Orca Bio to Present Cell Therapy Data at 66th ASH Annual Meeting

Orca Bio, a biotechnology company based in Menlo Park, California, has announced the presentation of new clinical data at the upcoming American Society of Hematology (ASH) Annual Meeting, which will take place from December 7-10 in San Diego, California. The data includes three-year survival outcomes from a Phase 1b clinical trial involving their lead investigational allogeneic T-cell immunotherapy, Orca-T, and will be showcased in three oral sessions.

Orca-T is being tested on patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), and high-risk myelodysplastic syndrome (MDS). This therapy is composed of highly purified regulatory T-cells, CD34+ stem cells, and conventional T-cells derived from peripheral blood from either related or unrelated matched donors. Orca-T is currently under evaluation in a pivotal Phase 3 clinical trial and has received the Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration.

In addition to the three-year survival data for Orca-T, the ASH Annual Meeting will feature initial feasibility, safety, and efficacy data from an investigator-sponsored trial. This trial examines the combination of Orca-T with allogeneic CD19/CD22-CAR-T cells in patients with high-risk B-cell acute lymphoblastic leukemia (B-ALL).

The third oral session will present data from a multicenter Phase 1 clinical trial involving Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy, Orca-Q. This trial includes patients with hematologic malignancies who were treated without any post-treatment graft versus host disease (GvHD) prophylaxis. Orca-Q is a unique composition of stem cells combined with specific T-cell subsets derived from healthy donors, engineered using Orca Bio’s high-precision platform.

Ivan Dimov, Ph.D., co-founder and CEO of Orca Bio, expressed enthusiasm about presenting the new data. He highlighted the importance of the three-year follow-up data for Orca-T, which is currently being evaluated in a pivotal Phase 3 clinical trial, and the results of treating patients with Orca-Q without the use of GvHD prophylaxis. He emphasized that these findings represent significant progress in Orca Bio’s mission to deliver high-precision cell therapies to more patients who could potentially benefit.

Orca Bio is dedicated to developing high-precision cell therapies for the treatment of cancer and autoimmune diseases. Their investigational products aim to replace a patient's diseased blood and immune system with a healthy one, with the goal of improving outcomes and reducing risks compared to current standard treatments. The company’s proprietary manufacturing platform uses single-cell precision to create uniquely-defined products that have the potential to transform allogeneic cell therapy. Orca Bio strives to make curative cell therapies more effective and safer, pushing the boundaries of the field and redefining its future.