Orca Biosystems, Inc.

Orca Bio, operating as Orca Biosystems, Inc., is a privately held biotechnology company headquartered in Menlo Park, California, with additional facilities in Sacramento, California, and Princeton, New Jersey. The company's mission is to transform the lives of patients through high-precision cell therapy, aiming to redefine the future of cell therapy.

Orca Bio specializes in developing allogeneic T-cell immunotherapies for the treatment of high-risk blood cancers, including acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS), and mixed-phenotype acute leukemia (MPAL). The company is also expanding its focus to include autoimmune diseases. Its key products include Tregzi (clinically known as Orca-T) and Orca-Q, which are designed to replace a patient's diseased blood and immune system with a healthy one. Orca Bio leverages its proprietary OrcaSort technology for precise cell separation and purification, enabling the creation of highly defined cell therapy products.

Co-founded by Nate Fernhoff, PhD, who serves as CEO, and Jeroen Bekaert, PhD, who is the President, Orca Bio recently achieved a significant milestone. On June 30, 2026, the U.S. FDA approved TREGZI™ (Orca-T®), marking it as the first and only precision-engineered cell therapy for allogeneic transplant in adults with hematological malignancies. This approval transitions Orca Bio into a commercial-stage biotechnology company, and it is actively expanding its manufacturing capacity to support the launch of Tregzi.