Orca Bio Completes Patient Enrollment for Phase 3 Orca-T Study

Orca Biosystems, a biotechnology firm dedicated to revolutionizing patient care through precise cell therapy, has announced the successful completion of patient enrollment for its pivotal Precision-T Phase 3 clinical trial, enrolling 187 patients across 19 U.S. sites. The study, which surpassed its initial target of 174 patients, focuses on evaluating the safety and effectiveness of Orca Bio’s leading investigational therapy, Orca-T, compared to the conventional allogeneic hematopoietic stem cell transplant (alloHSCT) for patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), and high-risk myelodysplastic syndrome (MDS). Topline results from the trial are anticipated in the first half of 2025.

Orca-T, an allogeneic T-cell immunotherapy derived from donors, aims to replace diseased blood and immune systems with healthy counterparts. The Precision-T study (NCT05316701) is both randomized and open-label, involving multiple centers and assessing Orca-T's performance against standard alloHSCT treatments. The primary goal of the trial is to achieve survival free from moderate-to-severe chronic graft versus host disease (GvHD). Secondary endpoints include the time taken to reach moderate-to-severe chronic GvHD, graft-versus-host-disease and relapse-free survival (GRFS), and overall survival rates.

Dr. Ivan Dimov, co-founder and CEO of Orca Bio, emphasized the significance of completing the enrollment phase, marking a crucial step towards their mission of providing potentially life-saving treatments to patients who have historically faced substantial risks with standard care. He expressed gratitude to the patients, their families, and the trial site investigators for their participation, and voiced anticipation for sharing the pivotal data with the broader blood cancer community.

Orca-T offers the potential for improved patient outcomes by mitigating the severe complications and treatment-related mortality associated with traditional alloHSCT. The therapy utilizes highly purified regulatory T cells to balance the risks of relapse and serious toxicity. Early single-arm trials of Orca-T have yielded promising results, which were recently presented at key medical conferences including the Annual Meeting of the EBMT, the 2024 Tandem Meetings of ASTCT® and CIBMTR®, and the American Society of Hematology (ASH) Annual Meeting.

Orca-T consists of regulatory T-cells, CD34+ stem cells, and conventional T-cells sourced from peripheral blood of either related or unrelated matched donors. This investigational therapy is currently under evaluation in the pivotal Phase 3 clinical trial at prominent transplant centers throughout the United States. Additionally, Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA).

Orca Bio, as a late-stage biotechnology company, focuses on developing high-precision cell therapies to treat cancer, autoimmune diseases, and genetic blood disorders. Their investigational products aim to safely replace diseased blood and immune systems with healthy ones, promising significantly better outcomes with fewer risks compared to standard treatments. The company's advanced manufacturing platform employs single-cell precision to create unique and proprietary products, potentially transforming the field of allogeneic cell therapy. Orca Bio is committed to making curative cell therapies more effective and safer, pushing the boundaries of current medical practice, and redefining the future of the field.