Precision-T over-enrolled with 187 total patients at 19 clinical trial sites across the U.S.

Topline results expected in 1H 2025

Orca Bio, a biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced that it has completed enrollment in the pivotal Precision-T Phase 3 clinical study.

A randomized, open-label multicenter study, Precision-T (NCT05316701) is evaluating the safety and efficacy of Orca Bio’s lead investigational allogeneic T-cell immunotherapy, Orca-T, compared to a standard of care allogeneic hematopoietic stem cell transplant (alloHSCT) in patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and high-risk myelodysplastic syndrome (MDS). Orca-T is a donor-derived product designed to replace a patient’s diseased blood and immune system with a healthy one.

“Completing enrollment in our multicenter Phase 3 study of Orca-T is an important milestone toward our ultimate goal of delivering a potentially life-saving product to patients who have long had to settle for a standard of care that carries significant risks,” said Ivan Dimov, Ph.D., co-founder and chief executive officer of Orca Bio. “We’re immensely grateful to the patients, their families and the trial site investigators who participated in our study, and look forward to sharing pivotal data in the near future with the broader blood cancer community.”

The primary endpoint of the Precision-T study is the rate of survival free from moderate-to-severe chronic graft versus host disease (GvHD). Secondary endpoints include time to moderate-to-severe chronic GvHD, graft-versus-host-disease and relapse-free survival (GRFS) and overall survival. Topline results from the study are expected in the first half of 2025. The study has enrolled 187 patients, exceeding the original target of 174 patients.

Orca-T is designed to deliver improved outcomes for patients while overcoming the limitations of standard alloHSCT, which carries the risk of serious complications and treatment-related mortality. Orca-T uses highly purified regulatory T cells with the goal of reducing the tradeoff between the risk of relapse and the risk of serious toxicity, a primary objective of the cell therapy field. Orca-T has demonstrated promising results in early single-arm trials which were recently presented at the Annual Meeting of the EBMT, the 2024 Tandem Meetings of ASTCT® and CIBMTR® and the American Society of Hematology (ASH) Annual Meeting.

More information about the Precision-T study can be found at www.precisiontstudy.com or www.clinicaltrials.gov.

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 comprised 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 a pivotal Phase 3 clinical trial at leading transplant centers across the U.S. 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, autoimmune diseases and genetic blood disorders. Our investigational products are designed to safely replace a patient’s diseased blood and immune system with a healthy one, delivering significantly better outcomes with dramatically fewer risks than the standard of care. Our manufacturing platform uses single-cell precision to create proprietary, uniquely-defined products that have the potential to transform allogeneic cell therapy. At Orca Bio, our mission is to make curative cell therapies both more effective and safer, and in doing so, push past the field’s current boundaries and redefine its future. For more information, visit www.orcabio.com and follow Orca Bio on X: @OrcaBio.

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