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US FDA orders Adaptimmune to halt fat cancer cell therapy trial

By Gareth MacDonald+

05-Aug-2016
Last updated on 05-Aug-2016 at 13:27 GMT2016-08-05T13:27:32Z

Liposarcoma - connective tissue cancer (wikipedia)

Liposarcoma - connective tissue cancer (wikipedia)

The US FDA has ordered Adaptimmune to halt a trial of its candidate liposarcoma therapy and asked for more information about how the treatment is made.

UK based Adaptimmune announced the partial clinical hold yesterday, stressing that the US regulator had not raised any safety questions about the therapy, NY-ESO Spear.

Instead the Food and Drug Administration (FDA) has asked for “additional chemistry, manufacturing, and control [CMC]” information and answers to questions about study design according to Adaptimmune. The firm said it plans to respond “shortly.”

The study – which is designed to examine the cell therapy in patients suffering a connective tissue cancer called myxoid round cell liposarcoma (MRCLS) – has not yet enrolled any patients.

The firm plans to discuss the clinical hold during its second quarter conference call on Monday.

SPEAR

All of Adaptimmune's SPEAR (Specific Peptide Enhanced Affinity Receptor) therapies are based on T-cells isolated from the blood of cancer patients.

The firm’s approach is to make the harvested cells better at attaching to tumours by modifying the genes that encode the cell surface proteins - T cell receptors - that recognize and bind cancerous cells. 

Adaptimmune uses Thermo Fisher’s Dynabeads CD3/CD28 CTS T-cell isolation, activation and expansion technology to modify the cells, under a recently expanded technology licensing deal.

In 2014 , Oxford, based Adaptimmune entered into an agreement worth up to $350m with GSK to co-develop Adaptimmune’s cancer testis antigen programme, NY-ESO-1, and several other TCR-targeted candidates.

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