Quell Therapeutics Ltd, a leading developer of engineered T-regulatory cell therapies for serious immune-driven medical conditions, has announced the advancement of its autologous engineered CAR-Treg cell therapy, QEL-001, into the efficacy phase of the LIBERATE Phase 1/2 trial in liver transplant patients. This move follows the successful dosing of the initial safety cohort (n=3) and approval by the trial’s independent Data Safety and Monitoring Board (DSMB) after reviewing the clinical data.

At the American Transplant Congress in Philadelphia, PA, USA, Prof. Alberto Sánchez-Fueyo, a co-founder of Quell and a distinguished figure in hepatology, presented progress updates from the LIBERATE study. The presentation outlined several key findings:

1. Tregs isolated and expanded from liver transplant patients can be utilized to generate engineered CAR-Tregs with enhanced safety and therapeutic features, including proprietary technologies like Foxp3 Phenotype Lock™ and a safety switch.
2. QEL-001 infusion was well tolerated in the safety cohort.
3. Confirmation of engraftment and trafficking of QEL-001 to the liver allograft, with persistence of infused cells for up to six months post-infusion.
4. Initial data supporting further investigation of QEL-001 CAR-Treg therapy in HLA-A2 mismatched liver transplant patients to induce operational tolerance and reduce the side-effects of immunosuppressive therapy.

Quell will now proceed to evaluate QEL-001 in the efficacy cohort of liver transplant patients, aiming to assess tolerance induction at two and 12 months post full withdrawal of immunosuppressive therapy. This approach could potentially predict longer-term operational tolerance.

Quell Therapeutics, expressed enthusiasm about advancing to the next phase of the trial, recognizing its significance for liver transplant patients who currently rely on lifelong systemic immunosuppression and its associated complications. The LIBERATE trial offers a promising avenue to shift this paradigm, with QEL-001 designed to provide targeted and enduring immune tolerance, thereby eliminating the need for chronic immunosuppression.

QEL-001 is an antigen-specific CAR-Treg cell therapy developed using Quell’s unique multi-modular engineered Treg platform. It includes three proprietary modules—a chimeric antigen receptor (CAR) for tissue targeting, the Foxp3 Phenotype Lock™ module, and a safety switch—allowing its activity to be localized to the site of the transplanted organ in HLA-A2 mismatched liver transplant patients.

The LIBERATE trial (NCT05234190) is a multi-center, first-in-human, open-label, single-arm Phase 1/2 study evaluating the safety and efficacy of QEL-001 in approximately 18 HLA-A2 mismatched liver transplant patients, 1-5 years post liver transplant, at sites in the UK, Belgium, and Spain.

Liver transplantation is a crucial treatment for thousands of patients annually in the US and EU5. However, the standard post-transplant care involving lifelong systemic immunosuppression often leads to severe non-liver complications. This highlights the urgent need for innovative therapies like QEL-001 to improve patient outcomes and quality of life.

 

Source: globenewswire.com

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