Achilles Therapeutics receives CTA Approval for Phase I/II Study in Metastatic or Recurrent Melanoma

Achilles Therapeutics (“Achilles”), a biopharmaceutical company developing personalised cancer immunotherapies, today announces the approval by the UK Medicines and Healthcare products Regulatory Agency (MHRA) of its Clinical Trial Application (CTA) to conduct a Phase I/II study using clonal neoantigen targeting T cells (cNeT) in patients with metastatic or recurrent melanoma. The study is expected to enrol the first patient later in 2019.


“To have received our second CTA approval in as many weeks is highly encouraging,” said Dr Iraj Ali, CEO of Achilles Therapeutics. “We look forward to bringing this potentially transformative treatment option into the clinic later this year.”

Professor James Larkin, Consultant Medical Oncologist at The Royal Marsden and Reader at the Institute of Cancer Research, said: “The Achilles approach to leveraging the leading science in tumour evolution to tackling solid tumours using cNeT has the potential to change the immune-oncology space and bring life-changing treatment options to patients. We look forward to the start of clinical development.”

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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