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US FDA clears Adaptimmune to start fat cancer cell therapy trial

By Gareth MacDonald+

10-Nov-2016
Last updated on 10-Nov-2016 at 14:52 GMT2016-11-10T14:52:46Z

iStock/mipan
iStock/mipan

The US FDA has cleared Adaptimmune to start a trial of its fat cancer cell therapy, lifting the clinical hold imposed in August when the agency asked for more manufacturing data.

Adaptimmune announced the clinical hold had been lifted yesterday , explaining that it will begin recruiting the 15 Myxoid/Round Cell Liposarcoma (MRCLS) patients it needs for the trial before the end of the year.

The US Food and Drug Administration (FDA) imposed the partial clinical hold in August . At the time the agency said it wanted more information on how the product is made, specifically “additional chemistry, manufacturing, and control [CMC].

Adaptimmune - which announced its third quarter results today - did not respond to a request for comment.

In a press statement the firm said it will "provide an overview of the removal of the partial clinical hold during its conference call" today.

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.

The therapy is being made by Caladrius Biosciences’ subsidiary PCT, which was hired by Adaptimmune after the clinical hold was imposed.

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