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Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company dedicated to discovering, developing, and commercializing a cure for patients suffering from chronic hepatitis B infection (cHBV). Utilizing its extensive expertise in virology, Arbutus focuses on developing a portfolio of drug candidates with multiple mechanisms of action aimed at curing Hepatitis B virus (HBV) disease. The company's lead RNA interference (RNAi) therapeutic, imdusiran (AB-729), targets HBV proteins to reduce viral antigens and reawaken the host's immune response. Imdusiran is currently undergoing multiple Phase 2a clinical trials, demonstrating promising results in reducing hepatitis B surface antigen (HBsAg) levels and achieving functional cures in a subset of patients.
Arbutus leverages its proprietary lipid nanoparticle (LNP) technology and expertise in RNAi therapeutics to develop innovative treatments. Beyond HBV, the company has a robust pipeline that includes AB-101, an oral PD-L1 inhibitor, currently in Phase 1a/1b trials. This compound aims to enable controlled checkpoint blockade while minimizing systemic safety issues.
Recent clinical data highlight the potential of Arbutus' combination therapies. In the IM-PROVE I trial, imdusiran combined with pegylated interferon alfa-2a (IFN) and nucleos(t)ide analogue (NA) therapy demonstrated sustained HBsAg loss in some patients, suggesting a path toward a functional cure. Another study, IM-PROVE II, showed that combining imdusiran with VTP-300, an immunotherapeutic, resulted in meaningful reductions in HBsAg levels and the discontinuation of NA therapy in a significant number of patients.
Financially, Arbutus maintains a strong position with a cash runway extending into the first quarter of 2026. They are actively involved in ongoing patent litigation to protect their LNP technology, seeking fair compensation for its use in mRNA COVID-19 vaccines by Moderna and Pfizer/BioNTech.
Arbutus continues to engage in strategic collaborations and partnerships to advance its mission of curing HBV and other chronic infectious diseases. For more detailed information, visit www.arbutusbio.com.
Arbutus Biopharma (Nasdaq: ABUS) has announced promising new data presented at the European Association for the Study of the Liver (EASL) Congress regarding its RNAi therapeutic, Imdusiran, combined with the T-cell stimulating immunotherapeutic VTP-300. The Phase 2a trial showed significant reductions in Hepatitis B surface antigen (HBsAg) levels. At 24-weeks post end-of-treatment, 94% of patients in the treatment arm achieved HBsAg levels <100 IU/mL, with 36% achieving <10 IU/mL. The treatment was generally safe, with no serious adverse events reported. The trial's results highlight the potential for Imdusiran and VTP-300 to enhance immune responses and reduce HBsAg in chronic hepatitis B patients.
Arbutus Biopharma (Nasdaq: ABUS) reported promising data from its Phase 2a trial (IM-PROVE I) for imdusiran in treating chronic hepatitis B virus (cHBV). Imdusiran, combined with interferon (IFN) and nucleoside analogue (NA) therapy, led to sustained undetectable HBsAg levels in 33.3% of patients (48-week imdusiran+24-week IFN) and 23.1% (24-week imdusiran+24-week IFN). Six patients remained HBsAg and HBV DNA-free off all therapy, with two maintaining this status for 12 weeks. The treatment was well-tolerated, with transient ALT elevations and injection site bruising as the most common adverse events. These results were presented at the EASL Congress 2024, showcasing imdusiran's potential for a functional cure for cHBV.
Arbutus Biopharma (Nasdaq: ABUS) announced it will participate in the Jefferies Global Healthcare Conference in New York. The company's management team is scheduled to present and hold one-on-one meetings with investors on June 5, 2024, at 9:30 am ET. Arbutus is focused on developing a functional cure for chronic hepatitis B (cHBV). A live webcast will be available, with an archived replay accessible on the Arbutus website for a time.
Arbutus Biopharma (Nasdaq: ABUS) announced that it will present data on its RNAi therapeutic, imdusiran (AB-729), at the EASL Congress 2024 from June 5-8 in Milan. Two abstracts were accepted for presentation. The first discusses the effects of imdusiran combined with pegylated interferon alfa-2a on HBeAg-negative chronic HBV patients, showing a 28% HBsAg loss in certain subjects. The second presents findings on imdusiran in combination with VTP-300, demonstrating better maintenance of lower HBV surface antigen levels compared to imdusiran alone. Both studies highlighted the safety and efficacy of imdusiran. Additional data will be shared at the conference and subsequently on Arbutus' website.
Whitefort Capital, a long-term investor and the second largest shareholder of Arbutus Biopharma (NASDAQ: ABUS), published an open letter to shareholders on May 17, 2024, outlining strategies to maximize shareholder value. Whitefort emphasizes that Arbutus' patent infringement claims against Moderna and Pfizer/BioNTech could be worth billions, urging the company to halt further share issuances to prevent dilution. They also recommend a strategic review of Arbutus' Hepatitis B Virus (HBV) portfolio by year-end, including potential licensing and collaborations. Whitefort plans to vote against proposed share increases in the company’s incentive plan, citing substantial historical dilution and unnecessary new share authorization. The company’s litigation claims, cash reserves, and upcoming clinical trial data are key focal points for future strategic decisions.
Arbutus Biopharma (Nasdaq: ABUS) will participate in two upcoming investor conferences in New York. The management team will engage in one-on-one meetings at The Citizens JMP Life Sciences Conference on May 14, 2024, and at C. Wainwright 2nd Annual BioConnect Investor Conference on May 20, 2024. Investors can access the live webcast of the fireside chats on the company's website.
Arbutus Biopharma reported its first quarter 2024 financial results and corporate update, highlighting progress in advancing its HBV assets, particularly imdusiran and AB-101. The company has a strong financial position with expected cash runway extended through the second quarter of 2026. End-of-treatment data from Phase 2a combination clinical trials with imdusiran will be presented at the EASL Congress in June 2024. Court ruling in the ongoing patent infringement lawsuit against Moderna was in favor of Arbutus. The company's revenue declined in Q1 2024 compared to the same period in 2023, primarily due to lower license revenue and royalties. Despite an increase in operating expenses, including research and development costs, the net loss for Q1 2024 was $17.9 million.
Arbutus Biopharma announced the retirement of Dr. Michael Sofia, its Chief Scientific Officer, effective December 31, 2024. Dr. Sofia, a renowned antiviral drug discovery scientist, co-founded the company and played a important role in developing potential cures for chronic HBV. The company expressed gratitude for his contributions and emphasized its commitment to continue clinical development under new leadership.
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