Achilles Therapeutics doses first patient in Phase I/II Study in recurrent or metastatic malignant melanoma with first TIL therapy to specifically target clonal neoantigens

Achilles Therapeutics (“Achilles”), a clinical stage biopharmaceutical company developing personalised cancer immunotherapies, today announced that it has dosed the first patient in a Phase I/II study of a clonal neoantigen T cell (cNeT) therapy in patients with recurrent or metastatic malignant melanoma. This is the first tumour-infiltrating lymphocyte (TIL) therapy to enter clinical trials where the TILs have been specifically selected to target clonal neoantigens – antigens which are believed to be present on all tumour cells.


The THETIS study is an open-label, multi-centre Phase I/II trial evaluating the safety, tolerability and clinical efficacy of cNeT therapy as a single dose in patients with recurrent or metastatic malignant melanoma. The trial is expected to recruit approximately 20 patients and report initial data in the first half of 2021. Recruitment is ongoing across sites in the UK, with additional sites to open in the US and Europe. Link to Study.

“The dosing of our first melanoma patient with a cell therapy to specifically target all cancer cells, marks a significant milestone in delivering the first precision TIL therapy. We have used a unique and proprietary data set derived from cancer patients over a period of many years (TRACERx) to generate a powerful predictive tool which, together with the DNA of a patient’s own tumour, can be used to create an entirely personalised cell therapy designed to be exquisitely specific and effective,” said Dr Iraj Ali, CEO of Achilles Therapeutics. “As we continue to navigate the unprecedented COVID-19 pandemic, we are incredibly grateful to patients and their families, investigators and their colleagues at clinical study sites, and our employees for working to advance this important study that has the potential to treat a very challenging and life-threatening cancer.”

“Patients with metastatic melanoma have very limited treatment options after immune checkpoint inhibitors have failed,” said Professor Ruth Plummer, Clinical Professor of Experimental Cancer Medicine, Faculty of Medical Sciences, Newcastle University and The Newcastle upon Tyne Hospitals NHS Foundation. “This is the first patient in the UK to receive a personalised clonal neoantigen reactive T cell product and we are very excited that this has been achieved in Newcastle in the midst of such unprecedented times, and is testament to the great collaboration between us and Achilles.”

Achilles is developing personalised T cell therapies for solid tumours targeting clonal neoantigens: protein markers unique to each patient that are present on the surface of all cancer cells. Using its PELEUS™ bioinformatics platform, Achilles can identify clonal neoantigens from each patient’s unique tumour profile which are present on every cancer cell. Achilles uses its proprietary process to manufacture T cells (cNeT) which exquisitely target a specific set of clonal neoantigens in each patient. Targeting multiple clonal neoantigens that are present on all cancer cells, but not on healthy cells, reduces the risk that new mutations can induce immune evasion and therapeutic resistance, and allows individualised treatments to target and destroy tumours without harming healthy tissue.

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