Orca Bio to Present New Data on TREGZI® and the Company’s Clinical Pipeline at the 68th Annual American Society of Hematology Annual Meeting

Two-year follow-up from the pivotal Phase 3 Precision-T trial highlights durable survival outcomes with TREGZI^® compared to conventional allogeneic hematopoietic stem cell transplant

Preliminary outcomes of Orca-Q^® with reduced intensity or nonmyeloablative conditioning in patients with matched related and matched unrelated donors

Phase 1 ACCESS-T trial evaluating Orca-T^® with dual-agent tacrolimus/ruxolitinib GvHD prophylaxis in myeloablative HLA-mismatched allogeneic transplant

Additional presentations will outline the Phase 2 SERENE-T trial of Orca-T following reduced intensity or nonmyeloablative conditioning in AML and MDS, and examine the impact of federal donor eligibility criteria on outcomes in Precision-T

MENLO PARK, Calif.--(BUSINESS WIRE)--Orca Bio, a commercial-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced that new clinical data will be presented in four poster sessions at the American Society of Hematology (ASH) Annual Meeting from December 12-15 in New Orleans, LA, with one additional abstract accepted for online publication. The presentations will include two-year follow-up of TREGZI^® from the pivotal Phase 3 Precision-T trial, as well as data from ongoing studies evaluating Orca-T^® and the company’s next-generation candidate, Orca-Q^®.

“Orca Bio is committed to advancing the science and body of evidence that support the value and potential of high-precision therapies in blood cancers,” said J. Scott McClellan, MD, Ph.D., chief development officer of Orca Bio. “We look forward to sharing our data presentations at ASH, highlighting the results from the two-year follow up from the TREGZI pivotal trial, Precision-T, along with data exploring the benefit of Orca-T and Orca-Q across a range of transplant settings and patient types.”

The ASH abstracts are now available at www.hematology.org. Details of the Orca Bio poster presentations follow:

Poster Session: 721. Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Toxicities: Poster I
Title: Trial in Progress: A Phase 2 Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome (SERENE-T)
Publication Number: 2457
Date and Time: December 12, 2026 at 5:30 PM - 7:30 PM CST
Location: Ernest N. Morial Convention Center – Hall F

Poster Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster I
Title: Clinical Overview of Acute GVHD Events with Orca-T Compares to Conventional Allograft with tac/MTX in Phase 3 Precision-T trial
Publication Number: 2485
Date and Time: December 12, 2026 at 5:30 PM – 7:30 PM CST
Location: Ernest N. Morial Convention Center – Hall F

Poster Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster II
Title: Preliminary Outcomes of Reduced Intensity Conditioning or Nonmyeloablative Conditioning with Orca-Q in Matched Related and Matched Unrelated Donors
Publication Number: 4244
Date and Time: December 13, 2026 at 6:00 PM - 8:00 PM CST
Location: Ernest N. Morial Convention Center – Hall F

Poster Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster II
Title: ACCESS-T: A Phase 1 Trial of Orca-T with Dual-Agent Tacrolimus/Ruxolitinib Prophylaxis for Myeloablative HLA-Mismatched Allogeneic HCT
Publication Number: 4227
Date and Time: December 13, 2026 at 6:00 PM - 8:00 PM CST
Location: Ernest N. Morial Convention Center – Hall F

Poster Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster III
Title: Two-Year Follow-Up of Orca-T Compared to Conventional Allogeneic Hematopoietic Stem Cell Transplant Demonstrates Durable Survival Outcomes: Updated Results from the Precision-T Phase 3 Trial
Publication Number: 5992
Date and Time: December 14, 2026 at 6:00 PM - 8:00 PM CST
Location: Ernest N. Morial Convention Center – Hall F

Online Publication Only: Impact of Federal Eligibility Criteria for Donors on Post-Transplant Outcomes in the Orca-T Phase 3 Precision-T Trial
Publication Number: 8384

About TREGZI^®

TREGZI^® is the first-and-only FDA approved precision-cell therapy for allogeneic transplant in adults with hematologic malignancies to improve survival free of cGVHD. It is indicated for use in matched donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host-disease-free survival, in the treatment of adults with hematological malignancies.

TREGZI is a personalized treatment manufactured for each individual patient using living cells from a matched donor. TREGZI uses hematopoietic stem and progenitor cells (HSPCs) to reconstitute the immune system, highly purified regulatory T cells (Tregs) to suppress GVHD and conventional T cells (Tcons) to accelerate immune reconstitution and produce graft-versus-leukemia (GVL) activity.

The FDA approval of TREGZI was based on the results of Precision-T, a randomized, open-label, multi-center study that evaluated the safety, efficacy and tolerability of TREGZI compared with conventional allogeneic hematopoietic stem cell transplant (alloHSCT).

Click here for Important Safety Information.

About Orca-Q^®

Orca-Q^® is Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy under evaluation in clinical trials for the treatment of multiple hematologic malignancies, including in patients with haploidentical and mismatched donors. Orca-Q is a proprietary composition of stem cells combined with specific T-cell subsets derived from healthy donors and engineered by Orca Bio’s high-precision platform.

About Orca Bio

Orca Bio is a commercial-stage biotechnology company developing high-precision cell therapies for the treatment of blood cancer and autoimmune diseases. The company’s manufacturing platform uses single-cell precision to create proprietary, uniquely defined products designed to replace a patient’s diseased blood and immune system with a healthy one. At Orca Bio, we are on a mission to redefine what’s possible for patients by transforming the field of curative allogeneic cell therapy. For more information, visit www.orcabio.com.