The goal of this clinical trial is to learn about the action of Imdusiran (AB-729) in the liver of people with chronic hepatitis B. The main questions it aims to answer are:
* how well is it working in the liver
* how does Imdusiran affect the hepatitis B virus
Participants will receive injections of Imdusiran, one injection every 8 weeks, for a total of 4 doses. They will also undergo 2 liver biopsies: one with the first dose of Imdusiran, and the second 8 weeks after the last dose of Imdusiran.

Start Date25 Jul 2024

Sponsor / Collaborator

University of Maryland Baltimore

[+1]

NCT06277037

/ RecruitingNot Applicable

A Long-Term Follow-up Study for Subjects With Chronic Hepatitis B Previously Treated With Imdusiran (AB-729)

This is a long term follow-up study for chronic hepatitis B (CHB) subjects who have received imdusiran treatment in a prior clinical trial, stopped NA therapy during that trial, and remain off therapy. Subjects may enroll after completing the end of study visit (baseline visit within 12 weeks ± 1 week from the end of study [EOS] visit) from their imdusiran clinical trial (the "parent study"). No interventions will be performed in this study other than blood sample collections, review of current medications, and reporting of any adverse events related to study procedures or NA therapy if restarted. Study participation will be for approximately 2 years (to complete a total of at least 3 years of follow-up while off NA therapy, inclusive of parent study participation).

Start Date11 Jul 2024

Sponsor / Collaborator

Arbutus Biopharma Corp.

NCT06245291

/ WithdrawnPhase 2

A Phase 2a, Open-Label Multiple Dose Study Evaluating the Safety, Tolerability, and Pharmacodynamics of Imdusiran (AB-729) in Combination With Intermittent Dosing of Durvalumab, a PD-L1 Monoclonal Antibody, in Subjects With Chronic HBV Infection

This is a phase 2a, open-label, multicenter study investigating the safety, tolerability, and antiviral activity of durvalumab administered at targeted times during a 48-week treatment period of imdusiran in virologically-suppressed CHB subjects

Start Date01 May 2024

Sponsor / Collaborator

Arbutus Biopharma Corp.

100 Clinical Results associated with Arbutus Biopharma Corp.

0 Patents (Medical) associated with Arbutus Biopharma Corp.

101

Literatures (Medical) associated with Arbutus Biopharma Corp.

21 Mar 2025·Organic Process Research & Development

Development of a Scalable Manufacturing Process for AB-343 Drug Substance: A Potential Candidate for the Treatment of Coronavirus Infections

Author: Singh, Rajeev K. ; Liu, Jia ; Pallerla, Mahesh ; Mason, Jeremy D. ; Vega, Marvin Marcus ; Wu, Zhenhua ; Sofia, Michael J. ; Pamulapati, Ganapati Reddy ; Pulipaka, Aravind B. ; Wang, Xu ; Spink, Jan M.

A scalable process for manufacturing of the anticoronavirus clin. candidate AB-343 has been developed.The lactam-containing subunit of the mol. was prepared using a novel synthetic route involving a nitro-Michael reaction and a rhodium-catalyzed nitro group hydrogenation followed by in situ translactamization sequence as a key transformation.The drug substance was assembled via sequential amide coupling and deprotection reactions, followed by a final dehydration of a primary amide to the corresponding nitrile using T3P.AB-343 drug substance was successfully manufactured on a multikilogram scale using this route, which was suitable for supporting IND-enabling studies and Phase I clin. development.

01 Dec 2024·Antiviral Research

Biological characterization of AB-343, a novel and potent SARS-CoV-2 Mpro inhibitor with pan-coronavirus activity

Article

Author: Chen, Chia-yi ; Ardzinski, Andrzej ; Fan, Kristi Y ; Konz Makino, Debora L ; Blaesse, Michael ; Wasserman, Adam ; Prasad, Archna ; Sheraz, Muhammad ; Bergmann, Andreas ; Mani, Nagraj ; Kultgen, Steven G ; Sofia, Michael J. ; Micolochick Steuer, Holly M. ; Chen, Chia-Yi ; McGovern-Gooch, Kayleigh R. ; Vega, Marvin ; Lam, Angela M ; von König, Konstanze ; Lam, Angela M. ; McGovern-Gooch, Kayleigh R ; Gotchev, Dimitar ; Nguyen, Duyan ; Cuconati, Andrea ; Cole, Andrew G. ; Lindstrom, Aaron ; Cole, Andrew G ; Weiss, Susan R ; Konz Makino, Debora L. ; Weiss, Susan R. ; Kultgen, Steven G. ; Wang, Xiaohe ; Fan, Kristi Y. ; Kowalski, Rose ; Wang, Xu ; Sofia, Michael J ; Bracci, Nicole ; Maskos, Klaus ; Micolochick Steuer, Holly M ; Tercero, Breanna

Since the SARS-CoV-2 outbreak, there have been ongoing efforts to identify antiviral molecules with broad coronavirus activity to combat COVID-19. SARS-CoV-2's main protease (M^pro) is responsible for processing the viral polypeptide into non-structural proteins essential for replication. Here, we present the biological characterization of AB-343, a covalent small-molecule inhibitor of SARS-CoV-2 M^pro with potent activity in both cell-based (EC₅₀ = 0.018 μM) and enzymatic (K_i = 0.0028 μM) assays. AB-343 also demonstrated excellent inhibition of M^pro of other human coronaviruses, including those from the alpha (229E and NL63) and beta (SARS-CoV, MERS, OC43, and HKU1) families, suggesting the compound could be active against future coronaviruses. No change in AB-343 potency was observed against M^pro of SARS-CoV-2 variants of concern, including Omicron, suggesting that AB-343 could be developed as a treatment against currently circulating coronaviruses. AB-343 also remained active against several M^pro variants which confer significant resistance to nirmatrelvir and ensitrelvir, which are presently the only M^pro inhibitors authorized for the treatment of COVID-19, further supporting the evaluation of AB-343 as a novel and potent therapeutic for COVID-19 and other coronaviruses.

14 Nov 2024·Journal of Medicinal Chemistry

Rational Design of Macrocyclic Noncovalent Inhibitors of SARS-CoV-2 M^pro from a DNA-Encoded Chemical Library Screening Hit That Demonstrate Potent Inhibition against Pan-Coronavirus Homologues and Nirmatrelvir-Resistant Variants

Article

Author: Sofia, Michael J. ; Cuconati, Andrea ; Preuss, Franziska ; Zhang, Ying ; Mani, Nagraj ; Prasad, Archna ; Wang, Xu ; Wang, Xiaohe ; Maskos, Klaus ; Liu, Jenny ; von König, Konstanze ; Lam, Angela M. ; Keefe, Anthony D. ; McGovern-Gooch, Kayleigh ; Carpino, Philip ; Vega, Marvin M. ; Schmitt, Andreas ; Turcotte, Stéphane ; Clark, Matthew A. ; Johnstone, Shawn ; Cole, Andrew G. ; Gotchev, Dimitar ; Guilinger, John P. ; Chen, Chia-yi ; Tercero, Breanna ; Konz Makino, Debora L. ; Centrella, Paolo A. ; Fan, Kristi Yi

The recent global COVID-19 pandemic has highlighted treatments for coronavirus infection as an unmet medical need. The main protease (M^pro) has been an important target for the development of SARS-CoV-2 direct-acting antivirals. Nirmatrelvir as a covalent M^pro inhibitor was the first such approved therapy. Although M^pro inhibitors of various chemical classes have been reported, they are generally less active against nirmatrelvir-resistant variants and have limited pan-coronavirus potential, presenting a significant human health risk upon future outbreaks. We here present a novel approach and utilized DNA-encoded chemical library screening to identify the noncovalent M^pro inhibitor 5, which demonstrated a distinct binding mode to nirmatrelvir. A macrocyclization strategy designed to lock the active conformation resulted in lactone 12 with significantly improved antiviral activity. Further optimization led to the potent lactam 26, which demonstrated exceptional potency against nirmatrelvir-resistant variants as well as against a panel of viral main proteases from other coronaviruses.

246

News (Medical) associated with Arbutus Biopharma Corp.

23 Apr 2025

·investor.arbutusbio.com

Arbutus to Present Imdusiran and AB-101 Data at EASL Congress 2025

Five abstracts accepted for poster presentations WARMINSTER, Pa., April 23, 2025 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company focused on infectious disease, today announced that five abstracts, including one late-breaker, have been accepted for presentation at the European Association for the Study of the Liver (EASL) Congress 2025 taking place May 7 - 10, 2025 in Amsterdam, Netherlands. The following abstracts will be presented as posters in the Viral Hepatitis B and D: New Therapies, Unapproved Therapies or Strategies session on May 8, 2025, from 8:30 am – 5:00 pm CET. Abstract Number: 1768 Title: IM-PROVE I: characterization of chronic hepatitis B (CHB) subjects with functional cure or HBV DNA suppression after completion of imdusiran plus short courses of pegylated interferon alfa-2a (IFN) and discontinuation of nucleos(t)ide analogue (NA) therapy Presenter: Prof. Man-Fung Yuen Presentation Date: May 8, 2025 Key Findings: Within this small group of subjects who achieved functional cure or HBV DNA

Clinical ResultPhase 2siRNA

20 Mar 2025

·investors.barinthusbio.com

Barinthus Bio Reports Full Year 2024 Financial Results and Updates on Corporate Developments

Strategic transformation ongoing, positioning the Company as a focused leader in immunology and inflammatory diseases Highly differentiated, potentially curative immunotherapy for celiac disease (VTP-1000) in the clinic, with first data expected in third quarter of 2025 Proprietary SNAP-TI platform promoting antigen-specific immune tolerance is anticipated to drive multiple future pipeline and partnership opportunities Strategic prioritization of resources expected to provide a cash runway into 2027 OXFORD, United Kingdom and GERMANTOWN, Md., March 20, 2025 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS) (“Barinthus Bio,” or the “Company”), an immunology and inflammation (I&I) company focused on developing therapies that promote immune tolerance with curative potential, today announced its financial results for the year ended December 31, 2024 and provided an overview of the Company’s business updates. “We’ve entered 2025 with a refreshed strategic focus on immunological and inflammatory diseases. Following our restructuring, we are strongly positioned to advance our highly differentiated lead asset,VTP-1000, (and the underlying SNAP-TI platform) in patients with celiac disease. Through design innovations enabling greater targeting of disease antigens, intramuscular administration and potentially improved tolerability, VTP-1000 has promise to be a leading therapy for the approximate 80 million people worldwide with celiac disease. We look forward to reporting single-ascending dose Phase 1 data for this program in the third quarter of this year.” said Bill Enright, Chief Executive Officer of Barinthus Bio. “VTP-1000 is based on our innovative SNAP-TI platform, which is differentiated based on its capacity to promote antigen-specific immune tolerance that specifically guides a patient's T cells to suppress unwanted inflammation and restore the natural state of immune non-responsiveness to healthy tissue without affecting immunity against cancer or infections. Given this mild and potentially curative approach to restoring balance to the immune system, we believe SNAP-TI is poised to drive multiple future pipeline and partnership opportunities for the company particularly for autoimmune diseases where broadly immunosuppressive drugs are not optimal." “Turning to our development candidates designated for partnering, we reported highly encouraging results from two Phase 2 trials in our chronic hepatitis B (“CHB”) program demonstrating that VTP-300 contributed to the achievement of undetectable HBsAg levels in eight participants, with two participants meeting functional cure criteria. Further Phase 2 data are anticipated in the second quarter of 2025, which are expected to strengthen VTP-300’s market positioning as a component of a functional cure for CHB.” 2024 Corporate MilestonesClinical developments Celiac Disease (VTP-1000) In April 2024, Barinthus Bio received clearance from the U.S. Food and Drug Administration and Australian regulatory authorities on an Investigational New Drug application to progress VTP-1000 in a first in human clinical trial in celiac disease. In September 2024, Barinthus Bio initiated the first-in-human, Phase 1 AVALON trial for VTP-1000 in celiac disease. The AVALON trial aims to enroll 42 participants with celiac disease and will be conducted in two parts: the first part, a randomized double-blind placebo controlled single ascending dose, followed by the second part, a randomized double-blind placebo-controlled multiple ascending dose and incorporating a controlled gluten challenge to assess the impact of VTP-1000 administration on patients’ exposure to gluten. Chronic Hepatitis B (VTP-300) In June 2024, Barinthus Bio presented interim data from the two Phase 2 trials of VTP-300, which achieved 19% undetectable HBsAg levels across both studies, indicating potential rates of functional cure. The majority of patients who were assessed reached very low levels of HBsAg and eligibility for nucleos(t)ide discontinuation. In October 2024, the Company completed enrollment of the Phase 2b HBV003 clinical trial for VTP-300 in CHB. In November 2024 Barinthus Bio reported positive updated interim data from the Phase 2b HBV003 clinical trial for VTP-300 showing that as of the data cut off, eight participants achieved complete HBsAg loss (defined as HBsAg levels below the lower limit of quantitation [

Phase 2Clinical ResultPhase 1Executive Change

05 Mar 2025

·www.prnewswire.com

Global Interferons Market is Predicted to Reach ~USD 14 Billion by 2032 | DelveInsight

The increasing occurrence of chronic and infectious diseases is the main driver of the rising demand for interferon. Furthermore, advancements in interferon production and ongoing research and development of innovative interferon therapies are key factors fueling the expansion of the interferon market from 2025 to 2032. LAS VEGAS, March 5, 2025 /PRNewswire/ -- DelveInsight's Interferons Market Insights report provides the current and forecast market analysis, individual leading interferons companies' market shares, challenges, interferons market drivers, barriers, trends, and key market interferons companies in the market. Key Takeaways from the Interferons Market Report As per DelveInsight estimates, North America is anticipated to dominate the global interferons market during the forecast period. In the application segment of the interferon market, the leukemia category captured a significant revenue share in 2024. Notable interferons companies such as Bayer AG, Amega Biotech, Biogen, Merck KGaA, Novartis AG, Pfizer Inc., F. Hoffmann-La Roche Ltd., Biosidus, AOP Orphan Pharmaceuticals GmbH, Reliance Life Sciences, and several others, are currently operating in the interferons market. In September 2022, Eiger BioPharmaceuticals, a commercial-stage biopharmaceutical company focused on the development of innovative therapies for hepatitis delta virus (HDV) and other serious diseases, provided an update on the status of its planned request for emergency use authorization (EUA) of peginterferon lambda for the treatment of patients with mild-to-moderate COVID-19 based on its most recent communications with the U.S. Food and Drug Administration (FDA). To read more about the latest highlights related to the interferons market, get a snapshot of the key highlights entailed in the Global Interferons Market Report Interferons Overview Interferons (IFNs) are a group of signaling proteins that play a critical role in the immune response, particularly in defending against viral infections and modulating the activity of immune cells. They are classified into three main types: Type I (such as IFN-α and IFN-β), Type II (IFN-γ), and Type III (IFN-λ). Type I interferons are primarily produced in response to viral infections and function by activating antiviral pathways in host cells, inhibiting viral replication, and enhancing the activity of natural killer (NK) cells. IFN-γ, the sole Type II interferon, is crucial for activating macrophages and promoting adaptive immune responses, particularly in bacterial and tumor immunity. Type III interferons share functional similarities with Type I IFNs but act more selectively on epithelial cells, making them important in mucosal immunity. Beyond their antiviral properties, interferons have significant roles in cancer immunotherapy and autoimmune diseases. They enhance antigen presentation, stimulate cytotoxic T cells, and modulate the tumor microenvironment, contributing to immune surveillance against malignancies. Clinically, recombinant interferons have been used to treat conditions such as hepatitis B and C, multiple sclerosis, and certain cancers. However, prolonged interferon therapy can lead to adverse effects, including flu-like symptoms, fatigue, and autoimmune complications. Recent research is focused on optimizing interferon-based therapies and combining them with immune checkpoint inhibitors or other immunomodulators to improve efficacy while minimizing toxicity. Interferons Market Insights North America holds the largest interferons market share due to a strong presence of biopharmaceutical companies, robust R&D investments, and high healthcare expenditure. The U.S. market, in particular, benefits from a well-established regulatory framework and widespread adoption of advanced biotherapeutics. Meanwhile, Europe follows closely, with key contributions from Germany, France, and the UK, where government support for biotech innovation and access to novel biologics drive market expansion. In the Asia-Pacific region, the interferon market is witnessing rapid growth, fueled by rising healthcare infrastructure, an increasing prevalence of infectious diseases, and government initiatives to boost biopharmaceutical production. China and India are emerging as major players, with domestic companies investing heavily in biosimilar development and expanding manufacturing capacities. Latin America and the Middle East & Africa are also showing potential, albeit at a slower pace, due to improving healthcare access and growing awareness of biologic treatments. However, market expansion in these regions is challenged by high drug costs and regulatory hurdles, which may impact the adoption of interferon therapies. To know more about why North America is leading the market growth in the interferons market, get a snapshot of the Interferons Market Outlook Interferons Market Dynamics The interferons market is driven by their critical role in treating viral infections, autoimmune diseases, and various cancers. Interferons (IFNs) are a class of cytokines that modulate the immune response, making them valuable in antiviral therapies (such as hepatitis B and C), multiple sclerosis, and oncology applications. The increasing prevalence of these diseases, along with rising research into novel interferon-based therapies, continues to fuel market growth. However, the market faces challenges due to the emergence of alternative therapies, such as monoclonal antibodies and small-molecule inhibitors, which offer higher efficacy and fewer side effects. One of the key factors influencing market dynamics is the shift from traditional interferon therapies to newer, more targeted treatments. For instance, in the treatment of hepatitis C, direct-acting antiviral agents (DAAs) have largely replaced interferon-based regimens due to their superior cure rates and reduced adverse effects. Similarly, in multiple sclerosis, oral therapies and monoclonal antibodies such as ocrelizumab and natalizumab have overshadowed interferon-beta treatments. Despite this, interferons remain relevant in certain applications, such as rare cancers and specific immune disorders where alternative treatments are not as effective. Another factor shaping the interferons market is the regulatory landscape. Interferons are biologic drugs, meaning they are subject to stringent approval processes and high production costs. The development of biosimilar interferons has the potential to make these therapies more accessible, especially in emerging markets. However, biosimilars face challenges in gaining market traction due to concerns about immunogenicity and physician preference for established brands. Companies investing in next-generation interferons with improved efficacy and safety profiles may have an opportunity to capture a share of this evolving market. Looking ahead, the future of the interferons market will be shaped by ongoing innovation, competitive pressures, and the need for cost-effective biologics. While traditional interferon therapies may continue to decline in some areas, their role in niche indications and combination therapies could sustain market demand. Companies focusing on improving delivery methods, reducing side effects, and exploring novel interferon applications in immuno-oncology and rare diseases may unlock new growth opportunities in this evolving landscape. Get a sneak peek at the interferons market dynamics @ Interferons Market Dynamics Analysis Interferons Market Assessment Interferons Market Segmentation Interferons Market Segmentation By Type: Alpha, Beta, and Gamma Interferons Market Segmentation By Application: Hepatitis B, Hepatitis C, Leukemia, Multiple Sclerosis, and Others Interferons Market Segmentation By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, and Others Interferons Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the interferons market are set to emerge as the trendsetter explore @ Interferons Companies Table of Contents Interested in knowing the interferons market by 2032? Click to get a snapshot of the Interferons Market Trends Related Reports Multiple Sclerosis Market Multiple Sclerosis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple sclerosis companies, including Immune Response BioPharma, Inc., Clene Nanomedicine, Sanofi, Merck Healthcare KGaA, TG Therapeutics, Inc., Apimeds Inc., Bayer HealthCare, Novartis, Biogen, Alkermes, Genentech, among others. Multiple Sclerosis Pipeline Multiple Sclerosis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key multiple sclerosis companies, including Novartis, Sanofi, Immunic, Biocad, Apimeds, Genentech (Roche), Merck, AB Science, Apurano Pharmaceuticals, Biogen, Tiziana Life Sciences, Worg Pharmaceuticals, Antisense Therapeutics, RemeGen, Atara Biotherapeutics, Contineum Therapeutics, Stem Cell Medicine Ltd., Ever Supreme Bio Technology Co., Ltd., ImCyse, among others. Chronic Hepatitis B Market Chronic Hepatitis B Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key chronic hepatitis B companies, including GlaxoSmithKline, Ionis Pharma, Beijing Continent Pharmaceutical, Ascletis Pharmaceuticals, Vir Biotechnology, Brii Biosciences, Janssen, Arrowhead Pharmaceuticals, among others. Chronic Hepatitis B Pipeline Chronic Hepatitis B Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key chronic hepatitis B companies, including Vedanta Biosciences, Gilead Sciences, Dong-A ST Co, Assembly Biosciences, Arbutus Biopharma, Vir Biotechnology, Antios Therapeutics, Ascletis Pharmaceuticals, Shanghai HEP Pharmaceutical, Romark Laboratories, Qilu Pharmaceutical, Golden Biotechnology, Sunshine Lake Pharma, Ascentage Pharma, GlaxoSmithKline, Janssen Sciences, Henlix, Enyo Pharma, Tasly Tianjin Biopharmaceutical, Brii Biosciences, Vaxine Pty Ltd, Vaccitech limited, Zhejiang Palo Alto Pharmaceuticals, Suzhou Ribo Life Science, PharmaEssentia, Nucorion Pharmaceuticals, Jiangsu HengRui Medicine, Enanta Pharmaceuticals, Chong Kun Dang Pharmaceutical, Guangzhou Lupeng Pharmaceutical, VenatoRx Pharmaceuticals, Zhimeng Biopharm, among others. About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Immunotherapy

100 Deals associated with Arbutus Biopharma Corp.

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Pipeline Snapshot as of 18 May 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Imdusiran ( HBsAg )	Hepatitis B, Chronic More	Phase 2
AB-161 ( PAPD5 x PAPD7 )	Hepatitis B More	Phase 1
AB-101 (Arbutus Biopharma) ( PDL1 )	Hepatitis B, Chronic More	Phase 1
ARB-596 ( cccDNA )	Hepatitis B More	Preclinical
ARB-272572 ( PDL1 )	-	Preclinical

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