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.
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.