Rogerio Vivaldi, Sigilon CEO (Sigilon via website)

Flag­ship takes a rare knock as cell re­place­ment start­up based on Bob Langer tech gets slapped with clin­i­cal hold

In the age of Mod­er­na, it’s rare to see sto­ried start­up ma­chine Flag­ship Pi­o­neer­ing take a loss — let alone for a team backed by re­search from Bob Langer’s lab. Nev­er­the­less, a great pedi­gree doesn’t mean there won’t be set­backs, a les­son an old­er Flag­ship brand is find­ing out the hard way.

The FDA has placed a clin­i­cal hold on Sig­ilon Ther­a­peu­tics’ non-vi­ral cell ther­a­py for he­mo­phil­ia A, dubbed SIG-001, af­ter a pa­tient in a Phase I/II tri­al re­port­ed a case of Fac­tor VI­II in­hi­bi­tion, the biotech said Fri­day.

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