London, UK-based Quell has partnered with contract development and manufacturing organization (CDMO) eXmoor to manufacture autologous CAR-T-regulatory (Treg) cell therapies for autoimmune disorders. Tregs are white blood cells within your immune system, that control the response to foreign substances as well as substances produced by the body.
The partnership entails process transfer, scale-out, and Phase I/II clinical manufacture of multiple autologous CAR-Treg candidates while granting Quell access to eXmoor’s Bristol, UK facility.
To develop Treg cell therapies, Quell will use its Foxp3 phenotype-lock technology and its platform, and has advanced its lead candidate QEL-001, designed to help patients achieve operational tolerance after receiving liver transplants, into clinical trials. The financials and timelines associated with this partnership were not disclosed.
“Quell and eXmoor will work closely to transfer Quell’s process into eXmoor’s cell and gene therapy (CGT) center. Quell will support with training and technology transfer to enable eXmoor staff to manufacture clinical material for Quell’s use in clinical development,” Lucy Foley, chief technology officer (CTO), eXmoor Pharma told BioProcess Insider.
“For the initial scope, eXmoor will dedicate one of its Grade C cleanrooms to Quell’s manufacturing needs, which will enable the supply of multi-autologous CAR-Treg products from Quell’s pipeline.” She explained that eXmoor has additional capacity for expansion.
The 65,000 square-foot CGT facility opened in October 2023. It includes four GMP cleanrooms with fill/finish capacity, support spaces for all types of CGTs, process and analytical development, and quality-control laboratories. The Bristol facility received a Manufacturing and Import Authorization (MIA) license for Investigational Medicinal Products (IMP) from the Medicines and Healthcare Regulatory Agency (MHRA) in August 2024.
“Quell is developing a number of CAR-Treg programs addressing autoimmune and inflammatory diseases, and this expanded capacity will deliver clinical supply for these products,” Luke Henry, chief business officer (CBO), Quell Therapeutics told us.
“Quell has developed a manufacturing process that is currently delivering therapies to patients for their initial program in liver transplants. Quell will be transferring this process to eXmoor, who will use it to manufacture the therapies in their facility.”
This is not the first time Quell has partnered with a firm for CAR-Treg production. In 2021, the firm partnered with CGT Catapult expanding its manufacturing capabilities to develop engineered T-reg cell therapies. Through this partnership, Quell gained access to CGT Catapult’s large-scale production facility in Stevenage, UK.
This was followed by another partnership with Cellistic to support the expansion of Quell’s Treg cell-therapy pipeline in 2022. Under that, Quell used Cellistic’s expertise in human induced pluripotent stem cell (iPSC) research to form a process for differentiating iPSCs into functional Treg cell-therapy products.
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