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-

NCT06144697

/ TerminatedPhase 1

A Phase 1, Randomized, Double-blind, Placebo-controlled, First-in-human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Prodrug BMS-986465 and Its Active Derivative, BMS-986464, in Healthy Participants Including Healthy Participants of Japanese Ethnicity and an Open-label Assessment of Food, Formulation, and pH Effects on the Relative Bioavailability of BMS-986465 and BMS-986464

The purpose of this study is to evaluate safety, tolerability, drug and food effects on relative bioavailability of BMS-986465 and its active derivative BMS-986464 in healthy participants and healthy participants of Japanese ethnicity.

Start Date29 Jan 2024

Sponsor / Collaborator

Bristol Myers Squibb Co.

100 Clinical Results associated with Peginterferon alfa-2a

100 Translational Medicine associated with Peginterferon alfa-2a

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

4,049

Literatures (Medical) associated with Peginterferon alfa-2a

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 Sep 2025·INTERNATIONAL JOURNAL OF MEDICAL INFORMATICS

Interpretable machine learning model for prediction functional cure in chronic hepatitis B patients receiving Peg-IFN therapy: A multi-center study

Article

Author: Wang, Qinying ; Zheng, Peiyu ; Guo, Ying ; He, Peifeng ; Wang, Yan

BACKGROUND:

Functional cure is the ideal treatment goal for chronic hepatitis B (CHB) treatment. We developed and validated machine learning (ML) models to predict functional cure in CHB patients.

METHODS:

This study retrospectively recruited 534 CHB patients who received Peg-IFN treatment to construct model and 269 patients for external validation. We analyzed three strategies: baseline, week 12, week 24. Seven ML models were constructed using selected variables by Boruta and least absolute shrinkage and selection operator regression algorithm, and performance metrics, including area under the curve (AUC), sensitivity, specificity, and F1 score were applied to determine the best model. We utilized SHapley Additive exPlanation to visualize and interpret the best model and built a website to conveniently predict functional cure of CHB.

RESULTS:

A total of 272 participants were cured in our study. Compared to baseline and week 12 strategies, week 24 using Support Vector Machine (SVM) model can better predict functional cure of CHB, with reliable predictive performance (AUC = 0.981), calibration and clinical applicability in external validation cohort. Age, ALT ratio at week 12, HBsAg at week 24 and HBsAg ratio at week 24 were important features. In order to enhance clinical convenience and effectiveness of the constructed model, a web-based dynamic nomogram was created (Dynamic Nomogram (shinyapps.io)).

CONCLUSION:

This study developed SVM model to predict functional cure in CHB patients treated with Peg-IFN. Furthermore, we also built a website that clinicians can individualized predict the efficacy of Peg-IFN therapy in CHB patients.

06 May 2025·Microbiology Spectrum

Comparative efficacy and safety of pegylated interferon-alpha monotherapy vs combination therapies with entecavir or tenofovir in chronic hepatitis B patients

Article

Author: Zhang, Manying ; Yang, Jiaen ; Mao, Qianguo ; Zheng, Xiaoting ; Zhuang, Hongli ; Ruan, Qingfa ; Chen, Siyan ; Liu, Yaoyu ; Lin, Li ; Wu, Chuncheng ; Chen, Shaodong ; Liang, Huiqing ; Zhang, Luyun

ABSTRACT:

Current treatments for chronic hepatitis B (CHB) virus involve nucleos(t)ide analogs and pegylated interferon-alpha (PEG-IFNα). This study compares the efficacy and safety of PEG-IFNα monotherapy with its combinations with entecavir (ETV) and tenofovir disoproxil fumarate (TDF) in managing CHB. We included 147 treatment-naïve patients divided into three groups: Group A (PEG-IFNα-2b with ETV), Group B (PEG-IFNα-2b with TDF), and Group C (PEG-IFNα-2b monotherapy). Evaluations occurred every 12 weeks up to 48 weeks. The Kaplan-Meier method showed no significant differences in cumulative HBsAg loss, but HBV DNA clearance rates were higher in the TDF group than in the ETV group ( P = 0.01). Higher incidences of elevated alanine aminotransferase (ALT), aspartate aminotransferase, and thrombocytopenia were observed in the TDF group compared to other groups. After propensity score matching, the TDF group had a higher undetectable HBV DNA rate than the IFN group, but no significant differences in HBsAg clearance rates. Both TDF and ETV groups achieved more significant HBsAg reductions from baseline to week 48 than the IFN group ( P < 0.05). ETV showed a lower HBeAg clearance rate (30.00% vs 87.50%, P < 0.05) but higher ALT normalization (76.92% vs 45.45%, P < 0.05). In the TDF group, patients with lower baseline HBsAg levels, high ALT levels, and lower aspartate aminotransferase-to-platelet ratio index (APRI) scores were more likely to achieve HBsAg loss. These findings suggest that TDF and ETV are effective for viral suppression, with TDF showing superior HBV DNA clearance but more adverse events.

IMPORTANCE:

This study investigates how different treatments for chronic hepatitis B (CHB), a widespread liver infection, compare in effectiveness and safety. By evaluating the use of pegylated interferon-alpha alone and in combination with two other drugs, entecavir and tenofovir disoproxil fumarate (TDF), researchers found that TDF offers better viral suppression but also comes with more side effects. For patients receiving TDF combined with PEG-IFN therapy, low HBsAg levels, elevated alanine aminotransferase levels, and lower APRI scores were associated with a higher likelihood of achieving HBsAg loss. Consistent with previous findings, this study confirms the benefits of nucleos(t)ide analog plus PEG-IFN therapy for CHB treatment and further explores which patients are more likely to benefit from combination therapy. Furthermore, this study underscores the importance of further monitoring adverse events in patients receiving combination therapy.

News (Medical) associated with Peginterferon alfa-2a

31 Mar 2025

·pipelinereview.com

Brii Bio Unveils New Data from Its Ongoing Phase 2 ENSURE Study at APASL 2025, Showcasing BRII-179's Unique Potential to Prime and Boost Higher HBsAg Loss Through Target Patient Identification

DURHAM, NC, USA and BEIJING, China I March 30, 2025 I Brii Biosciences Limited (“Brii Bio,” or the “Company”, stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet medical needs, announced new data from its ongoing Phase 2 ENSURE study as a late-breaking oral presentation at the 34 th Annual Meeting of Asian Pacific Association for the Study of the Liver (APASL 2025) in Beijing, China. ENSURE (NCT05970289) is a multicenter, open-label Phase 2 study. Cohorts 1-3 were designed to evaluate the contribution of elebsiran, an investigational small interfering ribonucleic acid (siRNA), in combination with pegylated interferon alpha (PEG-IFNα) in participants with chronic HBV infection with baseline hepatitis B surface antigen (HBsAg) of 100-3,000 IU/mL. Participants who completed 9 doses of BRII-179, a recombinant protein-based therapeutic vaccine, in combination with elebsiran (BRII-835) in a previous APAC study BRII-179-835-001 (NCT04749368) were enrolled to Cohort 4 of this study and received elebsiran and PEG-IFNα combination treatment. The design of Cohort 4 as part of this study was based on insight from previous studies that a significant proportion of the chronic HBV patients fail to generate a sufficient immune response after receiving multiple doses of BRII-179, and therefore unlikely to have the immune support to achieve sustainable functional cure. Emerging data from Cohort 4 showed that participants who previously had BRII-179 induced anti-HBs response achieved a substantially higher rate of HBsAg seroclearance than those who did not. At Week 24, more than half of the BRII-179 responders (55.6% [10/18]) achieved HBsAg seroclearance, compared to only 10.0% (1/10) in non-responders. These latest data suggest that BRII-179 can serve as a predictive tool for enriching patients more likely to respond to curative therapies. Additional data from Cohorts 1-3 of the ENSURE study showed that higher end of treatment (EOT) HBsAg loss and seroconversion rates in participants receiving elebsiran in combination with PEG-IFNα than those receiving PEG-IFNα alone. “The positive Cohort 4 data from the ENSURE study opens new doors for HBV functional cure,” said Dr. Grace Lai-Hung Wong, Professor of Gastroenterology and Hepatology at CUHK Medical Data Analytics Centre (MDAC) and Department of Medicine and Therapeutics in Hong Kong SAR, China. “Previous studies have suggested that BRII-179 may offer a unique opportunity to identify CHB patients who are able to elicit the necessary HBsAg antibody response. I believe these new findings provide clear evidence supporting such value proposition and further substantiate the role of BRII-179 in shaping future combination therapies.” “We are encouraged that the Cohort 4 from the ENSURE study continue to support our enrichment strategy in developing a functional cure for chronic HBV in target populations,” said David Margolis, MD, Chief Medical Officer of Brii Bio. “The results underscore the potential of BRII-179 in identifying patients who are more likely to respond to regimens aimed at functional cure, thereby enhancing functional cure rates in the target population while reducing exposure to costly therapies for those with a lower probability of cure. We are committed to advancing BRII-179 in combination with various modalities through our ongoing studies and collaborations with strategic partners, aiming to deliver higher functional cure rates to 254 million patients worldwide living with chronic HBV infection.” Abstract Number: OP0335 Presentation Title: Responders to Prior BRII-179 Treatment Achieved Faster and Higher Rate of HBsAg Seroclearance Following Treatment of Elebsiran and PEG-IFNα in Participants with Chronic Hepatitis B Virus Infection: Preliminary Data from ENSURE Study Presenter: Grace Lai-Hung Wong, MBChB (CUHK), MD (CUHK), FRCP (Lond, Edin), FHKCP, FHKAM (Medicine), Professor of Gastroenterology and Hepatology at CUHK Medical Data Analytics Centre (MDAC) and Department of Medicine and Therapeutics in Hong Kong SAR, China Abstract Number: LB0009 Presentation Title: Higher end of treatment (EOT) HBsAg loss and seroconversion rates in participants with chronic HBV infection receiving elebsiran (BRII-835) and pegylated interferon alfa-2a (PEG-IFNα) compared to PEG-IFNα alone: Week 48 results from ongoing ENSURE study Presenter: Jidong Jia, M.D., Ph.D., Professor of Medicine at the Liver Research Centre, Beijing Friendship Hospital, Capital Medical University in Beijing, China As part of Brii Bio’s unique approach to developing a functional cure for HBV, the Company and its partners are actively progressing multiple combination studies with our differentiated portfolio, including BRII-179, a recombinant protein-based HBV immunotherapeutic being evaluated in multiple combination studies with elebsiran led by Brii Bio; elebsiran being evaluated in combination with PEG-IFNα in studies led by Brii Bio and tobevibart, an investigational broadly neutralizing monoclonal antibody targeting HBV, being evaluated in multiple Phase 2 and 3 tobevibart and elebsiran combination studies led by Vir Biotechnology. Key data readouts will be shared in the coming months at the scientific conferences throughout 2025. About Hepatitis B Hepatitis B virus (HBV) infection is one of the world’s most significant infectious disease threats with more than 254 million people infected globally. [1] Chronic HBV infection is the leading cause of liver disease and an estimated 820,000 people die of complications from chronic HBV infection each year. [1] HBV is of exceptional concern in China, where 87 million people are chronically infected. [2] About BRII-179 BRII-179 is a novel recombinant protein-based HBV immunotherapeutic candidate that expresses the Pre-S1, Pre-S2, and S HBV surface antigens, and is designed to induce enhanced and broad B-cell and T-cell immunity. In November 2023, the Center for Drug Evaluation (the “CDE”) of the National Medical Products Administration (the “NMPA”) granted BRII-179 Breakthrough Therapy Designation. About Elebsiran (BRII-835, VIR-2218) Elebsiran is an investigational subcutaneously administered HBV-targeting siRNA designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. It has the potential to have direct antiviral activity against HBV and HDV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. Brii Bio licensed exclusive rights to develop and commercialize elebsiran for the Greater China territory from Vir Biotechnology, Inc. in 2020. About Brii Bio Brii Biosciences Limited (“Brii Bio”, stock code: 2137.HK) is a biotechnology company developing therapies to address major public health challenges where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs against hepatitis B virus (HBV) infection. The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, the San Francisco Bay Area, Beijing and Shanghai. For more information, visit www.briibio.com . SOURCE: Brii Biosciences

Phase 2Clinical ResultBreakthrough TherapyLicense out/inVaccine

30 Mar 2025

·www.prnewswire.com

Brii Bio Unveils New Data from Its Ongoing Phase 2 ENSURE Study at APASL 2025, Showcasing BRII-179's Unique Potential to Prime and Boost Higher HBsAg Loss Through Target Patient Identification

Preliminary data from Cohort 4 of the ENSURE study supports a novel enrichment strategy to utilize BRII-179 to identify patients who are immune responders and have the potential to achieve higher HBsAg loss at EOT 48-week EOT data from Cohort 1-3 of the ENSURE study clearly suggests the added benefits of elebsiran towards achieving a higher rate of HBsAg loss in combination with PEG-IFNα DURHAM, N.C. and BEIJING, China, March 30, 2025 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio," or the "Company", stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet medical needs, announced new data from its ongoing Phase 2 ENSURE study as a late-breaking oral presentation at the 34th Annual Meeting of Asian Pacific Association for the Study of the Liver (APASL 2025) in Beijing, China. ENSURE (NCT05970289) is a multicenter, open-label Phase 2 study. Cohorts 1-3 were designed to evaluate the contribution of elebsiran, an investigational small interfering ribonucleic acid (siRNA), in combination with pegylated interferon alpha (PEG-IFNα) in participants with chronic HBV infection with baseline hepatitis B surface antigen (HBsAg) of 100-3,000 IU/mL. Participants who completed 9 doses of BRII-179, a recombinant protein-based therapeutic vaccine, in combination with elebsiran (BRII-835) in a previous APAC study BRII-179-835-001 (NCT04749368) were enrolled to Cohort 4 of this study and received elebsiran and PEG-IFNα combination treatment. The design of Cohort 4 as part of this study was based on insight from previous studies that a significant proportion of the chronic HBV patients fail to generate a sufficient immune response after receiving multiple doses of BRII-179, and therefore unlikely to have the immune support to achieve sustainable functional cure. Emerging data from Cohort 4 showed that participants who previously had BRII-179 induced anti-HBs response achieved a substantially higher rate of HBsAg seroclearance than those who did not. At Week 24, more than half of the BRII-179 responders (55.6% [10/18]) achieved HBsAg seroclearance, compared to only 10.0% (1/10) in non-responders. These latest data suggest that BRII-179 can serve as a predictive tool for enriching patients more likely to respond to curative therapies. Additional data from Cohorts 1-3 of the ENSURE study showed that higher end of treatment (EOT) HBsAg loss and seroconversion rates in participants receiving elebsiran in combination with PEG-IFNα than those receiving PEG-IFNα alone. "The positive Cohort 4 data from the ENSURE study opens new doors for HBV functional cure," said Dr. Grace Lai-Hung Wong, Professor of Gastroenterology and Hepatology at CUHK Medical Data Analytics Centre (MDAC) and Department of Medicine and Therapeutics in Hong Kong SAR, China. "Previous studies have suggested that BRII-179 may offer a unique opportunity to identify CHB patients who are able to elicit the necessary HBsAg antibody response. I believe these new findings provide clear evidence supporting such value proposition and further substantiate the role of BRII-179 in shaping future combination therapies." "We are encouraged that the Cohort 4 from the ENSURE study continue to support our enrichment strategy in developing a functional cure for chronic HBV in target populations," said David Margolis, MD, Chief Medical Officer of Brii Bio. "The results underscore the potential of BRII-179 in identifying patients who are more likely to respond to regimens aimed at functional cure, thereby enhancing functional cure rates in the target population while reducing exposure to costly therapies for those with a lower probability of cure. We are committed to advancing BRII-179 in combination with various modalities through our ongoing studies and collaborations with strategic partners, aiming to deliver higher functional cure rates to 254 million patients worldwide living with chronic HBV infection." Abstract Number: OP0335 Presentation Title: Responders to Prior BRII-179 Treatment Achieved Faster and Higher Rate of HBsAg Seroclearance Following Treatment of Elebsiran and PEG-IFNα in Participants with Chronic Hepatitis B Virus Infection: Preliminary Data from ENSURE Study Presenter: Grace Lai-Hung Wong, MBChB (CUHK), MD (CUHK), FRCP (Lond, Edin), FHKCP, FHKAM (Medicine), Professor of Gastroenterology and Hepatology at CUHK Medical Data Analytics Centre (MDAC) and Department of Medicine and Therapeutics in Hong Kong SAR, China Among the 28 of the 31 participants enrolled in Cohort 4 with baseline HBsAg ≥ 100 IU/mL being analyzed, 18 participants with peak anti-HBs ≥ 10 IU/L induced by prior BRII-179 treatment were defined as BRII-179 responders and 10 participants with peak anti-HBs < 10 IU/L were defined as non-responders. At Week 24 of treatment with elebsiran + PEG-IFNα, 39.3% (11/28) of the Cohort 4 participants achieved HBsAg seroclearance. The rate of HBsAg seroclearance at Week 24 in the BRII-179 responders was 55.6% (10/18), notably higher compared to the non-responders at 10% (1/10). Responders to prior BRII-179 treatment appeared to achieve a faster HBsAg seroclearance compared to BRII-179 naïve participants receiving elebsiran + PEG-IFNα as previously reported. Elebsiran and PEG-IFNα combination therapy was generally safe and well tolerated in participants with virally suppressed chronic HBV infection. Treatment with elebsiran + PEG-IFNα is ongoing for 48 weeks. Abstract Number: LB0009 Presentation Title: Higher end of treatment (EOT) HBsAg loss and seroconversion rates in participants with chronic HBV infection receiving elebsiran (BRII-835) and pegylated interferon alfa-2a (PEG-IFNα) compared to PEG-IFNα alone: Week 48 results from ongoing ENSURE study Presenter: Jidong Jia, M.D., Ph.D., Professor of Medicine at the Liver Research Centre, Beijing Friendship Hospital, Capital Medical University in Beijing, China The rates of HBsAg seroclearance at EOT in elebsiran 200 mg + PEG-IFNα and elebsiran 100 mg + PEG-IFNα cohorts were 26.3% (5/19) and 33.3% (6/18), respectively, notably higher compared to PEG-IFNα alone cohort (5.6%) in participants with baseline HBsAg levels 100-3,000 IU/mL. Greater HBsAg reductions at EOT were observed in elebsiran + PEG-IFNα combination cohorts (mean [SE]: -2.47 [0.28] or -3.01 [0.28] log10 IU/mL in elebsiran 200 mg or 100 mg, respectively) than in PEG-IFNα cohort (-1.02 [0.30] log10 IU/mL). Elebsiran in combination with PEG-IFNα at both 200 mg and 100 mg doses achieved similar HBsAg reductions and seroclearance rates. Elebsiran and PEG-IFNα combination therapy was generally safe and well tolerated in participants with virally suppressed chronic HBV infection. Post-treatment follow-up is ongoing and will continue for 24 weeks after discontinuation of treatment. As part of Brii Bio's unique approach to developing a functional cure for HBV, the Company and its partners are actively progressing multiple combination studies with our differentiated portfolio, including BRII-179, a recombinant protein-based HBV immunotherapeutic being evaluated in multiple combination studies with elebsiran led by Brii Bio; elebsiran being evaluated in combination with PEG-IFNα in studies led by Brii Bio and tobevibart, an investigational broadly neutralizing monoclonal antibody targeting HBV, being evaluated in multiple Phase 2 and 3 tobevibart and elebsiran combination studies led by Vir Biotechnology. Key data readouts will be shared in the coming months at the scientific conferences throughout 2025. About Hepatitis B Hepatitis B virus (HBV) infection is one of the world's most significant infectious disease threats with more than 254 million people infected globally.[1] Chronic HBV infection is the leading cause of liver disease and an estimated 820,000 people die of complications from chronic HBV infection each year.[1] HBV is of exceptional concern in China, where 87 million people are chronically infected.[2] About BRII-179 BRII-179 is a novel recombinant protein-based HBV immunotherapeutic candidate that expresses the Pre-S1, Pre-S2, and S HBV surface antigens, and is designed to induce enhanced and broad B-cell and T-cell immunity. In November 2023, the Center for Drug Evaluation (the "CDE") of the National Medical Products Administration (the "NMPA") granted BRII-179 Breakthrough Therapy Designation. About Elebsiran (BRII-835, VIR-2218) Elebsiran is an investigational subcutaneously administered HBV-targeting siRNA designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. It has the potential to have direct antiviral activity against HBV and HDV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. Brii Bio licensed exclusive rights to develop and commercialize elebsiran for the Greater China territory from Vir Biotechnology, Inc. in 2020. About Brii Bio Brii Biosciences Limited ("Brii Bio", stock code: 2137.HK) is a biotechnology company developing therapies to address major public health challenges where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs against hepatitis B virus (HBV) infection. The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, the San Francisco Bay Area, Beijing and Shanghai. For more information, visit . SOURCE Brii Biosciences Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Clinical ResultBreakthrough TherapyLicense out/inVaccine

10 Feb 2025

·www.globenewswire.com

Tonix Pharmaceuticals Announces Acquisition of Preclinical Infectious Disease Portfolio from Healion Bio, Inc.

The Acquired Portfolio of Infectious Disease Assets Includes a Class of Potential Broad Spectrum Oral Antiviral Agents, TNX-3900 with a Host-Directed Mechanism Tonix Plans to Develop the TNX-3900 Series of Molecules as Oral Antivirals Either as Monotherapy or in Combination with Other Antivirals The TNX-3900 Class of Antivirals Has a Novel Mechanism of Action Based on Inhibition of Certain Cathepsin Proteases which are Required for Cell Infection by Many Viruses like SARS-CoV-2 Sina Bavari, Ph.D., Tonix EVP of Infectious Disease R&D and Director of the Frederick, MD Research and Development Center (RDC) was a Scientific Founder of Healion Bio, Inc. Feb. 02, 2023 -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced an agreement whereby Tonix has acquired all of the assets of Healion Bio, Inc. (Healion) including its entire portfolio of next-generation antiviral technology assets. Healion’s drug portfolio includes a class of broad-spectrum small molecule oral antiviral drug candidates with a novel host-directed mechanism of action. Host-directed antivirals modulate human cells and tissues and are different from direct-acting antivirals which inhibit virus proteins and processes. Tonix’s TNX-3900, formerly known as HB-121, are cathepsin protease inhibitors, some of which have strong activity in vitro against SARS-CoV-2. “We are excited to develop Healion’s drug programs that include TNX-3900, which is a class of drugs with potential broad spectrum anti-viral activity, either as monotherapies or in combination with other antivirals”, said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “Broad-spectrum antiviral agents have the potential to reduce viral load and allow the adaptive immune system to alert the other arms of the immune system to mount a protective response. Examples of other classes of host-directed antivirals that have been approved by the U.S. Food and Drug Administration (FDA) include alpha interferon like Pegasys® (peginterferon alfa-2a) for viral hepatitis, the CCR5 antagonist Selzentry® (maraviroc) for HIV, and the anti-IL-6 receptor antagonist monoclonal antibody Actemra® (tocilizumab) for COVID-19.” Sina Bavari, Ph.D., Executive Vice President for Infectious Disease Research at Tonix said, “I am pleased to be reunited with the infectious disease assets of Healion, since I was the scientific founder of Healion after I retired from my position as Chief of R&D at the United States Army Medical Research Institute of Infectious Disease (USAMRIID). While Healion made some progress developing these advanced technologies, Tonix’s state-of-the art facilities and depth of drug development expertise have the potential to advance the TNX-3900 class of drugs into clinical trials. On behalf of the talented scientific team that I direct at our 48,000 square-foot cutting-edge infectious disease research facility in Frederick, Md., I am pleased to add this technology to the therapeutic development programs underway.” TNX-3900 is the term for a series of molecules that inhibit essential cathepsins which are required by viruses such as coronaviruses and filoviruses to infect cells. Because of the unique antiviral mechanism of these compounds, the Company believes they can potentiate the activity of other antivirals with differing mechanisms. The Company believes this makes cathepsin inhibitors suitable for combination therapy. Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the second quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the first quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second quarter of 2023. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, TNX-801, a next-generation vaccine to prevent COVID-19, TNX-1850, a platform to make fully human monoclonal antibodies to treat COVID-19, TNX-3600, and humanized anti-SARS-CoV-2 monoclonal antibodies, TNX-3800, recently licensed from Curia. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the second half of 2023. The content above comes from the network. if any infringement, please contact us to modify.

VaccineBreakthrough TherapyImmunotherapyOrphan Drug

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.

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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.

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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
Chronic hepatitis C genotype 3	Phase 3	Germany	Hoffmann-La Roche, Inc.	01 Nov 2005
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
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
Kidney Failure, Chronic	Phase 3	France	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


Tandem Meetings ASTCT and CIBMTR2024 Manual	Not Applicable	Hematopoietic stem cell transplantation	12	Peginterferon-alpha (pegIFNα) 180 mcg	xbbjwxxjsv(txbvrbcseb) = zeuryqrunu lbtcjwlcjk (axivoccdyo, 58.7 - 100) View more	Positive	01 Feb 2024
NCT00932971 (HIDIT-II, Pubmed \| Liver Int)	Phase 2	Hepatitis D	-	PEG-IFNa + TDF	mwotopnbjy(icexoxwbsk) = zloocqfpdf ehoyzjqxvz (vsrmzfvgfn ) View more	Positive	01 Jan 2024
				PEG-IFNa + placebo	qearwzejoo(woyczdtuuw) = pberhmpkap kreqbjhklp (gsitzngxvt ) View more
WCD2023	Not Applicable	Cutaneous T-Cell Lymphoma	105	PEG IFN a-2a	ndltjvgmuv(zdswpjsjwp) = qgjivghjfb wyrfezcioj (zqefejiuji ) View more	-	08 Jul 2023
NCT01369212 (HBRN, CTgov)	Phase 3	Hepatitis B, Chronic	201	Tenofovir (Tenofovir)	hmsmguywpz = eqbmbqhkit bsmesjxbcb (cphmoipxut, ttdrlxtkcq - vgksfthgtt) View more	-	12 Oct 2022
				tenofovir+Pegasys (Peginterferon-alfa 2a and Tenofovir)	hmsmguywpz = gcaniglgzt bsmesjxbcb (cphmoipxut, hvhtselieo - cpfdoqnild) View more
NCT02328755 (CTgov)	Phase 1/2	Acute Myeloid Leukemia	37	Hematopoietic Cell Transplant (HCT)+peg-IFN-α+Tacrolimus+Methotrexate	ipbdwyxbyy = donixrcaam mmpmhgrjsk (kmznujyeec, eiuzchepag - qfecacuswo) View more	-	06 Oct 2021
NCT02328755 (Pubmed \| Blood Adv)	Phase 1/2	Relapsing acute myeloid leukemia	37	pegIFNα	jctufomvxt(enwpzyoowg) = gaajntwthp aomdqqqaou (jwxbjlfyvs ) View more	-	04 Oct 2021
EASL2020	Not Applicable	-	30	Bulevirtide 10 mg + Peginterferon alfa-2a	ijsohikrgc(hrfqfuhosb) = zmwzztflpd nikbctgnwb (hlhngglcrx ) View more	-	27 Aug 2020
				Bulevirtide 10 mg	ijsohikrgc(hrfqfuhosb) = tyvsluhfcj nikbctgnwb (hlhngglcrx ) View more
EASL2020	Not Applicable	Hepatitis B \| Hepatitis D HBsAg components \| HDV RNA \| HBV DNA ... View more	26	PEG-IFN	uiptucazke(ieqyqdmknh) = qhhbwlrlnp klmbnluaej (apbfketaqr ) View more	Positive	27 Aug 2020
NCT01524679 (PADD-ON, CTgov)	Phase 2	Hepatitis B, Chronic	170	Pegylated interferon alfa-2a plus nucleos(t)ide(s) (Treatment Group)	zqdxiwhrvt: P-Value = <0.0001 View more	-	18 Feb 2020
				nucleos(t)ide (Control Group)
NCT01259856 (MPD-RC, Pubmed \| Circulation \| Blood) Manual	Phase 2	Polycythemia Vera \| Thrombocythemia, Essential	115	Pegylated interferon alfa-2a (essential thrombocythemia)	ehobisbmay(tqlfptjqdr) = uhprlicjfb tpnclsvbof (mcsvfdzvuk ) View more	Positive	31 Oct 2019
				Pegylated interferon alfa-2a (polycythemia vera)	ehobisbmay(tqlfptjqdr) = kutpkeszzw tpnclsvbof (mcsvfdzvuk ) View more

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