New data evaluating Orca-T® with reduced intensity conditioning for the treatment of hematological malignancies in patients 60 to 75 years of age
Clinical findings of Orca-Q® with and without the use of GvHD prophylaxis in patients with hematological malignancies including AML, ALL and MDS
Expanded feasibility data on the combination of Orca-T and an allogeneic CAR-T (OrCAR-T™) in patients with high-risk B-ALL
Additional presentations will highlight overall survival and non-relapse mortality with Orca-T versus PTCy, and additional subsets from the pivotal Phase 3 study including relapse-free survival and patient-reported outcomes
MENLO PARK, CA, November 3, 2025 – 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 three oral and three poster sessions at the American Society of Hematology (ASH) Annual Meeting from December 6-9 in Orlando, FL. The presentations will span its 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 ongoing clinical evaluation of our pipeline across diverse patient populations, conditioning regimens and donor types underscores our commitment to advancing care for people with blood cancer,” said Nate Fernhoff, Ph.D., co-founder and chief executive officer of Orca Bio. “We look forward to presenting new and expanded evidence from the pivotal Phase 3 study of our lead T-cell immunotherapy, Orca-T, along with data highlighting the potential of our next-generation candidate, Orca-Q, to enable treatment without GvHD prophylaxis. Overall, these findings mark meaningful progress toward our goal of delivering our high-precision approach to more patients who may benefit.”
The ASH abstracts are now available at www.hematology.org. Details of the Orca Bio oral and poster presentations follow:
Oral Session: 721. Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Toxicities: Improving Outcomes by Decreasing Transplant-Related Complications
Title: Allogeneic HSC and Regulatory T cell (Orca-T) Engineered Cell Therapy Following Reduced Intensity Conditioning: Results of a Single Center Phase 1 Study
Abstract Number: 111
Date and Time: December 6, 2025 at 10:00 AM EST
Location: OCCC – Chapin Theater (320)
Oral Session: 732. Allogeneic Transplantation: Disease Response and Comparative Treatment Studies: Biologic Predictors and Novel Platforms Integrating CAR T with Transplant
Title: Superior Efficacy and Persistence of Orca-T-Allogeneic CAR19/22 Versus Autologous CAR19/22 in High-Risk Adult B-ALL
Abstract Number: 514
Date and Time: December 7, 2025 at 10:15 AM EST
Location: OCCC – Chapin Theater (320)
Oral Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: GVHD Prevention: Post-transplant cyclophosphamide and beyond
Title: Preliminary Safety and Efficacy of Myeloablative Orca-Q with Tacrolimus or without GVHD Prophylaxis for Treatment of Advanced Hematologic Malignancies
Abstract Number: 932
Date and Time: December 8, 2025 at 3:00 PM EST
Location: OCCC – W331
Poster Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster I
Title: Orca-T Improves cGVHD-free Survival in Patients with a Broad Range of Demographic and Clinical Variables: Results of Randomized, Phase 3 Trial
Abstract Number: 2477
Date and Time: December 6, 2025 at 5:30 PM – 7:30 PM EST
Location: OCCC – West Halls B3-B4
Poster Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster I
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)
Abstract Number: 2473
Date and Time: December 6, 2025 at 5:30 PM – 7:30 PM EST
Location: OCCC – West Halls B3-B4
Poster Session: 722. Allogeneic Transplantation: Acute and Chronic GVHD and Immune Reconstitution: Poster III
Title: Observational Comparison of Orca-T to Registry-Based Post-Transplant Cyclophosphamide Patients using Matched Unrelated Donor
Abstract Number: 6029
Date and Time: December 8, 2025 at 6:00 PM – 8:00 PM EST
Location: OCCC – West Halls B3-B4
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