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.
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.