Arbutus Announces Multiple Abstracts Highlighting Imdusiran Data Accepted for Presentation at AASLD - The Liver Meeting® 2024
Arbutus Biopharma (Nasdaq: ABUS) announced that clinical data for imdusiran, an RNAi therapeutic for chronic hepatitis B virus (cHBV) infection, will be presented in four posters at the AASLD - The Liver Meeting® 2024. Two late-breaking posters will feature data from the IM-PROVE I and IM-PROVE II Phase 2a clinical trials.
Key findings from regular abstracts include:
- Imdusiran with interferon treatment showed distinct phases of immune biomarker signatures, with Th1 activation during imdusiran lead-in and Th2 signatures associated with HBsAg seroconversion.
- The imdusiran target site is highly conserved in cHBV subjects, with in vitro testing confirming activity against tested variants.
Imdusiran is designed to reduce all HBV viral proteins and antigens, potentially enabling immune system reawakening. It is currently in multiple Phase 2a clinical trials.
Arbutus Biopharma (Nasdaq: ABUS) ha annunciato che i dati clinici per imdusiran, una terapia RNAi per l'infezione da virus epatite B cronica (cHBV), saranno presentati in quattro poster al AASLD - The Liver Meeting® 2024. Due poster con risultati recenti presenteranno dati dagli studi clinici di fase 2a IM-PROVE I e IM-PROVE II.
I risultati chiave degli abstract regolari includono:
- Imdusiran in combinazione con il trattamento con interferone ha mostrato fasi distinte di firme biomarcatori immunitari, con attivazione Th1 durante la fase di introduzione di imdusiran e firme Th2 associate alla sieroconversione di HBsAg.
- Il sito bersaglio di imdusiran è altamente conservato nei soggetti cHBV, con test in vitro che confermano l'attività contro le varianti testate.
Imdusiran è progettato per ridurre tutte le proteine e gli antigeni virali dell'HBV, potenzialmente consentendo un risveglio del sistema immunitario. Attualmente è in corso in vari studi clinici di fase 2a.
Arbutus Biopharma (Nasdaq: ABUS) anunció que se presentarán datos clínicos sobre imdusiran, una terapia de RNAi para la infección crónica por el virus de la hepatitis B (cHBV), en cuatro pósters durante el AASLD - The Liver Meeting® 2024. Dos pósters de última hora presentarán datos de los ensayos clínicos de fase 2a IM-PROVE I y IM-PROVE II.
Los hallazgos clave de los resúmenes regulares incluyen:
- Imdusiran, junto con el tratamiento de interferón, mostró fases distintas de firmas de biomarcadores inmunitarios, con activación Th1 durante la fase de introducción de imdusiran y firmas Th2 asociadas con la seroconversión de HBsAg.
- El sitio objetivo de imdusiran está altamente conservado en sujetos con cHBV, con pruebas in vitro que confirman actividad contra las variantes probadas.
Imdusiran está diseñado para reducir todas las proteínas y antígenos virales del HBV, lo que potencialmente podría permitir la reactivación del sistema inmune. Actualmente se encuentra en múltiples ensayos clínicos de fase 2a.
아르부투스 바이오파마 (Nasdaq: ABUS)는 만성 B형 간염 바이러스(cHBV) 감염을 위한 RNAi 치료제인 임두시란의 임상 데이터가 AASLD - The Liver Meeting® 2024에서 네 개의 포스터로 발표될 것이라고 발표했습니다. 두 개의 최근 발표 포스터는 IM-PROVE I 및 IM-PROVE II 2상 임상 시험의 데이터를 포함합니다.
정기 초록의 주요 발견 사항은 다음과 같습니다:
- 임두시란과 인터페론 치료의 병용은 면역 바이오마커 서명의 뚜렷한 단계를 보여주었으며, 임두시란 도입 중 Th1 활성화와 HBsAg의 면역 반응과 관련된 Th2 서명이 있습니다.
- 임두시란의 표적 부위는 cHBV 환자에서 매우 보존되어 있으며, 시험된 변종에 대한 활성을 확인하는 인 비트로 테스트가 수행되었습니다.
임두시란은 모든 HBV 바이러스 단백질과 항원을 줄이도록 설계되었으며, 이는 면역 체계의 재각성을 가능하게 할 수 있습니다. 현재 여러 2상 임상 시험이 진행 중입니다.
Arbutus Biopharma (Nasdaq: ABUS) a annoncé que des données cliniques sur imdusiran, un thérapeutique à base d’ARNi pour l’infection chronique par le virus de l'hépatite B (cHBV), seront présentées sous forme de quatre affiches lors du AASLD - The Liver Meeting® 2024. Deux affiches de dernière minute présenteront des données des essais cliniques de phase 2a IM-PROVE I et IM-PROVE II.
Les résultats clés des résumés réguliers incluent :
- Imdusiran en traitement combiné avec l'interféron a montré des phases distinctes de signatures de biomarqueurs immunitaires, avec une activation Th1 pendant la phase d'introduction de l'imdusiran et des signatures Th2 associées à la séronégativité HBsAg.
- Le site cible de l'imdusiran est hautement conservé chez les sujets cHBV, avec des tests in vitro confirmant l'activité contre les variants testés.
Imdusiran est conçu pour réduire toutes les protéines et antigènes viraux du HBV, pouvant ainsi permettre un réveil du système immunitaire. Il est actuellement en cours dans plusieurs essais cliniques de phase 2a.
Arbutus Biopharma (Nasdaq: ABUS) gab bekannt, dass klinische Daten zu imdusiran, einer RNAi-Therapie gegen chronische Hepatitis-B-Virus(cHBV)-Infektionen, auf vier Postern beim AASLD - The Liver Meeting® 2024 präsentiert werden. Zwei aktuelle Poster werden Daten aus den Phase-2a-Studien IM-PROVE I und IM-PROVE II enthalten.
Die wichtigsten Erkenntnisse aus den regulären Abstracts umfassen:
- Imdusiran in Kombination mit Interferon-Behandlung zeigte unterschiedliche Phasen von Immunbiomarker-Signaturen, mit Th1-Aktivierung während der Imdusiran-Einführungsphase und Th2-Signaturen, die mit der HBsAg-Sero-Konversion assoziiert sind.
- Die Zielstelle von Imdusiran ist in cHBV-Patienten stark konserviert, wobei In-vitro-Tests die Aktivität gegen getestete Varianten bestätigen.
Imdusiran wurde entwickelt, um alle HBV-Virusproteine und -antigene zu reduzieren und könnte potenziell eine Reaktivierung des Immunsystems ermöglichen. Es befindet sich derzeit in mehreren Phase-2a-Studien.
- Imdusiran demonstrates clinical activity against HBV genotypes A-E
- Imdusiran treatment shows distinct phases of immune biomarker signatures, indicating potential immune activation
- Imdusiran target site is highly conserved in cHBV subjects, suggesting broad applicability
- In vitro testing confirms imdusiran activity against tested variants
- None.
Insights
The acceptance of multiple abstracts on imdusiran for presentation at AASLD 2024 is a positive development for Arbutus Biopharma. Key findings from two studies provide valuable insights:
- Imdusiran combined with interferon showed distinct phases of immune biomarker signatures, potentially indicating a pathway to HBsAg seroconversion.
- The imdusiran target site is highly conserved across chronic HBV subjects, suggesting broad applicability across different viral genotypes.
These data support imdusiran's mechanism of action in reducing HBV viral proteins and potentially reawakening the immune response. With imdusiran in multiple Phase 2a trials, these results could strengthen its clinical profile and advance Arbutus' goal of developing a functional cure for chronic HBV.
However, while promising, this news primarily represents incremental progress rather than a major catalyst. The true impact will depend on the full data presentation and how it compares to competing HBV therapies in development.
From an investor perspective, this news has immediate financial impact but supports Arbutus' long-term potential. Key points to consider:
- Multiple abstract acceptances at a major liver disease conference enhance scientific credibility and visibility for imdusiran.
- Positive data on immune activation and target site conservation could increase confidence in imdusiran's efficacy and applicability across patient populations.
- However, imdusiran is still in Phase 2a trials, meaning significant revenue potential is likely years away.
- The chronic HBV market is large (250 million patients worldwide) but competitive, with several companies pursuing functional cures.
For a company with a
WARMINSTER, Pa., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS), (“Arbutus” or the “Company”) a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop a functional cure for people with chronic hepatitis B virus (cHBV) infection, today announced that clinical data with imdusiran, an RNAi therapeutic, will be highlighted in four poster presentations at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2024, scheduled from November 15-19, 2024 in San Diego, CA. This includes two late-breaking posters with imdusiran data from the IM-PROVE I and IM-PROVE II Phase 2a clinical trials.
Regular Abstracts Accepted as Poster Presentations
Presentation Title: Soluble Immune Biomarker Profiling of Chronic Hepatitis B Subjects Treated with Imdusiran in Combination with Pegylated Interferon (IFN) Alfa Reveals Phases of Immune Activation
Presenter: Emily Thi, Senior Director, Immunobiology and Biomarkers Research, Arbutus Biopharma
Date and Time: November 15, 2024, 8:00 am - 5:00 pm PT
Key Findings: Imdusiran treatment in combination with IFN was associated with distinct phases of soluble immune biomarker signatures. Immune biomarkers associated with Th1 immune activation and regulation of inflammation were observed in subjects during imdusiran lead-in, coinciding with the establishment of a plateau in HBsAg reduction. Secondary transient elevations of these immune biomarkers were observed to occur during IFN treatment and were followed by appearance of Th2 immune biomarker signatures that were associated with HBsAg seroconversion.
Presentation Title: HBV Target Site for the RNA Interference Therapeutic Imdusiran is Highly Conserved in Chronic Hepatitis B Subjects
Presenter: Emily Thi, Senior Director, Immunobiology and Biomarkers Research, Arbutus Biopharma
Date and Time: November 15, 2024, 8:00 am - 5:00 pm PT
Key Findings: The imdusiran target site is highly conserved in baseline samples from cHBV subjects enrolled in imdusiran clinical studies assessed to date. In vitro testing in an HBV cell-based model confirmed retention of imdusiran activity against tested variants, suggesting that these single nucleotide polymorphisms (SNPs) have no apparent influence on HBsAg declines in subjects treated with imdusiran. Imdusiran has demonstrated clinical activity against HBV genotypes A-E.
Arbutus intends to make the poster presentations available on its website on November 15, 2024. At that time, posters can be accessed through the Publications section at https://www.arbutusbio.com/publications/.
About Imdusiran (AB-729)
Imdusiran is an RNA interference (RNAi) therapeutic specifically designed to reduce all HBV viral proteins and antigens including hepatitis B surface antigen, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. Imdusiran targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine (GalNAc) delivery technology enabling subcutaneous delivery. Clinical data generated thus far has shown single and multiple doses of imdusiran to be generally safe and well-tolerated, while also providing meaningful reductions in hepatitis B surface antigen and hepatitis B DNA. Imdusiran is currently in multiple Phase 2a clinical trials.
About HBV
Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV). HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. Chronic HBV infection represents a significant unmet medical need. The World Health Organization estimates that over 250 million people worldwide suffer from chronic HBV infection, while other estimates indicate that approximately 2.4 million people in the United States suffer from chronic HBV infection. Approximately 820,000 people die every year from complications related to chronic HBV infection despite the availability of effective vaccines and current treatment options.
About Arbutus
Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics with distinct mechanisms of action, which can potentially be combined to provide a functional cure for patients with chronic hepatitis B virus (cHBV). We believe the key to success in developing a functional cure involves suppressing HBV DNA, reducing surface antigen, and boosting HBV-specific immune responses. Our pipeline of internally developed, proprietary compounds includes an RNAi therapeutic, imdusiran (AB-729), and an oral PD-L1 inhibitor, AB-101. Imdusiran has generated meaningful clinical data demonstrating an impact on both surface antigen reduction and reawakening of the HBV-specific immune response. Imdusiran is currently in two Phase 2a combination clinical trials. AB-101 is currently being evaluated in a Phase 1a/1b clinical trial. For more information, visit www.arbutusbio.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, forward-looking statements). Forward-looking statements in this press release include statements about the potential to lead to a functional cure for HBV, our future development plans for our product candidates; the expected results of our clinical development plans and clinical trials with respect to our product candidates; our expectations with respect to the release of data from our clinical trials and the expected timing thereof; and the potential for our product candidates to achieve success in clinical trials.
With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the effectiveness and timeliness of preclinical studies and clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued demand for Arbutus’ assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies.
Additionally, there are known and unknown risk factors which could cause Arbutus’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: anticipated pre-clinical studies and clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested product candidate; Arbutus may elect to change its strategy regarding its product candidates and clinical development activities; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus’ products; economic and market conditions may worsen; market shifts may require a change in strategic focus.
A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus’ Annual Report on Form 10-K, Arbutus’ Quarterly Reports on Form 10-Q and Arbutus’ continuous and periodic disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.
Contact Information
Investors and Media
Lisa M. Caperelli
Vice President, Investor Relations
Phone: 215-206-1822
Email: lcaperelli@arbutusbio.com
FAQ
What is the main focus of Arbutus Biopharma's (ABUS) presentations at AASLD 2024?
What are the key findings from Arbutus Biopharma's (ABUS) imdusiran studies?
When and where will Arbutus Biopharma (ABUS) present the imdusiran data?
What is the current development stage of imdusiran for Arbutus Biopharma (ABUS)?
