What FDA Clearance means for GammaDelta cell cancer therapy

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.”

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