Quell Therapeutics Reaches Milestone in Type 1 Diabetes CAR-Treg Therapy

Quell Therapeutics Ltd, known for its pioneering work in engineered T-regulatory (Treg) cell therapies for immune-mediated conditions, has announced a significant milestone in its collaboration with AstraZeneca. AstraZeneca has chosen a lead candidate for development in the Type 1 Diabetes (T1D) Treg cell therapy program. This notable achievement stems from their 2023 partnership aimed at creating, manufacturing, and commercializing autologous Treg cell therapies for T1D and Inflammatory Bowel Disease (IBD).

With the achievement of this research milestone, AstraZeneca has activated its exclusive option to license the therapy for further development and commercialization, leading to a $10 million payment to Quell. AstraZeneca will now focus on further clinical and preclinical development of the selected candidate, while Quell will provide necessary chemistry, manufacturing, and controls (CMC) support. This includes supplying good manufacturing practice (GMP) grade drug products for the initial human trials.

Quell retains the option to co-develop the chosen T1D candidate within the United States, which would involve more milestone payments and increased royalties from US sales. Iain McGill, CEO of Quell Therapeutics, expressed optimism about the collaboration's progress, highlighting the smooth integration and strong commitment between their respective research teams. He emphasized that this milestone validates their CAR-Treg cell therapy approach for autoimmune diseases and complements advancements in their internal transplantation program, QEL-001.

Regina Fritsche Danielson, Senior Vice President, and Head of Early Research & Development in Cardiovascular, Renal, and Metabolism at AstraZeneca, acknowledged the importance of this achievement. She noted the challenges T1D poses for patients and highlighted the potential of the CAR-Treg program to harness the body's immune system to target disease drivers in T1D, potentially slowing or halting disease progression.

The collaboration agreement between Quell and AstraZeneca, established in June 2023, focuses on developing and commercializing autologous Treg cell therapies for T1D and IBD. The agreement leverages Quell’s proprietary Treg cell engineering modules, including the Foxp3 Phenotype Lock, to create multi-modular autologous Treg cell therapy candidates for both diseases. Quell received an initial $85 million from AstraZeneca and stands to gain over $2 billion through future development and commercialization milestones, along with tiered royalties.

Quell Therapeutics is recognized for its advanced engineered T-regulatory (Treg) cell therapies, aimed at harnessing and optimizing these cells' immune suppressive properties to treat severe immune-driven conditions. The company utilizes its unique Foxp3 Phenotype Lock technology and a multi-modular platform, coupled with integrated manufacturing capabilities, to develop a pipeline of Treg cell therapies with enhanced persistence, potency, and stability compared to previous generations.

Quell’s leading candidate, QEL-001, is in the Phase 1/2 LIBERATE clinical trial, investigating its ability to induce operational tolerance following liver transplantation. This could potentially protect the liver post-transplant without the need for long-term immunosuppressive drugs. Additionally, Quell is advancing other programs in Type 1 Diabetes and Inflammatory Bowel Disease in collaboration with AstraZeneca, as well as developing iPSC-derived allogeneic Tregs and various discovery research initiatives.