The TeGenero impact

TeGenero Immuno Therapeutics AG's Phase I trial blowup in the U.K. - in which six healthy volunteers ended up hospitalized - has spawned an inquiry focusing on how the transition from preclinical to first-in-man testing should be regulated in the case of novel therapeutic modalities. In fact, existing guidelines for moving into human studies are not specific, meaning the response to this single clinical event could result in sea changes in regulatory thinking, both reactive and innovative.

TeGenero's lead product TGN1412, a humanized antibody against CD28, was in development for chronic lymphocytic leukemia (CLL) and T cell-mediated autoimmune diseases like rheumatoid arthritis (RA) and multiple sclerosis (MS). The antibody differs from most other therapeutic antibodies in that it acts as an agonist at CD28, leading it to activate T cells independent of the co-stimulatory ligands normally required to activate the receptor. ...