A check­point 2.0 drug runs in­to trou­ble as Alpine gets hit with the lat­est in a string of clin­i­cal holds

The FDA is once again prov­ing that it’s ready to hit the red light on a tri­al in an in­stant when some­thing bad hap­pens to a pa­tient.

This morn­ing its Alpine Im­mune Sci­ences’ turn as its lead drug — dav­o­ceti­cept (ALPN-202) — com­bined with Keytru­da was in­volved with a pa­tient death. The pre­vi­ous­ly treat­ed pa­tient suf­fered from choroidal melanoma be­fore he re­ceived a sin­gle treat­ment. Now that tri­al is on par­tial hold, with no new re­cruit­ment in­to the tri­al be­fore in­ves­ti­ga­tors suss it out.

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