#ASH22: Re­gen­eron re­veals its first PhII da­ta in con­test­ed CD20xC3 bis­pe­cif­ic race

NEW OR­LEANS — Re­gen­eron re­port­ed the first in­ter­im re­sults from a Phase II clin­i­cal tri­al of its bis­pe­cif­ic an­ti­body for cer­tain lym­phomas.

The phar­ma will need the da­ta to carve a space in the CD20xCD3 field as it ap­proach­es a reg­u­la­to­ry fil­ing next year for ac­cel­er­at­ed ap­proval. Gen­mab and Ab­b­Vie’s bis­pe­cif­ic is al­ready un­der re­view at FDA.

The drug, dubbed odronex­tam­ab, has pre­vi­ous­ly been hit by hic­cups be­cause of cy­tokine re­lease syn­drome safe­ty hur­dles ear­li­er in a Phase I/II study, but af­ter in­tro­duc­ing a mod­i­fied step-up reg­i­men, on­ly one pa­tient was re­port­ed to have a Grade 3 ver­sion of the side ef­fect, Re­gen­eron re­port­ed at this year’s Amer­i­can So­ci­ety of Hema­tol­ogy con­fer­ence. But the safe­ty pro­file al­so in­clud­ed five treat­ment-re­lat­ed deaths, in­ves­ti­ga­tors re­port­ed, with one re­lat­ed to Covid-19 and four deemed “oth­er Grade 5 events.”

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