GammaDelta Therapeutics’ Investigational New Drug (IND) application has been cleared by the US Food and Drug Administration (FDA) for its 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, commented: “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 I clinical trial for patients with measurable residual disease (MRD) positive AML. Expected to begin in late 2021 as a multicentre study in the US, the trial will evaluate safety, tolerability and anti-leukemic activity of GDX012.
GammaDelta is advancing its novel T cell platform under an ongoing collaboration with Takeda formed in 2017.
Dr. Michael Koslowski, Head of R&D and Chief Medical Officer of GammaDelta, 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%. 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.”