Back in late 2014, MacroGenics $MGNX CEO Scott Koenig touted the potential of his bispecific CD19/CD3 drug for B-cell malignancies, claiming MGD011 (duvortuxizumab) looked like it could beat the CAR-T drugs that were beginning to gather rapt attention. And J&J bought in, claiming worldwide rights in a deal launched with $125 million in cash and $575 million in milestones.
Today, the drug is likely dead and J&J is throwing in the towel on the Phase I after patients in the study experienced neurotoxicity. Ironically, the smash up occurred the same week CAR-T was heralded for an historic first approval, with most analysts ready to applaud the cell therapy’s potential as a game changer for B-cell malignancies.
Shares of the Rockville, MD-based biotech tumbled about 9% in premarket trading.
Koenig said in a statement that the neurotoxicity was likely the result of targeting CD19. And with J&J tossing back rights and halting the study, he was prepared to shrug off the drug.
Said Koenig: “Given our large portfolio of product candidates currently being pursued, it is unlikely that we will continue development of this molecule at this time.”
David Nierengarten at Wedbush says that this is the second study to be scrapped for the drug. The partners halted another study using a combination of their drug plus ibrutinib but suspended it late last year without explanation.
The progress made by CAR-Ts recently, culminating in the approval of Kymriah this week, likely motivated J&J to withdraw from deal, with the improving toxicity profile of CAR-Ts and greater challenge in recruiting patients for trials when a (likely) more potent treatment option is available probably factoring into the decision.
The partnership isn’t over. J&J is still at work on the preclinical MGD015 (AKA JNJ-9383), a bispecific DART that targets CD3 plus an unspecified antigen.
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