Press release

Menlo Park, CA

September 8, 2022

Orca Bio Expands Manufacturing Capabilities to Develop and Commercialize its Precision Cell Therapies

– New state-of-the art manufacturing facility is designed to enable the reliable production of Orca Bio's investigational cell therapies from late-stage clinical development through potential commercialization – 

– The 100,000-square-foot facility is located in Metro Air Park, Sacramento – 

MENLO PARK, CA, September 8, 2022 Orca Bio, a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer, genetic blood disorders and autoimmune diseases, today announced the expansion of its current manufacturing capabilities with the construction of a new 100,000-square-foot commercial facility in Sacramento, CA. This facility will support the late-stage clinical development and commercialization of Orca Bio’s precision cell therapies, including Orca-T, which is currently being evaluated in a Phase 3 registrational trial.

“The new state-of-the-art facility represents critical infrastructure to enable the advancement of our pipeline and the future commercial availability of our potentially life-saving products,” said Jeroen Bekaert, Ph.D., co-founder and chief operating officer of Orca Bio. “With the capacity to manufacture approximately 3,000 cell therapy products per year, the facility will allow us to scale to meet future demand. Investing in our manufacturing capabilities is essential to our mission of delivering a cure without compromise while ensuring timely access to the patients who need it, when they need it.” 

The new facility is strategically located in Sacramento's newly developed Metro Air Park next to the Sacramento International Airport, enabling direct shipping access to transplant centers across the U.S. It is also in close proximity to Orca Bio's existing clinical manufacturing building. The facility is uniquely tailored to manufacture precision cell therapies designed to replace cancerous blood and immune systems with healthy ones. It touts modular production suites, which are adjustable for future growth, quality control laboratories, warehouse space and offices. The construction began in August of 2021 and is scheduled to be completed later this year. The facility is expected to be fully validated and operational in the first half of 2023. 

“Throughout the clinical development of our products, we have demonstrated the ability to reliably manufacture and deliver high-precision cell therapies with rapid turnaround times, regardless of donor and patient location,” said Ivan Dimov, Ph.D., co-founder and chief executive officer of Orca Bio. “This new facility will further enhance our capabilities to deliver our therapies urgently and seamlessly to patients at scale, while meeting the highest quality and regulatory standards.”

Orca Bio’s unique approach uses precision cell selection technology to identify the less than 1% of the 100 billion donor cells that potentially contain therapeutic benefits for patients. These cells are then manufactured into potentially curative cell therapies designed to maximize efficacy of treatment and significantly limit treatment-related risks. Orca Bio recently announced Precision-T, its pivotal Phase 3 study evaluating Orca-T for the treatment of acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and high-risk myelodysplastic syndromes (MDS), is open for enrollment at leading transplant centers across the U.S.

About Orca-T

Orca-T is an investigational high-precision allogeneic cellular therapy consisting of infusions containing regulatory T-cells, conventional T-cells and CD34+ stem cells derived from peripheral blood from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and is being studied to treat multiple hematologic malignancies.

About Orca Bio

Orca Bio is a clinical-stage biotechnology company developing purified, high-precision cell therapies for the treatment of cancer, autoimmune diseases and genetic blood disorders. Our investigational therapies are designed to deliver better survival rates with dramatically fewer risks than standard allogeneic stem cell transplants, like graft versus host disease and other debilitating transplant-related toxicities. At Orca Bio, we hope to not only replace patients' blood and immune systems with healthy ones, but restore their quality of life. For more information, visit www.orcabio.com and follow Orca Bio on Twitter: @OrcaBio

Contact:

Corporate Communications

Kelsey Grossman

media@orcabio.com

Investor Relations

Joshua Murray

ir@orcabio.com