technologies, reported the immediate availability of the PSXi013 iPSC line made under GMP (Press release, panCELLa, JAN 7, 2025, View Source [SID1234649470]). This off-the-shelf, readily available cell line will revolutionize the cell and gene therapy landscape, breaking the mold of how cells are supplied, and offering an unprecedented solution for researchers and developers seeking to accelerate clinical translation of their iPSC-based therapies.
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Avoiding many of the pitfalls associated with conventional iPSC reprogramming methods that can introduce genetic instability, PSXi013 has been reprogrammed using our state-of-the-art, footprint-free natural-nucleotide, mRNA technology. This innovative approach eliminates the risk of insertional mutagenesis and incorporation of synthetic nucleotides into the genome, ensuring the highest quality and safety for therapeutic applications. As the lowest passage iPSC bank available on the market (delivered at Passage 10), PSXi013 effectively minimizes the risk of genetic drift, allows the customer to select a clone on their schedule, and provides a more stable and clinically relevant starting material versus higher passage cell banks. PLSXi013 is available for immediate licensing with a simplified structure directly through Pluristyx.
"We are thrilled to launch PSXi013, a true game-changer in the field of regenerative medicine," said Dr. Benjamin Fryer, Chief Executive Officer of Pluristyx. "We have already licensed this line to several leading therapeutic developers and are excited to now share this new line with the wider industry. PSXi013 embodies our commitment to the most advanced, reliable, and clinically relevant iPSC solutions. We are empowering researchers to dramatically accelerate the development of their life-changing cell therapy with our unmatched quality, low passage number, potential for genetic modification, and robust regulatory support. "
PSXi013 is manufactured from a healthy adult donor consented under IRB approved protocols, and has been rigorously tested to meet or exceed regulatory guidelines for clinical use in all major global regulatory jurisdictions and indications.
Key features of the stem cell line that set it apart:
Prospectively designed for genetic editing and process optimization: PSXi013 is available in polyclonal format unlike all other current lines where a clone is automatically preselected by the supplier. Polyclonal iPSC pools eliminate genetic bottlenecks and enable end users to edit and/or select their cells for desired phenotype and process functionality.
Unmatched Quality and Genomic Integrity: Extensive testing, including extended serial passaging, confirms the exceptional genomic stability of PSXi013, making it an ideal foundation for large-scale, consistent clinical manufacturing.
Streamlined Regulatory Pathway: The GMP PSXi013 iPSC line will be supported by a Drug Master File (DMF) submission to the US FDA to simplify the Investigational New Drug (IND) application process and accelerate clinical trial initiation.
Proven Differentiation Potential: PSXi013 demonstrates robust differentiation potential across a wide array of therapeutically relevant cell types, including but not limited to beta islets, hepatocytes, cardiomyocytes, Natural Killer (NK) cells, mesenchymal stem/stromal cells (MSCs), and neuronal progenitors. This versatility makes it a powerful tool for developing treatments for a broad spectrum of diseases.
Addressing key safety concerns surrounding iPSC-based therapies, such as immunogenicity and uncontrolled proliferation, Pluristyx also offers custom manufacturing of genetically modified variants of PSXi013. These variants can incorporate hypoimmune technology to evade immune rejection, and Pluristyx’s proprietary FailSafe suicide switch technology to selectively eliminate proliferating cells, enhancing the manufacturability, safety, and efficacy of the final cell therapy product. Hypoimmune and FailSafe edits are currently available in iPSC lines for preclinical research and development and can be performed under GMP conditions upon request.
The launch of the GMP PSXi013 iPSC Master Cell Bank marks a pivotal moment in Pluristyx’s ongoing mission to accelerate the development of stem cell therapies. By providing a high-quality, low-passage iPSC line backed by comprehensive testing and regulatory support, Pluristyx is empowering researchers and developers to bring tomorrow’s cell therapies to patients today.
Pluristyx CEO Benjamin Fryer will be presenting the company and hosting one-on-one meetings during the JP Morgan Healthcare Conference in San Francisco next week.