A CAR-T program in Phase II trials (from Juno Therapeutics) was suspended by the FDA after 3 deaths, which could be treatment-related. How will this impact the field, given that most CAR-T Biotechs share the same target?
UPDATE (article originally published on 8/7/2016): the FDA has allowed Juno Therapeutics to resume its CAR-T trial with JCAR015, the Biotech’s leading candidate. At the same time, the number of patient deaths may actually be 4. What does this mean for the company and CAR-T? See the end of the article for more details.
As a personalised medicine technology, CAR-T is one of the main developments in the field of blood cancers. The near-miraculous treatment boasted impressive remission rates in relapsed/refractory patients. The French biotech Cellectis’ therapy even ‘saved’ two terminally-ill babies – before the start of any trial.
Of course, the possibility of some serious adverse effects (such as cytokine storms) were not a minor issue and CAR-T companies were already researching ways to get around it (such as a therapy ‘off-switch’