Imdusiran
- Generic Name
- Imdusiran
Arbutus Biopharma to Present Promising Imdusiran and AB-101 Data for Chronic Hepatitis B at EASL Congress 2025
• Arbutus Biopharma will present five abstracts at EASL Congress 2025, showcasing data on imdusiran and AB-101 for chronic hepatitis B treatment, including one late-breaker abstract.
• Clinical data reveals that imdusiran, when combined with pegylated interferon and nucleos(t)ide analogue therapy, achieved meaningful functional cure rates in chronic hepatitis B patients through targeted RNAi action.
• AB-101, an oral PD-L1 inhibitor, demonstrated promising safety profiles and dose-responsive receptor occupancy in early trials, potentially offering controlled immune checkpoint blockade with fewer systemic side effects than antibody therapies.
Robust Pipeline of 55+ Therapies Advancing Toward Potential Functional Cure for Chronic Hepatitis B
• Over 50 pharmaceutical companies are actively developing 55+ pipeline therapies for chronic hepatitis B virus (HBV) infection, signaling a robust research landscape aimed at achieving functional cures beyond current suppressive treatments.
• Promising candidates include Pradefovir (Ligand Pharmaceuticals) in Phase III and RG6346 (Dicerna/Roche) in Phase II, with the latter demonstrating over 99.9% reduction in circulating HBsAg in preclinical models.
• GlaxoSmithKline and Vir Biotechnology are pioneering combination approaches, with GSK evaluating sequential therapy of ASO compound (GSK3228836) and CHB-TI (GSK3528869A) to potentially enhance efficacy over monotherapy in chronic HBV patients.
Genevant and Arbutus Launch Global Patent Battle Against Moderna Over LNP Technology in COVID-19 Vaccine
• Genevant Sciences and Arbutus Biopharma have filed five international lawsuits against Moderna, targeting alleged patent infringement of their lipid nanoparticle (LNP) technology in 30 countries.
• The companies are seeking monetary damages and injunctions against Moderna's Spikevax® and mRESVIA® products, with evidence suggesting these products contain LNPs covered by their patents.
• Legal actions span multiple jurisdictions including Canada, Japan, Switzerland, and the Unified Patent Court, expanding their existing U.S. litigation scheduled for trial in September 2025.
Arbutus Biopharma Advances cHBV Program with Imdusiran Phase 2b Trial Initiation Planned for 2025
• Arbutus Biopharma plans to initiate a Phase 2b clinical trial of imdusiran, combined with interferon and nucleos(t)ide analogue therapy, in the first half of 2025 for cHBV.
• The planned Phase 2b trial will enroll approximately 170 HBeAg-negative cHBV patients with baseline HBsAg levels ≤1000 IU/mL, pending regulatory approval.
• Arbutus's oral PD-L1 inhibitor, AB-101, is currently in Phase 1a/1b trials, with data from the 10 mg cohort expected in the first half of 2025.
• The company's financial update indicates a strong cash position, with resources sufficient to fund operations through Q1 2028, including the imdusiran Phase 2b trial.
VRON-0200 Shows Promise in Phase 1b Trial for Chronic Hepatitis B Functional Cure
• Virion Therapeutics' Phase 1b trial of VRON-0200 has completed enrollment for the first two cohorts, involving 27 chronic hepatitis B patients on antiviral therapy.
• VRON-0200, a T cell-based immunotherapy, demonstrated safety, tolerability, and anti-HBV activity in early data, even in patients with impaired HBV immunity.
• Barinthus Bio's VTP-300, combined with low-dose nivolumab, shows encouraging results in Phase 2b trial, with 8 participants achieving HBsAg loss.
• VTP-300 is designed to stimulate the immune system and encourage the production of de novo, disease-specific T cells, enabling long-term viral control.
Barinthus Bio Shifts Focus to Immunology and Inflammation, Announces Financial Restructuring
Barinthus Biotherapeutics has announced a strategic shift towards immunology and inflammation (I&I) indications, prioritizing the development of VTP-1000 for celiac disease and postponing further development of VTP-300 for chronic hepatitis B until a partner is found. The company also revealed a financial restructuring plan, including a significant workforce reduction and the closure of its U.K. site, to extend its cash runway to the start of 2027.
Phase 1 Trial Launches for Novel Hepatitis B Antibody Treatment GIGA-2339
GigaGen Inc. has initiated Phase 1 clinical trials for GIGA-2339, a groundbreaking recombinant polyclonal antibody therapy targeting chronic hepatitis B virus (HBV) infection. This innovative treatment, designed to target the Hepatitis B surface antigen (HBsAg), represents a potential breakthrough in achieving a functional cure for the 296 million people affected by chronic HBV worldwide.
Syndax's Revuforj Approved for Leukemia, Biosion Inks $940M Antibody Deal with Aclaris
• Syndax Pharmaceuticals' Revuforj (revumenib) received FDA approval as the first menin inhibitor for relapsed or refractory acute leukemia with specific genetic translocations.
• Biosion granted Aclaris Therapeutics exclusive global rights to develop two antibodies, including BSI-045B (anti-TSLP) and BSI-502 (bispecific TSLP/IL4R), for up to $940 million.
• Novartis expanded its radiopharma portfolio, licensing a somatostatin receptor 2 radiotherapeutic candidate from Ratio Therapeutics for cancer, potentially worth $745 million plus royalties.
Arbutus Biopharma's Imdusiran Shows Promise in Hepatitis B Functional Cure
• Arbutus Biopharma's IM-PROVE I Phase 2a trial reveals potential advancements in chronic hepatitis B (cHBV) treatment using imdusiran.
• The trial achieved a 25% functional cure rate overall, with 50% in HBeAg-negative patients with low baseline HBsAg levels.
• Combination therapy of imdusiran, pegylated interferon alfa-2α, and nucleos(t)ide analogue was well-tolerated, with no serious adverse events.
• Arbutus plans to advance imdusiran into a Phase 2b clinical trial, aiming for more effective cHBV treatment solutions.
Imdusiran, VTP-300, and Nivolumab Combination Shows Promise in Chronic Hepatitis B
• A Phase 2a trial shows that imdusiran, VTP-300, and low-dose nivolumab led to significantly greater HBsAg declines in chronic hepatitis B patients.
• 23% of participants receiving the combination therapy achieved HBsAg loss by Week 48, indicating a potential path to functional cure.
• The triple combination was generally well-tolerated, with no immune-related adverse events reported during the study period.
• These findings support the strategy of combining surface antigen reduction with immune reawakening in HBV treatment.
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