- Cell therapy biotech Cellectis will build an 82,000-square-foot commercial manufacturing facility in North Carolina to make its allogeneic CAR-T products, announcing last week that it had signed a lease for the site.
- Dubbed IMPACT, the planned facility in Raleigh, North Carolina, will handle both clinical and commercial production, Cellectis said.
- The drugmaker has also begun construction of a 14,000-square-foot facility in Paris, France to make the starting material supply for its UCART products. Both the Paris and North Carolina plants are intended to be Good Manufacturing Practice-compliant.
Like many biotechs before it, Cellectis has relied on contract manufacturers to produce clinical trial supply and starting materials for its flagship UCART products.
Last year, however, the company decided it would take manufacturing — a critical step in cell therapy — in house.
"Now is the right time to create our own supply competencies," said Cellectis CEO André Choulika in a March 7 statement. "Cellectis will gain autonomy, control and expertise in manufacturing operations, allowing us to continue to build competitive advantage and remain the leader in our field."
Cellectis' announcement on the planned North Carolina plant comes three months after the company took on a new head of U.S. manufacturing, Bill Monteith, and tasked him with overseeing the establishment of commercial manufacturing capabilities in the U.S.
Cellectis has been a player in the CAR-T space for some time, but has moved slowly with development of its allogeneic technology.
Unlike the approved CAR-T products Yescarta (axicabtagene ciloleucel) and Kymriah (tisagenlecleucel), allogeneic CAR-Ts use donor cells rather than the patient's own cells.
By Cellectis' approach, donor T cells are engineered using the biotech's TALEN gene editing technology to express a CAR capable of targeting cell-surface antigens. Allogeneic CAR-T holds the potential to side-step the time-consuming logistics required to ship patient cells to a manufacturing center and back again, earning the technology the moniker of "off-the-shelf."
With speedier manufacturing, allogeneic cells could potentially cost less and be delivered more quickly, enabling faster treatment. Those advantages, however, come with greater immunogenic risk and, so far, the technology has proved challenging to develop.
Last April, Pfizer gave the then-newly created company Allogene Therapeutics control to development of 16 preclinical allogeneic CAR-T candidates originally licensed from Cellectis — a move some interpreted as frustration with the French biotech's progress. Pfizer kept a 25% stake in Allogene, which is led by former leaders of CAR-T pioneer Kite Pharma.
Allogene also secured rights to an allogeneic CAR-T candidate, UCART19, which had been licensed from the French company Servier.
While Allogene and Cellectis are in the forefront of allogeneic CAR-T developments, other biotechs like Tmunity are following close behind.