Regenerex LLC is a late clinical stage biotechnology company engaged in the development of innovative cellular therapies with the goal of providing long-term durable responses eliminating the burden of chronic immunosuppression in selected organ transplant and autoimmune conditions. In an ongoing Phase 2 study, the Company’s proprietary allogeneic cell therapy product, FCRx, has been shown to induce tolerance in recipients of solid organ transplants from unmatched and unrelated donors, allowing living donor kidney transplant recipients to wean completely off immunosuppression one year after transplant. FCRx is a platform technology that has also shown potential to safely treat a number of organ transplants, autoimmune diseases, red blood cell disorders, and inherited metabolic disorders, without myeloablative conditioning and without the toxicities of a standard Hematopoietic Stem Cells (HSC) transplant.
FDA has granted clearance to proceed with a number of INDs and IDEs for the FCRx technology. The most mature indication is FCRx in combination with a Living Donor Kidney transplant (IND #16834), which has received Phase III FDA clearance to proceed and Orphan Drug Status.
Regenerex manufactures FCRx therapies through a proprietary process that uses a donor’s HSC and Facilitating Cells (FC) to achieve stable chimerism without requiring HLA matching. Regenerex has developed a fully trained team to perform manufacturing, Quality Control, and Quality Assurance and operates fully equipped GMP-compliant, Phase III-ready cleanroom suites in Louisville, Kentucky in collaboration with the Institute for Cellular Therapeutics.
Collaboration with the Institute for Cellular Therapeutics (ICT)
Regenerex has established a novel strategic collaboration with the Institute for Cellular Therapeutics (ICT) at the University of Louisville. Company employees work together with University scientists to manufacture the FCRx product and study the mechanism of action of the facilitating cell’s functions in this unique translational research environment.