- Gilead's cell therapy-focused subsidiary, Kite Pharma, announced Tuesday plans for a new facility that will develop and manufacture viral vectors, a crucial building block for the production of cell-based medicines like Kite's Yescarta.
- The facility will span 67,000 square feet and be located in Oceanside, California, tucked into an existing Gilead site for biologics. The big biotech declined to provide financials for the project.
- Oceanside would further expand Kite's footprint, and comes at a time when Gilead leadership is signaling that cell therapy will be a "critical piece" of the company's future. In May 2018, Kite said it had leased a 117,000-square-foot facility in the Netherlands meant to engineer its cell therapies for European markets. Less than a year later, the subsidiary disclosed plans for a 20-acre cell therapy site in Urbana, Maryland.
Kite has significantly expanded in the almost two years since Gilead acquired it for $12 billion, reflective of the opportunity Gilead sees in cell therapy.
"Cell therapy oncology is in a ultra-competitive area," Daniel O'Day, a Roche veteran who in March began as Gilead CEO, said on his first earnings call with the company. "I think we have a leadership position, but I think we need to maintain that leadership position."
Toward that end, Gilead leadership announced in May their decision to untether Kite and allow it to function as its own business unit with its own CEO, who would report directly to O'Day. Last week, Gilead confirmed it had tapped Christi Shaw, head of Eli Lilly's Bio-Medicines unit, for the new CEO position.
Shaw will take the helm as Kite works through label expansions for its first commercial product, Yescarta (axicabtagene ciloleucel), as well as advancing a few clinical-stage assets. The subsidiary said it intends to file with regulators later this year KTE-X19, a successor product to Yescarta for relapsed/refractory mantle cell lymphoma.
With another commercial prospect on the horizon, Gilead and Kite are now making sure they have adequate manufacturing capacity.
"Viral vectors are one of the key components in cell therapy production, however, the industry’s current development and manufacturing capabilities are not widely established and supply is limited," Tim Moore, executive vice president of technical operations at Kite, said in a July 16 statement.
"By pursuing our own viral vector facility, we will be able to advance viral vector development and supply to allow for accelerated process development of current CAR T and future pipeline therapies, while continuing to partner with external suppliers," Moore added.
Kite isn't alone in such pursuits, however. Its chief rival Novartis, which markets the only other approved CAR-T therapy in Kymriah (tisagenlecleucel), expanded cell manufacturing capabilities in February through the completed acquisition of CellforCure, a France-based contract manufacturer specialized in cell and gene therapy.
Allogene Therapeutics, Iovance Biotherapeutics and Hitachi Chemical have also invested more into cell therapy manufacturing this year.
A Gilead spokesperson wrote in an email to BioPharma Dive that the existing Oceanside facility was recently renovated, and "included shell space for future use."
"When evaluating our opportunities for viral vector production, the Oceanside facility was an opportune location," the spokesperson wrote.