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.