Noah Stansfield

The platform technology designation is a new designation established by the FDA.

The chimeric antigen receptor T-cell therapy (CAR T) from Cabaletta Bio has already been cleared for trials in systemic lupus erythematosus, myositis, and systemic sclerosis.

Among 10 patients evaluated, compared with their baseline at 1 week after receiving their final dose in the trial, 30% demonstrated clinical improvement on the Alzheimer’s disease composite score.

Both the second and first patients dosed in the study received the lower of the 2 doses of the gene therapy that Taysha Gene Therapies is evaluating in the phase 1/2 REVEAL trial.

The program will initially allow 6 sponsors of clinical trials to participate and will provide sponsors with the opportunity for frequent advice and regular communication regarding clinical trial design and other development issues.