Arbutus Biopharma (ABUS) and Barinthus Biotherapeutics (BRNS) announced new preliminary data from the Phase 2a IM-PROVE II clinical trial of people with chronic hepatitis B virus, or cHBV, at the American Association for the Study of Liver Diseases, or AASLD. The data from Groups A and B were previously presented at the European Association for the Study of the Liver, or EASL, Congress in June. Group C enrolled a total of 22 non-cirrhotic, virally suppressed cHBV participants with HBsAg equal to 100 to less than 5,000 IU/mL at screening who were on stable nucleos(t)ide analogue therapy for 12 months. Thirteen of these participants were eligible to receive low-dose nivolumab and nine participants were not eligible, based on the trial criteria. “These data demonstrated the impact of the combination of an immune stimulant such as VTP-300 and a low dose of the checkpoint inhibitor nivolumab in helping participants reach HBsAg loss,” said Dr. Leon Hooftman, Chief Medical Officer of Barinthus Bio. “While these are early data, the imdusiran, VTP-300 and low-dose nivolumab regimen is promising and is consistent with the data we are seeing from our HBV003 trial of VTP-300 plus low-dose nivolumab.” “These data continue to support our belief that lowering surface antigen is key to promoting HBV-specific immune reawakening,” commented Dr. Karen Sims, Chief Medical Officer of Arbutus Biopharma. “In this trial, imdusiran provided meaningful reductions in HBsAg prior to treatment with the immunomodulatory agents VTP-300 and low dose nivolumab, leading to improved response rates with this combination.”
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