Achilles Therapeutics receives CTA approval for Phase I/II Study in Non-Small Cell Lung Cancer

Achilles Therapeutics (“Achilles””), a biopharmaceutical company developing personalised cancer immunotherapies, today announces that its Clinical Trial Application (CTA) to conduct a Phase I/II study with its lead product, a tumour-derived T cell therapy targeting clonal neoantigens, in development for the treatment of advanced Non-Small Cell Lung Cancer (NSCLC), has been approved by the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA). The study, an open-label, multi-centre Phase I/II trial evaluating the safety and clinical activity of clonal neoantigen T cells (cNeT) in patients with advanced NSCLC, is expected to enrol the first patient in 2H 2019.


“Approval of our first CTA represents an important validation of our approach and a significant milestone for Achilles,” said Dr Iraj Ali, CEO of Achilles Therapeutics. “Achilles was founded by world-leading experts in cancer evolution, bioinformatics and the delivery of cell-based immunotherapies and we are bringing together these disciplines to develop next-generation, patient-specific T cell therapies that harness the immune system to destroy cancer cells."

“The Achilles approach is a technological step forward in the immune-oncology space with the potential to bring the next wave of revolutionary new immunotherapies to cancer patients,” said Dr Martin Forster, Chief Investigator for the study at University College London Hospitals (UCLH), the lead clinical site. “We are excited to be part of the study and look forward to enrolling patients into the clinical trial.”

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 a cancer cell. Using its PELEUS™ bioinformatics platform, Achilles can identify clonal neoantigens from each patient’s unique tumour profile which are present on every cancer cell and can be recognised by the immune system. Achilles uses its proprietary process to manufacture clonal neoantigen T cells (cNeT) which exquisitely target the specific set of clonal neoantigens in each patient. The starting material for cNeT are tumour infiltrating lymphocytes (TILs) which are isolated from the patient’s own tumour sample. These T cells are already programmed to invade and attack the tumour, and previous clinical studies have shown that expanded TILs can debulk solid tumours with durable and potent responses. 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.

A second clinical study in patients with metastatic or recurrent melanoma is anticipated to open later in 2019.

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