The U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for GammaDelta Therapeutics’ allogeneic variable delta 1 (Vδ1) gamma-delta (γδ) T cell therapy, GDX012, to be investigated as a treatment for haematological malignancies.
The FDA also granted orphan drug designation to allogeneic Vδ1 γδ T cell therapy (GDX012) for the treatment of Acute Myeloid Leukaemia (AML).
Dr. Paolo Paoletti, CEO of GammaDelta Therapeutics, said: “The clearance of our IND application for GDX012 marks an important step for our company in establishing a portfolio of innovative allogeneic cell therapies. The unique properties of Vδ1 γδ T cells will be evaluated for the first time in a clinical study for patients with AML.
“This important milestone results from our efforts to establish a robust pipeline of cellular immunotherapies derived from our proprietary platforms and processes for the isolation and expansion of Vδ1 γδ T cells from both blood and tissues for targeting haematological malignancies and solid tumours.”
GammaDelta plans to initiate a Phase 1 clinical trial for patients with measurable residual disease (MRD) positive AML. Expected to begin later in 2021 as a multicentre study in the US, the trial will evaluate safety, tolerability and anti-leukemic activity of GDX012.
GammaDelta Therapeutics is advancing its novel T cell platform under an ongoing collaboration with Takeda Pharmaceutical Company Limited formed in 2017.
Dr. Michael Koslowski, Head of R&D and Chief Medical Officer of GammaDelta Therapeutics, said: “Although progress has been made in the treatment of AML, the median overall five-year survival rate for patients diagnosed with AML remains under 30 percent.
“With the development of GDX012 we are aiming to change the treatment paradigm for AML and potentially other haematologic malignancies. The unique biological characteristics of Vδ1 γδ T cells offer a first-in-class Vδ1 γδ T cell therapy for AML, where the development of cell therapies has been historically limited due to the lack of specific targets.”
Dr. Chris Arendt, Oncology Therapeutic Area Unit Head of Takeda, said: “The progression of GammaDelta Therapeutics’ platform technology underscores the potential of γδ T cells and the power of the innate immune system.
“Through collaboration with pioneers like GammaDelta Therapeutics, we hope to advance next-generation cell therapies and to maximise off-the-shelf treatments in the battle against hard-to-treat cancers.”
GammaDelta has developed proprietary technologies to generate both blood-and tissue-derived allogeneic immunotherapies based on Vδ1 γδ T cells for the treatment of haematologic malignancies and solid tumours.
Both platforms have enabled the creation of highly active and selective non-engineered and genetically engineered allogeneic cell therapies, which demonstrate cellular activity and tumour cell killing capacity.
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.