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Neoantigen player Achilles gets OK for first clinical trial

Will test the candidate in advanced NSCLC patients

lung

Achilles Therapeutics is now a clinical-stage biotech after getting regulatory approval to start a phase 1/2 trial of its lead lung cancer therapy.

The Stevenage, UK biotech is developing personalised T cell therapies targeted at clonal ‘neoantigens’ – antigens that are found in cancerous but not healthy tissues – and will now move ahead with a trial of its candidate for advanced non-small cell lung cancer (NSCLC) after getting a green light from the MHRA.

The first patient is scheduled to be enrolled in the trial of the clonal neoantigen T cell (cNeT) therapy in the second half of this year, according to Achilles, which also hopes to start a second trial in advanced melanoma before the end of 2019.

Achilles’ approach is a form of cancer immunotherapy, and the company uses DNA sequencing data and bioinformatics to identify neoantigens specific to an individual patient, creating cNeTs that target them from tumour infiltrating lymphocytes (TILs) isolated from the patient’s own tumour sample.

The number of cells is expanded and then delivered to the patient as a personalised cell therapy that in theory should target and destroy tumours without harming healthy tissues.

“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,” said Achilles in a statement.

Achilles launched in 2016 with funding of just over £13m ($17m) as an offshoot from life sciences  group Syncona and Cancer Research Technology, the commercial arm of Cancer Research UK, bringing together immuno-oncology researchers from University College London and the Francis Crick Institute.

Syncona managing partner Iraj Ali (pictured below) took on the permanent role of chief executive at Achilles in December, at the same time that biotech veteran Edwin Moses – which was CEO at Ablynx before it was sold to Sanofi last year for $4.8bn – took over as chair of the UK biotech.

Iraj Ali

The company has made no secret of its intention to follow an Ablynx-like path and become an integrated biotech focused on developing and commercialising its own therapies. It’s operating in a busy field in immuno-oncology, with a clutch of companies focusing on neoantigens as a way to tackle cancer using drug, vaccine or cell therapy approaches.

“Approval of our first [clinical trial application] represents an important validation of our approach and a significant milestone for Achilles,” said Ali.

Article by
Phil Taylor

22nd January 2019

From: Research, Regulatory

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