U.K. developer Quell Therapeutics hired eXmoor Pharma to make supplies of its pipeline of novel immunosuppressive cell therapies—called CAR-Tregs—at its new cell and gene therapy facility.
Quell recently teamed with fellow U.K.-based eXmoor in a “strategic partnership” that will see the contractor make its candidate autoimmune disease cell therapies for early-phase clinical studies. Quell’s pipeline consists of cell therapies derived from CAR-Tregs, a subset of T lymphocyte cells that act to maintain immune tolerance by suppressing unwanted immune responses. CAR-Tregs differ markedly from CAR-T therapies in terms of both their therapeutic function and how they are manufactured, according to Quell CBO, Luke Henry.
“Quell’s proprietary platform has been developed to generate engineered CAR-Treg cell therapies that can be directed to specific tissues via CAR engineering, to focus the suppressive activity of the CAR-Treg cells at the site of disease,” he said. “This could be applicable across multiple disease areas where there is immune dysregulation, including transplantation, autoimmunity, and inflammation.
Different strategy
“This strategy is different from traditional CAR-T products, which use the other major subset of T cells—the cytotoxic T effector cells—to induce the elimination of cancer cells.
This was echoed by Lucy Foley, PhD, CTO, at eXmoor, who said “Manufacturing CAR-Tregs requires a unique, proprietary manufacturing process specific for Treg cells, which is different from conventional CAR-T processes.”
Quell has developed a GMP manufacturing process to produce CAR-Tregs and has already made supplies of QEL-001 for the ongoing Phase I/II “LIBERATE” study, which is focused on preventing organ rejection in liver transplantation.
Under the partnership, the firms will work together on process transfer and scale-out for several candidates in Quell’s pipeline. Manufacturing will take place at eXmoor’s cell and gene therapy center in Bristol in the U.K.
“The Center has been designed as a flexible and scalable manufacturing hub, with integrated process development and analytical labs, four Grade C GMP clean rooms, and fill/finish capability,” Foley tells GEN. “It can support scaleup, optimization, and manufacture of cell therapies, RNA therapies, and viral vectors, with up to 2 x 200 L bioreactors and multiple autologous cell therapy stations per suite. In addition, the cutting-edge zero-carbon facility relies entirely on solar technology and heat pumps.”
The partnership will also see eXmoor set aside more manufacturing space for Quell, according to Foley, who adds, “This expanded capacity will enable the supply of these products as they transition into clinical development in the next few years.”
