With manufacturing a major hang-up for cell therapies, late-stage player Orca Bio is also looking beyond the clinic.
Orca, focused on development of precision cell therapies for cancer, genetic blood disorders and autoimmune diseases, has drafted plans to build a new, 100,000-square-foot commercial facility in Sacramento, California.
The plant will be used to tackle late-stage development of Orca’s pod of cell therapy prospects including Orca-T, the company’s most advanced allogeneic candidate, which is in phase 3 testing in a trio of blood cancers.
Should Orca-T and its kin pass muster with regulators, the company plans to use the new facility for commercial production, too.
The plant will ultimately have the capacity to crank out roughly 3,000 cell therapy products per year, plus it will be equipped to scale to meet future demand, Orca co-founder and chief operating officer Jeroen Bekaert, Ph.D., said in a press release announcing the plans.
Unlike CAR-T cell therapies, Orca’s candidates aren’t genetically modified, according to comments a spokesperson emailed Fierce Pharma. The company’s platform leverages a precision cell selection process in a bid to overhaul the traditional allogeneic hematopoietic stem cell transplant (allo-HSCT) process, the company explained. It uses the process to parse through the more than 100 billion donor cells patients would typically receive in a standard allo-HSCT down to the less than 1% that potentially provide therapeutic benefits.
From there, Orca builds “a new designer immune system for patients.”
Turnaround time, meanwhile—or the span from collection and manufacturing of cells to their infusion into the patient—is a key concern for personalized medicines like Orca’s cell therapies, which are being targeted at some of the sickest blood cancer patients.
Orca-T, for instance, is made of “fresh, living cells that need to be infused on an extremely rapid timeline,” Orca's spokesperson said over email.
The spokesperson said Orca’s maintained vein-to-vein turnaround times of “72 hours or less throughout [its] history as a company.”
To further hasten delivery to patients, Orca’s new plant will be situated in Sacramento’s Metro Air Park right next to the city’s international airport. In turn, Orca will be able to ship directly to transplant centers across the U.S. The plant is also located close to Orca’s existing clinical manufacturing building, the company noted in its press release.
“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,” Ivan Dimov, Ph.D., co-founder and chief executive at Orca, said in the release.
The plant will boast modular production suites, which are “adjustable for future growth,” according to the release. The facility will also contain quality control labs, warehouse space and offices.
Construction kicked off in August of 2021 and is scheduled to wrap up “later this year,” Orca said in its announcement. Following the project’s completion, Orca anticipates the plant will be fully validated and operational by the first half of 2023.
Orca is keeping the number of staffers its hiring at the new facility under wraps for now, the company's spokesperson told Fierce. Today, Orca employs about 50 people at its current manufacturing facility in Sacramento. It expects to “scale that number” once the new plant is fully up and running.