Arbutus Biopharma Corp. is a clinical-stage biopharmaceutical company, which engages in developing novel therapeutics that target specific viral diseases. It focuses on the Hepatitis B virus, SARS-CoV-2, and other coronaviruses. The company was founded on October 6, 2005 and is headquartered in Warminster, PA.
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- A Delaware federal court has significantly limited Moderna's invalidity defenses ahead of a March 2026 trial, blocking the company's obviousness and derivation challenges to Arbutus patents covering lipid nanoparticle technology used in COVID-19 vaccines. - The court ruled that over $8.2 billion in Moderna's government vaccine sales remain subject to the patent dispute after rejecting Moderna's Section 1498 defense, determining that vaccine use benefited patients rather than the government itself. - Arbutus faces a heightened burden to prove patent infringement after the court applied prosecution history estoppel, requiring literal infringement rather than allowing claims under the doctrine of equivalents. - The case centers on four Arbutus patents covering nucleic acid-lipid nanoparticles, the key delivery technology for mRNA vaccines, with trial scheduled to begin March 9, 2026.
- Moderna has filed an opposition in Delaware federal court against Arbutus Biopharma's request to reconsider limitations on patents in their ongoing royalty dispute over COVID-19 vaccine technology. - The pharmaceutical giant accused Arbutus and co-plaintiff Genevant Sciences of making inconsistent factual representations to avoid case limitations, calling their approach "unabashedly inconsistent" and "opportunistic." - This legal battle centers on Arbutus's claim for royalties from Moderna's COVID-19 vaccine, highlighting the complex intellectual property disputes surrounding pandemic vaccine development.
- 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.
- Moderna has filed patent infringement lawsuits against Pfizer/BioNTech in multiple countries, claiming their Comirnaty vaccine infringes on mRNA technology patents that Moderna pioneered and invested billions in developing. - The legal battle has expanded globally with Moderna scoring a recent victory in Germany, while simultaneously suffering defeats at the USPTO's Patent Trial and Appeal Board where some of its patents were found unpatentable. - With combined COVID-19 vaccine sales exceeding $100 billion, the financial stakes are enormous, as evidenced by significant settlements already reached with NIH—$400 million from Moderna and $791.5 million from BioNTech.
- 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 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.
• 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.
- Arbutus Biopharma's Phase 2 trials show significant surface antigen loss in chronic hepatitis B patients, indicating potential for functional cure. - The company reports a solid financial footing with $131 million in cash, expected to fund operations into Q4 2026. - Ongoing litigation with Moderna and Pfizer BioNTech regarding LNP intellectual property is progressing, with trial dates set for 2025. - Early trials of AB-101, an oral PD-L1 inhibitor, demonstrate a favorable safety profile and receptor occupancy.
- Delaware District Court Judge Mitchell Goldberg sided with Arbutus Biopharma and Genevant Sciences in their patent infringement case against Moderna regarding lipid nanoparticle technology used in COVID-19 vaccines. - The ruling favored Arbutus and Genevant's interpretation of two disputed patent claims concerning lipid percentages and cationic lipid specifications, rejecting Moderna's more restrictive definitions. - The lawsuit, initially filed in February 2022, seeks compensation for Moderna's alleged unauthorized use of patented lipid nanoparticle delivery technology that was crucial to its COVID-19 vaccine success.
- Moderna filed patent infringement lawsuits against Pfizer and BioNTech in August 2022, claiming their COMIRNATY vaccine infringes three foundational mRNA patents filed between 2011 and 2016. - The lawsuit centers on allegations that Pfizer and BioNTech unlawfully copied critical mRNA technology components, including N1-methylpseudouridine chemical modifications and full-length spike protein encoding design. - Moderna is seeking monetary damages for vaccine sales outside of 92 low- and middle-income countries but is not requesting an injunction to remove COMIRNATY from the market. - The patent dispute reflects a complex intellectual property landscape in mRNA technology, with multiple companies including Arbutus Biopharma, Alnylam Pharmaceuticals, and CureVac filing similar lawsuits over various mRNA vaccine components.
