Orca Bio, a late-stage biotechnology company developing high-precision cell therapies for the treatment of cancer, genetic blood disorders and autoimmune diseases, announced the expansion of its current manufacturing capabilities with the construction of a new 100,000-square-foot commercial facility in Sacramento. 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 Greater Sacramento Economic Council (GSEC) worked with community partners including Sacramento County, SMUD, Buzz Oates, UC Davis and Sacramento State to help Orca Bio expand in the Greater Sacramento region, specifically at Metro Air Park in Sacramento.
“We are thrilled Orca Bio decided to expand and build a new manufacturing facility at Metro Air Park,” GSEC Board Chair and President & CEO of Buzz Oates Larry Allbaugh said. “As we look at our development footprint at the premier industrial business park, we are becoming more innovative with our adaptable uses for companies. We worked hard to ensure Orca Bio would have what it needed to manufacture its cell therapies here because we value these types of life science jobs in the Greater Sacramento region.”
“As an elected leader in Sacramento County, it’s important we help companies efficiently get through the permitting process,” Sacramento County Supervisor Phil Serna said. “Our economic development team worked efficiently to help Orca Bio get through the permitting process and worked with the utility department to get started on their building quickly. Metro Air Park is an important industrial development for our county, which is why we have spent a lot of time making sure its infrastructure plan is future-thinking for businesses’ growth.”
Orca Bio’s 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 near 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 digitally enabled modular production suites, which are adjustable for future growth, quality control laboratories, warehouse space and offices. The construction began in August 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 small fraction 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.
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 late-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.
About the Greater Sacramento Economic Council
The Greater Sacramento Economic Council is the catalyst for innovative growth strategies in the Capital Region of California. The organization spearheads community-led direction to retain, attract, grow and scale tradable sectors, develop advanced industries and create jobs and investment throughout a six-county region. Greater Sacramento represents a collaboration between local and state governments, market leaders, influencers and stakeholders, with the sole mission of driving inclusive economic growth. The Greater Sacramento region was founded on discovery, built on leadership and fueled by innovation.
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