Cellectis is building a 14,000-square-foot facility in Paris to produce clinical supplies, but the French biotech will also outfit a facility nearly six times that size in the U.S. as it looks toward commercial production of its CAR-T treatments.
The company last week said it has leased an 82,000-square-foot commercial-scale manufacturing facility in Raleigh, North Carolina, to handle both clinical supply and commercial production of the allogeneic CAR-T treatments on which it is working. The biotech has said it expects to invest about $100 million in two facilities.
The Raleigh facility will hire about 200 employees and is getting about $4 million in local and state incentives, according to the North Carolina Department of Commerce.
“We have perfected our manufacturing process throughout the past years and successfully produced several GMP campaigns at our CMOs, which have been and will remain key partners,” CEO André Choulika said in a statement. By combining the capabilities from both plants, Choulika said Cellectis will “gain autonomy, control and expertise in manufacturing operations," which he believes will give it a competitive advantage.
Like some other biotechs working in the CAR T arena, Cellectis will use allogeneic T cells that come from donors and can be stored for so-called “off the shelf” use. Novartis’ Kymriah and Gilead's Yescarta, the first two CAR T treatments approved by the FDA are made from autologous T cells taken directly from patients.
The Cellectis announcement comes just weeks after a tangentially related biotech said it would build a 118,000-square-foot cell therapy manufacturing facility in Newark, California, to produce its own treatments using allogeneic T cells. Allogene is working on CAR T assets it got from Pfizer, which in turn licensed them from Cellectis.
Choulika said at the J.P. Morgan Healthcare Conference in January that he believes allogeneic CAR-T therapy is the future because it has the potential to avoid the pitfalls that can come with using a patient’s own T cells. Some patients can’t benefit from autologous CAR-T because they don’t have enough T cells or T cells of good enough quality to make those treatments.
Novartis, which has run into difficulties producing Kymriah with patients' own T cells, has said it is exploring other approaches and is working with Intellia Therapeutics to investigate off-the-shelf CAR-T cells using CRISPR-Cas9 gene editing.