NEWS RELEASE


GammaDelta Therapeutics Initiates First-in-Human Phase 1 Trial of GDX012 for the Treatment of Acute Myeloid Leukaemia

2021-09-15 00:00:00

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

London, UK, 15 Sept 2021: GammaDelta Therapeutics Ltd. (GDT), a biotechnology company pioneering the discovery and development of allogeneic gamma delta T cell therapies for cancer, today announced that it has initiated a first-in-human Phase I clinical trial evaluating GDX012 for the treatment of acute myeloid leukaemia (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 leukaemia 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%1.

“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 haematological malignancies and solid tumours”, said Dr. Paolo Paoletti, CEO of GDT.

GDT’s Phase I trial, conducted in the U.S., is an open-label, multi-centre 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-leukaemic 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 haematological tumours.”

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 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.

GDT has developed proprietary technologies to generate both blood-and tissue-derived allogeneic immunotherapies based on Vδ1 γδ T cells for the treatment of haematological malignancies and solid tumours. Both platforms have enabled the creation of non-engineered and genetically engineered allogeneic cell therapies, which demonstrate cellular activity and tumour cell killing capacity in pre-clinical models.

For further information and to view a video on the science behind GDT’s proprietary technologies visit https://gammadeltatx.com/the-science/

For more information about the clinical trial design, please visit: www.clinicaltrials.gov (NCT05001451).

1. https://seer.cancer.gov/statfacts/html/amyl.html

Notes to editors

 

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Dr. Paolo Paoletti, CEO of GammaDelta Therapeutics

Dr. Michael Koslowski, Head of R&D and Chief Medical Officer of GammaDelta Therapeutics

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Gamma Delta Therapeutics www.gammadeltatx.com

GammaDelta Therapeutics (GDT) is a UK headquartered biotechnology company founded in 2016 upon world-class academic research conducted by Professor Adrian Hayday and Dr Oliver Nussbaumer, at King’s College London and the Francis Crick Institute and supported by Cancer Research Technology. The company’s technologies have attracted significant investment from Takeda Pharmaceutical Company Limited and leading life sciences investor, Abingworth LLP.

In 2018 GDT acquired Lymphact – Lymphocyte Activation Technologies, S.A. to provide access to a complementary technology platform to derive a subset of γδ T cells from blood.

GDT has the capability to generate both blood-and tissue-derived allogeneic immunotherapies based on Vδ1+ T cells with potential to provide additional patient benefit in the treatment of haematological malignancies and solid tumours.

The company has developed and optimised in-house proprietary platforms for selective isolation and expansion of Vδ1+ T cell populations from human tissues. This technology has been leveraged alongside complementary expertise and ground-breaking research from the laboratory of Professor Bruno Silva-Santos at the University of Lisbon to isolate and expand Vδ1+ T cells from human blood.

Using its technology platform, the company has developed the foundations of a pipeline of first in class allogeneic cell therapies for the potential treatment of cancer.