Management announced Friday afternoon that lead product FG001 was found safe and to have lit up brain tumours in 25 of 27 pts in part 1 of its phase 1/2 trial. With an optimal dose now selected, the next step will be to optimise dose timing, so management expects part 2 (the efficacy part) of the trial to begin in Q1/22, as previously guided. We have yet to see safety data, but, overall, it appears to be about as good a result as one could hope for. Small positive.
An important step in the right direction
We note that the two patients whose cancers did not light up were treated with the lower doses, so in our view, this is not of concern. Indeed, it is promising that of the two brain cancers that were not glioblastoma, both also lit up, suggesting broader utility of FG001 in brain cancers than we had initially anticipated.
Generalt om Commissioned Research: Bemærk, at man bør se bort fra eventuelle kursestimater i såkaldt commissioned research, og den underliggende analyse skal også tolkes med forsigtighed, da negative aspekter ikke nødvendigvis fremhæves.