Press release

Menlo Park, CA

January 21, 2026

Orca Bio to Present New Clinical Data on Its High-Precision Cell Therapies at the 2026 Tandem Meetings of ASTCT® and CIBMTR®

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 

MENLO PARK, CA, Jan. 21, 2026  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 TimeWednesday, February 4, 3:15 PM - 3:30 PM MST 

Location: Ballroom AB 

 

Oral SessionSession 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 TimeThursday, February 5, 3:15 PM - 3:30 PM MST 

Location: Ballroom AB 

 

Poster SessionMyeloid Neoplasms Including Relapse – Clinical 

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

 Presentation ID: 534  

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

Location: Poster Hall AB 

 

Poster SessionCell and Gene Therapy – Clinical 

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

 Presentation ID: 161 

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

Location: Poster Hall AB 

 

Poster SessionGVHD Clinical – Prevention and Treatment 

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

 Presentation ID: 366 

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

Location: Poster Hall AB 

 

Poster SessionGVHD Clinical – Prevention and Treatment 

TitlePreliminary Safety and Efficacy of Myeloablative Orca-Q in Patients with Haploidentical Donors 

 Presentation ID: 345 

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

Location: Poster Hall AB  

 

Poster SessionConditioning Regimens 

TitleSingle 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 TimeThursday, February 5, 6:30 PM - 8:00 PM MST 

Location: Poster Hall AB 

 

Poster SessionHealth Services and Barriers to Access 

TitleOrca-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 TimeThursday, February 5, 6:30 PM - 8:00 PM MST 

Location: Poster Hall AB 

 

Poster SessionHealth Services and Barriers to Access 

TitleCost-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 TimeThursday, 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 under evaluation 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 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 Prescription Drug User Fee Act (PDUFA) target action date of April 6, 2026.   

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 personalized cell therapy products intended 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.  

Trademarks or registered trademarks used in this press release are the property of their respective owners.  

Contact:

Corporate Communications

Kelsey Grossman

media@orcabio.com

Investor Relations

Joshua Murray

ir@orcabio.com