Quell Therapeutics Achieves Milestone for Type 1 Diabetes CAR-Treg Cell Therapy Program

• Achievement of first significant research milestone triggers an option exercise payment of $10 million from AstraZeneca
• AstraZeneca will progress preclinical and clinical development of the selected lead T1D candidate
• Quell will be accountable for CMC in support of CTA/IND-enabling studies and GMP product supply for a first-in-human trial

London, UK – November 18, 2024 – Quell Therapeutics Ltd (“Quell”), a leader in developing engineered T-regulatory (Treg) cell therapies for serious medical conditions driven by the immune system, announces that AstraZeneca has selected a candidate to progress in the Type 1 Diabetes (T1D) Treg cell therapy program.

This is the first significant research milestone achieved under its 2023 collaboration agreement with AstraZeneca to develop, manufacture and commercialize autologous, engineered Treg cell therapies for two autoimmune disease indications – T1D and Inflammatory Bowel Disease (IBD).

As a result of this research milestone, AstraZeneca has exercised its exclusive option to license the potential therapy for further development and commercialization, resulting in a milestone payment to Quell of $10 million.

AstraZeneca will now progress further CTA/IND-enabling studies and clinical development of the selected candidate, with Quell providing chemistry, manufacturing and controls (CMC) support including GMP supply of drug product for a first-in-human trial. 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.

Iain McGill, CEO of Quell Therapeutics, said: “Our collaboration with AstraZeneca is progressing extremely well and the achievement of this first significant milestone in the Type 1 Diabetes program is highly encouraging. It 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. Further, 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.”

Regina Fritsche Danielson, SVP and Head of Early Research & Development, Cardiovascular, Renal and Metabolism at AstraZeneca, added: “We are pleased to have achieved this important early milestone in our collaboration with Quell Therapeutics. Type 1 Diabetes can be challenging for patients in terms of long-term disease management and impact on quality of life, with no options for disease-modifying therapies. 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.”