First-in-human Phase I trial begun for AML treatment 

GammaDelta Therapeutics 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. 

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 five-year survival rate of approximately 30%1. 

Dr Paolo Paoletti, CEO of GDT, said: “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 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”. 

GDT’s Phase I 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. 

Dr Michael Koslowski, Head of R&D and Chief Medical Officer of GDT, added: “This is an important milestone in the development of our lead product candidate, GDX012, for patients with AML that present with MRD after SOC treatment. Supported by encouraging preclinical data we believe that GDX012 can provide an attractive treatment option for these AML patients that are at high risk of relapse. We are very excited to bring GDX012 into clinical development and we look forward to advancing our growing pipeline of allogeneic, ‘off-the-shelf’ Vδ1 γδ T cell products for solid and haematological tumours.” 

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. 

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