Genethon to share new clinical and pre-clinical data from collaboration with Hansa Biopharma at ESGCT 2025
Lund, Sweden, 26 September, 2025. Hansa Biopharma AB, “announced that Genethon will present preliminary efficacy and safety data from the first patient treated in the GNT-018-IDES Phase II trial of imlifidase and GNT-0003 in severe Crigler-Najjar syndrome at the European Society of Gene and Cell Therapy (ESGCT) 32nd annual congress. On Thursday 9 October, between 8:30 AM and 10:30 AM CEST, Giuseppe Ronzitti, PhD, from Genethon will present pre-clinical data from the Genethon-Hansa collaboration. The clinical data will be presented by Jeremy Do Cao, MD, co-investigator of the clinical trial and paediatrician at Antoine-Béclère Hospital, AP-HP, Paris, France on Friday 10 October, between 9:00 AM and 10:30 AM CEST.
GNT-018-IDES is a single-arm Phase II trial sponsored by Genethon evaluating the efficacy and safety of a single intravenous administration of Genethon’s gene therapy GNT-0003 following pre-treatment with imlifidase. In this trial, Hansa’s first-in-class immunoglobulin G (IgG) antibody cleaving enzyme therapy is being evaluated in patients with severe Crigler-Najjar syndrome and pre-existing antibodies to AAV serotype 8 (AAV8). The trial is set to enroll a total of three patients with severe Crigler-Najjar syndrome, pre-existing anti-AVV8 antibodies and a requirement for prolonged daily phototherapy.
Renée Aguiar-Lucander, CEO, Hansa Biopharma said, “We look forward to the data from the first patient treated in the GNT-018-IDES trial that Genethon will present at ESGCT. This is an important step as we continue to gather evidence on the potential of imlifidase in enabling gene therapy, where presence of anti-AAV antibodies continues to be a barrier that precludes up to 1 in 3 patients from being eligible to receive these treatments.”
| Speaker | Abstract Title | Presentations details |
| Giuseppe Ronzitti, Genethon | INV37: Harnessing the potential of Immunoglobulin G degrading enzymes (Ide) for the treatment of AAV-seropositive patients | Thursday 9 October, 8:30 AM – 10:30 AM CEST. SESSION 7a: Immune Responses to GT |
| Jeremy Do Cao, Antoine-Béclère Hospital, AP-HP, France | OR086: Overcoming AAV8 Immunity: First Seropositive Crigler-Najjar Patient Treated with GNT0003 Following Imlifidase Pretreatment (GNT-018-IDES clinical trial) | Friday 10 October, 9:00 AM – 10:30 AM CEST. SESSION 11a: Metabolic Diseases II |
