Orca Bio, a late-stage biotechnology company focused on transforming patient care through high-precision cell therapy, presented clinical findings today at the 66th American Society of Hematology (ASH) Annual Meeting. The data highlights the use of Orca-Q, its investigational second-generation allogeneic T-cell immunotherapy, without graft versus host disease (GvHD) prophylaxis in patients with various hematological conditions.
Preliminary data from a subset of the multicenter Phase 1 clinical trial of Orca-Q in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), and myelofibrosis (MF) demonstrated promising patient outcomes without the use of graft-versus-host disease (GvHD) prophylaxis. These early findings showed low rates of GvHD, infection, and non-relapse mortality (NRM) in patients with fully matched donors.
“Conventional allogeneic stem cell transplants typically involve potent immunosuppressive drugs to control GvHD, which can impair immune recovery and increase the risk of infections, organ damage, and relapse,” said Dr. Mehrdad Abedi, hematologist and professor of medicine at UC Davis Comprehensive Cancer Center. “The potential to achieve a cure without preventative agents could significantly expand treatment options for patients with hematologic malignancies. While further data is needed, these early results suggest that Orca-Q without GvHD prophylaxis may offer a transformative approach to treatment.”
This analysis involved 14 patients enrolled in the HLA-identical donor dose expansion arm who received myeloablative conditioning (MAC) with Orca-Q and either busulfan, fludarabine, and thiotepa (BFT) or total body irradiation-based conditioning (TBI). The median time to engraftment for neutrophils and platelets was 11 days, and the rates of GvHD and serious infections were low. In the subgroup of patients receiving Orca-Q and BFT, there were no cases of chronic GvHD and only two instances of grade 2 acute GvHD. No cases of NRM were reported among the 14 patients. Both relapse-free survival (RFS) and overall survival (OS) were 85% across all patients, with 90% in the BFT subgroup. GvHD-free, relapse-free survival (GRFS) was 77% across all patients and 90% in the BFT group.
Orca-Q was consistently manufactured with vein-to-vein delivery times of 72 hours or less across the U.S.
“We are excited by the potential of developing a product that could eliminate the need for GvHD prophylaxis while maintaining safety and efficacy,” said Nate Fernhoff, PhD, co-founder and chief scientific officer at Orca Bio. “These preliminary results provide an encouraging glimpse into the future therapeutic potential of Orca-Q.”
About Orca-Q
Orca-Q is Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy, currently being evaluated in clinical trials for treating multiple hematologic malignancies, including those with haploidentical donors. Orca-Q is a proprietary combination of stem cells and specific T-cell subsets derived from healthy donors, engineered using Orca Bio’s high-precision platform.
About Orca Bio
Orca Bio is a late-stage biotechnology company focused on developing high-precision cell therapies for cancer and autoimmune diseases. Their investigational therapies aim to replace a patient’s diseased blood and immune system with a healthy one, improving outcomes with fewer risks compared to current treatments. Orca Bio’s manufacturing platform uses single-cell precision to create uniquely-defined products that have the potential to revolutionize allogeneic cell therapy. The company’s mission is to make curative cell therapies more effective and safer, pushing the boundaries of the field to redefine its future.
