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Chunk #40 — Therapeutic approaches to toxic tau gain of function — Approach 5: passive immune clearance of tau — Monoclonal antibodies

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Targeting tau: Clinical trials and novel therapeutic approaches.
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BIIB092 (BMS-986168, IPN007; Gosuranemab) is a monoclonal IgG4 antibody against the N-terminal region initially developed from IPN002, a mouse antibody with a specific epitope spanning N-terminal amino acids 15–24, which has been found to reduce levels of both full length tau and secreted eTau in cell culture and transgenic animal models. [99] Phase 1 studies in 65 health controls demonstrated safety and tolerability, with dose-related reductions in N-terminal fragments, though four patients developed anti-drug antibodies (ADA) [103]. A subsequent Phase 1 study in 48 PSP patients was announced to be well-tolerated at a dose of 2100 mg infused monthly for three doses (NCT02460094). Importantly, this study demonstrated target engagement of N-terminal tau fragments by BIIB092 [104].