New data evaluating Orca-T^® with reduced intensity conditioning versus PTCy for the treatment of hematological malignancies

Orca-T outcomes in patients with myelodysplastic syndromes to be presented for the first time; includes retrospective comparison to PTCy

Additional presentations will highlight the combination of Orca-T and an allogeneic CAR-T (OrCAR-T™), manufacturing and nationwide distribution data reported on Orca–T and clinical findings of Orca-Q^® in patients with haploidentical donors

Orca Bio, a late-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 two oral and seven poster sessions at the 2026 Tandem Meetings of ASTCT and CIBMTR from February 4-7 in Salt Lake City, UT.

The presentations will include data on the company's pipeline of investigational allogeneic T-cell immunotherapies for the treatment of multiple hematological malignancies, including Orca-T, Orca-Q and the Orca-T and allogeneic CAR-T combination therapy, OrCAR-T.

“Our presentations at this year’s Tandem Meetings reflect the growing body of evidence supporting the use of Orca-T as a precision-engineered cellular immunotherapy administered through an allogeneic stem cell transplant,” said Nate Fernhoff, Ph.D., co-founder and chief executive officer of Orca Bio. “From new data in myelodysplastic syndromes, to evaluations in reduced intensity conditioning, and a report on our ability to reliably distribute our products to patients nationwide, these findings represent our ongoing efforts to improve outcomes for the transplant community. We look forward to engaging with our peers and partners to discuss how these advancements can help redefine the treatment landscape for patients with blood cancer.”

The Tandem abstracts are now available at www.tandemmeetings.com. Details of the Orca Bio presentations follow:

Oral Session: Session A - Clinical Progress in GVHD Prevention, Risk Stratification, and Treatment

Title: Interim Clinical Outcomes in Orca-T with Reduced Intensity Conditioning: An Observational Comparison to Registry-Based Post-Transplant Cyclophosphamide Patients

Presentation ID: 7

Date and Time: Wednesday, February 4, 3:15 PM - 3:30 PM MST

Location: Ballroom AB

Oral Session: Session E - Acute Lymphoid Leukemias: Advances in CAR T and Transplant Approaches

Title: Mature Outcomes from the Phase I Trial of Orca-T and Allogeneic CD19/CD22 CAR-T cells for Adults with High-Risk B-ALL

Presentation ID: 31

Date and Time: Thursday, February 5, 3:15 PM - 3:30 PM MST

Location: Ballroom AB

Poster Session: Myeloid Neoplasms Including Relapse – Clinical

Title: Clinical Outcomes in Myelodysplastic Syndrome Patients Treated with Orca-T or Post-Transplant Cyclophosphamide Patients: A Registry-Based Comparison

Presentation ID: 534

Date and Time: Thursday, February 5, 6:30 PM - 8:00 PM MST

Location: Poster Hall AB

Poster Session: Cell and Gene Therapy – Clinical

Title: Scalable Manufacturing and Nationwide Distribution of Orca-T: A Precision-Engineered Allogeneic Immune Cell Therapy

Presentation ID: 161

Date and Time: Thursday, February 5, 6:30 PM - 8:00 PM MST

Location: Poster Hall AB

Poster Session: GVHD Clinical – Prevention and Treatment

Title: Clinical Outcomes in Orca-T and Registry-Based Post-Transplant Cyclophosphamide Patients: An Observational Comparison

Presentation ID: 366

Date and Time: Thursday, February 5, 6:30 PM - 8:00 PM MST

Location: Poster Hall AB

Poster Session: GVHD Clinical – Prevention and Treatment

Title: Preliminary Safety and Efficacy of Myeloablative Orca-Q in Patients with Haploidentical Donors

Presentation ID: 345

Date and Time: Thursday, February 5, 6:30 PM - 8:00 PM MST

Location: Poster Hall AB

Poster Session: Conditioning Regimens

Title: Single Center Phase 1b Study of Orca-T Following Escalated Doses of Total Marrow and Lymphoid Irradiation (TMLI) in Patients with Acute Leukemia or MDS

Presentation ID: 172

Date and Time: Thursday, February 5, 6:30 PM - 8:00 PM MST

Location: Poster Hall AB

Poster Session: Health Services and Barriers to Access

Title: Orca-T Demonstrates Favorable Quality of Life and Healthcare Resource Use Compared to Standard AlloHSCT Plus Tac/MTX for GVHD Prevention in a Randomized Phase 3 Clinical Trial (Precision-T)

Presentation ID: 402

Date and Time: Thursday, February 5, 6:30 PM - 8:00 PM MST

Location: Poster Hall AB

Poster Session: Health Services and Barriers to Access

Title: Cost-Effectiveness of Orca-T Vs Allo-HCT with Conventional GVHD Prophylaxis for the Treatment of Advanced Hematologic Malignancies in the United States

Presentation ID: 401

Date and Time: Thursday, February 5, 6:30 PM - 8:00 PM MST

Location: Poster Hall AB

About Orca-T

Orca-T is an investigational allogeneic T-cell immunotherapy being evaluated for the treatment of multiple hematologic malignancies including acute leukemias and myelodysplastic syndromes. Orca-T is composed of highly purified regulatory T-cells, hematopoietic stem cells and conventional T-cells derived from peripheral blood from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation for the prevention of graft versus host disease or death in patients eligible for hematopoietic stem cell transplant from the U.S. Food and Drug Administration (FDA). The Biologics License Application (BLA) for Orca-T is currently under Priority Review with the FDA with a PDUFA target action date of April 6, 2026.

About Orca-Q

Orca-Q is Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy being evaluated 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 late-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.

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"Our presentations at this year’s Tandem Meetings reflect the growing body of evidence supporting the use of Orca-T as a precision-engineered cellular immunotherapy administered through an allogeneic stem cell transplant."