NurExone reports enhanced scalability and clinical readiness for upcoming exosome-based clinical trials for neurological conditions
The Israeli regenerative medicine company is moving one step closer to clinical trials for serious neurological indications such as TBI, spinal cord injury, etc.
They presented key findings on the cell viability and potency from its proprietary Master Cell Bank (MCB), which will serve as the key mesenchymal stem cell resource for its cGMP-compliant exosome product, ExoPTEN. Here’s a post about ExoPTEN’s preclinical data showing improved motor function (with videos) in murine models.
The company mentioned that the mesenchymal stem cells in the MCB had a robust growth performance, and population doubling time (PDT) of 20.4hr±1.56 for up to 9 passages. PDT refers to the time required for the number of cells to double, serving as an indicator of the proliferative capacity of MSCs (Sci Rep. 2021;11(1):3403). A shorter PDT indicates greater proliferative capability. The new data highlights improvements in both upstream (initial cell growth) and downstream (exosome collection and purification) manufacturing processes, demonstrating consistent exosome yields and preserved biological potency across multiple production runs.
NurExone intends to transfer this manufacturing process to its wholly-owned, U.S.-based subsidiary, Exo-Top, which will establish GMP-compliant MSC-derived exosome production to support future clinical trials as well as potential commercial supply.
Jacob Licht, recently appointed CEO of Exo-Top, stated: “The cells from the MCB serve as the biological molds from which exosomes are produced and cell quality is key for consistency, scalability, and therapeutic reliability. Early manufacturing data suggests that these proprietary cells will provide a strong foundation for establishing a robust, U.S.-based infrastructure to support NurExone’s clinical pipeline and could position Exo-Top as a leader in clinical-grade exosome production and supply.”
NurExone reports that ExoPTEN is under development as a first-in-class, exosome-based therapy targeting significant neurological indications, including acute spinal cord injury, optic nerve damage, facial nerve injury, and other conditions such as traumatic brain injury. NurExone expects to initiate a first-in-human clinical trial of ExoPTEN in 2026 and continues to expand its manufacturing capabilities for broader development of exosome-based regenerative therapies.
