In August, Orca Bio announced a Phase III clinical trial of its Orca-T. By using a precision process, Orca says it can quickly make cell therapy products.
Orca-T is intended to maintain the function of a stem-cell transplant and fend off graft-versus-host disease plus relapse of the original disease. The company’s “mission is to revolutionize the field of cell therapy for patients with blood cancer, autoimmune diseases, and genetic blood disorders with our unique, high-precision approach that could greatly expand the number of patients who are eligible for treatment,” says Jeroen Bekaert, PhD, co-founder and COO of Orca Bio.
When asked what is unique about Orca Bio’s bioprocessing, Bekaert says, “Our platform uses a precision cell-selection process that sorts the more than 100 billion donor cells that patients would typically receive in a standard allogeneic hematopoietic stem cell transplant process down to the less than 1% that actually provide therapeutic benefits.” From these cells, Bekaert says, “we build a new designer immune system for patients.” Plus, the company’s platform does not rely on viral vectors. “So, we don’t have to deal with procurement and capacity challenges seen in viral vector manufacturing,” Bekaert explains.
In April, at the Transplantation & Cellular Therapy ASTCT and CIBMTR Tandem Meetings, Orca Bio demonstrated that it can reliably manufacture all products from its current cGMP facility and deliver them to patients in under 72 hours regardless of donor and patient location. “The majority of these products were manufactured and delivered in under 60 hours,” Bekaert says.
To keep control of the process, Orca Bio does all of the manufacturing in-house. To meet the expected demand, the company created a 100,000-square-foot manufacturing facility in the Metro Air Park next to the Sacramento International Airport. “Our new commercial facility consists of a number of cGMP production suites that can be adjusted for future growth, quality control laboratories, warehouse areas, and administrative space,” Bekaert says. “We’ve accommodated the installation of existing and upcoming automation techniques and the integration of cloud-based GMP systems to support the entire end-to-end process.”
As Orca Bio shows, location is not only important in real estate. “The close proximity of our manufacturing sites to an international airport will help ensure our ability to continue to meet the necessary 72-hour vein-to-vein turnaround times for patients across the U.S.,” Bekaert says. With cell therapies, in particular, speed can save lives.