AstraZeneca has exercised its exclusive option to license Quell Therapeutics' lead CAR-Treg cell therapy candidate for inflammatory bowel disease (IBD), marking a significant advancement in engineered T-regulatory cell therapy development. The milestone achievement triggered a $10 million payment to Quell and represents the second major progress marker in their strategic collaboration.
Strategic Partnership Delivers Second Milestone
The licensing decision follows AstraZeneca's selection of a lead Treg cell therapy candidate from the IBD program under the companies' 2023 collaboration agreement. This achievement represents the second significant research milestone in their strategic alliance, with the first milestone payment triggered in November 2024 following selection of a lead candidate in the Type 1 diabetes program.
"Our collaboration with AstraZeneca continues to be highly productive," said Iain McGill, CEO of Quell Therapeutics. "Achieving this milestone in IBD, the second important milestone after similar progress in Type 1 diabetes under our collaboration with AstraZeneca, demonstrates the strength of our science and transformative potential of our novel Treg cell therapy approach in treating complex immune-mediated diseases."
Advanced Cell Engineering Technology
The selected therapy leverages Quell's proprietary toolbox of Treg cell engineering modules, including its Foxp3 Phenotype Lock technology, to develop multi-modular autologous Treg cell therapy candidates. This pioneering approach aims to create highly engineered Treg cell therapies with greater potential for persistence, potency and stability than earlier generations of Treg cell therapy approaches.
Attilio Bondanza, VP Immunology Cell Therapy, BioPharmaceuticals R&D at AstraZeneca, emphasized the clinical need: "The burden represented by Inflammatory Bowel Disease is significant and growing. We need novel and innovative therapies that address the underlying drivers of the condition and represent a significant advancement for patients."
Development and Manufacturing Responsibilities
Under the licensing agreement, AstraZeneca will progress further CTA/IND-enabling studies and clinical development of the selected candidate. Quell will provide chemistry, manufacturing and controls (CMC) support, including GMP supply of drug product for a first-in-human trial.
The collaboration, established in June 2023, focuses on developing, manufacturing and commercializing autologous, engineered Treg cell therapies for two immune-mediated disease indications: IBD and Type 1 diabetes. Quell received $85 million in upfront payments from AstraZeneca and is eligible to receive over $2 billion for further development and commercialization milestones, plus tiered royalties.
Broader Pipeline Progress
Beyond the AstraZeneca collaboration, Quell continues advancing its proprietary internal clinical program with QEL-001, designed to induce sustained immune tolerance in mismatched liver transplant patients. The company expects to share first efficacy data from the LIBERATE Phase 1b/2 trial later this year.
McGill noted the parallel progress: "At the same time, our proprietary internal clinical program with QEL-001 designed to induce sustained immune tolerance in mismatched liver transplant patients is advancing and we look forward to sharing first efficacy data from the LIBERATE Phase 1b/2 trial later this year."
The advancement represents a significant step forward in applying engineered T-regulatory cell therapy to address serious medical conditions driven by immune system dysfunction, with potential applications across multiple autoimmune and inflammatory diseases.
