ACHILLES THERAPEUTICS RECEIVES CTA APPROVAL FOR PHASE I/II STUDY IN METASTIC OR RECURRENT MELANOMA – Second CTA approval in 2019 – the first was for a NSCLC study
Stevenage, UK 13 February 2019 – 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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Dr Iraj Ali – Chief Executive Officer
+44 (0)1438 906 906
Julia Wilson – Head of Communications
+44 (0)7818 430877
About Achilles Therapeutics
Achilles Therapeutics is a biopharmaceutical company developing personalised T cell therapies targeting clonal neoantigens: protein markers unique to the individual that are expressed on the surface of every cancer cell. Achilles uses DNA sequencing data from each patient, together with the proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient, and then develop personalised T cell-based therapies specifically targeting those clonal neoantigens.
Achilles was founded by lead investor Syncona Ltd and its shareholders include the CRT Pioneer Fund, UCL Technology Fund, Cancer Research Technology, with the support of UCL Business (UCLB) and the Francis Crick Institute. For further information please visit the Company’s website at: www.achillestx.com
Melanoma, the most serious form of skin cancer, is characterised by the uncontrolled growth of pigment-producing cells. The incidence of melanoma has been increasing over the past four decades – approximately 232,000 new cases were diagnosed worldwide in 2012. In the U.S., melanoma is one of the most common types of cancer diagnosed and is responsible for the vast majority of skin cancer deaths. In 2016, an estimated 76,380 people are expected to be diagnosed and an estimated 10,130 people are expected to die of the disease in the U.S. alone.