FDA grants IND clearance to GammaDelta cancer therapy

The FDA also granted orphan drug designation to allogeneic Vδ1 γδ T cell therapy (GDX012) for the treatment of Acute Myeloid Leukaemia (AML)

GammaDelta Therapeutics, a company focused on the use of gamma delta (γδ) T cells in immunotherapy, has announced the FDA has cleared the investigational new drug application for the company’s 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 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%. 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.”

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 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 subset of T cells that recognise and are activated by molecular patterns of dysregulation on cancer cells. The non-MHC-restricted activity of Vδ1 γδ T cells makes them suitable for the development of fully allogeneic, “off-the-shelf” cell therapies.