BioNTech, DualityBio steer ADC into PhIII, with aim to compete in HER2-low subgroup with Enhertu

BioN­Tech is step­ping on As­traZeneca and Dai­ichi Sankyo’s turf with the launch of a Phase III tri­al for its an­ti­body-drug con­ju­gate aim­ing at a sub­set of breast can­cer pa­tients who his­tor­i­cal­ly have had few treat­ment op­tions.

The Ger­man biotech li­censed DB-1303, or BNT323, in April as part of a deal where it paid Chi­na’s Du­al­i­ty­Bio $170 mil­lion up­front. Like oth­er AD­Cs, it con­sists of an an­ti­body that homes in on the tar­get (in this case, HER2), a pay­load to kill the can­cer cells and a link­er to con­nect the two. Specif­i­cal­ly, it uti­lizes a topoi­so­merase-1 in­hibitor as the can­cer-killing pay­load.

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