tobevibart (VIR-3434) / Vir Biotech, Brii Biosci, Norgine - LARVOL DELTA

MTE #6: New Hepatitis B Virus and Hepatitis D Virus Treatments Including Drugs in Development (Ticketed) (AASLD 2026) - "This expert session focuses on new treatments for HBV monoinfection and HBV/HDV coinfection including: Capsid assembly modulators (CAMs; eg, pevifoscorvir) Small interfereing RNA (SiRNA; eg, elebsiran) and antisense oligonucleotides (ASO; eg, bepirovirsen) Monoclonal hepatitis B surface (HBs) antibodies (eg, tobevibart) Gene editing nucleases (eg, PBGENE-HBV) Other novel therapies Discussion leaders present a representative case and integrate new clinical trial data to illustrate the role of newer therapies for persons living with HBV or HBV/HDV infection. Evaluate agents in combination for the treatment of HBV/HDV coinfection. List the remaining barriers to HBV and HDV infection cure."

Hepatitis B • Hepatology • Infectious Disease • Inflammation

Advancing Chronic Hepatitis Delta Therapy: Efficacy of Tobevibart (VIR-3434) + Elebsiran (VIR-2218) in Chronic Hepatitis Delta Infection (IDWeek 2026) - No abstract available

Clinical • Infectious Disease

Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434 (clinicaltrials.gov) - P1 | N=88 | Completed | Sponsor: Vir Biotechnology, Inc. | Recruiting ➔ Completed | N=144 ➔ 88 | Trial completion date: Apr 2027 ➔ Dec 2025 | Trial primary completion date: Sep 2026 ➔ Dec 2025

Enrollment change • Monotherapy • Trial completion • Trial completion date • Trial primary completion date • Hepatology • Immunology

Not Just Managing but Vanquishing: The New Era of Hepatitis Antivirals (IDWeek 2026) - P2 | "Tobevibart+elebsiran Q4W combination therapy resulted in rapid and durable HDV RNA suppression, with 88% achieving undetectable HDV RNA by week 96, along with sustained HBsAg reduction and ALT improvements. Adverse events were generally mild to moderate and transient. These results support further development of tobevibart+elebsiran Q4W, which is now being evaluated in the phase 3 ECLIPSE program for chronic HDV infection."

Infectious Disease • Influenza

Dose-Escalation Prime/Boost Therapeutic Vaccination Study Of 2 Chimp Adenoviral Vectors in Adults With Chronic HBV On Nucleos(t)Ide Therapy (clinicaltrials.gov) - P1 | N=35 | Completed | Sponsor: Virion Therapeutics | Active, not recruiting ➔ Completed | N=56 ➔ 35

Enrollment change • Trial completion • Hepatitis B • Infectious Disease • Inflammation

Combination therapeutics for hepatitis delta virus infection: implications of the tobevibart-elebsiran SOLSTICE phase 2 trial. (PubMed, Transl Gastroenterol Hepatol) - No abstract available

Journal • P2 data • Infectious Disease • Inflammation

ECLIPSE 2: A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide (clinicaltrials.gov) - P3 | N=150 | Active, not recruiting | Sponsor: Vir Biotechnology, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Inflammation

SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection. (clinicaltrials.gov) - P2 | N=95 | Active, not recruiting | Sponsor: Vir Biotechnology, Inc. | Trial completion date: Aug 2029 ➔ May 2032 | Trial primary completion date: Aug 2029 ➔ Nov 2031

Trial completion date • Trial primary completion date • Infectious Disease • Inflammation

VIR-2218-1006: A Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of Regimens Containing VIR-2218, VIR-3434, and/or PEG-IFN? in Subjectsnwith Chronic Hepatitis B Virus Infection (clinicaltrialsregister.eu) - P1/2 | N=24 | Completed | Sponsor: Vir Biotechnology Inc. | Active, not recruiting ➔ Completed

Trial completion • Hepatitis B • Infectious Disease • Inflammation

SOLSTICE week 48 subgroup analysis: Impact of BMI on ALT normalization after successful viral control in participants with chronic hepatitis delta virus infection treated with tobevibart plus elebsiran (EASL 2026) - No abstract available

Hepatology • Infectious Disease • Inflammation

A single VRON-0200 prime dose, followed by a monthly antiviral combination regimen, resulted in rapid, profound, and durable HBsAg declines in chronically hepatitis B-infected patients (EASL 2026) - " CHB pts, NUC-suppressed with HBsAg <500IU/mL(Cohorts 1 and 2; C1/2),or <1,000IU/mL(Cohort 3; C3), were randomized to receive i.m. VRON-0200 prime on D1, w/wo VRON-0200 boost on D91; C3 receive VRON-0200 prime, followed by 6 monthly doses of elebsiran plus tobevibart (E+T) starting on D28, alone, or with a VRON-0200 boost on D196. In this Phase 1b study, VRON-0200 alone, or in combination, had no observed safety concerns, and was well tolerated. VRON-0200-induced anti-HBV activity was enhanced in combination with antivirals and produced rapid and profound HBsAg declines in all patients. This novel approach, where anti-HBV immunity is "sparked" (i.e."

Clinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Efficacy and safety of tobevibart (VIR-3434) alone or in combination with elebsiran (VIR-2218) in participants with chronic hepatitis delta virus infection: week 96 endpoint results from the phase 2 SOLSTICE trial (EASL 2026) - P2 | "Participants receiving tobevibart+elebsiran Q4W showed numerically greater rates of HDV RNA TND and HBsAg <10 IU/mL, at weeks 72 and 96 than those receiving tobevibart Q2W. TND rates increased over time with combination therapy, while rates plateaued with monotherapy. Adverse events were generally mild to moderate and transient."

Clinical • Combination therapy • P2 data • Fibrosis • Hepatology • Infectious Disease • Inflammation • Influenza • Respiratory Diseases

Monoclonal anti-HBs antibody, tobevibart, induces myeloid expansion and activation through phago-lysosomal processes (EASL 2026) - "Tobevibart-mediated HBsAg reduction induces activation of phago-lysosomal pathways as a precursor for HBV antigen degradation in myeloid cell lineages in the liver of CHB patients."

Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation • FCGR2A • FCGR3A

SOLSTICE week 48 subgroup analysis: Impact of BMI on ALT normalization after successful viral control in participants with chronic hepatitis delta virus infection treated with tobevibart plus elebsiran (EASL 2026) - P2 | "At 48 weeks, participants receiving tobevibart+elebsiran Q4W therapy achieved high rates of HDV RNA TND. ALT normalization at week 48 was more frequently observed in participants with lower baseline BMI, which suggests that elevated BMI could be independently contributing to elevated ALT even in participants achieving HDV RNA TND receiving tobevibart+elebsiran therapy."

Fibrosis • Hepatology • Infectious Disease • Inflammation

VRON-0200 alone and in combination with investigational antivirals for participants with chronic hepatitis B virus infection receiving stable nucleos(t)ide therapy: a phase 1b, randomised, open-label, multicentre trial. (PubMed, Lancet Microbe) - P1 | "VRON-0200 alone or with investigational antiviral agents had no observed safety concerns and was well tolerated. Despite not targeting HBsAg, a single VRON-0200 dose induced broad and sustained anti-HBV immunity in most participants. When combined with antivirals, rapid and profound HBsAg declines were observed in all participants. This novel approach, in which anti-HBV immunity is sparked (ie, primed) with VRON-0200 and then fanned (ie, boosted) by HBV removal, could position VRON-0200 as a key agent for a future HBV functional cure."

Journal • P1 data • Hepatitis B • Infectious Disease • Inflammation • IFNG

ECLIPSE 2: A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Vir Biotechnology, Inc.

Trial initiation date • Infectious Disease • Inflammation

MARCH: Study of VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection (clinicaltrials.gov) - P2 | N=244 | Completed | Sponsor: Vir Biotechnology, Inc. | Active, not recruiting ➔ Completed

Trial completion • Hepatitis B • Infectious Disease • Inflammation

A Study to Evaluate Tobevibart+Elebsiran in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Vir Biotechnology, Inc.

Trial initiation date • Infectious Disease • Inflammation

A Study to Evaluate Tobevibart+Elebsiran in Chronic Hepatitis Delta Virus (HDV) Infection (ECLIPSE 1) (ANZCTR) - P3 | N=120 | Active, not recruiting | Sponsor: Vir Biotechnology, Inc. | Not yet recruiting ➔ Active, not recruiting | Initiation date: Mar 2025

Enrollment closed • Trial initiation date • Infectious Disease • Inflammation

Combination therapy with tobevibart and elebsiran potently reduces hepatitis B virus surface antigen levels in preclinical in vivo models. (PubMed, Antimicrob Agents Chemother) - "Combined treatment improved suppression of HBsAg (maximum mean reductions of 2.81 log in the AAV-HBV model and 2.51 log in human liver-chimeric mice) and HBV DNA over monotherapy. Tobevibart and elebsiran have been tested in clinical trials for the treatment of chronic hepatitis B and chronic hepatitis Delta."

Journal • Preclinical • Hepatitis B • Hepatocellular Cancer • Infectious Disease • Inflammation • Liver Cancer • Solid Tumor

Tobevibart and elebsiran for the treatment of chronic hepatitis delta. (PubMed, J Hepatol) - No abstract available

Journal • Inflammation

A Study to Evaluate Tobevibart+Elebsiran Versus Bulevirtide in Chronic HDV Infection (clinicaltrials.gov) - P2 | N=100 | Active, not recruiting | Sponsor: Vir Biotechnology, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2031 ➔ Jul 2030

Enrollment closed • Trial completion date • Infectious Disease • Inflammation

Latham Advises Norgine on Exclusive Licensing Agreement With Vir Biotechnology (Legal Desire) - "Under this agreement, Norgine will commercialize the combination of tobevibart and elebsiran for the treatment of Chronic Hepatitis Delta (CHD) in Europe, Australia, and New Zealand. Under the terms of the license agreement, Vir Biotechnology will receive a €55 million initial reimbursement payment and up to €495 million in potential regulatory and commercial milestone payments."

Licensing / partnership • Hepatitis B

A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B Infection (clinicaltrials.gov) - P1/2 | N=33 | Completed | Sponsor: Vir Biotechnology, Inc. | Active, not recruiting ➔ Completed | N=150 ➔ 33 | Trial completion date: Mar 2027 ➔ Aug 2025

Enrollment change • Trial completion • Trial completion date • Hepatitis B • Infectious Disease • Inflammation

SOLSTICE: tobevibart plus elebsiran for hepatitis D. (PubMed, Nat Rev Gastroenterol Hepatol) - No abstract available

Journal • Inflammation