Ixaka and Minaris Regenerative Medicine Sign Tech Transfer and GMP Manufacturing Agreement for Lead Cell Therapy Candidate REX-001
- REX-001 is an autologous multi-cell therapy (MCT) in development for the treatment of chronic limb-threatening ischemia (CLTI) in patients with diabetes
- REX-001 is currently being evaluated in the randomized double-blind placebo controlled pivotal Phase 3 clinical trial (SALAMANDER trial) and the furthest advanced product in this indication
London, UK and Munich, Germany – June 27, 2022 – Ixaka Ltd, an integrated cell and gene therapy company, and Minaris Regenerative Medicine GmbH (“Minaris”), a leading contract development and manufacturing service provider for the cell and gene therapy industry, today announced that they have signed an agreement to enable technology transfer as well as clinical and commercial manufacture of REX-001, Ixaka’s lead autologous multi-cell therapy (MCT) being developed for the treatment of chronic limb-threatening ischemia (CLTI) in patients with diabetes.
Under the terms of agreement, Minaris will perform technology transfer of REX-001 manufacturing and QC testing activities from Ixaka’s Seville facilities to Minaris’ facilities near Munich. The move will take place in preparation for the upcoming REX-001-006 Phase 3 clinical trial, which is the second of two Phase 3 studies for REX-001.
REX-001 is an MCT product in clinical development as a patient-specific cellular immunotherapy. The product is produced using cells extracted from a patient’s own bone marrow and enriched for white blood cells. Re-administration into the affected limb delivers multiple immune and progenitor cells directly to the diseased vessels to address the complex disease processes that lead to the clinical progression of CLTI (plaque deposition, inflammation, ischemia, vessel degeneration, ulcer formation).
The scope of the manufacturing agreement includes the scale-up and technology transfer with the goal of supplying the Phase 3 clinical trials and supporting commercial supplies in the EU and later in the United States.
Joe Dupere, Chief Executive Officer at Ixaka, commented:
“Partnering with Minaris will provide essential capacity and expertise as we move into the next phase of expansion of our REX-001 Phase 3 clinical trials in Europe and, in time, the United States. We look forward to working with Minaris to bring this life-changing therapy to patients globally.”
Dusan Kosijer, CEO at Minaris Regenerative Medicine GmbH, commented:
“We are pleased to see that cell and gene therapies are leaving their niche of rare diseases and are increasingly being used in major indications such as diabetes-related conditions. We look forward to successfully supporting Ixaka with our clinical and commercial manufacturing experience and are eager to see REX-001 succeed in improving the lives of patients with chronic limb-threatening ischemia.”