Orca Bio Adds East Coast Manufacturing Capacity and Triples West Coast Manufacturing Workforce Ahead of Potential Orca-T® Launch

A new site in Princeton, NJ, and strategic expansion of its Sacramento-based commercial manufacturing team strengthens the Company’s readiness to scale delivery of its high-precision cell therapy pipeline

MENLO PARK, Calif.--(BUSINESS WIRE)--Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced key manufacturing updates ahead of the anticipated commercial launch of its lead investigational cell therapy, Orca-T, including new East Coast manufacturing capacity in Princeton, NJ, and significant expansion of its existing manufacturing team in Sacramento, CA. These advancements reflect a broader effort to build the manufacturing, supply chain and quality infrastructure required to deliver Orca-T at scale following potential U.S. Food and Drug Administration (FDA) approval.

“Delivering personalized allogeneic cell therapies at scale carries immense operational complexity, and we are addressing those challenges now, ahead of commercialization,” said Jeroen Bekaert, Ph.D., co-founder and president at Orca Bio. “By establishing a bicoastal manufacturing footprint and a reliable supply chain, we are working to ensure that logistics and capacity never stand between a patient and our high-precision cell therapies.”

Orca Bio’s additional manufacturing capacity in Princeton will serve as a strategic East Coast manufacturing “bridge” that complements Orca Bio’s existing Sacramento-based manufacturing facilities. While the existing facilities in Sacramento can meet near-term logistics and capacity needs, the new space creates a bicoastal production network that allows the company to further reduce “vein-to-vein” time for patients across the country and meet future demand. The Princeton site will initially produce therapies for patients in Orca Bio's ongoing clinical programs, and is expected to support commercial production following the potential FDA approval of Orca-T and validation of its manufacturing lines.

To support the company’s commercial preparedness efforts, Orca Bio has more than tripled the size of its Sacramento-based operations team over the past year. This expansion enhances the company’s internal expertise in manufacturing, supply chain logistics, Chemistry, Manufacturing and Controls (CMC) and quality assurance. By proactively scaling its human and technical infrastructure ahead of the commercial curve, Orca Bio is well positioned to provide seamless support to the clinical community and patients upon potential launch.

Orca Bio also continues to invest in the infrastructure and donor registry engagement needed to ensure a steady supply as it scales, reinforcing its commitment to supply chain stability and access for patients. Orca-T is made from healthy donor cells; therefore, consistent and dependable access to donor starting material is essential to successful commercial manufacturing and delivery to patients.

“Orca Bio’s transition from a development-stage organization to a commercial-ready partner is a testament to the agility of our platform and the dedication of our team,” said Lauren Smith, chief quality officer at Orca Bio. “By establishing an initial East Coast footprint that we will expand over time, we are removing the geographic and logistical barriers that have historically challenged cell therapy delivery.”

About Orca-T

Orca-T is an investigational allogeneic stem cell and T-cell immunotherapy under evaluation for the treatment of multiple hematologic malignancies including acute leukemias and myelodysplastic syndromes. Orca-T consists of highly purified hematopoietic stem cells, regulatory T-cells and conventional T-cells derived from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation for the prevention of graft versus host disease or death in patients eligible for hematopoietic stem cell transplant from the U.S. Food and Drug Administration (FDA). The Biologics License Application (BLA) for Orca-T is currently under review with the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of July 6, 2026.

About Orca Bio

Orca Bio is a late-stage biotechnology company developing high-precision cell therapies for the treatment of blood cancer and autoimmune diseases. The company’s manufacturing platform uses single-cell precision to create proprietary, uniquely defined products designed to replace a patient’s diseased blood and immune system with a healthy one. At Orca Bio, we are on a mission to redefine what’s possible for patients by transforming the field of curative allogeneic cell therapy. For more information, visit www.orcabio.com.

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