Arbutus Biopharma

Robust Pipeline of 55+ Therapies Advancing Toward Potential Functional Cure for Chronic Hepatitis B

2 months ago

• 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.

Moderna and Pfizer/BioNTech Locked in Escalating mRNA Patent Battle with Billions at Stake

3 months ago

• 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 and Arbutus Launch Global Patent Battle Against Moderna Over LNP Technology in COVID-19 Vaccine

3 months ago

• 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.

Biopharma Industry Faces Continued Layoffs in 2025 Amid Strategic Realignments

5 months ago

• Biopharma companies continue to announce layoffs in 2025, driven by strategic realignments, pipeline reprioritizations, and challenging financial conditions. • Several companies, including Intellia Therapeutics and IGM Biosciences, are cutting a significant portion of their workforce to focus on key programs and extend cash runways. • These workforce reductions are often accompanied by discontinuation of certain drug development programs and a shift in strategic focus towards core assets. • The layoffs reflect a broader trend in the industry as companies adapt to evolving market dynamics and prioritize efficiency and long-term sustainability.

Phase 1 Trial Launches for Novel Hepatitis B Antibody Treatment GIGA-2339

5 months ago

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.

Acoramidis Gains Global Momentum: FDA Approval, EU Recommendation, and Promising Clinical Data

6 months ago

• Acoramidis (Attruby), developed by Stanford Medicine and BridgeBio, receives FDA approval for transthyretin amyloid cardiomyopathy (ATTR-CM) treatment, marking a significant milestone. • The European Medicines Agency's CHMP recommends acoramidis for EU marketing authorization based on positive Phase 3 ATTRibute-CM trial results. • Clinical trials demonstrate acoramidis' efficacy in reducing cardiovascular-related hospitalizations and improving survival rates for ATTR-CM patients. • Bayer and BridgeBio collaborate to commercialize acoramidis, with Bayer holding EU rights and plans for a launch in Europe in early 2025.

Arbutus Biopharma Announces Promising Phase 2 Hepatitis B Data and Strong Financial Position

7 months ago

• 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.

GSK Files Patent Lawsuit Against Moderna Over mRNA Vaccine Technology

7 months ago

• GSK has initiated legal action against Moderna, claiming ownership of seven foundational patents essential to Moderna's mRNA vaccine portfolio, seeking damages and licensing fees. • The disputed patents originate from Christian Mandl's team at Novartis (2008-2015), whose breakthrough work on mRNA vaccine formulations was later acquired by GSK through a business deal. • This lawsuit adds to a growing web of patent litigation in the mRNA vaccine space, following similar disputes involving Pfizer, BioNTech, CureVac, and other biotech companies.

FDA Accepts UroGen's NDA for UGN-102 in Low-Grade Non-Muscle Invasive Bladder Cancer

7 months ago

• The FDA has accepted UroGen Pharma's NDA for UGN-102 (mitomycin) intravesical solution for treating low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). • UGN-102, if approved, would be the first FDA-approved treatment for LG-IR-NMIBC, offering a novel non-surgical approach. • The NDA is supported by Phase 3 ENVISION trial data, demonstrating a 79.6% complete response rate at 3 months and an 82.3% duration of response at 12 months. • The FDA has set a PDUFA target action date of June 13, 2025, for the decision on UGN-102.