Analysis Shows Consistent Manufacturing and Distribution of Orca-T in Hematologic Malignancies

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Key Takeaways

End-to-end execution proved robust, with successful manufacture and infusion in all 243 patients and near-universal delivery within the 72-hour product expiry window.
Cell composition metrics were consistent, including mean Treg dose 2.7×10^6/kg, Treg purity 92%, HSPC dose 6.2×10^6/kg, and low residual T-cell dose.
Orca‑T combines highly purified Tregs, HSPCs, and controlled-dose Tcons from matched related or unrelated donors to establish early immunoregulation and support immune reconstitution.
Phase 3 data supporting regulatory filing showed 1-year moderate-to-severe chronic GVHD–free survival of 78% with Orca‑T versus 38.4% with conventional allo-HSCT, with markedly lower chronic GVHD incidence.

An analysis showed the manufacturing and distribution of Orca-T was consistent for patients with hematologic malignancies.

An analysis of manufacturing data for Orca-T from a phase 1b (NCT04013685) and the phase 3 Precision-T (NCT05316701) trials showed consistent distribution and quality for the novel allogeneic immunotherapy in the treatment of patients with hematologic malignancices.¹

Findings presented at the 2026 Transplantation & Cellular Therapy Meetings showed that Orca-T was manufactured, delivered, and infused for all 243 patients receiving the therapy across the 2 studies. Notably, 99% of patients received Orca-T within the product’s 72-hour expiry window.

The manufacturing analysis demonstrated that the adjusted ideal bodyweight was 74 kg (standard deviation [SD], 13; range, 46-104), and the regulatory T-cell (Treg) dose was 2.7 x 10⁶ cells/kg (SD, 0.4; range, 1.3-3.7). Furthermore, Treg purity was reported at 92% (SD, 3%; range, 78%-97%). The hematopoietic stem and progenitor cells (HSPC) dose was 6.2 x 10⁶ cells/kg (SD, 3.0; range, 1.1-15.2), and the residual T-cell dose was 17 x 10³ cells/kg (SD, 134; range, 0-1825). Conventional T cells (Tcons) were administered at controlled doses of 3 x 10⁶ cells/kg.

“These data demonstrate that high-precision Orca-T can be scaled on our manufacturing platform, reliably distributing high-quality products to patients across the United States using our logistics solution,” lead study author Amy Putnam, site head of the clinical manufacturing facility at Orca Bio, and colleagues wrote in a poster presentation of the data.

What is Orca-T, and how is it being evaluated for patients with hematologic malignancies?

Manufacturing Data for Orca-T in Hematologic Malignancies

In phase 1b and 3 studies evaluating Orca-T in patients with hematologic malignancies, manufacturing and quality outcomes for the immunotherapy were consistent.

Overall, 99% of patients received Orca-T within the 72-hour expiry window.

The Treg purity rate was 92% (SD, 3%; range, 78%-97%), and the HSPC dose was 6.2 x 10⁶ cells/kg (SD, 3.0; range, 1.1-15.2)

Orca-T is an investigational allogeneic T-cell immunotherapy comprising highly purified Tregs, hematopoietic stem cells, and Tcons derived from the peripheral blood from either related or unrelated matched donors.² The agent is being evaluated for the treatment of patients with hematological malignancies, such as acute leukemias and myelodysplastic syndromes.

In October 2025, the FDA granted priority review to a biologics license applicationseeking the approval of Orca-T for the treatment of select patients with hematologic malignancies, including acute myeloid leukemia, acute lymphoblastic leukemia, and MDS.

This application was supported by prior data from the Precision-T trial, which showed that patients treated with Orca-T (n = 93) achieved a 1-year moderate-to-severe chronic graft-vs-host disease (GVHD)–free survival rate of 78% (95% CI, 65%-86.6%) compared with 38.4% (95% CI, 26.2%-50.5%) for those treated with conventional allogenic stem cell transplant (allo-HSCT; n = 94; HR, 0.26; 95% CI, 0.14-0.47; P < .00001).³ Moderate-to-severe chronic GVHD was reported in 12.6% (95% CI, 5.3%-23.1%) the Orca-T arm vs 44.0% (95% CI, 31.3%-56.1%) in the allo-HSCT arm (HR, 0.19; 95% CI, 0.08-0.43; P = .00002).

What was the rationale and design of the manufacturing analysis for Orca-T?

When donor cells are collected, they are sent to a good manufacturing process (GMP) facility for the production of Orca-T via a scalable platform before the treatment is distributed within the United States.¹ Patients receiving Orca-T are given HSPCs and Tregs on day 0 with the goal of starting hematopoietic reconstitution and establishing a high-precision immunoregulatory niche. Tcons are then administered at a controlled dose on day +2 to +3 to further promote immune reconstitution.

In the manufacturing analysis, investigators gathered data on all Orca-T products created for patients being treated in the phase 1b study or Precision-T. During these studies, donor products mobilized via granulocyte colony-stimulating factor were transported to the GMP facility in Sacramento, California, for manufacturing before Orca-T was distributed to respective treatment centers.

References

Putnam A, Chaddock K, Goldman J, et al. Scalable manufacturing and nationwide distribution of Orca-T: a precision-engineered allogeneic immune cell therapy. Presented at: 2026 Transplantation & Cellular Therapy Meetings; February 4-7, 2026; Salt Lake City, UT. Abstract 161.
Orca Bio announces FDA acceptance and priority review of the biologics license application (BLA) for Orca-T to treat hematological malignancies. News release. Orca Bio. October 6, 2025. Accessed February 23, 2026. https://orcabio.com/orca-bio-announces-fda-acceptance-and-priority-review-of-the-biologics-license-application-bla-for-orca-t-to-treat-hematological-malignancies/
Meyer EH, Salhotra A, Gandhi AP, et al. 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. Presented at: 51st Annual EBMT Meeting; March 30-April 2, 2025; Florence, Italy. Abstract OS15-01.