In the challenging, capacity-constrained cell therapy sector, the multiyear move toward leaner, more virtual models of drug development is reversing. Now, biotechs want their own infrastructure—and are taking out leases to secure the ability to do work in house.
Artiva Biotherapeutics, a private developer of off-the-shelf natural killer (NK) cell-based therapies, is the latest startup to splash out on new digs. Next year, Merck-partnered Artiva plans to open a 52,000-square-foot facility in San Diego that will house its research and process development laboratories and a multisuite GMP manufacturing center.
Currently, Artiva is reliant on the 300,000-square-foot cell center run by its partner GC LabCell in the Republic of Korea. Artiva will continue to make use of the research labs, process development labs and GMP cell therapy manufacturing facility at the site but will also have its own U.S. capacity.
Performing more work in the U.S. could simplify Artiva’s supply chain. As it stands, Artiva sources cord blood in the U.S. and ships it to Korea for processing. GC then sends the resulting cryopreserved drug product to the U.S. for distribution to clinical trial sites. In IPO paperwork filed in April, Artiva listed its reliance on GC as a risk, noting programs could be delayed if the relationship is terminated.
That model has enabled Artiva to get candidates into the clinic. A phase 1/2 trial of unmodified NK cell therapy AB-101 in combination with rituximab is underway in non-Hodgkin lymphoma. Artiva is set to follow up with a pair of CAR-NK therapies engineered to target HER2 and CD19. INDs for the CAR-NKs are planned for next year.
Artiva’s desire to add internal capacity to support the programs is in keeping with the activities of other cell therapy startups. In recent weeks, Nkarta and Sana Biotechnology have shared plans to establish their own production capacity. All three companies are setting up cell therapy sites in California.
Nkarta and Sana raised big IPOs to fund their expansions. Hot on the heels of a $120 million series B, Artiva filed to join the biotechs on public markets in April. However, Artiva is yet to complete the IPO or update its filing.