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Quell Therapeutics and AstraZeneca Advance CAR-Treg Cell Therapy for Type 1 Diabetes with $10 Million Milestone

8 months ago3 min read
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Key Insights

  • AstraZeneca has selected a lead candidate from Quell Therapeutics' Type 1 Diabetes CAR-Treg cell therapy program, triggering a $10 million milestone payment under their 2023 collaboration agreement.

  • The achievement marks the first significant research milestone in developing autologous, engineered T-regulatory cell therapies for autoimmune diseases, with AstraZeneca now progressing the candidate through preclinical and clinical development.

  • The CAR-Treg approach aims to harness the body's immune system to target disease drivers in Type 1 Diabetes and potentially slow or stop disease progression, addressing an unmet need for disease-modifying therapies.

Quell Therapeutics has achieved a significant milestone in its collaboration with AstraZeneca for developing CAR-Treg cell therapies targeting Type 1 Diabetes, with AstraZeneca selecting a lead candidate that triggers a $10 million milestone payment. The achievement represents the first major research milestone under the companies' 2023 collaboration agreement to develop autologous, engineered T-regulatory cell therapies for autoimmune diseases.

Milestone Achievement Triggers Option Exercise

AstraZeneca has exercised its exclusive option to license the selected Type 1 Diabetes candidate for further development and commercialization. The pharmaceutical giant will now progress CTA/IND-enabling studies and clinical development of the candidate, while Quell will provide chemistry, manufacturing and controls (CMC) support, including GMP supply of drug product for the first-in-human trial.
Under the collaboration terms, Quell retains an option to co-develop the optioned T1D candidate in the United States in exchange for additional milestone payments and increased royalties on US net sales.

Addressing Unmet Medical Need in Type 1 Diabetes

The CAR-Treg program represents a novel approach to treating Type 1 Diabetes, a condition that presents significant challenges for patients in terms of long-term disease management and quality of life impact. According to Regina Fritsche Danielson, SVP and Head of Early Research & Development, Cardiovascular, Renal and Metabolism at AstraZeneca, there are currently "no options for disease-modifying therapies" for Type 1 Diabetes.
"Our ambition with this CAR-Treg program is to harness the body's immune system to target disease drivers in T1D and potentially slow or stop disease progression," Fritsche Danielson stated.

Technology Platform and Broader Applications

The collaboration centers on Quell's proprietary toolbox of Treg cell engineering modules, including its Foxp3 Phenotype Lock technology, to develop multi-modular autologous Treg cell therapy candidates. Iain McGill, CEO of Quell Therapeutics, emphasized the broader potential of the platform: "The nomination of this first candidate in T1D nicely complements the advances we are making with QEL-001, our internal program in transplantation, and demonstrates the potential of our powerful technology to unlock a broad opportunity across autoimmune and inflammatory diseases."

Collaboration Structure and Financial Terms

The 2023 collaboration agreement between Quell and AstraZeneca encompasses two autoimmune disease indications: Type 1 Diabetes and Inflammatory Bowel Disease. Quell received $85 million in upfront payments and is eligible to receive over $2 billion in development and commercialization milestones if successful, plus tiered royalties.
McGill noted that the milestone achievement "highlights the strong commitment and rapid integration of our respective research teams as well as providing important early validation of our novel CAR-Treg cell therapy approach to autoimmune diseases."
The companies' engineered T-regulatory cell therapy approach aims to harness, direct and optimize immune suppressive properties to address serious medical conditions driven by the immune system, representing a potentially transformative approach to treating autoimmune diseases.
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