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.”
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Notes to Editors
About the Agreement with AstraZeneca
Quell and AstraZeneca entered a collaboration, exclusive option and license agreement in June 2023 to develop, manufacture and commercialize autologous, engineered Treg cell therapies for two autoimmune disease indications – Type 1 Diabetes (T1D) and Inflammatory Bowel Disease (IBD).
The agreement centres on the application of Quell’s proprietary toolbox of Treg cell engineering modules, including its Foxp3 Phenotype Lock, to develop multi-modular autologous Treg cell therapy candidates in both disease areas.
Quell received $85 million in upfront payments from AstraZeneca and is eligible to receive over $2 billion for further development and commercialization milestones, if successful, plus tiered royalties. In addition, Quell retains an option to co-develop Treg cell therapies from the T1D program with AstraZeneca in the United States in exchange for additional milestone payments and increased royalties on US net sales.
About Quell Therapeutics
Quell Therapeutics is the world leader in developing engineered T-regulatory (Treg) cell therapies that aims to harness, direct and optimize their immune suppressive properties to address serious medical conditions driven by the immune system.
The Company is leveraging its pioneering Foxp3 Phenotype Lock™ technology, unique multi-modular platform and integrated manufacturing capabilities to design and develop a pipeline of highly engineered Treg cell therapies with greater potential for persistence, potency and stability than earlier generations of Treg cell therapy approaches.
Quell’s lead candidate QEL-001 is advancing in the Phase 1/2 LIBERATE clinical trial designed to investigate its ability to induce operational tolerance following liver transplantation, with the potential to protect the post-transplant liver without the need for chronic immunosuppressive medications. Quell is also advancing additional programs in Type 1 Diabetes and Inflammatory Bowel Disease with AstraZeneca, iPSC-derived allogeneic Tregs and multiple discovery research programs. www.quell-tx.com.
Contacts
Luke Henry, Chief Business Officer
Quell Therapeutics
IR@quell-tx.com
Media: Mark Swallow, Sandi Greenwood, Erica Hollingsworth
MEDiSTRAVA
Quell-Tx@Medistrava.com
Investors: Corey Davis
LifeSci Advisors
cdavis@lifesciadvisors.com