Bad news for Adaptimmune as partial clinical hold placed on T-cell oncology trial

pharmafile | August 4, 2016 | News story | Research and Development |  Adaptimmune, T cell, oncology, t-cell 

Adaptimmune Therapeutics has received notice from the US Food and Drug Administration (FDA) that a partial clinical hold has been placed on its pivotal study evaluating NY-ESO SPEAR T-cell therapy in myxoid round cell liposarcoma, before the trial has even started.

The trial is not yet active, and has not recruited any patients, and the FDA’s notice is not based on safety concerns, according to the company. The regulator requested additional information on chemistry, manufacturing and controls, as well as answers to certain trial design questions.

Adaptimmune indicates that will provide the required information to the FDA.

James Noble, Adaptimmune CEO, says: “Adaptimmune is running a number of different studies with its NY-ESO program and continues to enrol patients in synovial sarcoma, ovarian, and lung cancer trials in the US. We have been in dialogue with the FDA since achieving breakthrough status earlier this year and this partial clinical hold requires a number of questions to be answered before we can start a new myxoid round cell liposarcoma trial intened to be used for registration purposes. We will be providing a full response to the FDA shortly and will update the markets when we have further news to report.”

Sean Murray