A Multi-center, Randomized, Open-label, Phase II Study to Evaluate the Efficacy and Safety of BW-20507 Injection Combined With Pegylated Interferon Alfa in Patients With Chronic Hepatitis B Infection

This is a randomized, open-label, multicenter phase II study to evaluate the efficacy and safety of BW-20507 in combination with PEG-IFNα in CHB patients

Start Date02 Sep 2025

Sponsor / Collaborator

Shanghai Argo Biopharma Co., Ltd.

NCT06092333

/ RecruitingPhase 2IIT

A Pilot Study of the Combination of VIR-2218 and Peginterferon Alfa-2a for Chronic Hepatitis B

Background:
Chronic hepatitis B virus (HBV) infection affects 292 million people worldwide; 887,000 die each year from cirrhosis, liver cancer, and related issues. Treatment options are limited.
Objective:
To test 2 drugs (VIR-2218 and peginterferon) in people with mild or inactive HBV infection.
Eligibility:
People aged 18 to 65 years with mild or inactive HBV infection.
Design:
Participants will be screened. They will have blood tests and an eye exam. They will have imaging scans of the liver to check the health of the liver.
Participants will be in the study for over 2 years.
VIR-2218 is an injection given under the skin of the stomach, upper arm, or thigh. Participants will come to the clinic to receive this injection once a month for 6 months.
Peginterferon is also injected under the skin. Participants will have this shot once a week for 6 months. They may either inject themselves at home or come to the clinic to get the injections.
Participants will get just the VIR-2218 for 3 months, then both shots for 3 months, then just the peginterferon for 3 months.
Participants will have two 3-day stays in the hospital. Tests will include:
Liver biopsy. A sample of tissue will be taken from their liver. After the procedure, participants will lie on their right side for 2 hours and then on their back for 4 hours.
Fine needle aspiration. A small needle will be used to collect cells from the liver.
After the last injection of peginterferon, follow-up visits will continue in the outpatient clinic every 4 to 12 weeks.

Start Date31 Jan 2025

Sponsor / Collaborator

National Institute of Diabetes & Digestive & Kidney Diseases

NCT06696664

/ RecruitingNot ApplicableIIT

Exploring the Genome-wide Association Study of the Advantageous Population for Clinical Cure of Chronic Hepatitis B With Long-acting Interferon Therapy

This study is a real-world case-control study conducted, with 120 CHB patients who received continuous treatment with PEG-IFN-α for more than 24 weeks as study subjects. Among them, the clinical cure group obtained through PEG-IFN-α treatment is the case group; The group that did not achieve clinical cure after PEG-IFN-α treatment was used as the control group, and the case group and control group were allocated cases in a 2:1 ratio. Collect blood samples from subjects as sequencing samples for candidate genes, use high-throughput sequencing technology to detect the whole genome of subjects, identify relevant genetic polymorphism that have predictive value for clinical cure of chronic hepatitis B treated with PEG-IFN-α, and establish a predictive model and calculation formula between gene polymorphism and the efficacy of PEG-IFN-α antiviral therapy.

Start Date01 Aug 2024

Sponsor / Collaborator-

100 Clinical Results associated with Peginterferon alfa-2a

100 Translational Medicine associated with Peginterferon alfa-2a

100 Patents (Medical) associated with Peginterferon alfa-2a

4,190

Literatures (Medical) associated with Peginterferon alfa-2a

31 Dec 2025·Emerging Microbes & Infections

High HBsAg clearance rate and viral dynamics in HBeAg-positive, ALT-normal children and adolescents with chronic HBV infection: results from the prospective sprout project

Article

Author: Tang, Qiyuan ; Wang, Xin ; Zhang, Zheng ; Lei, Jia ; Li, Ruiling ; Lai, Changxiang ; Li, Zhiyu ; Xie, Yuyin ; He, Qing ; Wang, Fang ; Zhang, Hongfei

Hepatitis B e antigen (HBeAg)-positive chronic hepatitis B virus (HBV) infection in children and adolescents with normal alanine aminotransferase (ALT) levels constitutes a substantial population in China, yet the optimal timing for antiviral therapy remains unclear. This prospective, real-world study, conducted as the primary centre of the Sprout Project, evaluated the hepatitis B surface antigen (HBsAg) loss rate and viral-immune dynamics of pegylated interferon α (PEG-IFN-α) treatment in 85 chronic HBV patients aged 3-18 years over a 24-month period. A total of 27 HBeAg-positive, ALT-normal patients were selected for analysis. Patients were treated with a combination of PEG-IFN-α and entecavir. After 24 months, the overall HBsAg loss rate was 48.15%, with 47.37% in the immune-tolerant phase and 50% in the grey zone phase. Among those who cleared HBsAg, 84.62% had ALT elevation prior to anti-HBsAg antibody (HBsAb) seroconversion, which occurred 28-400 days before HBsAg loss. While HBsAg and HBV DNA were cleared by 24 months in the HBsAg loss group, 23.08% of children remained HBeAg-positive. Notably, 61.54% developed detectable HBsAb prior to HBsAg loss. Children aged 3-7 years had significantly higher clearance rates than those aged 8-18 years. These findings support the effectiveness of PEG-IFN-α combined with nucleos(t)ide analogs in achieving high HBsAg loss rates in young, HBeAg-positive, ALT-normal chronic HBV children and adolescents, with immune activation potentially preceding ALT elevation, and offers valuable insights into the viral-immune dynamics during treatment, highlighting the potential of antiviral therapy in this population.

31 Dec 2025·ANNALS OF MEDICINE

The remodeling of B-cell subsets was correlated with the clearance of hepatitis B antigen during pegylated IFN α-2a therapy in CHB patients

Article

Author: Wu, Zeqian ; Tan, Lei ; Mo, Zhishuo ; Zhu, Jianyun ; Gao, Zhiliang ; Gan, Weiqiang

BACKGROUND:

B-cell may participate in the cellular immune process of hepatitis B antigen clearance. However, the function and specific mechanism of B-cell during interferon-pegylated interferon α-2a (Peg-IFN-α) treatment in chronic hepatitis B (CHB) patients have not yet been described.

METHODS:

A total of 150 CHB patients enrolled in this study, who received 48 weeks of Peg-IFN α treatment. The differentiation clusters CD19, CD24, CD27, CD38, CD40, and CD80 of B cell surface markers in CHB patients were detected by flow cytometry. Spearman correlation and Logistic regression analysis were performed for the analysis.

RESULTS:

The clearance rate of HBsAg increased significantly with the duration of Peg-IFN-α treatment, reaching 32.2% by 48 weeks. During the Peg-IFN-α therapy, the frequency of B-cell and its subsets increased significantly. However, we did not observe any significant difference in the frequency of the B-cell and its subsets in patients with or without HBsAg clearance after 48 weeks Peg-IFN-α treatment. The change in HBsAg value was negatively related to the change in plasmablasts (CD19⁺CD38⁺) level before and after 48 weeks treatment (r = -0.326, p = 0.006). Moreover, the results showed that HBsAg <288.70 IU/mL at baseline and HBsAg <58.05 IU/mL at 12 weeks were strong predictors of HBsAg clearance in patients with 48 weeks Peg-IFN-α treatment.

CONCLUSION:

The remodeling of B cell subsets, especially plasmablasts (CD19⁺CD38⁺), during Peg-IFN-α treatment was closed associated with the clearance of hepatitis B antigen.

01 Dec 2025·ANTIVIRAL RESEARCH

Pretreatment viral quasispecies characteristics and evolutionary phases correlate with HBsAg seroconversion in peginterferon-alfa-2a-treated children with HBeAg-positive chronic hepatitis B

Article

Author: Liu, Zhihua ; He, Haitang ; Fu, Qunfang ; Meng, Ran ; Zhao, Qian ; Wu, Xiaoting ; Luo, Kangxian ; Yang, Guifeng ; Yang, Juncheng ; Li, Zhuoyue ; Liu, Hai

BACKGROUND & AIMS:

To evaluate baseline HBV quasispecies (QS) characteristics as a predictor of HBsAg seroconversion in peginterferon-alfa-2a-treated HBeAg-positive pediatric chronic hepatitis B (CHB).

METHODS:

25 patients achieved HBsAg seroconversion (SS group) and another 25 did not (SN group) were enrolled, matched for baseline profiles. Full-length HBV genomes were obtained from pretreatment serum via clone sequencing. Twelve untreated carriers (CA group) served as controls.

RESULTS:

SN group demonstrated significantly higher genetic distance (GD) and mutation frequency index (MFI) in the preCore/Core (preC/C) gene versus SS and CA groups (p < 0.05). Treatment failure exclusively correlated with G1896A/C1913A/C2078G mutations. Jonckheere-Terpstra test confirmed a CA→SS→SN diversity gradient in preC/C (p < 0.05). Non-invasive fibrosis indices increased across CA→SS→SN (p < 0.05) and correlated positively with QS diversity. Evolutionary analyses revealed divergent haplotype clustering in SN versus star-like radiation patterns in CA/SS. Phylogenetic analysis positioned CA/SS haplotypes at earlier evolutionary phases, while SN haplotypes at a later phase. Notably, haplotypes harboring the three aforementioned mutations were also located at the later phase. Positive selection analysis identified two SN-specific mutations (codon 34[C1913A] and 89[C2078G]). A LASSO-derived predictive model (age, C1913A/C2078G, preC/C MFI) yielded the area under the receiver operating characteristic curve (AUROC) 0.814 (sensitivity 92 %, specificity 68 %).

CONCLUSIONS:

Lower baseline HBV quasispecies diversity predicts Peginterferon-alfa-2a-induced HBsAg seroconversion in pediatric CHB. The observed diversity continuum, association with fibrosis indices, suggests seroconversion occurs preferentially during earlier hepatitis phases. Pretreatment viral genetic profiling may optimize therapeutic timing, highlighting its prognostic value for childhood HBV management.

News (Medical) associated with Peginterferon alfa-2a

07 Oct 2025

·www.globenewswire.com

Arbutus Announces Four Abstracts Accepted for Presentation at AASLD - The Liver Meeting® 2025

Multiple abstracts accepted featuring imdusiran clinical data – highlighting progress toward a potential functional cure for chronic hepatitis B virus AB-101 clinical data abstract recognized as a Poster of Distinction WARMINSTER, Pa., Oct. 07, 2025 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company focused on infectious disease, today announced that three abstracts featuring imdusiran data and one abstract featuring AB-101 data, have been accepted for poster presentations at the American Association for the Study of Liver Diseases (“AASLD”) – The Liver Meeting 2025, taking place November 7–11 in Washington, DC. Notably, the AB-101 abstract has been selected as a Poster of Distinction. Regular Abstracts Accepted as Poster Presentations: Publication Number: 1160Presentation Title: Imdusiran (AB-729) is safe and well-tolerated after repeat dosing in chronic hepatitis B patients: An integrated safety analysis of Phase 1 and 2 imdusiran clinical trialsPresenter: Tilly Varughese, MD, Medical Director, Clinical Development, Arbutus BiopharmaDate and Time: November 7, 2025, 8:00 am - 5:00 pm ETKey Findings: Imdusiran therapy in patients with chronic hepatitis B virus (“cHBV”) was safe and well tolerated when administered at both 60 mg and 90 mg dose levels every 8 weeks for 4 – 6 doses (24 – 48 weeks) and through up to 48 weeks of follow up after imdusiran dosing. Publication Number: 1244Presentation Title: IM-PROVE I: Hepatitis B virus (“HBV”) genotype responsiveness to pegylated interferon alfa-2a may be enhanced with imdusiran combination treatmentPresenter: Emily Thi, Senior Director, Immunobiology and Biomarkers Research, Arbutus BiopharmaDate and Time: November 7, 2025, 8:00 am - 5:00 pm ETKey Findings: In this limited dataset, the majority of subjects who achieved HBsAg response during pegylated interferon alfa-2a (“IFN”) treatment with or following imdusiran dosing were genotype B or C. These findings contrast with historical data from IFN therapy and suggest that imdusiran may enhance IFN responsiveness in cHBV patients with specific HBV genotypes. Further studies in larger cohorts are warranted to confirm these observations. Publication Number: 1184Presentation Title: Elevated soluble immune biomarkers in subjects with HBsAg loss after treatment with imdusiran and immunotherapeutic agents in the IM-PROVE I and IM-PROVE II studies Presenter: Emily Thi, Senior Director, Immunobiology and Biomarkers Research, Arbutus BiopharmaDate and Time: November 7, 2025, 8:00 am - 5:00 pm ETKey Findings: Imdusiran treatment is associated with increases in soluble immune biomarkers in both IM-PROVE I and IM-PROVE II studies. In subjects who lost HBsAg and had anti-HBs antibodies, a greater breadth and magnitude of immune biomarker increases were observed in IM-PROVE I subjects compared to IM-PROVE II. In both studies, subjects who showed increases in soluble immune biomarkers on-treatment met nucleos(t)ide analogue (“NA”) therapy discontinuation criteria and had baseline HBsAg ≤1000 IU/mL. Poster of DistinctionPublication Number: 1123Presentation Title: Safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of AB-101, a small-molecule PD-L1 inhibitor, in chronic hepatitis B patientsPresenter: Tilly Varughese, MD, Medical Director, Clinical Development, Arbutus BiopharmaDate and Time: November 7, 2025, 8:00 am - 5:00 pm ET. The poster will remain available for the full duration of the conference.Key Findings: Oral doses of AB-101 up to 30 mg QD for 28 days were generally well tolerated in NA-suppressed cHBV patients. Preliminary interim pharmacodynamic data indicate dose-related increases in PD-L1 receptor occupancy, with 83% mean maximal receptor occupancy at the 30 mg dose. Cohort 3B is ongoing and all available data, including safety, PK, receptor occupancy and HBV biomarkers, will be presented. The regular accepted abstracts are available to the public on the AASLD website and will be published in the October supplement of HEPATOLOGY. The poster presentations will be available on the AASLD website beginning November 7, 2025 at 8:00 am ET and will also be found on Arbutus’ website in the Publications section at https://www.arbutusbio.com/publications/. About Imdusiran (AB-729) Imdusiran is an RNAi therapeutic specifically designed to reduce all hepatitis B viral proteins and antigens including HBsAg, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to control the virus. Imdusiran targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine (“GalNAc”) delivery technology enabling subcutaneous delivery. To date, Arbutus has reported a total of eight patients with cHBV who have achieved a functional cure following treatment with imdusiran and NA therapy in combination with either IFN or low dose nivolumab plus an immunotherapeutic. Clinical data generated thus far has shown imdusiran to be generally safe and well-tolerated, while also providing meaningful reductions in HBsAg and hepatitis B virus DNA. About AB-101 AB-101 is an oral PD-L1 inhibitor candidate that is designed to allow for controlled checkpoint blockade while minimizing the systemic safety issues typically seen with checkpoint antibody therapies. Immune checkpoints such as PD-1/PD-L1 play an important role in the induction and maintenance of immune tolerance and in T-cell activation, for example against HBV. In Arbutus’ ongoing Phase 1a/1b clinical trial, AB-101 has been generally safe and well-tolerated with evidence of high receptor occupancy. About HBV Hepatitis B is a potentially life-threatening liver infection caused by HBV. HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. cHBV infection represents a significant unmet medical need. The World Health Organization estimates that over 250 million people worldwide suffer from cHBV infection, while other estimates indicate that approximately 2 million people in the United States suffer from cHBV infection. Approximately 1.1 million people die every year from complications related to cHBV infection despite the availability of effective vaccines and current treatment options. About Arbutus Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company focused on infectious disease. The Company is currently developing imdusiran (AB-729) and an oral PD-L1 inhibitor (AB-101) for the treatment of cHBV infection. The Company is also consulting closely with and supporting its exclusive licensee, Genevant Sciences, to protect and defend its intellectual property, which is the subject of on-going lawsuits against Moderna and Pfizer/BioNTech for use of Arbutus’s patented LNP technology in their COVID-19 vaccines. 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; the potential for Arbutus’ product candidates to achieve success in clinical trials; and Arbutus’ pipeline and development plans for its cHBV programs. 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 clinical trials, and the usefulness of the data; 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: ongoing and anticipated 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’ product candidates; economic and market conditions may worsen; and 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: Arbutus Biopharma Corporation / ir@arbutusbio.com

Clinical ResultVaccineClinical StudyImmunotherapy

19 Sep 2025

·www.prnewswire.com

AusperBio Completes Enrollment in Two Phase II Clinical Trials of AHB-137 for Chronic Hepatitis B

SAN FRANCISCO, Sept. 18, 2025 /PRNewswire/ -- AusperBio Therapeutics, Inc. and Ausper Biopharma Co., Ltd. (collectively AusperBio), a clinical-stage biotechnology company advancing targeted oligonucleotide therapies for chronic hepatitis B (CHB) functional cure, today announced the completion of patient enrollment in two Phase II clinical trials evaluating its lead candidate, AHB-137, in patients with chronic hepatitis B ( CHB), marking an important milestone in the clinical development program. The Phase II study AB-10-8007 (NCT07069569) is a randomized, open-label, multicenter study to evaluate the efficacy and safety of AHB-137 Injection in combination with either a hepatitis B vaccine or pegylated interferon α-2b (Peg-IFN) in participants with HBeAg-negative CHB receiving nucleos(t)ide analogue (NA) therapy. The Phase II study AB-10-8008 (NCT06829329) is a randomized, multicenter study to evaluate the efficacy and safety of AHB-137 Injection in treatment-naïve participants with CHB. "Combination therapies have historically been a key to treat or cure chronic viral infections, including HIV and HCV." said Dr. Guofeng Cheng, Co-founder and CEO of AusperBio. "The AB-10-8007 study aims to combine AHB-137 with approved HBV treatments to further increase functional cure rates, while the AB-10-8008 study explores the potential to expand AHB-137 treatment to a broader patient population. Together, these studies could further establish AHB-137 as the potential backbone therapy for HBV functional cure. We look forward to sharing interim results at international conferences throughout 2026." "We are deeply grateful to the patients, investigators, site teams, and our AusperBio colleagues for their dedication and contributions to reaching this important milestone," said Dr. Chris Yang, Co-founder and CSO of AusperBio. "The completion of enrollment in these Phase II trials positions us well as we move into the pivotal Phase III study of AHB-137, which was recently approved in China. We are excited and committed to advancing new treatment options with the goal of bringing a functional cure to a broader population of patients living with HBV." About AHB-137 AHB-137, a novel unconjugated antisense oligonucleotide ( ASO) designed using AusperBio's proprietary Med-Oligo™ ASO technology platform and an investigational medicine, is being developed to achieve a functional cure for chronic hepatitis B. Its clinical development has generated promising data, with key preclinical and clinical results presented at global leading conferences including EASL (2023, 2024, 2025), AASLD (2024), and APASL (2025). This novel dual-mechanism ASO has completed its global Phase 1 trial and is currently advancing through multiple Phase 2 trials and a phase 3 trial in China. Supported by a clear global development strategy, AHB-137 is progressing rapidly toward delivering a potential cure for HBV. About AusperBio. AusperBio is a clinical-stage biopharmaceutical company with operations in the USA and China, dedicated to advancing oligonucleotide and targeted delivery technologies for transformative therapies, with an initial focus on achieving functional cure for chronic hepatitis B infection. The company has developed a proprietary Med-Oligo™ ASO platform which has been shown to substantially enhance the current ASO therapeutics, through novel insights into ASO design. Combining with efficient targeted delivery conjugation technologies, the modular Med-Oligo™ Platform empowers ASO therapeutics to treat a broad range of diseases, including viral infections, metabolic conditions, genetic disorders, and immune diseases. For further information, please contact: Media Contact Email: [email protected] Investor Relations Contact: Tel: 650-888-1756 (US) Email: [email protected] SOURCE AusperBio Therapeutics Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2OligonucleotidePhase 3Phase 1Vaccine

28 Jul 2025

·www.einpresswire.com

Virion Therapeutics Provides Update on its VRON-0200 Clinical Development Program for HBV Functional Cure on World Hepatitis Day 2025

This “Spark and Fan” treatment strategy could potentially offer a simple and well tolerated solution for a wide range of future HBV functional cure regimens for patients worldwide.” — Dr. Sue Currie, COO, Virion PHILADELPHIA, PA, UNITED STATES, July 28, 2025 / EINPresswire.com / -- Virion Therapeutics, LLC, a clinical-stage biotechnology company, developing novel T cell-based immunotherapies that utilize first-in-class checkpoint modifiers, today, on World Hepatitis Day, provided a corporate update highlighting continued progress across its functional cure program for chronic hepatitis B virus (CHB). KEY PROGRAM HIGHLIGHTS o VRON-0200’s Phase 1b program is fully enrolled, with 34 CHB patients now treated with VRON-0200, including a combination cohort with investigational antivirals; longer term clinical data from the full cohort is expected in Q4 2025 o VRON-0200 clinical data, presented earlier this year at APASL and EASL demonstrated: - VRON-0200 was safe and well tolerated, with no serious treatment-related adverse events (SAEs), treatment discontinuations, or treatment-related clinical laboratory abnormalities reported - HBsAg declines were observed in patients treated with an intramuscular (IM) injection of VRON-0200 even though VRON-0200 does NOT directly target S-antigen, suggesting a possible broadening, and restoration of anti-HBV immune responses - After a single VRON-0200 prime dose, rapid and profound HBsAg declines were observed in all evaluable patients 7 days after the first combination dose. These types of responses have not been previously reported, even with PEG-IFN containing regimens - These data suggest VRON-0200 could be the key backbone agent in future HBV functional cure regimens o The Phase 1b study is ongoing – these data, from all Cohorts, as well as the long-term followup and exploratory analyses, will further inform future treatment strategies to maximize functional cure rates and potentially expand patient populations o A global Phase 2b study (“SPARK-B”) for HBV Functional Cure is in development; in parallel, additional manufacturing activities to support late-stage development are ongoing o Virion is in partnership discussions to further accelerate development and maximize access to a potential functional cure for persons living with CHB worldwide “Despite a preventative HBV vaccine, CHB remains a widespread global problem affecting 254 million persons and contributing to 1.1 million deaths/year from liver related complications. On this World Hepatitis Day, Virion, along with its partners, are committed to finding a cure for CHB,” said Dr. Andrew D. Luber, CEO of Virion. Luber added, “It is exciting to see the VRON-0200 Phase 1b data support our “Spark and Fan” treatment model, with VRON-0200 “sparking” a new HBV-specific immune response, and then the “fanning” of this response with the addition of antivirals, which remove the virus and it’s immunosuppressive effects.” Dr. Sue Currie, Virion’s COO commented, “This “Spark and Fan” treatment strategy could potentially offer a simple and well tolerated solution for a wide range of future HBV functional cure regimens for patients worldwide. We are excited to continue our current VRON-0200 clinical development program, including the planning of our future SPARK-B Phase 2b clinical trial. On this World Hepatitis Day, we are aware of the burden of CHB, and the urgent unmet medical need to achieve a functional cure that is safe, convenient, effective, and accessible for persons worldwide. What makes VRON-0200 so promising, besides being the first new immune modulator to restore broad anti-HBV immunity since pegylated-interferon, is its ease of dosing (a single i.m. injection), and favorable safety and tolerability profile, all critical factors to future functional cure treatments for persons with CHB.” ABOUT CHRONIC HEPATITIS B Despite a preventative vaccine, cases of chronic hepatitis B (HBV) continue to rise, with an estimated 254 million persons infected worldwide and 1.1 million deaths per year from HBV-related liver complications. Chronic HBV remains a global health issue with a high unmet medical need since there is no cure available. The current standard of care requires lifelong antiviral therapy to maintain control of the virus. To learn more about hepatitis and World Hepatitis Day, visit: www.worldhepatitis.org ABOUT VRON-0200 VRON-0200 is a therapeutic immunotherapy, administered by intramuscular injection, designed with the goal of providing a functional cure for chronic HBV infection. While the virus itself stimulates HBV-specific CD8+ T cells, for those patients that can’t clear the initial infection, their T cells soon become exhausted, placing limits on their ability to proliferate and control the virus. An ongoing Phase 1b trial has shown VRON-0200 to be safe, well tolerated, immunogenic, and has anti-HBV activity in chronically HBV-infected patients on nucleos(t)ide therapy. More details of the study can be found at ClinicalTrials.gov (Identifier: NCT06070051). ABOUT VIRION THERAPEUTICS (VIRION) Virion Therapeutics, LLC is a clinical-stage company developing novel T cell-based immunotherapies to cure cancer and chronic infectious diseases that utilize proprietary genetically encoded checkpoint modifiers to enhance and broaden CD8+ T cell responses to a tumor or chronic infection. Virion has since developed a robust pipeline, including its lead VRON-0200 clinical program, and several additional IND-enabling programs, such as its VRON-0300 oncology program for advanced solid tumors, leveraging its proprietary platform technologies. To learn more, visit www.VirionTx.com Sue Currie, PhD Virion Therapeutics, LLC scurrie@viriontx.com Visit us on social media: LinkedIn Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Phase 2ImmunotherapyPhase 1Clinical Result

100 Deals associated with Peginterferon alfa-2a

External Link

KEGG	Wiki	ATC	Drug Bank
D02747	Peginterferon alfa-2a	L03AB11	DB00008

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hepatitis B	Japan	Chugai Pharmaceutical Co., Ltd.	16 Oct 2003
Hepatitis C	Japan	Chugai Pharmaceutical Co., Ltd.	16 Oct 2003
Hepatitis B, Chronic	European Union	Pharma& Schweiz GmbH	20 Jun 2002
Hepatitis B, Chronic	Iceland	Pharma& Schweiz GmbH	20 Jun 2002
Hepatitis B, Chronic	Liechtenstein	Pharma& Schweiz GmbH	20 Jun 2002
Hepatitis B, Chronic	Norway	Pharma& Schweiz GmbH	20 Jun 2002
Hepatitis C, Chronic	European Union	Pharma& Schweiz GmbH	20 Jun 2002
Hepatitis C, Chronic	Iceland	Pharma& Schweiz GmbH	20 Jun 2002
Hepatitis C, Chronic	Liechtenstein	Pharma& Schweiz GmbH	20 Jun 2002
Hepatitis C, Chronic	Norway	Pharma& Schweiz GmbH	20 Jun 2002

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Polycythemia Vera	NDA/BLA	European Union	Pharma& Schweiz GmbH	27 Jun 2024
Thrombocythemia, Essential	NDA/BLA	European Union	Pharma& Schweiz GmbH	27 Jun 2024
Chronic hepatitis C genotype 1	Phase 3	Hungary	Hoffmann-La Roche, Inc.	01 Jun 2006
Compensated cirrhosis	Phase 3	Japan	Chugai Pharmaceutical Co., Ltd.	01 Jun 2006
Pseudohyperkalemia Cardiff	Phase 3	Japan	Chugai Pharmaceutical Co., Ltd.	01 Jun 2006
Hepatitis D, Chronic	Phase 3	Romania	Hoffmann-La Roche, Inc.	01 Oct 2005
Complete atrioventricular block	Phase 3	Italy	Hoffmann-La Roche, Inc.	01 Jul 2005
Coinfection	Phase 3	Belgium	Hoffmann-La Roche, Inc.	01 Mar 2005
Kidney Failure, Chronic	Phase 3	Austria	Hoffmann-La Roche, Inc.	01 Jun 2004
Kidney Failure, Chronic	Phase 3	Brazil	Hoffmann-La Roche, Inc.	01 Jun 2004

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01718301 (BOC-HIV, CTgov)	Phase 3	Chronic hepatitis C genotype 1 \| Coinfection \| HIV Infections ... View more	108	Peginterferon alfa-2a+boceprevir+Peginterferon alfa-2b+Ribavirin	deqzottytx = wdrjijncyw ojgxxdnbry (pnsjgeywof, ixtswqjyxs - jbaamtoubn) View more	-	24 Aug 2025
ASH2024	Not Applicable	-	-	Peginterferon alpha-2a 180 mcg	wbkqcatzcn(luxtxzwvbt) = grade 1-2 fatigue and cytopenias in 71.4%, G4 neutropenia in 14.3%, G4 febrile neutropenia with sepsis in 14.3% hkbclpzpaj (pzcyflsbvh ) View more	-	08 Dec 2024
				Bictegravir/Emtricitabine/Tenofovir alafenamide (Biktarvy)
1807 (ASH2024)	Phase 2	Polycythemia Vera \| Thrombocythemia, Essential JAK2+ \| CALR \| MPL ... View more	-	PEG-IFN in Essential Thrombocytopenia	pdzydjdxzy(vxzjfgqqzc) = jyfrnyefln kuvgoxvzvi (icvwlovrku )	Positive	07 Dec 2024
Tandem Meetings ASTCT and CIBMTR2024 Manual	Not Applicable	Hematopoietic stem cell transplantation	12	Peginterferon-alpha (pegIFNα) 180 mcg	kdfpfxkkvg(vezvduojxq) = qrheqnkwku cdwiqptybb (lqmbgmfhuc, 58.7 - 100) View more	Positive	01 Feb 2024
NCT00932971 (HIDIT-II, Pubmed \| Liver Int)	Phase 2	Hepatitis D	-	PEG-IFNa + TDF	ltblnknwmj(vmlnvlpcsl) = ikjspeuwlo sgptfcjeiw (aikbfstghl ) View more	Positive	01 Jan 2024
				PEG-IFNa + placebo	owxebykotx(ekahbuiffl) = wjdheqjmnk catjtceavl (tsuljbfumt ) View more
NCT01369212 (Pubmed \| Am J Gastroenterol)	Not Applicable	Hepatitis B, Chronic	201	Tenofovir disoproxil fumarate (TDF) + Peginterferon (PegIFN) alfa-2a	ateulcnqtp(vsobhaefoy) = fmiyrozgbc jikvsypzdl (nusvfyifbg )	-	05 Jan 2023
				Tenofovir disoproxil fumarate (TDF) alone	ateulcnqtp(vsobhaefoy) = bvhzbkjjlp jikvsypzdl (nusvfyifbg )
NCT01369212 (HBRN \| Hepatitis B Research Network Immune-Active Trial, CTgov)	Phase 3	Hepatitis B, Chronic	201	Tenofovir (Tenofovir)	lbbtkslbrh = hngjhdmfhe wbkenmugpz (goadabdpxr, ankxzdagkb - bzcvcnmykt) View more	-	12 Oct 2022
				tenofovir+Pegasys (Peginterferon-alfa 2a and Tenofovir)	lbbtkslbrh = lzhwonvbuu wbkenmugpz (goadabdpxr, btypxonqst - nnhzwvcxgl) View more
NCT01769833 (Pubmed \| PLoS One)	Phase 3	Hepatitis B, Chronic Maintenance	149	PegIFN alfa-2a	qknbzvnemj(upnzcdhxjn) = xzbosoffyy qhivinlzed (zgcxhpxfse ) View more	-	01 Jan 2022
				Nucleos(t)ide analogue	qknbzvnemj(upnzcdhxjn) = dqqxskihrw qhivinlzed (zgcxhpxfse ) View more
NCT02328755 (CTgov)	Phase 1/2	Acute Myeloid Leukemia	37	Hematopoietic Cell Transplant (HCT)+peg-IFN-α+Tacrolimus+Methotrexate	ltglawucxm = jsgdlvfsbr mpqpeifpds (nmwzjxtxxq, joohwepmkc - ilrwdkjmwr) View more	-	06 Oct 2021
NCT02328755 (Pubmed \| Blood Adv)	Phase 1/2	Relapsing acute myeloid leukemia	37	pegIFNα	mwarucwljp(cgzdssvmsq) = prvnjycihl xsoeixszti (ydqdqlzvss ) View more	-	04 Oct 2021

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