GammaDelta Therapeutics Ltd, a biotechnology company pioneering the discovery and development of allogeneic gamma delta T cell therapies for cancer, has initiated a first-in-human Phase 1 clinical trial evaluating GDX012 for the treatment of acute myeloid leukaemia (AML). GDX012 is an allogeneic, non-engineered, variable delta 1 gamma-delta T cell therapy manufactured from healthy donor blood. AML is the most common form of acute leukaemia in adults with an estimated 20,000 new cases per year in the US. Despite progress in the development of targeted therapies over recent years, the prognosis for patients with AML remains poor, with an average overall five-year survival rate of approximately 30%.

“The unique biological characteristics of non-engineered variable delta 1 gamma-delta T cells potentially open a new modality for innate cell therapy. Variable delta 1 gamma-delta T cells provide a basis for ‘off-the-shelf use’ and the platforms developed by our team further support gene engineering of these cells to enable the foundations of our allogeneic cell therapy pipeline for haematological malignancies and solid tumours,” said Dr Paolo Paoletti, CEO of GDT.

GDT’s Phase 1 trial, conducted in the US, is an open-label, multi-centre study of GDX012 enrolling adults diagnosed with AML and presenting with measurable residual disease (MRD) after standard of care (SOC) treatment. The objectives of the trial are to evaluate the safety, tolerability, pharmacokinetics, anti-leukaemic activity and maximum tolerated dose of GDX012.

GDT is advancing its novel T cell platforms under an ongoing collaboration with Takeda Pharmaceutical Company Limited formed in 2017. These technology platforms are based on pioneering world-class research funded in part by Cancer Research UK, conducted by Professor Adrian Hayday and Dr Oliver Nussbaumer, at King’s College London and the Francis Crick Institute, and Professor Bruno Silva-Santos at the University of Lisbon. GDT was formed in 2016 by Abingworth with support from Cancer Research UK’s commercial partnership team.