Orca Bio, a biotech firm advancing precise cell therapies for cancer, autoimmune disorders, and genetic blood conditions, has unveiled promising results for its lead investigational therapy, Orca-T, at the 2024 Tandem Meetings hosted by ASTCT and CIBMTR.
In the first oral presentation, a retrospective analysis compared outcomes between Orca-T and standard alloHSCT plus post-transplant cyclophosphamide (PTCy) prophylaxis in hematologic malignancy patients undergoing myeloablative conditioning (MAC). Across various conditioning regimens and disease types, Orca-T showed favorable results in relapse-free survival (RFS), non-relapse mortality (NRM), and overall survival (OS).
Dr. Alexandra Gomez-Arteaga, Assistant Professor of Medicine at Weill Cornell Medicine and hematologist oncologist at NewYork-Presbyterian/Weill Cornell Medical Center, stated, “Physicians often balance relapse risk and toxicities in treating hematological malignancies. While advances in prophylaxis reduce graft versus host disease rates, our analysis suggests Orca-T may enhance survival metrics, underscoring the need for novel approaches.”
The analysis also compared 48 Orca-T MAC patients from a Phase 1b trial with single-agent tacrolimus (TAC) to 61 PTCy cohort patients from CIBMTR literature. Patients, predominantly with AML and MDS, had median follow-up times of 15 and 12 months, respectively.The outcomes at 12 months are summarized in the table below:
| Orca-T with BFT/TAC | Standard alloHSCT with CNI/MMF/PTCy | |
| RFS | 86% | 63% |
| NRM | 0% | 17% |
| OS | 100% | 76% |
During the second oral presentation, Orca Bio shared results from a subgroup analysis of their Phase 1b clinical trial, focusing on patients with AML, MDS, and ALL who received Orca-T with BFT conditioning. The analysis revealed that Orca-T demonstrated similar outcomes in both older (55+ years of age) and younger (18-54 years of age) patients undergoing MAC. Notably, Orca-T showed comparable results in relapse-free survival (RFS), non-relapse mortality (NRM), and overall survival (OS) across age groups. Across all patients, Orca-T was consistently manufactured and delivered within 72 hours or less across the U.S. These findings were previously presented at the 65th ASH Annual Meeting in December 2023.
Dr. Scott McClellan, Chief Medical Officer at Orca Bio, commented, “These findings support Orca-T’s potential to achieve durable remission while minimizing treatment-related toxicity, offering a promising therapeutic option, even for older patients. We eagerly anticipate further investigation of Orca-T in our randomized Phase 3 study, Precision-T.”
About Orca-T
Orca-T is an investigational high-precision allogeneic cell therapy under evaluation for various hematologic malignancies. It comprises infusions containing regulatory T-cells, CD34+ stem cells, and conventional T-cells sourced from peripheral blood of matched donors. Orca-T is currently undergoing evaluation in a pivotal Phase 3 clinical trial at leading transplant centers across the U.S. and has received RMAT designation from the FDA.
