The FDA is tapping the brakes on one of Adaptimmune T-cell studies, looking for some clarifications before it gives the green light to start testing NY-ESO SPEAR T-cell therapy in myxoid round cell liposarcoma.
No doubt there were a few skipped heart beats among investors, but the UK biotech $ADAP hurried on to explain that regulators are simply looking to get a few answers for a registration trial that has yet to start recruiting patients.
Immuno-oncology has exploded in recent years, in a good way. New players like Adaptimmune have attracted billions in investment cash. But as Juno demonstrated recently with its lead CAR-T study, a sudden halt following the death of patients can raise questions about the entire field.
It’s important to note, though, that the FDA lifted its hold on Juno just days after imposing a clinical hold on the study, satisfied that the biotech had answered its questions about safeguarding patients from any further unnecessary risk. And Bank of America analysts note that this pause is not tied to the use of fludarabine, which Juno says was responsible for killing several patients.
“We spoke with management who reiterated that the information requested by FDA is clarification of definitions rather than related to fludarabine use or CMC manufacturing issues that have plagued other T cell therapies. ADAP plans to respond to the FDA shortly and expects the FDA to take 30 days to review their responses, resulting in a delay in the trial timeline.”
Whatever the case, Adaptimmune shares slipped 4% in after market trading as some nervous investors fretted.
“Adaptimmune is running a number of different studies with its NY-ESO program and continues to enroll patients in synovial sarcoma, ovarian, and lung cancer trials in the U.S.,” said James Noble, Adaptimmune CEO, in a statement. “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 MRCLS trial intended 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.”
Adaptimmune’s lead program is a SPEAR T-cell therapy targeting the NY-ESO cancer antigen. The company is a specialist in TCR tech.
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