First patients given novel cell therapy in Leukaemia trial

GammaDelta Therapeutics, a biotechnology company co-founded by researchers from the Francis Crick Institute and King's College London, has announced that it has initiated a First-in-Human Phase I clinical trial in the US, evaluating a unique gamma-delta (γδ) T cell therapy for the treatment of acute myeloid leukaemia.

It’s a privilege to see our lab discoveries translated so quickly into treatments that are now reaching patients
Adrian Hayday

The treatment, GDX012, is an “off-the-shelf” T cell therapy, manufactured from healthy donor blood. This is the first time that non-engineered γδ T cells have been tested in patients.

As part of the phase 1 trial, researchers will evaluate safety, tolerability and anti-leukemic activity of GDX012, offered to patients with acute myeloid leukaemia who still have measurable residual disease after standard of care treatment. 

Adrian Hayday, co-founder of GammaDelta Therapeutics and head of the Crick’s Immunosurveillance Laboratory, said: “Our years of work have all been leading to this point, when we can finally see what promise γδ T cells hold for the treatment of cancer. It’s a privilege to see our lab discoveries translated so quickly into treatments that are now reaching patients. 

“These unique cells that kick into action where molecular patterns have lost their direction, could provide an immune boost for patients with leukaemia, but also hopefully other types of cancer and auto-inflammatory diseases.”

GammaDelta was co-founded in 2016 by Adrian Hayday and Oliver Nussbaumer of the Crick and King's College London, with support from life sciences investors Abingworth and Cancer Research UK’s commercial partnerships team.

The Company aims to exploit the unique activities of gamma delta (γδ) T cells that are found in the body's tissues where cancers and inflammatory diseases take hold. These distinct immune cells specifically recognise and are activated by molecular patterns of dysregulation associated with cancer. And GammaDelta has harnessed the activity of these cells to develop “off-the-shelf” therapies. 

Veronique Birault, Director of Translation at the Crick said: “Seeing the translation from lab discovery to potential cancer treatment of these γδ T cell therapies is incredibly inspiring. This is a brilliant example of where ideas can lead with the right support and an outstanding team. We look forward to seeing how this treatment performs in trials.”

Dr. Paolo Paoletti, CEO of GammaDelta Therapeutics, commented: “The unique biological characteristics of non-engineered Vδ1 γδ T cells potentially open a new modality for innate cell therapy. Vδ1 γδ T cells provide a basis for ‘off-the-shelf use’ and further gene engineering of these cells will form the foundation of our allogeneic cell therapy pipeline for haematological malignancies and solid tumours.”
 

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