Orca Bio gets FDA nod for world’s first precision-engineered allogeneic cell therapy

The U.S. FDA has approved Orca Bio’s Tregzi, marking the company’s first approved therapy and the first and only precision-engineered cell therapy for allogeneic transplant in adults with hematological malignancies.

Tregzi is a personalized treatment manufactured for each individual patient using living cells from a matched donor. It uses hematopoietic stem and progenitor cells (HSPCs) to reconstitute the immune system, highly purified regulatory T cells (Tregs) to suppress GVHD and conventional T cells (Tcons) to accelerate immune reconstitution and produce graft-versus-leukemia (GVL) activity.

“For transplant physicians, one of our greatest challenges has long been preserving the vital graft-versus-leukemia effect while minimizing the risk of GVHD and infection,” said Miguel-Angel Perales, MD, medical oncologist and chief of the Adult Bone Marrow Transplant Service at Memorial Sloan Kettering. “The FDA approval of Tregzi signals a new era in transplant medicine.”

The approval comes after the FDA extended the review timeline for Orca's BLA by three months, after requesting the company submit updated CMC information. Approval is based on the pivotal Precision-T study which demonstrated patients receiving Tregzi were twice as likely to be alive without chronic GVHD at one year compared with conventional allogeneic transplant.