Orca-T® Hits Primary Endpoint in Precision-T Phase 3 Study for Hematologic Cancers
Orca Bio, a late-stage biotechnology company focused on revolutionizing patient care through advanced cell therapies, today announced it will present positive findings from the pivotal Phase 3 Precision-T study (NCT05316701) of its investigational allogeneic T-cell immunotherapy, Orca-T, for hematologic malignancies. The presentation will take place at the 51st Annual Meeting of the EBMT, set to occur from March 30 to April 2, 2025, in Florence, Italy.
Orca Bio, a late-stage biotechnology company committed to revolutionizing patient care through high-precision cell therapy, has made significant strides in its efforts to treat hematologic malignancies. The company recently announced the successful outcomes from the pivotal Phase 3 Precision-T study (NCT05316701), which evaluates the safety, efficacy, and tolerability of Orca-T, an investigational allogeneic T-cell immunotherapy.
This study focused on patients with hematologic conditions such as acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS), and mixed-phenotype acute leukemia (MPAL). The results demonstrate that Orca-T is superior to conventional allogeneic hematopoietic stem cell transplant (alloHSCT) in terms of improving survival free of moderate-to-severe chronic graft versus host disease (cGvHD). This finding represents a major milestone in Orca Bio’s ongoing mission to redefine treatment options for patients facing aggressive blood cancers.
The Precision-T study met its protocol-specified primary endpoint, showing a statistically significant improvement in the survival rate of patients free from moderate-to-severe chronic GVHD when treated with Orca-T compared to those receiving traditional alloHSCT. These findings are pivotal, as chronic GVHD is a severe and often debilitating complication following stem cell transplants, and its prevention is a critical goal in improving long-term patient outcomes.
The results of the Precision-T study will be presented during an oral session at the 51st Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT), which will take place in Florence, Italy, from March 30 to April 2, 2025.
The session, titled “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,” will be held on April 2, 2025, at 10:30 AM CEST in the Michelangelo (S-1) room. Ivan Dimov, Ph.D., co-founder and CEO of Orca Bio, emphasized that the presentation at EBMT marks a critical moment in the company’s journey toward offering a new standard of care for patients battling aggressive blood cancers.
“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 Dr. Dimov. “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 EBMT meeting is known for being one of the largest and most prestigious international congresses for cell therapy and hematology, offering an ideal platform to present the latest breakthroughs in the field. Dr. Everett Meyer, M.D., Ph.D., presenting author and primary investigator of the Precision-T study, expressed his excitement about presenting the safety and efficacy data derived from the trial. Dr. Meyer, a hematologist and associate professor of medicine specializing in Blood and Marrow Transplantation and Cellular Therapy at Stanford Health Care, will present the findings in an oral session that has garnered significant attention within the medical community.
In addition to the presentation on Orca-T’s impact on chronic GVHD, two other oral sessions have been accepted for presentation at the EBMT meeting. The first, “Observational Comparison of Overall Survival Between Phase 1b Orca-T® and Registry-Based Post-Transplant Cyclophosphamide Patients,” will be held on March 31, 2025, at 2:30 PM CEST in the Cavaniglia 2 room.
The second session, “Differential Immune Reconstitution Profiles Between Orca-T® and CD34 Allograft Recipients Provide Insight for Control of Viral Infections,” will also take place on March 31, 2025, at 2:30 PM CEST in the Roma (S1) room. These additional sessions will provide further insight into the potential benefits of Orca-T in improving survival outcomes and mitigating complications related to viral infections and immune system reconstitution following transplant procedures.
The full program for the 51st Annual Meeting of the EBMT can be found on the official EBMT website.
About Precision-T
Precision-T is a randomized, open-label, multicenter Phase 3 clinical trial designed to evaluate the safety, efficacy, and tolerability of Orca-T compared to conventional alloHSCT. The trial has received guidance from the U.S. Food and Drug Administration (FDA) and involves leading treatment centers from across the United States. It enrolled a total of 187 patients, specifically targeting those with AML, ALL, high-risk MDS, and MPAL. This comprehensive study aims to provide robust evidence for Orca-T’s potential as a transformative therapy for these challenging conditions.
About Orca-T
Orca-T is an investigational allogeneic T-cell immunotherapy that is currently being evaluated in several clinical trials for the treatment of hematologic malignancies. The therapy consists of highly purified regulatory T-cells, CD34+ stem cells, and conventional T-cells derived from peripheral blood of matched donors. Orca-T is designed to replace the patient’s diseased immune system with a healthy one, offering a precision-based approach to treatment. The investigational therapy has already received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, which reflects its potential to address serious conditions with few current treatment options.
About Orca Bio
Orca Bio is a biotechnology company at the forefront of high-precision cell therapies, focused on revolutionizing the treatment of cancer and autoimmune diseases. Using a unique manufacturing platform, Orca Bio develops proprietary products that provide single-cell precision to replace diseased blood and immune systems with healthy, functional ones. With a mission to redefine curative therapies for allogeneic cell transplantation, Orca Bio is committed to transforming the lives of patients through innovative, precision-based treatments.
