In the lat­est set­back to Vi­cal/Astel­las part­ner­ship, lead CMV vac­cine fails a piv­otal PhI­II study

When Vi­cal’s lead vac­cine flopped in a Phase II her­pes study in 2016, the biotech and its part­ners at Astel­las switched fo­cus to a piv­otal Phase III tri­al in he­mo­topoi­et­ic stem cell trans­plant re­cip­i­ents. To­day, the part­ners say that too has failed.

The cy­tomegalovirus vac­cine ASP0113 is de­signed to in­duce an im­mune re­sponse against the CMV virus with the en­cod­ed CMV phos­pho­pro­tein 65 and gly­co­pro­tein B anti­gens. The DNA vac­cine failed both the pri­ma­ry com­pos­ite end­point and the sec­ondary end­points: the for­mer be­ing over­all mor­tal­i­ty and CMV end-or­gan dis­ease through the first year fol­low­ing the trans­plant; the lat­ter mea­sured time to first CMV viremia and time to first use of ad­ju­di­cat­ed CMV-spe­cif­ic an­tivi­ral ther­a­py.

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