NurExone Biologic’s U.S. Subsidiary Exo-Top and BioXtek Sign LOI to Partner On Exosome Manufacturing and Commercialization

Key Points

• Exo-Top and BioXtek signed a non-binding LOI to explore a strategic partnership for exosome manufacturing and commercialization.
• The proposed collaboration would focus on GMP production, clinical supply, and potential U.S. and international distribution of bone marrow-derived mesenchymal stem cell exosomes.
• BioXtek could support future U.S. clinical supply for NurExone’s lead candidate ExoPTEN, which is being developed for acute spinal cord injury and optic nerve damage.

NurExone Biologic’s U.S. subsidiary, Exo-Top, has signed a non-binding letter of intent with BioXtek to explore a strategic partnership in regenerative therapies centered on exosome manufacturing and commercialization. The companies plan to negotiate a partnership that would support U.S. GMP manufacturing, clinical supply, and potential commercialization of bone marrow-derived mesenchymal stem cell (MSC) exosomes in the U.S. and international markets.

What the companies plan to do

The proposed partnership would combine Exo-Top’s MSC Master Cell Bank and exosome production know-how with BioXtek’s U.S. manufacturing infrastructure and commercialization capabilities. The companies said the goal is to improve manufacturing readiness, expand production capacity, and support a more consistent supply of clinical and commercial exosomes.

A key part of the proposed partnership is NurExone’s proprietary Master Cell Bank, which the company says is designed to support batch consistency, technology transfer, and scalable GMP production.

Under the LOI, the companies are exploring work in several areas:

• Improving MSC exosome manufacturing consistency and quality processes
• Supporting GMP supply for U.S. and international markets
• Targeting applications such as wound care, pain management, and orthopedics
• Potentially supplying exosomes for regenerative aesthetics and other regulated markets
• Supporting manufacturing for planned U.S. clinical trials

Potential role in ExoPTEN development

BioXtek may support the manufacturing of naïve MSC exosomes for U.S. clinical trials of ExoPTEN, NurExone’s lead drug candidate. ExoPTEN is being developed for acute spinal cord injury and optic nerve damage, with a potential path toward FDA approval.

Under the proposed structure, Exo-Top would provide platform know-how and support technology transfer, while BioXtek could act as a Florida-based GMP manufacturing and commercial partner. BioXtek may also receive customer-specific distribution rights for naïve MSC exosomes. Exo-Top may use exosomes produced through the collaboration in its own proprietary therapies and nanodrugs that use loaded exosomes to deliver therapeutic cargo.

We interviewed Nurexone’s CEO here!

Want to keep up on regenerative medicine? Get the weekly newsletter here.