Af­ter long de­lay fol­low­ing pa­tient death, FDA lifts tri­al hold on Ad­vax­is/As­traZeneca com­bo

The FDA has lift­ed its months-long clin­i­cal hold on an Ad­vax­is com­bo ther­a­py — first brought on by a pa­tient death in its Phase I/II tri­al back in March — set­ting the New Jer­sey biotech up to move for­ward.

The news has sent Ad­vax­is’ stock $ADXS soar­ing Fri­day morn­ing, up 22% as of press time.

Its drug is called ax­al­imo­gene filolis­bac, an im­munother­a­py that at­tacks HPV-as­so­ci­at­ed can­cers by al­ter­ing a live strain of bac­te­ria to gen­er­ate can­cer-fight­ing T cells and neu­tral­iz­ing the tu­mor’s nat­ur­al pro­tec­tions. The drug was be­ing test­ed along­side As­traZeneca’s ap­proved PD-L1 ther­a­py Imfinzi be­fore the pa­tient death halt­ed the tri­al.

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