Quell Therapeutics Achieves Key Milestone in its CAR-Treg Cell Therapy Program for Inflammatory Bowel Disease

  • AstraZeneca exercises option to license the first candidate from the IBD joint research program for further development and commercialization
  • Achievement of second significant research milestone in the Quell-AstraZeneca strategic alliance triggers payment of $10 million from AstraZeneca
  • 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 – 11 June, 2025 – 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 lead Treg cell therapy candidate to progress from the Inflammatory Bowel Disease (IBD) program.

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

The associated payment marks the second milestone achieved by Quell under its 2023 collaboration agreement with AstraZeneca to develop, manufacture and commercialize autologous, engineered Treg cell therapies for two immune-mediated disease indications – IBD and Type 1 Diabetes (T1D). The first milestone payment was triggered in November 2024 following the selection of a lead Treg cell therapy candidate in the T1D program.

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.

Iain McGill, CEO of Quell Therapeutics, said: “Our collaboration with AstraZeneca continues to be highly productive. 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. We are proud to see the progress of this programme and look forward to continuing to work with AstraZeneca to bring these innovative therapies to patients in need.

“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.”

Attilio Bondanza, VP Immunology Cell Therapy, BioPharmaceuticals R&D, at AstraZeneca, added: “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. We are pleased that achieving this important early milestone in our collaboration with Quell Therapeutics marks the progress we are making in delivering the possibility a new transformative treatment in IBD.”

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

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