NurExone Biologic Secures Master Cell Bank
Thursday, January 09, 2025
NurExone Biologic Inc., a developer of exosome-based therapies for regenerative medicine, is pleased to announce that it has acquired a master cell bank from a U.S. manufacturer for an undisclosed amount (the “Acquisition”). The Acquisition marks a major step in ensuring a stable and scalable supply chain for production of exosome-based therapies for clinical needs and eventual patient treatment.
The master cell bank provides a well-characterized, Good Manufacturing Practices (“GMP”) grade and exclusive source of human bone marrow mesenchymal stem cells (“MSCs”), the foundation for producing exosomes. The acquired master cell bank contains a large volume of high-concentration MSCs at their earliest stage (Passage Zero), ensuring the cells retain their therapeutic potential and remain potent over very long usage in exosome production. These are stored and handled under stringent U.S. Food and Drug Administration (“FDA”) guidelines and GMP, meeting the high-quality standards for clinical use. Exosomes, naturally occurring nanoparticles derived from human MSCs, play a key role in promoting healing and regeneration. This strategic Acquisition positions NurExone to advance revenue-generating opportunities that leverage exosomes both as a therapeutic agent and as a versatile drug delivery system for targeted applications across various indications.
Dr. Lior Shaltiel, CEO of NurExone, stated: “securing this high-quality master cell bank is a pivotal milestone for NurExone. It ensures access to the raw materials essential for advancing our innovative therapies. We negotiated a fixed-price cell purchase order that enables NurExone to avoid product royalty fees for the cell line and eliminate the annual licensing fees that companies based on commercial cells typically incur as they approach clinical trials. The Acquisition reflects our commitment to delivering minimally invasive, effective therapies designed to improve patient outcomes while unlocking the potential of exosomes as a targeted drug delivery platform.”
The Acquisition was executed at a strategic time as the FDA just approved the first-ever Mesenchymal Stromal Cell-based therapyi. This landmark decision underscores the transformative potential of Mesenchymal Stromal Cell-based therapies and allogeneic (donor-derived, rather than patient’s own cells) treatments, paving the way for broader adoption in cell therapy applications and marking a major milestone in the field of regenerative medicine.
Yoram Drucker, Chairman of NurExone’s Board, added: “the Acquisition underscores our dedication to building a sustainable foundation for our products and the future of exosome-based therapeutics. With this resource in place, we are well-positioned to meet the growing clinical demand for innovative treatments in spinal cord, optic nerve, and other therapeutic areas as well as to collaborate with pharma companies looking to develop siRNA-based therapies which are loaded onto and delivered by our exosomes. Moreover, the ability to produce large quantities of high quality, GMP-manufactured exosomes may enable the Company to supply exosomes to companies for a wide range of applications - from dermal treatments to drug delivery development.”
Source: globenewswire.com
