Artiva’s new 52,000-square-foot facility will support the development and manufacture of allogeneic natural killer (NK) cell therapy and CAR-NK cell therapies.
The additional facility will complement the 300,000-square-feet of space that Artiva holds in South Korea, at GC LabCell’s location, for R&D and manufacture.
According to the company, the San Diego facility build-out is already taking place and is expected to be completed in 2022.
Fred Aslan, president and CEO of Artiva, told BioPharma-Reporter that the exact investment made in the facility would remain undisclosed, but that the capital employed would be predominantly focused on outfitting the location, with the existing building only needing to be modified to requirements.
Aslan stated that the new facility will complement its current manufacturing capacity that it holds through its partner, which already allows Artiva to manufacture at commercial scale.
Allogeneic NK therapy
Artiva’s lead therapeutic candidate is AB-101, which is in Phase I trials, in combination with rituximab, for the treatment of B-cell malignancies. The treatment is an ADCC (antibody-dependent cellular cytotoxicity) enhancer, which could improve patients’ response to monoclonal antibody therapy for either hematological or solid tumors.
The company also has two targeted CAR-NK product candidates, AB-201 and AB-202, at the IND enabling stage.
Aslan stated that its therapeutic approach offers manufacturing advantages over current CAR-T treatments: “NK cell therapy has the potential to be an off-the-shelf (allogeneic), cryopreserved product. CAR-T therapy is based on an autologous process, relying on a process that starts with the patient’s cells and requires individual expansion, so it’s not a scalable process and takes time.”
He continued to say that Artiva’s aim is to be able make NK cell therapy off-the-shelf, as with other biologic products, so that it can be made more broadly available to patients. As part of this strategy, the company has developed a ‘manufacturing-first’ approach.
“Many clinical-stage companies in the NK cell space are generally not producing their therapies in a scalable process and are not able to cryopreserve them. In essence, they’ve left the manufacturing process for later, whereas Artiva has taken a “manufacturing first” approach,” he explained.
As a result, Artiva is already delivering off-the-shelf, cryopreserved treatments for its clinical trials, he added.
The company’s platform generates the NK cells from donor umbilical cord blood, which is selected according to certain characteristics. According to the company, each single cord blood unit allows Artiva to create thousands of doses of therapy.
Moving into the future, Aslan stated that the US expansion “will allow us to not only think about pipeline expansion going forward, but also to further refine the process to get ready for pivotal clinical trials, and ultimately, for commercial supply.”