Industry News: GammaDelta Therapeutics initiates first-in-human Phase 1 trial of GDX012 for the treatment of acute myeloid leukemia

First dose delivered to patients in a multi-center U.S. clinical trial to evaluate novel gamma-delta T cell cancer therapy

16 Sep 2021


GammaDelta Therapeutics Ltd. (GDT), a biotechnology company pioneering the discovery and development of allogeneic gamma delta T cell therapies for cancer, has announced that it has initiated a first-in-human Phase I clinical trial evaluating GDX012 for the treatment of acute myeloid leukemia (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 leukemia 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%.

“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 hematological malignancies and solid tumors”, said Dr. Paolo Paoletti, CEO of GDT.

GDT’s Phase I trial, conducted in the U.S., is an open-label, multi-center 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-leukemic 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 hematological tumors.”

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 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.

Vδ1 γδ T cells are a unique subset of T cells that specifically recognize 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 hematological malignancies and solid tumors. Both platforms have enabled the creation of non-engineered and genetically engineered allogeneic cell therapies, which demonstrate cellular activity and tumor cell killing capacity in pre-clinical models.

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