Pre­ci­sion Bio­Sciences gets pos­i­tive CMC feed­back for al­lo­gene­ic CAR-T can­di­date

Gene edit­ing biotech Pre­ci­sion Bio­Sciences re­ceived pos­i­tive feed­back from FDA for its CAR-T can­di­date, the biotech an­nounced Fri­day.

The North Car­oli­na biotech said that the fed­er­al reg­u­la­to­ry agency gave pos­i­tive Type C feed­back on Pre­ci­sion’s an­a­lyt­i­cal meth­ods, along­side its chem­istry and man­u­fac­tur­ing con­trols (CMC) process­es for az­er­cab­ta­gene za­preleu­cel (Az­er-cel), the biotech’s lead al­lo­gene­ic CAR-T can­di­date that tar­gets CD19.

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