Orca Bio’s Orca-T® Meets Primary Endpoint in the Pivotal Precision-T Phase 3 Clinical Study for Hematologic Malignancies

Orca Bio to present efficacy and safety data with Orca-T compared to conventional allogeneic hematopoietic stem cell transplant (alloHSCT) at the 51st Annual Meeting of the EBMT

MENLO PARK, Calif.--(BUSINESS WIRE)--Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced it will present positive results from the pivotal Phase 3 Precision-T study (NCT05316701) of its investigational allogeneic T-cell immunotherapy, Orca-T, in people with hematologic malignancies at the 51st Annual Meeting of the EBMT held March 30-April 2, 2025 in Florence, Italy.

The randomized Precision-T study evaluated the safety, efficacy and tolerability of Orca-T in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS) and mixed-phenotype acute leukemia (MPAL) compared to a conventional allogeneic hematopoietic stem cell transplant (alloHSCT). The Precision-T study met the protocol-specified primary endpoint of a statistically significant improvement in survival free of moderate-to-severe chronic graft versus host disease (cGvHD) with Orca-T versus alloHSCT.

Session details follow:

Oral Session: OS15 Oral Session 15 | GVHD (II)
Title: Orca-T® Demonstrates Improved Survival Free of Chronic GVHD Compared to Conventional Allogeneic Hematopoietic Stem Cell Transplant: A Randomized Phase 3 Trial in Advanced Hematologic Malignancies
Date and Time: April 2, 2025 at 10:30AM CEST
Location: Michelangelo (S-1)

“The Precision-T study marks a critical milestone in our mission to redefine the treatment landscape for patients facing aggressive blood cancers like AML, MDS and ALL, and we eagerly await the opportunity to share the results at EBMT,” said Ivan Dimov, Ph.D., co-founder and chief executive officer at Orca Bio. “We look forward to discussing the Phase 3 findings with the FDA as we advance toward our ultimate goal of bringing Orca-T to the patients who need it most.”

“The annual meeting of the EBMT is one of the largest and most prestigious international congresses for exchanging groundbreaking clinical advancements in the cell therapy space,” said Everett Meyer, M.D., Ph.D., presenting author and primary investigator, hematologist, associate professor of medicine of Blood and Marrow Transplantation and Cellular Therapy at Stanford Health Care. “I am excited and honored to present efficacy and safety data from the pivotal Phase 3 Precision-T study.”

Information on two additional oral sessions accepted for presentation at EBMT follow:

Oral Session: OS03 Oral Session 3 | ATMP Preclinical and Clinical
Title: Observational Comparison of Overall Survival Between Phase 1b Orca-T® and Registry-Based Post-Transplant Cyclophosphamide Patients
Date and Time: March 31, 2025 at 2:30PM CEST
Location: Cavaniglia 2

Oral Session: OS01 Oral Session 1 | Viral Infections
Title: Differential Immune Reconstitution Profiles Between Orca-T® and CD34 Allograft Recipients Provide Insight for Control of Viral Infections
Date and Time: March 31, 2025 at 2:30PM CEST
Location: Roma (S1)

The program for the 51st Annual Meeting of the EBMT is now available at https://www.ebmt.org/annual-meeting-2025.

About Precision-T

Precision-T (NCT05316701) is a randomized, open-label multi-center study that evaluated the safety, efficacy and tolerability of Orca Bio’s lead investigational allogeneic T-cell immunotherapy, Orca-T, compared to conventional allogeneic hematopoietic stem cell transplant (alloHSCT). Orca Bio received guidance from the U.S. Food and Drug Administration on the design of Precision-T, which evaluated Orca-T in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS) and mixed-phenotype acute leukemia (MPAL). There are 19 leading treatment centers participating in the trial, which enrolled 187 patients across the U.S.

About Orca-T

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

About Orca Bio

Orca Bio is a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer and autoimmune diseases. Our manufacturing platform uses single-cell precision to create proprietary, uniquely-defined products designed to replace a patient’s diseased blood and immune system with a healthy one. At Orca Bio, we are on a mission to redefine what’s possible for patients by transforming the field of curative allogeneic cell therapy. For more information, visit www.orcabio.com.