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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) announced exciting clinical data at the Global Hepatitis Summit 2023 regarding their HBV treatments AB-729 and AB-161. Seven out of nine patients with chronic hepatitis B (cHBV) who were treated with AB-729 maintained low HBV DNA and HBsAg levels for over 1.5 years without needing nucleos(t)ide analogue therapy. The treatment showed no adverse effects during follow-up. Additionally, AB-161 demonstrated strong anti-HBV activity in preclinical models, effectively reducing HBV RNA and HBsAg. Both AB-729 and AB-161 are positioned as pivotal components in developing a potential functional cure for cHBV. Ongoing Phase 2a clinical trials for AB-729 are set to report preliminary data this year.
Arbutus Biopharma Corporation (Nasdaq: ABUS) announced a verbal notification from the U.S. FDA that its Investigational New Drug (IND) application for AB-101, an oral PD-L1 inhibitor aimed at treating chronic hepatitis B virus (HBV) infection, has been placed on clinical hold. An official Clinical Hold letter is expected within 30 days, and as a result, Arbutus will not report initial data from the Phase 1 clinical trial in late 2023. AB-101 is designed to enhance the immune response in chronic HBV patients and could potentially lead to a functional cure when combined with other therapies. However, the company acknowledges the hold may impact the timing and future development of AB-101, adding uncertainty to its ongoing clinical programs.
Arbutus Biopharma Corporation (Nasdaq: ABUS) has announced its schedule for the first quarter 2023 financial results and corporate update, set for May 4, 2023. The press release will be available at 7:30 a.m. ET, followed by a conference call/webcast at 8:45 a.m. ET. Arbutus specializes in developing innovative therapeutics for viral diseases, focusing on Hepatitis B, SARS-CoV-2, and other coronaviruses. The company is advancing its lead compound, AB-729, which is currently being tested in phase 2 clinical trials, and is also pursuing oral agents for coronaviruses. An archived webcast will be accessible on the company’s website after the event.
Arbutus Biopharma Corporation (Nasdaq: ABUS) announced two oral presentations at the Global Hepatitis Summit 2023 in Paris, scheduled for April 27, 2023. The presentations will cover significant findings related to the company's HBV research.
The first presentation focuses on AB-729, showcasing results from 48 weeks of therapy leading to substantial declines in HBsAg levels among patients. Follow-up data indicates sustained low HBV DNA levels even after therapy cessation.
The second presentation highlights AB-161, an oral HBV inhibitor displaying strong antiviral activity in preclinical studies. Both compounds aim to contribute toward a functional cure for chronic hepatitis B.
Additionally, Arbutus is in multiple Phase 2a trials for AB-729, emphasizing the need for innovative treatments targeting HBV, which affects over 290 million people globally.
Arbutus Biopharma Corporation (Nasdaq: ABUS) and Genevant Sciences filed a lawsuit against Pfizer (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) in the U.S. District Court for New Jersey, claiming patent infringement related to COVID-19 mRNA-LNP vaccines. The lawsuit seeks damages for the unlicensed use of patented lipid nanoparticle (LNP) delivery technologies that are crucial for mRNA vaccine efficacy. Arbutus asserts that the rapid development of Pfizer-BioNTech's vaccines depended on their patented technologies, which are vital for delivering mRNA safely and effectively. Arbutus intends to protect its intellectual property vigorously.
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