Quell Therapeutics receives CTA approval to begin first clinical trial with a multi-modular engineered treg cell company

pharmafile | October 27, 2021 | News story | Research and Development  

The MHRA has approved Quell Therapeutics’ first clinical trial for its lead cell therapy candidate QEL-001. This approval paves the way for the first ever clinical trial of a multi-modular engineered CAR-Treg therapy, and patient recruitment is expected to begin before the end of the year. QEL-001 is a first-in-class antigen-specific CAR-Treg cell therapy candidate engineered with three proprietary modules.

Dr Dominik Hartl, Chief Medical Officer, said: “We are very pleased to receive approval to advance QEL-001 into clinical studies in this important and underserved indication. While liver transplant today is a life-saving procedure, recipients still face the prospect of lifelong systemic immunosuppression, which comes with a significant risk of serious complications, including increased rates of certain malignancies and infections, diabetes, and cardiovascular disease and irreparable kidney damage requiring dialysis and further transplant. As a result, the ten-year survival rate for liver transplant patients is poor and similar to that for common cancers.”

The standard of care for liver transplant patients is to receive systemic immunosuppression for the rest of their lives. There have been no significant improvements in therapy options since the 1990s. Current treatments such as calcineurin inhibitors cause significant non-liver comorbidities resulting in poor post-transplant survival with the 10-year survival outcome of liver transplant patients being around 60% and comparable to that of common malignancies, such as colon cancer, cancer of the uterus or Non-Hodgkin’s lymphoma. Further, long-term immunosuppressive therapy is nephrotoxic, leading to progressive and irreparable kidney damage that eventually requires dialysis and transplant.

Quell Therapeutics is the world leader in developing engineered T-regulatory (Treg) cell therapies that aim to harness, direct and optimise their immune suppressive properties to address serious medical conditions driven by the immune system.

Ana Ovey


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