A biotechnology company founded by researchers from King’s and the Francis Crick Institute has announced that it has initiated a first-in-human Phase I clinical trial evaluating GDX012 for the treatment of acute myeloid leukaemia (AML).
GDX012 is an allogeneic, non-engineered, variable delta 1 (Vδ1) gamma-delta (γδ) T cell therapy manufactured from healthy donor blood.
GammaDelta Therapeutics’s technology platforms are based on pioneering world-class research conducted by Professor Adrian Hayday and Dr Oliver Nussbaumer, at King’s and the Francis Crick Institute and Professor Bruno Silva-Santos at the University of Lisbon. The early-stage development of the company was supported by Cancer Research Technology. The early stage research was supported by the infrastructure of the National Institute for Health Research Guy’s and St Thomas’ Biomedical Research Centre.
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 the recent years the prognosis for patients with AML remains poor, with an average overall 5‐year survival rate of approximately 30%1.
GDT’s Phase I trial, conducted in the U.S., 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
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. – Professor Adrian Hayday, from the School of Immunology & Microbial Sciences
He continued: “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.”
GDT is advancing its novel T cell platforms under an ongoing collaboration with Takeda Pharmaceutical Company Limited formed in 2017. GDT’s technology platforms are based
Vδ1 γδ T cells are a unique subset of T cells that specifically recognise and are activated by molecular patterns of dysregulation on cancer cells. The non-MHC-restricted activity of Vδ1 γδ T cells makes them a unique cell type for the development of fully allogeneic, ‘off-the-shelf’ cell therapies.
GDT has developed proprietary technologies to generate both blood-and tissue-derived allogeneic immunotherapies based on Vδ1 γδ T cells for the treatment of haematological malignancies and solid tumours. Both platforms have enabled the creation of non-engineered and genetically engineered allogeneic cell therapies, which demonstrate cellular activity and tumour cell killing capacity in pre-clinical models.