Orca Bio's Orca-T® Achieves Primary Endpoint in Phase 3 Study for Blood Cancers

MENLO PARK, Calif.--Orca Bio, a biotechnology company focused on developing cutting-edge cell therapies, has announced promising outcomes from its Phase 3 Precision-T study involving the investigational immunotherapy, Orca-T. The results will be presented at the 51st Annual Meeting of the EBMT, set to take place from March 30 to April 2, 2025, in Florence, Italy. This study highlights the potential of Orca-T in treating hematologic cancers such as acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS), and mixed-phenotype acute leukemia (MPAL).

The randomized Precision-T study was designed to compare the safety, efficacy, and tolerability of Orca-T against the traditional allogeneic hematopoietic stem cell transplant (alloHSCT). The study achieved its main goal, showing a significant improvement in survival without moderate-to-severe chronic graft versus host disease (cGvHD) for patients treated with Orca-T compared to those who underwent alloHSCT.

Ivan Dimov, Ph.D., co-founder and CEO of Orca Bio, highlighted the significance of the Precision-T study, emphasizing its role in potentially transforming treatment options for patients battling aggressive blood cancers. He expressed anticipation for sharing these findings at the EBMT meeting and discussing them with the FDA to advance Orca-T's availability to patients in need.

Everett Meyer, M.D., Ph.D., from Stanford Health Care and the primary investigator of the study, will present the data. He underscored the importance of the EBMT meeting as a prestigious platform for disseminating groundbreaking advancements in cell therapy.

In addition to the main presentation, two other oral sessions related to Orca-T have been accepted for the EBMT conference. One session will present a comparison of overall survival between Phase 1b Orca-T recipients and patients treated with post-transplant cyclophosphamide. Another session will delve into the differences in immune reconstitution profiles between Orca-T and CD34+ allograft recipients, particularly in managing viral infections.

The Precision-T study, identified as NCT05316701, is a multi-center, open-label trial that assessed Orca-T's performance in patients with various hematologic disorders. The study involved 19 top treatment centers across the United States, with 187 patients enrolled.

Orca-T, an investigational allogeneic T-cell immunotherapy, is under evaluation in clinical trials for multiple blood cancers. It is composed of purified regulatory T-cells, CD34+ stem cells, and conventional T-cells sourced from either matched related or unrelated donors. Orca-T is currently in the pivotal Phase 3 Precision-T trial and has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration.

Orca Bio is at the forefront of developing high-precision cell therapies aimed at treating cancer and autoimmune diseases. Their innovative manufacturing platform employs single-cell precision to create products that aim to replace diseased blood and immune systems with healthy alternatives. Orca Bio is committed to redefining possibilities for patients by advancing the field of curative allogeneic cell therapy.