Blinatumomab is a bispecific T-cell engager (BiTE) that binds to CD3 on T-cells and CD19 on B-cells. It has been approved for use in Acute lymphoblastic leukemia (ALL) with a regimen that requires constant infusion for four weeks per treatment cycle [1-4].
An advantage of monoclonal antibodies (mAbs) as drugs is their high potency and specificity for their target. This greatly reduces the chance of off-target toxicity common to small molecules, where toxicity is often caused by interacting similar targets. As a result, toxicity for large molecules is often driven by on-target off-tissue toxicology where the target of the drug is expressed not just on the target cell type, but in other tissues where the same pharmacology is undesirable. Because of their high potency even low expression of the target i
Model-informed drug discovery and development (MID3) uses mathematical modeling to inform decision-making in drug development programs. Applying MID3 early in development can reduce late-stage risk by determining feasibility of drugging a given target, prioritizing between targets, or defining optimal drug properties for a target product profile. However, the lack of pharmacokinetic (PK) and pharmacodynamic (PD) data available at early stages can make modeling a challenge.
Published in Frontiers in Pharmacology