Rexgenero extends European reach with expanded manufacturing
Rexgenero has expanded manufacturing of its lead candidate with its previously announced partnership with the German Red Cross blood donor service.
After signing an agreement with the blood donor service earlier this year, the regenerative medicine company, focused on developing advanced cell-based therapies for critical limb ischaemia (CLI), has bolstered its manufacturing capabilities for its lead candidate, REX-001.
The lead candidate is an autologous cell-based therapy that is manufactured using a patient’s own bone marrow. According to Rexgenero, manufacture of the drug candidate is time sensitive and administration of the ‘fresh product’ must be within 48 hours.
The drug candidate is already manufactured at the company’s facility in Seville, Spain, and has been used at clinical trial sites in Spain and Portugal.
However, with the additional manufacturing partnership, the German Red Cross blood donor service will manufacture REX-001 for the use at trial sites in Germany, Poland, Czech Republic, Hungary, the Netherlands, the UK, and Austria.
After the transfer of manufacturing technology, a sufficient supply of the drug candidate is ensured for patients enrolled in Phase III trials of REX-001 for the treatment of CLI in patients with diabetes.
Halvard Bönig, professor at the Institute for Transfusion Medicine and Immunohematology at Goethe-University, will oversee production of REX-001 at the German Red Cross blood service in Frankfurt, Germany and Main, Germany.
