Orca Bio Gains FDA Approval for TREGZI to Improve Stem Cell Transplant Outcomes
Orca Bio has received approval from the U.S. Food and Drug Administration (FDA) for TREGZI™ (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq), a precision-engineered cell therapy developed for adults with haematological malignancies undergoing matched-donor haematopoietic stem cell transplantation (HSCT).
The therapy is designed to support immune system recovery and improve chronic graft-versus-host disease (GVHD)-free survival following transplantation.
TREGZI is the first FDA-approved regulatory T cell (Treg)-based immunotherapy for this setting. It is a personalised treatment produced from living cells donated by a matched donor for each patient.
The therapy combines haematopoietic stem and progenitor cells (HSPCs), purified regulatory T cells (Tregs) and conventional T cells (Tcons) to rebuild the immune system, reduce the risk of GVHD and preserve the beneficial graft-versus-leukaemia effect.
The approval is based on findings from the Phase III Precision-T trial involving 187 adult patients with acute myeloid leukaemia (AML), acute lymphoblastic leukaemia (ALL), myelodysplastic syndrome (MDS) and mixed-phenotype acute leukaemia (MPAL).
After 12 months, chronic GVHD-free survival reached 78% in the TREGZI group compared with 38% in patients receiving conventional allogeneic HSCT.
The therapy also reduced chronic GVHD rates, improved overall survival, lowered non-relapse mortality and decreased severe infections.
The approval represents a significant advancement in precision cell therapy, offering a new transplant option that aims to improve long-term outcomes and reduce treatment-related complications for patients with blood cancers.
