MHRA helps Achilles Therapeutics treat non-small cell lung cancer through innovation.

In 2017, Achilles Therapeutics approached the MHRA to discuss quality, non-clinical, clinical and regulatory aspects of ATL001, an advanced therapy medicinal product consisting of autologous clonal neoantigen reactive T cells derived from patients’ tumour-infiltrating lymphocytes. The proposed initial indication was for the treatment of non-small cell lung cancer.

By sequencing a patient’s own tumour, comparing it to the germline DNA of the patient and applying bioinformatics algorithms, it is possible to identify tumour-specific mutations. Additionally, independently, human leukocyte antigen-typing of the germline blood sample is performed. All of this information is then integrated to predict which of the mutations will be the most likely candidates.

The corresponding neoantigen peptides are manufactured and cultured with antigen presenting cells, which can process them for presentation to T cells. Using these clonal neoantigen peptides (to specifically expand clones of tumour-infiltrating lymphocytes) enhances the number of tumour-infiltrating lymphocytes able to recognise such neoantigens and to target the cells that express them. This is effectively an anti-cancer treatment that is specific to the individual patient and should specifically target all cancer cells as the clonal neoantigens are contained within each and every cancer cell.

Posted on the UK MHRA website on 29 January 2020