Cost-driven process redesign, automation and scale-out for commercial manufacture of REX-001 therapy

"Rexgenero's lead program (REX-001) is an innovative autologous cell therapy in late-stage development for critical limb ischaemia, a major disease with high unmet medical need. REX-001 is in the last phase of clinical development, but making this potential new treatment available to the many patients who need it is currently limited by the ability to manufacture and deliver sufficient doses in a robust, cost-effective manner, transportation logistics and shelf life.

The proposed collaborative project between Rexgenero, the Cell and Gene Therapy Catapult (CGTC), TrakCel and Fisher Bioservices (FBS) will develop a commercial-scale manufacturing process for REX-001 production, with automated needle-to-needle supply chain management and extended shelf life, which is critical to increasing availability to the many patients who are likely to benefit and the usability at the hospital. The Project will enable relocation of Rexgenero's late stage clinical cell therapy manufacture from Spain to the UK's CGTC Catapult Manufacturing Centre in Stevenage, making the UK Rexgenero's manufacturing site for future commercial supply for European markets.

Establishing a commercially-viable REX-001 manufacturing process will provide major economic and health benefits to the UK and provide substantial quality of life and health benefits to patients suffering with critical limb ischaemia."