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 Date28 Nov 2024

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 / RecruitingPhase 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

2,644

Literatures (Medical) associated with Peginterferon alfa-2a

31 Dec 2024·JOURNAL OF DERMATOLOGICAL TREATMENT

Effectiveness and safety of interferon α-2a combined with phototherapy for patients with early-stage mycosis fungoides - a single-arm prospective study in 13 patients

Article

Author: Zhang, Shiyu ; Liu, Yuehua ; Song, Hongbin ; Hu, Zhonghui ; Wang, Tao ; Feng, Jindi ; Lu, Lu ; Yang, Lu

Background: Mycosis fungoides (MF) is the most common type of cutaneous T-cell lymphoma.Objectives: This study was conducted to evaluate efficacy and safety of interferon (IFN) α-2a combined with phototherapy for early-stage MF.Methods: Thirteen patients with early-stage MF received subcutaneous injections of IFN α-2a at 3 million IU combined with phototherapy three times per week for 6 months. Treatment efficacy was measured by changes in body surface area (BSA) score and modified severity-weighted assessment tool (mSWAT) score at 1, 3, and 6 months after treatment. Histopathologic examinations of skin lesions were performed before and after treatment.Results: After 3 months of treatment, all 13 patients achieved a partial response, and BSA and mSWAT scores were significantly lower than those at baseline (p < 0.001). After 6 months, BSA and mSWAT scores were significantly lower than those at baseline (p < 0.001) and after 3 months (p < 0.05). Eleven patients achieved complete remission and two patients achieved a partial response (overall response rate, 100%). Histopathologic examination showed a significant decrease in the number of atypical lymphocytes in both epidermis and dermis. No severe adverse effects occurred.Conclusion: IFN α-2a in combination with phototherapy may be an effective and safe alternative modality for early-stage MF.

01 Dec 2024·Lancet Gastroenterology & Hepatology

VIR-2218 (elebsiran) plus pegylated interferon-alfa-2a in participants with chronic hepatitis B virus infection: a phase 2 study

Article

Author: Lim, Tien-Huey ; Yuen, Man-Fung ; Gane, Edward ; Cloutier, Daniel ; Yoon, Ki Tae ; Gupta, Sneha V ; Arizpe, Andre ; Lim, Young-Suk ; Mao, Shenghua ; Heo, Jeong ; Thanawala, Vaidehi ; Cathcart, Andrea L ; Tak, Won Young ; Hwang, Carey ; Tangkijvanich, Pisit

BACKGROUND:

Chronic hepatitis B virus (HBV) remains a global concern, with current treatments achieving low rates of HBsAg seroclearance. VIR-2218 (elebsiran), a small interfering RNA agent against HBV transcripts, reduces HBsAg concentrations. We aimed to evaluate the safety and antiviral activity of VIR-2218 with and without pegylated interferon-alpha-2a treatment in participants with chronic HBV.

METHODS:

This open-label, phase 2 study was conducted at 23 sites in six countries (New Zealand, Australia, Hong Kong, Thailand, South Korea, and Malaysia). Adults (aged 18-65 years) with chronic HBV infection without cirrhosis and with HBsAg more than 50 IU/mL and HBV DNA less than 90 IU/mL who were on continued nucleoside or nucleotide reverse transcriptase inhibitor (NRTI) therapy for 2 months or longer were eligible. Participants were enrolled into one of six cohorts to receive VIR-2218 200 mg subcutaneously every 4 weeks, with or without 180 μg subcutaneous pegylated interferon-alfa-2a once per week. Cohort 1 received six doses of VIR-2218 (total 20 weeks); cohort 2 received six doses of VIR-2218 starting at day 1, plus 12 doses of pegylated interferon-alfa-2a starting at week 12 (total 24 weeks); cohort 3 received six doses of VIR-2218 and 24 doses of pegylated interferon-alfa-2a (total 24 weeks); cohort 4 received six doses of VIR-2218 and up to 48 doses of pegylated interferon-alfa-2a (total 48 weeks); cohort 5 received up to 13 doses of VIR-2218 and up to 44 doses of pegylated interferon-alfa-2a (total 48 weeks); and cohort 6 received three doses of VIR-2218 and 12 doses of pegylated interferon-alfa-2a (total 12 weeks). The primary endpoints were the incidence of adverse events and clinical assessments (including results of laboratory tests). Secondary endpoints were the mean maximum reduction of serum HBsAg at any timepoint; the proportion of participants with serum HBsAg seroclearance at any timepoint and for more than 6 months after the end of treatment; and the proportion of participants with anti-HBs seroconversion at any timepoint. For patients who were HBeAg-positive, we also assessed the proportion with HBeAg seroclearance or anti-HBe seroconversion at any timepoint. This study is registered with ClinicalTrials.gov, NCT03672188, and is ongoing.

FINDINGS:

Between July 2, 2020, and Nov 2, 2021, 124 individuals were screened for eligibility, 84 of whom were enrolled (15 in cohort 1, 15 in cohort 2, 18 in cohort 3, 18 in cohort 4, 13 in cohort 5, and five in cohort 6). Participants were predominantly HBeAg-negative, Asian, and male (66 [79%] participants were male and 18 [21%] were female). Most treatment emergent adverse events were grades 1-2. Three (20%) participants in cohort 1, four (27%) in cohort 2, eight (44%) in cohort 3, seven (39%) in cohort 4, six (46%) in cohort 5, and two (40%) in cohort 6 reported treatment-emergent adverse events related to VIR-2218. 12 (80%) participants in cohort 2, 12 (67%) in cohort 3, 14 (78%) in cohort 4, 13 (100%) in cohort 5, and three (60%) in cohort 6 reported treatment-emergent adverse events related to pegylated interferon-alfa-2a. Two (13%) participants in cohort 1 had elevations in alanine aminotransferase, compared with 13 (87%) participants in cohort 2, 15 (83%) in cohort 3, 17 (94%) in cohort 4, 11 (85%) in cohort 5, and three (60%) in cohort 6. The mean maximum change from baseline at any timepoint in HBsAg concentration was -2·0 log₁₀ IU/mL (95% CI -2·1 to -1·8) in cohort 1, -2·2 log₁₀ IU/mL (-2·5 to -1·8) in cohort 2, -2·5 log₁₀ IU/mL (-2·8 to -2·1) in cohort 3, -2·4 log₁₀ IU/mL (-3·1 to -1·8) in cohort 4, -3·0 log₁₀ IU/mL (-3·7 to -2·3) in cohort 5, and -1·7 log₁₀ IU/mL (-2·1 to -1·4) in cohort 6. 11 participants (one in cohort 2, one in cohort 3, five in cohort 4, and four in cohort 5) receiving VIR-2218 plus pegylated interferon-alfa-2a had HBsAg seroclearance at any timepoint. Of these, ten (91%; one in cohort 2, five in cohort 4, and four in cohort 5) had anti-HBs seropositivity. Six participants (one in cohort 2, three in cohort 4, and two in cohort 5) had sustained HBsAg seroclearance through to 24 weeks after the end of treatment. No participants receiving VIR-2218 monotherapy (cohort 1) or VIR-2218 plus pegylated interferon-alfa-2a 12-week regimen (cohort 6) had HBsAg seroclearance. 12 (42%) of 26 participants (one of four in cohort 1, two of six in cohort 2, four of seven in cohort 3, four of six in cohort 4, and one of three in cohort 5) who were HBeAg positive at baseline had HBeAg seroclearance or anti-HBe seroconversion.

INTERPRETATION:

The results of this phase 2 study support further development of VIR-2218 as a potential therapy for patients with chronic HBV infection. Additional clinical trials of VIR-2218 with and without pegylated interferon-alfa-2a in combination with an HBsAg-targeting monoclonal antibody are ongoing.

FUNDING:

Vir Biotechnology.

01 Dec 2024·Lancet Gastroenterology & Hepatology

Does siRNA-based therapy require pegylated interferon-alfa-2a to cure HBV infection?

Article

Author: Zoulim, Fabien

News (Medical) associated with Peginterferon alfa-2a

15 Nov 2024

·www.globenewswire.com

Arbutus’ Imdusiran Achieves Functional Cure in cHBV Patients when Combined with a Short Course of Interferon

50% of patients who had baseline HBsAg levels less than 1000 IU/mL achieved functional cure in Cohort A1 of the IM-PROVE I Phase 2a clinical trial Overall, in Cohort A1, 25% of patients achieved functional cure Data to be presented in late-breaker poster session at AASLD – The Liver Meeting® on Monday, November 18, 2024 WARMINSTER, Pa., Nov. 15, 2024 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop a functional cure for people with chronic hepatitis B virus (cHBV) infection, today announced new data from its IM-PROVE I Phase 2a clinical trial (AB-729-201) showing that six doses of imdusiran, the Company’s RNAi therapeutic candidate, and 24 weeks of pegylated interferon alfa-2α (IFN), a standard-of-care immunomodulator, added to ongoing nucleos(t)ide analogue (NA) therapy, led to a functional cure rate of 50% (3/6) in HBeAg-negative patients with baseline HBsAg levels less than 1000 IU/mL, and an overall functional cure rate of 25% (3/12). Patients with HBsAg levels less than 1000 IU/mL represent a significant portion of the cHBV population. These data will be presented as a late-breaker poster presentation on November 18, 2024 at The American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2024. “For the first time, we are seeing a meaningful percentage of HBV patients functionally cured with an RNAi therapeutic and interferon,” commented Professor Man-Fung Yuen, D.Sc., M.D., Ph.D., Chief of the Division of Gastroenterology and Hepatology, the University of Hong Kong and Principal Investigator of the IM-PROVE I clinical trial, who will present the data at AASLD. “While 48 weeks of interferon can be used as a standard of care treatment for HBV patients, historically less than 10% of patients experience a functional cure. Here, with the combination of imdusiran and 24 weeks of interferon, we see a 50% functional cure rate in HBV patients with HBsAg less than 1000 IU/mL at baseline and a 25% functional cure rate overall. In addition, I was pleased to see that this regimen with a short course of interferon was generally safe and well-tolerated. These data are extremely impressive and provide hope for the millions of HBV patients worldwide and the medical community that a finite curative treatment is possible with imdusiran and interferon.” Key data from patients in Cohort A1 that received 6 doses of imdusiran plus 24 weeks of IFN in addition to ongoing NA therapy include: 50% of patients (3/6) with baseline HBsAg <1000 IU/mL achieved a functional cure (defined as sustained HBsAg loss and HBV DNA less than the lower limit of quantification (LLOQ) 24 weeks off all treatment (including NAs), with or without hepatitis B surface antibodies (anti-HBs)).Overall, 25% of patients (3/12) achieved a functional cure.Those patients that achieved a functional cure also seroconverted with anti-HBs levels increasing as patients lost HBsAg.The combination of imdusiran and IFN was generally safe and well-tolerated. There were no serious adverse events (SAEs) related to imdusiran or IFN, and no adverse events (AEs) leading to discontinuation. The late-breaker poster, titled, “IM-PROVE I: Imdusiran in Combination with Short Courses of Pegylated Interferon Alfa-2a in Virally Suppressed, HBeAg Negative Subjects with Chronic HBV (cHBV) Infection Leads to Functional Cure”, is available on the Company’s website and provides the complete data set for all four cohorts of patients dosed in this clinical trial. Additional immune activation data in those patients in Cohort A1 that achieved a functional cure will be presented by Dr. Emily Thi, Senior Director, Immunobiology and Biomarkers Research at Arbutus Biopharma in a poster titled, “Soluble Immune Biomarker Profiling of Chronic Hepatitis B Subjects Treated with Imdusiran in Combination with Pegylated Interferon Alfa Reveals Phases of Immune Activation.” The data in this poster show that patients in Cohort A1 had greater increases in favorable immune biomarkers than those in other cohorts. Functionally cured patients and those with baseline HBsAg <1000 IU/mL had elevations of key immune biomarkers during the imdusiran lead-in, IFN treatment and follow-up periods, suggesting immune activation induced by imdusiran plus IFN treatment. “We are extremely excited to have functionally cured these patients with the imdusiran and interferon treatment regimen. There is a significant need for a functional cure for the more than 250 million patients chronically infected with HBV worldwide,” commented Dr. Karen Sims, Chief Medical Officer of Arbutus Biopharma. “Excess production of surface antigen is believed to contribute to host immune exhaustion, resulting in inadequate immune response and failure to suppress the virus. These data support our belief that lowering surface antigen with imdusiran and incorporating an immunomodulator in the treatment regimen provides a functional cure in some patients with cHBV. We thank all the patients and investigators who participated in this clinical trial.” All of the above posters that will be presented at AASLD – The Liver Meeting can be accessed through the Arbutus website under Publications. IM-PROVE I CLINICAL TRIAL DETAILS The IM-PROVE I Phase 2a Clinical trial (AB-729-201; NCT04980482) enrolled 43 HBeAg-negative, NA-suppressed patients with cHBV infection. After a 24-week lead-in with imdusiran (60 mg every 8 weeks, 4 doses) added to ongoing NA therapy, patients were randomized into one of the following four cohorts: Cohort A1: imdusiran (2 doses) + NA + IFN weekly for 24 weeks (n=12), Cohort A2: NA + IFN weekly for 24 weeks (n=13), Cohort B1: Imdusiran (1 dose) + NA + IFN weekly for 12 weeks (n=8) and Cohort B2: NA + IFN weekly for 12 weeks (n=10). After completion of the IFN treatment period (Week 52 for cohorts A1 and A2 and Week 40 for cohorts B1 and B2), patients underwent a 24-week follow-up period on NA therapy alone and were then assessed for discontinuation of NA therapy. Patients with ALT levels less than two times the upper limit of normal, undetectable HBV DNA, and HBsAg <100 IU/mL at two consecutive visits at least 24 weeks after the last dose of imdusiran qualified to discontinue all therapy and will be followed for at least 48 weeks. About Imdusiran (AB-729) Imdusiran is an RNA interference (RNAi) therapeutic specifically designed to reduce all HBV viral proteins and antigens including hepatitis B surface antigen, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. Imdusiran targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine (GalNAc) delivery technology enabling subcutaneous delivery. In a Phase 2a clinical trial, imdusiran achieved meaningful functional cure rates in patients with cHBV when combined with pegylated interferon alfa-2α and nucleos(t)ide analogue therapy. Additional clinical data generated thus far has shown imdusiran to be generally safe and well-tolerated, while also providing meaningful reductions in hepatitis B surface antigen and hepatitis B DNA. Plans are underway to advance imdusiran into a Phase 2b clinical trial. About HBV Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV). HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. Chronic HBV infection represents a significant unmet medical need. The World Health Organization estimates that over 250 million people worldwide suffer from chronic HBV infection, while other estimates indicate that approximately 2 million people in the United States suffer from chronic HBV infection. Approximately 1.1 million people die every year from complications related to chronic HBV infection despite the availability of effective vaccines and current treatment options. About Arbutus Arbutus Biopharma Corporation (Nasdaq: ABUS) is a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics with distinct mechanisms of action, which can potentially be combined to provide a functional cure for patients with chronic hepatitis B virus (cHBV). Arbutus believes the key to success in developing a functional cure involves suppressing HBV DNA, reducing surface antigen, and boosting HBV-specific immune responses. Arbutus’ pipeline of internally developed, proprietary compounds includes an RNAi therapeutic, imdusiran (AB-729), and an oral PD-L1 inhibitor, AB-101. Imdusiran has achieved meaningful functional cure rates in patients with cHBV when administered as combination therapy. Plans are underway to advance imdusiran into a Phase 2b clinical trial. AB-101 is currently being evaluated in a Phase 1a/1b clinical trial. For more information, visit www.arbutusbio.com. Forward-Looking Statements and Information 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 IM-PROVE I Phase 2a clinical trial data; the potential for finite curative treatment to be possible with imdusiran, interferon and NA therapy; the IM-PROVE I Phase 2a clinical trial data supporting Arbutus’ belief that lowering surface antigen with imdusiran and incorporating an immunomodulator in the treatment regimen combined with ongoing NA therapy provides a functional cure in some patients with cHBV; the potential to lead to a functional cure for HBV; Arbutus’ future development plans for its product candidates; the expected results of Arbutus’ clinical development plans and clinical trials with respect to its product candidates; Arbutus’ expectations with respect to the release of data from its clinical trials and the expected timing thereof; and the potential for Arbutus’ product candidates to achieve success in clinical trials. With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the effectiveness and timeliness of preclinical studies and clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued demand for Arbutus’ assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies. Additionally, there are known and unknown risk factors which could cause Arbutus’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: anticipated pre-clinical studies and clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested product candidate; Arbutus may elect to change its strategy regarding its product candidates and clinical development activities; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus’ products; economic and market conditions may worsen; market shifts may require a change in strategic focus. A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus’ Annual Report on Form 10-K, Arbutus’ Quarterly Reports on Form 10-Q and Arbutus’ continuous and periodic disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law. Contact Information Investors and Media  Lisa M. Caperelli  Vice President, Investor Relations  Phone: 215-206-1822  Email: lcaperelli@arbutusbio.com

Clinical ResultPhase 2

15 Nov 2024

·www.businesswire.com

Vir Biotechnology Announces Positive End-of-Treatment Results for Tobevibart and Elebsiran Combinations in Chronic Hepatitis B from the MARCH Study at AASLD The Liver Meeting

SAN FRANCISCO--( BUSINESS WIRE )--Vir Biotechnology, Inc. (Nasdaq: VIR) today announced end-of-treatment data from Part B of the MARCH Phase 2 clinical study evaluating combinations of tobevibart and elebsiran, with or without pegylated interferon alfa (PEG-IFNα), in participants with chronic hepatitis B. The study demonstrated promising rates of hepatitis B surface antigen (HBsAg) loss (seroclearance) in participants with low baseline HBsAg (<1000 IU/mL) in both combination regimens. The efficacy and safety profile support continued development to evaluate the potential to achieve a functional cure. Detailed data will be presented in a late-breaking oral presentation at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting ® , in San Diego, CA, on November 18 at 5:00 p.m. PT. Vir Biotechnology will host an investor conference call on November 19, at 5.15 a.m. PT / 8.15 a.m. ET. Chronic hepatitis B (CHB) is a long-lasting, inflammatory liver disease caused by the hepatitis B virus (HBV) 1 . The World Health Organization estimates that 254 million people live with CHB, and an estimated 1.1 million yearly deaths are associated with the disease 2 . Complications from CHB may include liver cirrhosis, liver failure and liver cancer 3 . Although CHB can be treated, there is no cure 1 . Participants in the trial received tobevibart and elebsiran alone (doublet regimen) or in combination with PEG-IFNα (triplet regimen). This analysis includes data from 51 participants in the doublet regimen arm and 27 participants in the triplet regimen arm at the end of treatment. Tobevibart was administered at 300 mg every 4 weeks; elebsiran, at 200 mg every 4 weeks; and PEG-IFNα at 180 µg weekly. Study primary endpoints include HBsAg seroclearance (defined as HBsAg below the lower limit of quantification) and treatment-emergent adverse events (TEAEs) at end of treatment. Secondary endpoints include anti-HBs seroconversion (defined as development of anti-HBs≥10 mIU/mL) at end of treatment. The doublet and triplet regimens resulted in HBsAg loss at the end of treatment in 39% (7/18) and 46% (5/11) of participants with baseline HBsAg<1,000 IU/mL, respectively. The proportion of participants with varying baseline HBsAg levels who achieved HBsAg loss at end of treatment was 16% (8/51) for the doublet and 22% (6/27) for the triplet regimen. The doublet regimen resulted in 50% (4/8) of participants who had achieved HBsAg loss also achieving anti-HBs seroconversion. All participants with HBsAg loss at the end of treatment who received the triplet regimen achieved anti-HBs seroconversion (100%, 6/6). Participants with HBsAg seroclearance at end of treatment who meet eligibility criteria will discontinue treatment. Functional cure assessment will occur 24 weeks after treatment discontinuation. “ People living with chronic hepatitis B must settle for life-long treatments that don’t eliminate the risk of disease progression to liver cancer,” said Edward J. Gane, M.D., Professor of Medicine at the University of Auckland, New Zealand and Chief Hepatologist, Transplant Physician and Deputy Director of the New Zealand Liver Transplant Unit at Auckland City Hospital. “ These latest data at end of treatment are encouraging as they suggest that tobevibart in combination with elebsiran could be key components for a hepatitis B functional cure. I look forward to the further results from this study anticipated next year.” The safety and tolerability profile of tobevibart and elebsiran was consistent with prior studies, with no new safety concerns identified. TEAEs were generally mild or moderate. “ At Vir Biotechnology our ambition is to develop a functional cure for chronic hepatitis B following a finite treatment regimen. The MARCH data suggests that tobevibart and elebsiran can clear HBsAg and re-ignite the immune system, producing antibodies to potentially keep the virus under control,” said Mark Eisner, M.D., M.P.H., Executive Vice President and Chief Medical Officer, Vir Biotechnology. “ We are encouraged by these results and eagerly anticipate the functional cure data in 2025, as it will be decisive for the next steps of clinical development.” The data will be presented in the oral presentation Tobevibart (VIR-3434) and elebsiran (VIR-2218) with or without pegylated interferon alfa-2a for the treatment of chronic HBV infection: end of treatment results after 48 weeks of therapy (MARCH study) by Edward Gane, M.D., during a late breaking parallel session at AASLD The Liver Meeting® on November 18 at 5:00 pm PT. Investor Conference Call Vir Biotechnology will host an investor conference call on November 19, 2024 at 5:15 a.m. PT / 8:15 a.m. ET. A live webcast will be available on https://investors.vir.bio/ and will be archived on www.vir.bio for 30 days. About the Phase 2 MARCH Trial MARCH is a Phase 2 study to evaluate the safety, tolerability, and efficacy of regimens containing tobevibart (VIR-3434), elebsiran (VIR-2218), alone or in combination with pegylated interferon alfa in patients with chronic hepatitis B. This Phase 2 study is a multi-center, open-label, non-randomized study. Primary endpoints include HBsAg seroclearance (defined as HBsAg below lower limit of quantification) and treatment-emergent adverse events (TEAEs) at end of treatment, as well as HBsAg loss at 24 weeks post-end of treatment. Secondary endpoints include anti-HBs seroconversion (defined as development of anti-HBs≥10mIU/mL) at end of treatment. Participants who achieve HBsAg seroclearance at end of treatment will discontinue treatment, and functional cure (evaluated as sustained off-treatment HBsAg loss) assessment will occur 24 weeks after treatment discontinuation. More information about this trial can be found at clinicaltrials.gov (NCT04856085). About Tobevibart Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen. It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes, and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart, which incorporates Xencor’s Xtend™ and other Fc technologies, has been engineered to have an extended half-life and was identified using Vir’s proprietary monoclonal antibody discovery platform. Tobevibart is administered subcutaneously, and it is currently in clinical development for treatment of patients with chronic hepatitis B and patients with chronic hepatitis delta. About Elebsiran Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. Current data indicates that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously, and it is currently in clinical development for treatment of patients with chronic hepatitis B and patients with chronic hepatitis delta. It is the first asset in Vir’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical studies. About Vir Biotechnology, Inc. Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Vir’s clinical-stage portfolio includes infectious disease programs for chronic hepatitis delta and chronic hepatitis B infections, in addition to programs across several clinically validated targets in solid tumor indications. Vir also has a preclinical portfolio of programs across a range of other infectious diseases and oncologic malignancies. Vir routinely posts information that may be important to investors on its website. References: 1 CDC Hepatitis B Basics | Hepatitis B | CDC 2 WHO Hepatitis B Factsheet - Hepatitis B (who.int) , accessed September 2024 3 NIH National Institute of Diabetes and Digestive and Kidney Diseases Hepatitis B - NIDDK (nih.gov) , accessed September 2024. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir’s expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding Vir’s strategy and plans, the potential clinical effects of tobevibart and elebsiran, the potential benefits, safety and efficacy of tobevibart and elebsiran, the timing, nature and significance of data from Vir’s multiple ongoing trials evaluating tobevibart and elebsiran, Vir’s plans and expectations for its CHD and CHB programs, and risks and uncertainties associated with drug development and commercialization. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data or results observed during clinical trials or in data readouts; the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; difficulties in collaborating with other companies; successful development and/or commercialization of alternative product candidates by Vir’s competitors; changes in expected or existing competition; delays in or disruptions to Vir’s business or clinical trials due to geopolitical changes or other external factors; and unexpected litigation or other disputes. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Clinical ResultPhase 2

31 Oct 2024

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Vir Biotechnology Reports Third Quarter 2024 Financial Results and Provides Corporate Update

SAN FRANCISCO--( BUSINESS WIRE )--Vir Biotechnology, Inc. (Nasdaq: VIR) today provided a corporate update and reported financial results for the third quarter ended September 30, 2024. “ This quarter was transformational for Vir. We have bolstered our clinical pipeline with three potential best-in-class dual-masked T-cell engagers in oncology, and have sharpened our focus within infectious diseases to the areas where we believe we can make the most significant impact for patients. We are also thrilled to welcome Jason O’Byrne as our new CFO. Jason brings a wealth of financial leadership experience, further strengthening our ability to bring these potentially transformative therapies to patients as quickly as possible,” said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. “ Looking ahead, this is an exciting time for the Company. We eagerly anticipate critical data in our hepatitis programs in the fourth quarter and look forward to sharing initial clinical data from our dual-masked T-cell engagers in the first quarter of 2025.” Pipeline Programs Chronic Hepatitis Delta (CHD) Preliminary data from the Phase 2 chronic hepatitis delta SOLSTICE study was presented at the European Study of the Liver (EASL) Meeting in June 2024. This data demonstrated the potential for transformative treatment for people living with chronic hepatitis delta, with both tobevibart as a monotherapy, and in combination with elebsiran, achieving high rates of virologic response and ALT normalization after 12 and 24 weeks of treatment. No treatment-related serious adverse events were observed. The combination of tobevibart and elebsiran has been granted Fast Track Designation by the U.S. FDA. Given the robust rates of virologic suppression observed with the combination, the Company is diligently working to advance this regimen into a pivotal development program as quickly as possible to address the urgent needs of these patients. At the upcoming American Association for the Study of Liver Diseases (AASLD) “The Liver Meeting” in November 2024, the Company will present additional data from the Phase 2 chronic hepatitis delta SOLSTICE trial, including: 24-week clinical data for both study cohorts in approximately 60 patients and further data for those patients who were on study beyond 24 weeks at the time of data cut-off. One cohort assesses the combination of tobevibart and elebsiran administered every four weeks, while a second cohort evaluates tobevibart monotherapy administered every two weeks. The SOLSTICE trial is evaluating the safety, tolerability and efficacy of tobevibart and elebsiran for the treatment of chronic hepatitis delta. Chronic Hepatitis B (CHB) The Company plans to share end-of-treatment data from the Phase 2 MARCH Part B trial as a Late Breaking presentation at the AASLD meeting in November 2024. The MARCH-B trial is evaluating the safety, tolerability and antiviral activity of the triplet combination of tobevibart and elebsiran plus peginterferon alfa-2a in approximately 30 participants, and approximately 50 participants treated with the doublet combination of tobevibart and elebsiran. The Company plans to share further data assessing a potential functional cure in the second quarter of 2025. Solid Tumors VIR-5818 is a dual-masked HER2-targeted T-cell engager in clinical development designed to minimize off-tumor toxicity, potentially allowing for higher doses and increased efficacy to address the significant unmet needs of patients with HER2 expressing cancers. A Phase 1 basket study of VIR-5818 as a monotherapy, and in combination with pembrolizumab, is on-going in multiple tumor types, including metastatic breast cancer and metastatic colorectal cancer. The Company plans to share initial clinical data for VIR-5818 in the first quarter of 2025. VIR-5500 is a dual-masked PSMA directed T-cell engager in clinical development designed to minimize off-tumor toxicity and potentially improve efficacy relative to the existing approved PSMA-targeted therapies. A Phase 1 dose escalation study of VIR-5500 is ongoing to assess its safety profile and optimal dose levels for future development in metastatic-castration resistant prostate cancer. The Company plans to share initial clinical data for VIR-5500 in the first quarter of 2025. VIR-5525 is a dual-masked EGFR targeted T-cell engager with a cleared Investigational New Drug Application (IND) from the U.S. FDA. The Company plans to initiate a Phase 1 basket study of VIR-5525 in the first quarter of 2025 in patients across a number of solid tumor indications of high unmet need, which may include metastatic head and neck squamous cell carcinoma, metastatic adenocarcinoma, squamous non-small cell lung cancer, and metastatic colorectal cancer. Preclinical Pipeline Candidates The Company continues to advance pre-clinical assets in respiratory syncytial virus in partnership with GSK and pursue HIV cure in collaboration with the Bill & Melinda Gates Foundation. Corporate Update On August 1, 2024 the Company announced an exclusive worldwide license to three clinical-stage masked T-cell engagers (TCEs) with potential applications in a range of cancers, as well as the exclusive use of the proprietary PRO-XTEN™ masking platform for oncology and infectious disease. The Company announced closing of the agreement with Sanofi on September 9, 2024. Key employees from Sanofi, possessing extensive scientific and development expertise in TCEs, and in-depth experience with the PRO-XTEN™ platform, joined the Company following the closing of the agreement. On August 1, 2024 the Company announced the phase-out of clinical programs in influenza, COVID-19, and its T-cell based viral vector platform. The Company is seeking partners to advance these clinical programs through further development. Additionally, the Company announced a workforce reduction of approximately 25%, or approximately 140 employees, and expects to end 2024 with approximately 435 employees – a decrease of approximately 200 from its peak headcount in the second quarter of 2023. On September 10, 2024, the Company announced the appointment of Jason O’Byrne as Executive Vice President and Chief Financial Officer, effective October 2, 2024. Mr. O’Byrne is an accomplished executive with more than 20 years of finance and operations experience, and brings leadership in capital allocation and formation, corporate strategy and operational excellence. The Company will host two virtual investor events instead of the previously scheduled R&D Day in the fourth quarter of 2024. The first event, focusing on our hepatitis programs, will be held in November 2024, following the AASLD conference, and will provide detailed updates on our hepatitis delta and hepatitis B programs. In the first quarter of 2025, the Company will share initial clinical data for our masked T-cell engager programs during a second dedicated investor event. Third Quarter 2024 Financial Results Cash, Cash Equivalents and Investments: As of September 30, 2024, the Company had approximately $1.19 billion in cash, cash equivalents and investments, representing a decrease of approximately $245.1 million during the third quarter of 2024. The decrease includes a $103.7 million upfront payment made to Sanofi upon the closing of the agreement and a $75.0 million escrowed milestone payment reclassified to restricted cash. The escrowed milestone is subject to VIR-5525 achieving "first in human dosing" by 2026. Excluding the impact of the Sanofi agreement, the decrease in cash, cash equivalents and investments in the third quarter was approximately $66.4 million. Revenues: Total revenues for the quarter ended September 30, 2024, were $2.4 million compared to $2.6 million for the same period in 2023. Cost of Revenue: Cost of revenue was nominal for the third quarter of 2024 and 2023. Research and Development Expenses (R&D): R&D expenses for the third quarter of 2024 were $195.2 million, which included $8.9 million of non-cash stock-based compensation expense, compared to $145.0 million for the same period in 2023, which included $15.8 million of non-cash stock-based compensation expense. The increase was primarily driven by $102.8 million of the Sanofi upfront payment being recognized as in-process research and development expense, partially offset by lower clinical development costs and manufacturing costs associated with the discontinued flu asset, VIR-2482. Selling, General and Administrative Expenses (SG&A): SG&A expenses for the third quarter of 2024 were $25.7 million, which included $7.8 million of non-cash stock-based compensation expense, compared to $40.9 million for the same period in 2023, which included $11.1 million of non-cash stock-based compensation expense. The decrease was largely related to cost savings initiatives implemented during the second half of 2023. Restructuring, long-lived assets impairment and related charges: Restructuring, long-lived assets impairment and related charges for the third quarter of 2024 were $12.7 million compared to $3.4 million for the same period in 2023. The increase was primarily driven by severance charges incurred related to our strategic restructuring announcement in August 2024 and to a lesser extent right-of-use asset impairment charges related to the closing of our Portland, Oregon facility, which was previously announced on December 13, 2023. Other Income: Other income for the third quarter of 2024 was $17.8 million compared to $20.1 million for the same period in 2023. The decrease was primarily due to lower interest income. (Provision for) Benefit from Income Taxes: Provision for income taxes for the third quarter of 2024 was $0.2 million compared to a benefit from income taxes of $3.2 million for the same period in 2023. Net Loss: Net loss attributable to Vir for the third quarter of 2024 was $(213.7) million, or $(1.56) per share, basic and diluted, compared to a net loss of $(163.4) million, or $(1.22) per share, basic and diluted for the same period in 2023. 20 24 Financial Guidance The Company has updated its operating expense guidance for the full-year 2024, which includes the upfront in-process research and development expense associated with the clinical-stage T-cell engagers licensed through its agreement with Sanofi: (in $ millions) GAAP operating expense range: $ 660 to $ 680 The following expenses are included in the GAAP operating expense range: Upfront payment to Sanofi recognized as R&D expense in the third quarter of 2024 $103 Stock-based compensation expense $ 90 to $ 80 Restructuring charges* $ 40 to $ 30 * Restructuring charges include employee severance cash payouts, as well as non-cash expense related to the closing of two R&D sites previously announced on December 13, 2023. The GAAP operating expense guidance does not include the effect of GAAP adjustments caused by events that may occur subsequent to the publication of this guidance, including, but not limited to, business development activities, litigation, in-process R&D impairments, and changes in the fair value of contingent considerations. Conference Call Vir will host a conference call to discuss the third quarter results at 1:30 p.m. PT / 4:30 p.m. ET today. A live webcast will be available on https://investors.vir.bio/ and will be archived on www.vir.bio for 30 days. About Tobevibart (VIR-3434) Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen. It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes, and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart, which incorporates Xencor’s Xtend™ and other Fc technologies, has been engineered to have an extended half-life and was identified using Vir’s proprietary monoclonal antibody discovery platform. Tobevibart is administered subcutaneously, and it is currently in clinical development for treatment of patients with chronic hepatitis B and patients with chronic hepatitis delta. About Elebsiran (VIR-2218) Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. Current data indicates that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously, and it is currently in clinical development for treatment of patients with chronic hepatitis B and patients with chronic hepatitis delta. It is the first asset in Vir’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical studies. About VIR-5818, VIR-5500, VIR-5525 VIR-5818, VIR-5500, VIR-5525 are investigational, clinical candidates currently being evaluated for the treatment of solid tumors. These assets leverage the PRO-XTEN™ masking technology with three different T-cell engagers (TCEs) targeting HER2, PSMA, and EGFR, respectively. TCEs are powerful anti-tumor agents that direct the immune system, specifically T-cells, to destroy cancer cells. The PRO-XTEN™ masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs leading to killing of cancer cells. By driving the activity exclusively to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with TCEs and increase their efficacy and tolerability. Additionally, the mask also helps drug candidates stay in the bloodstream longer in their inactive form, allowing them to better reach the site of action and potentially allowing more convenient dosing regimens for patients and clinicians. About Vir Biotechnology, Inc. Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Vir’s clinical-stage portfolio includes infectious disease programs for chronic hepatitis delta and chronic hepatitis B infections, in addition to programs across several clinically validated targets in solid tumor indications. Vir also has a preclinical portfolio of programs across a range of other infectious diseases and oncologic malignancies. Vir routinely posts information that may be important to investors on its website. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “should,” “could,” “may,” “might,” “will,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir’s expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding; Vir’s cash balance; Vir’s future financial and operating results and its expectations related thereto including Vir’s financial guidance; Vir’s ability to realize the anticipated benefits from the exclusive worldwide license agreement with Sanofi; potential of, and expectations for, Vir’s pipeline; Vir’s clinical and preclinical development programs; clinical studies, including the enrollment of clinical studies, and the expected timing of data readouts and presentations; the potential benefits, safety, and efficacy of Vir’s investigational therapies; Vir’s strategy and plans; and risks and uncertainties associated with drug development and commercialization. Many factors may cause differences between current expectations and actual results, including whether or when anticipated cost reductions will be achieved; unexpected safety or efficacy data or results observed during clinical studies or in data readouts; the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; difficulties in collaborating with other companies; successful development and/or commercialization of alternative product candidates by Vir’s competitors; changes in expected or existing competition; delays in or disruptions to Vir’s business or clinical studies due to geopolitical changes or other external factors; failure to achieve any necessary regulatory approvals; the timing and amount of actual expenses, including, without limitation, Vir’s anticipated combined GAAP R&D and SG&A expenses; and unexpected litigation or other disputes. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. PRO-XTEN™ is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company. VIR BIOTECHNOLOGY, INC. Condensed Consolidated Balance Sheets (in thousands, except share and per share data) (unaudited) September 30, 2024 December 31, 2023 ASSETS CURRENT ASSETS: Cash and cash equivalents $ 168,350 $ 241,576 Short-term investments 740,607 1,270,980 Restricted cash and cash equivalents, current 89,598 13,268 Equity investments 5,517 9,853 Prepaid expenses and other current assets 43,085 52,549 Total current assets 1,047,157 1,588,226 Intangible assets, net 19,258 22,565 Goodwill 16,938 16,937 Property and equipment, net 64,791 96,018 Operating lease right-of-use assets 60,779 71,182 Restricted cash and cash equivalents, noncurrent 6,382 6,448 Long-term investments 271,495 105,275 Other assets 11,556 12,409 TOTAL ASSETS $ 1,498,356 $ 1,919,060 LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES: Accounts payable $ 7,305 $ 6,334 Accrued and other liabilities 94,658 104,220 Deferred revenue, current 15,198 64,853 Total current liabilities 117,161 175,407 Operating lease liabilities, noncurrent 93,405 111,673 Contingent consideration, noncurrent 33,170 25,960 Other long-term liabilities 13,893 15,784 TOTAL LIABILITIES 257,629 328,824 Commitments and contingencies (Note 8) STOCKHOLDERS’ EQUITY: Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of September 30, 2024 and December 31, 2023; no shares issued and outstanding as of September 30, 2024 and December 31, 2023 — — Common stock, $0.0001 par value; 300,000,000 shares authorized as of September 30, 2024 and December 31, 2023; 136,706,350 and 134,781,286 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively 14 13 Additional paid-in capital 1,894,781 1,828,862 Accumulated other comprehensive gain (loss) 1,127 (815 ) Accumulated deficit (655,195 ) (237,824 ) TOTAL STOCKHOLDERS’ EQUITY 1,240,727 1,590,236 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 1,498,356 $ 1,919,060 VIR BIOTECHNOLOGY, INC. Condensed Consolidated Statements of Operations ( in thousands, except share and per share data ) (unaudited) Three Months Ended September 30, 2024 2023 Revenues: Collaboration revenue $ (1,102 ) $ (4,387 ) Contract revenue 1,391 289 Grant revenue 2,091 6,737 Total revenues 2,380 2,639 Operating expenses: Cost of revenue 50 38 Research and development 195,178 145,028 Selling, general and administrative 25,744 40,933 Restructuring, long-lived assets impairment and related charges 12,712 3,372 Total operating expenses 233,684 189,371 Loss from operations (231,304 ) (186,732 ) Other income: Change in fair value of equity investments 1,130 (2,707 ) Interest income 17,527 21,931 Other (expense) income, net (893 ) 882 Total other income 17,764 20,106 Loss before (provision for) benefit from income taxes (213,540 ) (166,626 ) (Provision for) benefit from income taxes (177 ) 3,213 Net loss (213,717 ) (163,413 ) Net loss attributable to noncontrolling interest — — Net loss attributable to Vir $ (213,717 ) $ (163,413 ) Net loss per share attributable to Vir, basic and diluted $ (1.56 ) $ (1.22 ) Weighted-average shares outstanding, basic and diluted 136,653,753 134,289,620

Phase 2Phase 1Financial StatementLicense out/inExecutive Change

100 Deals associated with Peginterferon alfa-2a

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

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Hepatitis B	JP	Chugai Pharmaceutical Co., Ltd.	16 Oct 2003
Hepatitis C	JP	Chugai Pharmaceutical Co., Ltd.	16 Oct 2003
Hepatitis B, Chronic	EU	Pharma& Schweiz GmbH	20 Jun 2002
Hepatitis B, Chronic	IS	Pharma& Schweiz GmbH	20 Jun 2002
Hepatitis B, Chronic	LI	Pharma& Schweiz GmbH	20 Jun 2002
Hepatitis B, Chronic	NO	Pharma& Schweiz GmbH	20 Jun 2002
Hepatitis C, Chronic	EU	Pharma& Schweiz GmbH	20 Jun 2002
Hepatitis C, Chronic	IS	Pharma& Schweiz GmbH	20 Jun 2002
Hepatitis C, Chronic	LI	Pharma& Schweiz GmbH	20 Jun 2002
Hepatitis C, Chronic	NO	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	EU	Pharma& Schweiz GmbH	27 Jun 2024
Thrombocythemia, Essential	NDA/BLA	EU	Pharma& Schweiz GmbH	27 Jun 2024
Compensated cirrhosis	Phase 3	JP	Chugai Pharmaceutical Co., Ltd.	01 Jun 2006
Chronic hepatitis C genotype 3	Phase 3	DE	Hoffmann-La Roche, Inc.	01 Nov 2005
Hepatitis D, Chronic	Phase 3	RO	Hoffmann-La Roche, Inc.	01 Oct 2005
Complete atrioventricular block	Phase 3	IT	Hoffmann-La Roche, Inc.	01 Jul 2005
Coinfection	Phase 3	BE	Hoffmann-La Roche, Inc.	01 Mar 2005
HIV Infections	Phase 3	BE	Hoffmann-La Roche, Inc.	01 Mar 2005
Kidney Failure, Chronic	Phase 3	AT	Hoffmann-La Roche, Inc.	01 Jun 2004
Kidney Failure, Chronic	Phase 3	BR	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	mmqokparet(osfafixzcn) = quegmeudti rcryfjcjbl (htfzwiafmd, 58.7 - 100) View more	Positive	01 Feb 2024
WCD2023	Not Applicable	Cutaneous T-Cell Lymphoma	105	PEG IFN a-2a	oxiztmxhhy(rgesqcuttn) = twzgkpjkyr upukeytwlc (fvkxosacts ) View more	-	08 Jul 2023
Pubmed	Not Applicable	Hepatitis B, Chronic	201	Tenofovir disoproxil fumarate (TDF) + Peginterferon (PegIFN) alfa-2a	xzkxmxixup(wtdekbybhu) = totvfemumu lntvrnuvbz (jxbbekofco )	-	05 Jan 2023
Pubmed	Not Applicable	Hepatitis B, Chronic	201	Tenofovir disoproxil fumarate (TDF) alone	xzkxmxixup(wtdekbybhu) = ykitkhwrcz lntvrnuvbz (jxbbekofco )	-	05 Jan 2023
NCT01369212 (HBRN, CTgov)	Phase 3	Hepatitis B, Chronic	201	Tenofovir (Tenofovir)	fpdenijkld(whzkutngtv) = ryistilcnz estawkgfxu (qoncpquxcn, xxaucujbye - agwsgjxtiq) View more	-	12 Oct 2022
NCT01369212 (HBRN, CTgov)	Phase 3	Hepatitis B, Chronic	201	tenofovir+Pegasys (Peginterferon-alfa 2a and Tenofovir)	fpdenijkld(whzkutngtv) = myjxbxfbwr estawkgfxu (qoncpquxcn, lahagojsqo - jueaindnck) View more	-	12 Oct 2022
NCT02328755 (CTgov)	Phase 1/2	Acute Myeloid Leukemia \| Leukemic Infiltration	37	Hematopoietic Cell Transplant (HCT)+peg-IFN-α+Tacrolimus+Methotrexate	wqijcfngqr(cojwxqmtyc) = wygbthvshs tavarwqtzc (qsaejcajcr, phnhrixstk - orhphvuhdo) View more	-	06 Oct 2021
NCT02328755 (Pubmed \| Blood Adv)	Phase 1/2	Relapsing acute myeloid leukemia	37	pegIFNα	uuowbvopxx(osdsvqpkdm) = xawtoqbmth dqvrpufnjx (pmujmgkwiy ) View more	-	04 Oct 2021
EASL2020	Not Applicable	-	30	Bulevirtide 10 mg + Peginterferon alfa-2a	inzvqyiwyg(juivmztfow) = dmfmfghlca hbolgvqcsk (zfzccttbrh ) View more	-	27 Aug 2020
EASL2020	Not Applicable	-	30	Bulevirtide 10 mg	inzvqyiwyg(juivmztfow) = zdtreqlpea hbolgvqcsk (zfzccttbrh ) View more	-	27 Aug 2020
EASL2020	Not Applicable	Hepatitis B \| Hepatitis D HBsAg components \| HDV RNA \| HBV DNA ... View more	26	PEG-IFN	zbkeomsxzl(iddltichpy) = mumffmhwse hzrdekzgwm (vkixxjbpst ) 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)	qlohtxvdhl(xxhyoggsxv): P-Value = <0.0001 View more	-	18 Feb 2020
NCT01524679 (PADD-ON, CTgov)	Phase 2	Hepatitis B, Chronic	170	nucleos(t)ide (Control Group)	qlohtxvdhl(xxhyoggsxv): P-Value = <0.0001 View more	-	18 Feb 2020

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