BioNTech CAR-T manufacturing change leads to fresh data with vaccine combo, with registrational trial plans: #ESMO23

MADRID — BioN­Tech is back with new da­ta to sup­port its BNT211 pro­gram in sol­id tu­mors af­ter a man­u­fac­tur­ing tweak. The com­pa­ny is now re­view­ing plans for the pos­si­bil­i­ty of a reg­is­tra­tional Phase II tri­al in germ cell tu­mors for next year, as well as the po­ten­tial of a mid-stage in­ves­ti­ga­tion in ovar­i­an can­cer.

BNT211, which com­bines BioN­Tech’s ther­a­peu­tic RNA vac­cine CAR­Vac with a Claudin-6 CAR-T cell ther­a­py, now has a more au­to­mat­ed man­u­fac­tur­ing process for its CAR-T and in­creased dos­ing for the vac­cine por­tion. The CAR-T is “more au­to­mat­ed, more scal­able and more ro­bust,” added Ben­jamin Rengstl, BioN­Tech di­rec­tor of clin­i­cal de­vel­op­ment and im­munore­cep­tor ther­a­py.

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