VNX-101

VNX-101 (AAV.CD3/CD19) is an in vivo gene therapy: AAV vector encoding a bispecific T-cell engager from Vironexis Biotherapeutics. A single intravenous dose of an adeno-associated virus vector that makes the liver secrete a CD3 x CD19 bispecific T-cell engager continuously. Its furthest stage is phase 1, for CD19-positive B-cell acute lymphoblastic leukaemia, B-cell lymphomas (large B-cell, follicular, mantle cell, marginal zone, Burkitt) and chronic lymphocytic leukaemia. ClinicalTrials.gov registers it in one study linked below. Phase 1/2 SENTRY-CD19 NCT06533579 recruiting. The company lists FDA Fast Track, Rare Pediatric Disease and Orphan Drug designations. Whether it works in people has not been established unless a trial below reports it.