Its lead product, Orca-T, is a donor-derived T cell therapy engineered to reduce graft-versus-host disease while preserving anti-cancer efficacy. Orca leverages proprietary methods to purify and balance immune cells from donors, aiming for safer post-transplant outcomes.

In October 2025, the U.S. Food and Drug Administration accepted Orca’s Biologics License Application (BLA) for Orca-T and granted it Priority Review, with a target decision date set for April 6, 2026. This regulatory milestone paves the way for potential market approval.

Orca has also made leadership updates to support its growth: in 2025, Nate Fernhoff, Ph.D. became CEO, and Jeroen Bekaert, Ph.D. was named President. The company is investing in manufacturing scale-up and commercial readiness to support anticipated product launch.

Its pipeline includes Orca-Q, a next-generation engineered T cell therapy designed to expand donor compatibility, and exploratory OrCAR programs combining Orca’s cellular platform with CAR technologies to broaden therapeutic reach.