FDA puts Ver­tex’s new Type 1 di­a­betes cell ther­a­py IND on hold; In­sil­i­co sets up for PhII of AI drug

Briefly men­tioned in Ver­tex Phar­ma­ceu­ti­cals’ JPM pre­sen­ta­tion Mon­day, the FDA has put an IND for Ver­tex’s new Type 1 di­a­betes cell ther­a­py, VX-264, on hold. CEO Resh­ma Ke­wal­ra­mani not­ed the com­pa­ny has yet to re­ceive the FDA’s ques­tions on the ex­per­i­men­tal treat­ment.

VX-264 us­es the same islet cells as Ver­tex’s T1D cell ther­a­py VX-880, which is al­ready in the clin­ic. In June, Ver­tex pre­sent­ed da­ta on two pa­tients in the VX-880 tri­al — the first pa­tient be­came in­sulin-in­de­pen­dent at around 9 months af­ter treat­ment, while the sec­ond saw a 30% re­duc­tion in in­sulin use at around 5 months.

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