US-based Orca Bio, today announced Precision-T, its pivotal phase 3 study, is open, enrolling and treating 174 leukemia patients at more than 20 clinical trial sites.

Precision-T is a randomized, open-label multi-center study that is evaluating the safety and efficacy of Orca Bio’s lead investigational high-precision cell therapy, Orca-T, compared to standard of care allogeneic hematopoietic stem cell transplant (standard allo-HSCT).

Orca Bio received guidance from the Food and Drug Administration (FDA) on the design of the study, which will evaluate Orca-T in patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and high-risk myelodysplastic syndromes (MDS).

Cell therapy

Robert Negrin, professor of medicine at the Stanford School of Medicine, one of the trial sits, said: “By precision engineering the donor graft, we aim to create a cell therapy that retains the benefits of transplant without serious complications like graft versus host disease and disease relapse. This has been demonstrated by the recent results of the phase 1b/2 single-arm trials with Orca-T, and we are pleased to be evaluating this novel cell therapy in a randomized Phase 3 clinical trial.”

Orca-T is an investigational high-precision allogeneic cellular therapy consisting of infusions containing regulatory T-cells, conventional T-cells and CD34+ stem cells derived from peripheral blood from either related or unrelated matched donors.

The primary endpoint of the Precision-T study is the rate of moderate-to-severe chronic graft versus host disease (GvHD)-free survival. The secondary endpoints are GvHD and relapse-free survival (GRFS), moderate-to-severe chronic GvHD and relapse-free survival. The randomized Phase 3 trial is being conducted concurrently with Orca Bio’s ongoing single-arm Phase 1b trial of Orca-T.

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Effective therapy

Ivan Dimov, co-founder and chief executive officer of Orca Bio, said: “We are pleased to collaborate with these clinical trial centers and the broader blood cancer community to advance this study with the ultimate goal of delivering a safe and effective therapy to the patients who need it.”

Orca-T is a first-in-class high-precision cell therapy that combines purified cells from a matched donor. It is designed to replace a patient’s diseased blood and immune system with a healthy one while lowering the risk of developing GvHD and other life-threatening transplant-related side effects. Almost 200 patients have been treated to date with Orca-T in single-arm trials with extremely encouraging results.

Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and is being studied to treat multiple hematologic malignancies.

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