London, UK – 3 March, 2026 – Quell Therapeutics Ltd (“Quell”), a leader in developing engineered T-regulatory (Treg) cell therapies for serious medical conditions driven by the immune system, today shared interim top-line data from its LIBERATE Phase 1/2 trial and provided an update on its broader clinical strategy – building on the validating insights from LIBERATE, Quell is now initiating the QEL-005 CHILL clinical trial in complex autoimmunity (see separate announcement today).
The LIBERATE trial investigates the ability of QEL‑001, a phenotype-locked anti-HLA‑A2 CAR‑Treg autologous cell therapy candidate, to facilitate weaning of standard-of-care immunosuppression (IS) in patients who have undergone liver transplantation.
Interim data from LIBERATE suggests evidence of QEL-001 safety and clinical activity enabling IS minimization:
- 9 patients dosed to date with QEL-001: 3 safety cohort patients and 6 expansion cohort patients, with no serious adverse events (SAEs), no dose-limiting toxicity (DLT) or drug-related adverse events (AEs) in the study period.
- Initial results of immunosuppression weaning (n=5 expansion cohort patients), indicates the potential of CAR-Tregs to enable very low levels of non-CNI based immunosuppression:
- All patients started the study on dual therapy; tacrolimus, a calcineurin inhibitor (CNI), and everolimus, an mTOR inhibitor.
- CNI-free immunosuppression was achieved in all weaned patients - with no evidence of rejection after tacrolimus withdrawal and all patients were stable for at least 6 months off tacrolimus.
- All weaned patients were able to reduce everolimus monotherapy to very low doses (<5ng/mL trough level).
- Progressive weaning to sub-therapeutic levels of everolimus (<3ng/mL trough level) was successful in 1 patient whilst 3 patients experienced mild-moderate rejection episodes when everolimus was removed or reduced below 3ng/mL at 8-9 months post QEL-001 dose. All rejection episodes resolved with re-introduction of immunosuppression.
Quell Phenotype-Locked™ CAR-Tregs – A stable, suppressive, and durable therapeutic approach:
- QEL-001 Phenotype-Locked™ CAR-Tregs remained detectable in the circulation for over 1 year post-dose, maintaining a stable, highly suppressive Treg phenotype characterized by expression of key functional markers (Foxp3, CTLA4, Helios).
- QEL-001 demonstrated durable engraftment (over 1 year), with Ki67 expression – consistent with maintained proliferative potential.
- Quell CAR-Tregs engrafted in the liver tissue where HLA-A2 is expressed with 10-20% enrichment of the Treg pool vs. <1% in the circulation.
- Quell CAR-Treg engraftment within the liver was focused on the periportal areas and is directly proportional to the baseline level of liver inflammation at the time of infusion.
Quell plans to provide further clinical and translational data from the LIBERATE study at key international medical congresses in 2026 and via peer-reviewed publication (in preparation).
Dr. Luke Devey, Chief Medical Officer at Quell, said: “The interim LIBERATE data demonstrate that QEL-001 has been well tolerated to date, with supportive translational evidence of durable in vivo persistence, trafficking to the transplanted liver, and suppressive Treg phenotype. These early data suggest that whilst QEL-001 may not enable full operational tolerance in solid organ transplantation, it may enable minimization of immunosuppression to CNI‑free, low‑dose mTOR monotherapy in liver transplant recipients. We sincerely thank all patients who have participated in LIBERATE, whose partnership we are deeply grateful for, and whose commitment is providing critical data that may pave the way for future Treg treatments.”
Dr. Alberto Sanchez-Fueyo, Chief Investigator of the LIBERATE trial, commented: “LIBERATE has shown what Quell’s Tregs can achieve: long-term durability, trafficking, and engraftment to where needed, while maintaining stability and suppressive capacity. The potential of CAR-Tregs to safely wean liver transplant patients off CNIs and reduce the immunosuppressive burden to very low doses of everolimus after a single infusion is extremely promising for patients.”
Based on the interim clinical and translational findings from LIBERATE, which validate Quell’s CAR-Treg platform, Quell has decided to explore partnership opportunities to further progress the QEL-001 program and will prioritize its capital allocation and near-term focus on the QEL-005 CHILL clinical program. QEL-005 is a novel CD19-targeting CAR-Treg designed to address a potentially larger commercial opportunity in multiple complex autoimmune diseases and provides the fastest path to further clinical data. Quell has initiated the CHILL Phase 1/2 trial to explore QEL-005 in refractory rheumatoid arthritis and systemic sclerosis (see separate announcement today) with early clinical data expected during Q1 2027.
-ENDS-
About QEL-001 and the LIBERATE Trial
The LIBERATE trial investigates QEL-001 CAR-Treg therapy in HLA-A2 mismatched liver transplant patients to induce operational tolerance and decrease the side-effects of immunosuppression. QEL-001 is a first-in-class, antigen-specific CAR-Treg cell therapy, designed using Quell’s unique multi-modular engineered Treg platform. QEL-001 comprises three proprietary modules: a chimeric antigen receptor (CAR) for tissue targeting, the Foxp3 Phenotype Lock™ module, and a safety switch. The QEL-001 CAR is specific for HLA-A2, which localizes its activity to the site of the transplanted organ in HLA-A2 mismatched liver transplant patients (i.e. HLA-A2 negative recipients who received an HLA-A2 positive donor liver). QEL-001 was dosed as a single IV infusion following lymphocyte depletion with low-dose anti-thymocyte globulin (ATG) in the expansion cohort.
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 asset QEL-005, a pipeline-in-a-product for complex autoimmune diseases will be initiating clinical development in the Phase 1/2 CHILL clinical trial in H1 2026 www.chillstudy.life. In addition, Quell is advancing two programs in partnership with AstraZeneca: QEL-002 for Type 1 Diabetes and QEL-003 for Inflammatory Bowel Disease. www.quell-tx.com.
Contacts
Quell Therapeutics
IR@quell-tx.com
Media: Mark Swallow, Sandi Greenwood, Erica Hollingsworth
MEDiSTRAVA
Quell-Tx@Medistrava.com