Im­muno­Gen maps new path to ac­cel­er­at­ed ap­proval; BioN­Tech scores €50M fund­ing from Eu­ro­pean bank

→ Ear­li­er this year, strug­gling Im­muno­Gen was shooed away by the FDA with their case for an ac­cel­er­at­ed ap­proval of their an­ti­body-drug con­ju­gate mirve­tux­imab so­rav­tan­sine, which had failed a Phase III study for ovar­i­an can­cer. But the com­pa­ny now has some hope­ful news to re­port as the FDA stat­ed that a “new sin­gle-arm study in plat­inum-re­sis­tant ovar­i­an can­cer could sup­port ac­cel­er­at­ed ap­proval” of the drug. The biotech will now ini­ti­ate that tri­al, SO­RAYA, to test the ef­fi­ca­cy of the monother­a­py in women with fo­late re­cep­tor al­pha (FRα)-high plat­inum-re­sis­tant ovar­i­an can­cer who have been pre­vi­ous­ly treat­ed with Avastin.

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