Annuncio • May 20
Vir Biotechnology, Inc. Presents Complete Week 96 Data from Phase 2 Solstice Clinical Trial in Hepatitis Delta Vir Biotechnology, Inc. announced the Company will present data from the Phase 2 SOLSTICE trial evaluating the combination of tobevibart and elebsiran for chronic hepatitis delta at the upcoming EASL Congress 2026 in Barcelona, Spain, May 27-30, 2026.
CHD is the most severe form of chronic viral hepatitis and was recently classified as carcinogenic by the International Agency for Research on Cancer. People living with the disease rapidly progress to cirrhosis, liver failure and liver-related death. Because ongoing hepatitis delta virus (HDV) replication drives disease progression, achieving undetectable virus, as defined by HDV RNA TND (target not detected), is considered an important virologic marker associated with improved clinical outcomes in CHD. Individuals with CHD who have detectable HDV RNA are at a higher risk of experiencing any liver-related event, including developing compensated and decompensated cirrhosis, hepatocellular carcinoma, liver transplantation and mortality, compared to patients with undetectable HDV RNA. There are currently no approved treatments in the U.S., and options are limited in the European Union and globally. Tobevibart and elebsiran are investigational agents being evaluated as a novel combination regimen administered monthly as two separate sequential subcutaneous injections for the treatment of CHD. The combination is designed to disrupt the HDV life cycle at multiple points by addressing both viral entry and the sustained presence of hepatitis B surface antigen (HBsAg) that enables ongoing HDV replication. Tobevibart is an investigational broadly neutralizing monoclonal antibody (mAb) targeting HBsAg. 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 was identified using Vir Biotechnology’s proprietary mAb discovery platform. The Fc domain has been engineered to increase immune engagement and clearance of HBsAg immune complexes and incorporates Xencor’s Xtend™ technology to extend half-life. Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) licensed from Alnylam Pharmaceuticals, Inc. It is designed to degrade hepatitis B virus RNA transcripts and limit the production of HBsAg. Annuncio • Apr 17
Vir Biotechnology, Inc., Annual General Meeting, May 26, 2026 Vir Biotechnology, Inc., Annual General Meeting, May 26, 2026. Annuncio • Apr 14
Vir Biotechnology Announces First Patient Dosed in Phase 1 Dose-Expansion Cohorts Evaluating PSMA-Targeted PRO-XTEN Dual-Masked T-Cell Engager VIR-5500 In Patients With Metastatic Prostate Cancer Vir Biotechnology, Inc. announced that the first patient has been dosed in one of three expansion cohorts in the Phase 1 trial evaluating VIR-5500, a prostate-specific membrane antigen (PSMA)-targeted, PRO-XTEN dual-masked T-cell engager (TCE) for metastatic prostate cancer (NCT05997615). The Phase 1 trial is measuring the safety and efficacy of VIR-5500 monotherapy in late-line metastatic castration-resistant prostate cancer (mCRPC), and of VIR-5500 in combination with an androgen receptor pathway inhibitor (ARPI) in early-line mCRPC and metastatic hormone-sensitive prostate cancer (mHSPC). The monotherapy expansion cohort in late-line mCRPC is the first to begin enrollment based on the monotherapy dose-escalation data that showed VIR-5500 has a favorable safety profile and promising anti-tumor activity in mCRPC. These safety and efficacy data were presented at the 2026 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium in February. Based on these data, the selected dose regimen to be evaluated in this monotherapy expansion cohort is Third Quarter 800/2000/3500 µg/kg step-up dosing. This expansion cohort will measure safety and efficacy, including Prostate-Specific Antigen (PSA) response rate and Objective Response Rate (ORR) in patients with mCRPC who are refractory following treatment with multiple prior lines of therapy including at least one second-generation ARPI and one taxane regimen in addition to standard-of-care radioligand-based therapy. Dose-escalation of VIR-5500 in combination with enzalutamide continues in early-line mCRPC patients. The Company anticipates dosing of first patients in the combination dose-expansion cohorts in both early-line mCRPC and mHSPC over the coming months, followed by pivotal Phase 3 trials in 2027. Annuncio • Feb 26
Vir Biotechnology, Inc. has completed a Follow-on Equity Offering in the amount of $150.000002 million. Vir Biotechnology, Inc. has completed a Follow-on Equity Offering in the amount of $150.000002 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 17,647,059
Price\Range: $8.5
Discount Per Security: $0.4675 Annuncio • Feb 25
Vir Biotechnology, Inc. has filed a Follow-on Equity Offering in the amount of $200 million. Vir Biotechnology, Inc. has filed a Follow-on Equity Offering in the amount of $200 million.
Security Name: Common Stock
Security Type: Common Stock Annuncio • Feb 24
Vir Biotechnology, Inc. Reports Positive Updated Phase 1 Results for Psma-Targeting, Pro-Xten®? Dual- Masked T-Cell Engager Vir-5500 in Patients with Metastatic Prostate Cancer Vir Biotechnology, Inc. announced new data from the ongoing Phase 1 clinical trial of VIR-5500, a prostate-specific membrane antigen (PSMA)-targeting, PRO-XTEN dual-masked T-cell engager (TCE) being evaluated in patients with advanced metastatic castration-resistant prostate cancer (mCRPC) who have progressed after multiple lines of therapy (NCT05997615). These data suggest that VIR-5500 monotherapy is well tolerated and exhibits promising anti-tumor activity. Data will be presented in an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium on February 26 in San Francisco, CA (Oral Abstract #17). When members of the executive team and Dr. de Bono will share the updated VIR-5500 Phase 1 data that is also being presented at the 2026 ASCO Genitourinary Cancers symposium on February 26. VIR-5500 is an investigational PRO-XTEN Dual-masked TCE currently being evaluated in an open-label, non-randomized Phase 1 clinical trial (NCT059976 15) designed to assess the safety, pharmacokinetics and preliminary efficacy in participants with metastatic castration- resistant prostate cancer (mCRPC). Vir Biotechnology's clinical development plans and expectations for VIR-5500, including protocols for and enrollment into ongoing and planned clinical trials (including monotherapy dose-expansion cohorts in late-line mCRPC and mHSPC in the second quarter of 2026, followed by pivotal Phase 3 trials in 2027), target endpoints and data readouts; Many factors may cause differences between current expectations and actual results, including, without limitation: unexpected safety or efficacy data or results observed during clinical studies or in data readouts, including the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; challenges in accessing manufacturing capacity; clinical site activation rates or clinical enrollment rates that are lower than expected; the timing and outcome of Vir Biotechnology's planned interactions with regulatory authorities, as well as general difficulties in obtaining any necessary regulatory approvals; successful development and/or commercialization of alternative product candidates by Vir Biotechnology's competitors, as well as changes in expected or existing competition; 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 studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. Annuncio • Jan 13
Vir Biotechnology, Inc. Provides Updates on Chronic Hepatitis Delta and Oncology Programs Vir Biotechnology, Inc. provided key program updates, including new positive data from the ongoing SOLSTICE Phase 2 trial in chronic hepatitis delta (CHD). Participants receiving the combination therapy of tobevibart, an investigational neutralizing monoclonal antibody (mAb), and elebsiran, an investigational small interfering RNA (siRNA), showed increased and sustained viral suppression of HDV RNA versus treatment with the antibody alone in participants who have reached Week 96 of treatment. Data from the Phase 2 SOLSTICE trial to be presented at the 44h Annual J.P. Morgan Healthcare Conference demonstrate that undetectable hepatitis delta virus RNA (HDV RNA Target Not detected, TND) was achieved and maintained by 77% (24/31) of participants receiving the combination of tobevibart and elebsiran at Week 72, and this rate increased to 88% (21/24) in the subset of participants evaluated through Week 96. Vir Biotechnology's clinical development plans and expectations for the ECLIPSE Phase 3 registrational program, including protocols for and enrollment into ongoing and planned clinical trials, target endpoints and data analyses or readouts (including the expectation of tobevibart 1 in the fourth quarter of 2026 for ECLIPSE 2 and ECLIPSE 3 in the first quarter of 2027); the therapeutic and potential of Vir Biotechnology's oncology solid tumor portfolio, preclinical pipeline and PRO-XTEN®? masking technology; Vir Biotechnology's clinical development plan and expectations for the VIR-5500 and VIR-5818 Phase 1 programs, including protocols for and enrolled by 77% (24/31) of participants receiving the combination tobevibart and Elebsiran at Week 72; and this rate increased to88% (21/24) In the subset of participants evaluated through week 96. Vir Biotechnology'sclinical development plans and expectations for theECLIPSE Phase 3 regulatory program, including protocols for and enrolling into ongoing and planned clinical trial, target endpoints and data analysis or readouts. Many factors may cause differences between current expectations and actual results, including, without limitation: unexpected safety or efficacy data or results observed during clinical studies or in data readouts, including the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; challenges in accessing manufacturing capacity; clinical site activation rates or clinical enrollment rates that are lower than expected; the timing and outcome of Vir Biotechnology's planned interactions with regulatory authorities, as well as general difficulties in obtaining any necessary regulatory approvals; successful development and/or commercialization of alternative product candidates by Vir Biotechnology's competitors, as well as changes in expected or existing competition; 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 studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. Annuncio • Nov 10
Vir Biotechnology, Inc. Announces AASLD The Liver Meeting®? Presentation & New England Journal of Medicine Publication of Phase 2 Data Demonstrating Tobevibart & Elebsiran Combination Deliver High Rates of Undetectable HDV RNA with Favorable Safety Profile Vir Biotechnology, Inc. announced that Week 48 endpoint analysis from the Company's Phase 2 SOLSTICE trial for chronic hepatitis delta (CHD) demonstrated that participants receiving a monthly dose of the combination of tobevibart and elebsiran achieved robust and sustained rates of hepatitis delta virus (HDV) RNA target not detected (TND), including those participants with cirrhosis and high baseline HDV RNA. The combination also showed alanine aminotransferase (ALT) reductions over time and a favorable safety profile. These data were presented in an oral session at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting®?, in Washington, D.C., and simultaneously published in the New England Journal of Medicine. Data demonstrate that 66% (21/32) of participants with CHD receiving a monthly dose of the combination of tobevibart and elebsiran achieved and sustained HDV RNA TND at 48 weeks. Additionally, approximately 90% of participants achieved reduction in hepatitis B surface antigen (HBsAg) to values. Annuncio • Nov 04
Vir Biotechnology, Inc. Announces Completion of Enrollment in ECLIPSE 1 Phase 3 Trial for Chronic Hepatitis Delta Vir Biotechnology, Inc. announced the completion of enrollment for ECLIPSE 1, a Phase 3 trial evaluating the safety and efficacy of the combination of tobevibart and elebsiran in patients with chronic hepatitis delta (CHD). ECLIPSE 1 is one of three trials in Vir Biotechnology's ECLIPSE registrational program for CHD, and it is designed to provide the efficacy and safety data needed for potential submission to global regulatory agencies, including in the U.S. and Europe. The last patient in ECLIPSE 1 is expected to reach the trial's primary endpoint (primary completion date) in the fourth quarter of 2026, with topline data expected in the first quarter of 2027. The objective is to eliminate the virus, and tobevibart in combination with elebsiran offers the potential to achieve this by tackling the viral lifecycle through multiple mechanisms. The significant unmet need in CHD and the potential for the combination of tobevIBart and elebsiran to provide a much-needed treatment option has been recognized by the U.S. Food and Drug Administration (FDA) with Breakthrough Therapy and Fast Track designations, and by the European Medicines Agency (EMA) with Priority Medicines (PRIME) and orphan drug designations. Annuncio • Oct 23
Vir Biotechnology, Inc. to Report Q3, 2025 Results on Nov 05, 2025 Vir Biotechnology, Inc. announced that they will report Q3, 2025 results at 4:00 PM, US Eastern Standard Time on Nov 05, 2025 Annuncio • Oct 10
Vir Biotechnology, Inc. Announces First Patient Dosed in Part 3 of Phase 1 Trial of Psma-Targeting PRO-XTEN Vir Biotechnology, Inc. announced that the first patient has been dosed in Part 3 of the Company's Phase 1 clinical trial evaluating VIR-5500 in combination with androgen receptor pathway inhibitors (ARPIs). VIR-5500 is an investigational PRO-XTEN dual-masked T-cell engager (TCE) targeting prostate-specific membrane antigen (PSMA) and will be evaluated in participants in first-line pre-taxane metastatic castration-resistant prostate cancer (mCRPC). VIR-5500 are the only dual-masked PSMA-targeting TCE currently in clinical trials. The Phase 1 clinical trial is an open-label, non-randomized study designed to assess the safety, pharmacokinetics and preliminary anti-tumor activity of VIR-5500 in collaboration with ARPIs in participants with metastatic prostate cancer. VIR-5500 is currently being evaluated in the same Phase 1 clinical trial as a monotherapy and has demonstrated promising early anti-tumor activity and a favorable safety profile in heavily pre-treated patients with mCRPC. VIR-5500 incorporates the universal PRO-XTEN®? masking technology, which is designed to enable the selective activation of the TCEs in the tumor microenvironment, mitigating damage to healthy cells and reducing toxicity. T-cell engagers (TCEs) are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. VIR-5500 are an investigational PRO-XTen®? masked TCE currently being evaluated in an open-label, non -randomized Phase 1 clinical trial (NCT05997615) designed to assess the safety, Pharmacokinetics, and preliminary efficacy of VIR-5500 In participants with metastatic castration-resistant cancer (mCRPC).VIR-5500 combines a bispecific PSMA and CD3 binding TCE with the PRO-XTEN®? masksing technology. Annuncio • Aug 06
Vir Biotechnology, Inc. Successfully Initiates All Trials in ECLIPSE Registrational Program for Chronic Hepatitis Delta Vir Biotechnology, Inc. announced the enrollment of the first participant in ECLIPSE 3. All three trials in the Company's registrational ECLIPSE program for chronic hepatitis delta (CHD) have now been initiated. ECLIPSE 3 is a Phase 2b trial designed to compare the combination of tobevibart and elebsiran to bulevirtide treatment in patients with CHD. ECLIPSE 3 will provide important supportive data to help establish access and reimbursement in key markets. CHD is the most severe form of chronic viral hepatitis,1 with people living with the disease rapidly progressing to cirrhosis, liver failure2 and liver-related death.1 The objective of therapy is to eliminate the virus. Cobevibart in combination with elebsiran offers the potential to achieve this by tackling the viral lifecycle through multiple mechanisms. The potential of the combination of tobevIBart and elebsiran has been recognized by Breakthrough Therapy and Fast Track designations from the U.S. Food and Drug Administration (FDA), along with Priority Medicines (PRIME) and orphan drug status from the European Medicines Agency (EMA). These designations support the expedited development of treatments for serious diseases where there is a significant unmet medical need. About the ECLIPSE Registrational Program: ECLIPSE is a registrational program to evaluate the safety and efficacy of tobevibart in combination with eleBSiran in patients with chronic hepatitis delta (CHD). words such as "should," "could," " may," " might," "will," "plan," "pot potential," "aim," "ex 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. Forward-looking statements contained in this press release include, but are not limited to, statements regarding: the therapeutic potential of the combination of to bevibart and Elebsiran to treat CHD and Vir Biotechnology's belief that it can establish a new standard of care in both newly diagnosed and previously treated patients with CHD; Vir Biotechnology's clinical development plans and expectations for the ECLIPSE Phase 3 registrational program, including protocols for and enrollment into ongoing and planned clinical studies, target endpoints and data readouts; Vir Biotechnology's strategy and plans; and any assumptions underlying any of the foregoing. Many factors may cause differences between current expectations and actual results, including, without limitation: unexpected safety or efficacy data or results observed during clinical studies or in data readouts, including the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; challenges in accessing manufacturing capacity; clinical site activation rates or clinical enrollment rates that are lower than expected; the timing and outcome of Vir Biotechnology's planned interactions with regulatory authorities, as well as general difficulties in obtaining any necessary regulatory approvals; successful development and/or commercialization of alternative product candidates by Vir Biotechnology's competitors, as well as changes in expected or existing competition; geopolitical changes or other external factors; and unexpected litigation or other disputes. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. 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. The actual results may vary from the anticipated results, and the variations may be material. Annuncio • Aug 01
Vir Biotechnology Initiates Second Pivotal Trial in Its Global Eclipse Registrational Program for Chronic Hepatitis Delta Vir Biotechnology, Inc. announced the enrollment of the first participant in the ECLIPSE 2 Phase 3 clinical trial, which is designed to compare the combination of tobevibart and elebsiran to continued bulevirtide monotherapy in participants with chronic hepatitis delta (CHD) who have not achieved undetectable hepatitis delta virus (HDV) RNA despite bulevirtide treatment. ECLIPSE 2 is one of three trials in Vir Biotechnology's registrational ECLIPSE program for CHD, which was initiated in March 2025.obevibart in combination with elebsiran offers the potential to achieve this by tackling the viral lifecycle through multiple mechanisms. The significant unmet need in CHD and the potential for tobevibart and Elebsiran to provide a much-needed treatment option has been recognized by the U.S. Food and Drug Administration (FDA) with Breakthrough Therapy and Fast Track designations, and by the European Medicines Agency (EMA) with Priority Medicines (PRIME) and oban drug designations. ECLIPSE is a registrational program to evaluate the safety and efficacy of tobevibart in combination with Elebsiran in patients with chronic hepatitis delta (CH D). Forward-looking statements contained in this press release include, but are not limited to, statements regarding: the therapeutic potential of the combination of tobevIBart and elebsiran To treat CHD and Vir Biotechnology's belief that it can be a highly effective and transformative treatment option for these patients; Vir Biotechnology's clinical development plans and expectations for the ECLIPSE Phase 3 registrational program, including protocols for and enrollment into ongoing and planned clinical studies, target endpoints and data readouts; Vir Biotechnology's strategy and plans; and any assumptions underlying any of the foregoing. Many factors may cause differences between current expectations and actual results, including, without limitation: unexpected safety or efficacy data or results observed during clinical studies or in data readouts, including the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; challenges in accessing manufacturing capacity; clinical site activation rates or clinical enrollment rates that are lower than expected; the timing and outcome of Vir Biotechnology's planned interactions with regulatory authorities, as well as general difficulties in obtaining any necessary regulatory approvals; successful development and/or commercialization of alternative product candidates by Vir Biotechnology's competitors, as well as changes in expected or existing competition; geopolitical changes or other external factors; and unexpected litigation or other disputes. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. 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. The actual results may vary from the actual results may vary from the time to time to time to time to date. Annuncio • Jul 24
Vir Biotechnology, Inc. Announces First Patient Dosed in Phase 1 Clinical Trial of EGFR-Targeting PRO-XTEN™? Dual- Masked T-Cell Engager VIR-5525 for the Treatment of Solid Tumors Vir Biotechnology, Inc. announced that the first patient has been dosed in the Company's Phase 1 clinical trial evaluating VIR-5525, an investigational dual-masked T-cell engager (TCE) targeting EGFR (epidermal growth factor receptor). VIR-5525 will be evaluated for the treatment of a variety of EGFR-expressing solid tumors in areas of high unmet need such as non-small cell lung cancer (NSCLC), colorectal cancer (CRC), head and neck squamous cell carcinoma (HNSCC), and cutaneous squamous cell carcinoma (cSCC). The Phase 1 clinical trial (NCT06960395) is a first-in-human open-label, non-randomized study designed to assess the safety, pharmacokinetics, and preliminary anti-tumor activity of VIR-5525 as a monotherapy and in combination with pembrolizumab. VIR-5525 is Vir Biotechnology's third dual-masked TCE in clinical trials. It incorporates the Company's clinically validated in-licensed PRO-XTEN™? masking technology, which is designed to enable the selective activation of the TCEs in the tumor microenvironment, mitigating damage to healthy cells and reducing toxicity. EGFR is a clinically validated target known to play a key role in cancer. Although EGFR-targeting therapies are available, they often face limitations due to the development of resistance mechanisms and high toxicities associated with treatment. The first patient dosing of VIR-5525 triggers a $75 million milestone payment as part of the Company's 2024 exclusive worldwide license agreement with Sanofi for the PRO-XTEN™? platform and clinical-stage T-cell engagers. This anticipated milestone payment has been held as restricted cash since the transaction closing and was included from the Company's $1.02 billion in cash, cash equivalents and investments reported as of March 31, 2025. The payment will be recognized as a research and development expense in the third quarter of 2025. Dose escalation continues for Vir Biotechnology's dual-masked TCEs VIR-5818 (targeting a variety of HER2-expressing solid tumors) and VIR-5500 (targeting PSMA in metastatic castration-resistant prostate cancer). Initial Phase 1 data presented in January 2025 [2] data presented in January 2025 [1] and VIR-5500 [2] in the first patient dosing of V IR-5525 triggers a $25 million milestone payment as part of The Company's 2024 exclusive worldwide license Agreement with Sanofi for the PRO -XTEN™? platform andclinical-stage T-cell engager. This anticipated milestone payment has be held as restricted cash since the transactions closing and was included from the company's $1.02 billion In cash, cash equivalents and investments reports as of March 31, 2025, the company's $1.2 billion in cash, cash equivalents, and investments reported as of March31, 2025. The payment will been recognized as a research and development expenses in the third quarter of 2025; Dose escalation continues for Vir biotechnology's dual-maskedTCEs VIR-58 18 (targeting a variety ofHER2-expressing solid tumors); and VIR-5500. Initial Phase 1 data presented in February 2025; and VIR-5500; Initial Phase 1 data presented in December 2021; and VIR-5525 will also be evaluated for the company's third dual-masked tCEs VIR-5819 (targeting PSMA in the tumor microenvironment; and VIR-55000 (PSMA), with compelling early clinical response signals and promising safety profiles. Annuncio • Jul 23
Vir Biotechnology, Inc. to Report Q2, 2025 Results on Aug 06, 2025 Vir Biotechnology, Inc. announced that they will report Q2, 2025 results at 4:00 PM, US Eastern Standard Time on Aug 06, 2025 Annuncio • May 09
Vir Biotechnology, Inc. Announces Preliminary 24-Week Post-End of Treatment Data for Tobevibart and Elebsiran Combinations in Chronic Hepatitis B from the March Study Vir Biotechnology, Inc. announced 24-week post-end of treatment data from Part B of the ongoing MARCH Phase 2 clinical study evaluating tobevibart and elebsiran without or with pegylated interferon alpha (PEG-IFNa) in participants with chronic hepatitis B (CHB). The study-defined primary endpoint, proportion of participants with undetectable hepatitis B surface antigen (HBsAg) at 24 weeks post-end of treatment, was achieved by 17% (3/18) and 21% (3/14) of participants with baseline HBsAgCHB is a long-lasting, inflammatory liver disease caused by the hepatitis B virus (HBV). 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. Complications from CHB may include liver cirrhosis, liver failure and liver cancer. Although CHB can be treated, there is currently no cure. Participants in the trial received tobevibart and Elebsiran without or with PEG-IFNa. Tobevibart was administered at 300 mg every 4 weeks; elebsiran, at 200 mg every 4 weeks; and PEG-IFNa, for patients receiving it, at 180 ug weekly. Participants with HBsAg loss (seroclearance) after 48 weeks of treatment who met eligibility criteria discontinued both NRTI (nucleos(t)ide reverse transcriptase inhibitor) as well as tobevibart and elebsirAN without or with PEG- IFNa treatment. Vir Biotechnology's anticipated cash runway; Vir Biotechnology's strategy and plans; and any assumptions underlying any of the foregoing. Many factors may cause differences between current expectations and actual results, including, without limitation: unexpected safety or efficacy data or results observed during clinical studies or in data readouts, including the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; challenges in accessing manufacturing capacity; clinical site activation rates or clinical enrollment rates that are lower than expected; the timing and outcome of Vir Biotechnology's planned interactions with regulatory authorities, as well as general difficulties in obtaining any necessary regulatory approvals; successful development and/or commercialization of alternative product candidates by Vir Biotechnology's competitors, as well as changes in expected or existing competition; geopolitical changes or other external factors; and unexpected litigation or other disputes. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. 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. The actual results may vary from the anticipated results, and the variations may be material. Annuncio • May 01
Vir Biotechnology, Inc. to Report Q1, 2025 Results on May 07, 2025 Vir Biotechnology, Inc. announced that they will report Q1, 2025 results After-Market on May 07, 2025 Annuncio • Apr 18
Vir Biotechnology, Inc., Annual General Meeting, May 29, 2025 Vir Biotechnology, Inc., Annual General Meeting, May 29, 2025. Annuncio • Mar 13
Vir Biotechnology, Inc. Enrolls First Patient in Phase 3 Eclipse Registrational Program for Chronic Hepatitis Delta Vir Biotechnology, Inc. announced the enrollment of the first patient in its Phase 3 ECLIPSE registrational program. The ECLIPSE registrational program is designed to evaluate the efficacy and safety of tobevibart in combination with elebsiran in people living with chronic hepatitis delta (CHD). ECLIPSE 1, the first trial of the program to be initiated, and ECLIPSE 2 are Phase 3 trials designed to provide the registrational data needed for submission to multiple regulatory agencies. ECLIPSE 3, a Phase 2b trial, is designed to provide important supportive data to help enable access and reimbursement strategies in key European markets. CHD is a debilitating inflammatory liver disease caused by the hepatitis delta virus (HDV). It is the most severe form of chronic viral hepatitis2 and on average, people living with CHD will progress to cirrhosis and liver failure within 5 years.3 There is a high unmet medical need for effective treatments, as there are no approved therapies in the U.S., and options are limited in the European Union and globally. The objective of therapy is to eliminate the virus. Tobevibart in combination with elebsiran offers the potential to achieve this by tackling the viral lifecycle through multiple mechanisms. The significant unmet need in CHD and the potential for tobevibart and elebsiran to provide a much-needed treatment option has been recognized by the U.S. Food and Drug Administration (FDA) with Breakthrough and Fast Track designations, and by the European Medicines Agency (EMA) Priority Medicines (PRIME) and orphan drug designation. ECLIPSE is a Phase 3 registrational program to evaluate the safety and efficacy of tobevibart in combination with elebsiran in patients with chronic hepatitis delta. ECLIPSE includes three randomized, controlled trials designed to evaluate the combination therapy in comparison to deferred treatment or bulevirtide. ECLIPSE 1, the first trial of the program to be initiated, is a Phase 3 trial that will assess the efficacy and safety of tobevibart and elebsiran compared to deferred treatment in regions such as the U.S. where bulevirtide is not available or other regions where its access is limited. ECLIPSE 2 is a Phase 3 trial that will evaluate the efficacy and safety of switching to tobevibart and elebsiran in people with CHD who have not achieved viral suppression with bulevirtide therapy. ECLIPSE 1 and 2 are designed to provide the registrational efficacy and safety data needed for potential submission to global regulatory agencies. ECLIPSE 3 is a Phase 2b head-to-head trial to evaluate tobevibart and elebsiran compared with bulevirtide in bulevirtide-naïve patients, and it is designed to provide important supportive data to help establish access and reimbursement in key markets. ECLIPSE 1 plans to enroll 120 participants in the U.S. or other regions where bulevirtide use is limited. Participants will be randomized 2:1 to receive either tobevibart in combination with elebsiran or deferred treatment. During the deferred treatment period, participants will receive only nucleoside reverse transcriptase inhibitors (NRTIs). After the initial delay period, participants will be switched to the combination therapy of tobevibart and elebsiran. The composite primary endpoint measures HDV RNA at the lower limit of quantification target not detected or HDV RNA TND (defined as HDV RNA < 0 IU/mL) and ALT normalization at Week 48, compared to the deferred treatment group at the end of their deferred treatment period. Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen (HBsAg). 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 was identified using Vir Biotechnology’s proprietary monoclonal antibody discovery platform. The Fc domain has been engineered to increase immune engagement and clearance of HBsAg immune complexes and incorporates Xencor’s Xtend™ technology to extend half-life. Tobevibart is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta and patients with chronic hepatitis B. Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) discovered by Alnylam Pharmaceuticals, Inc. It is 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 the treatment of patients with chronic hepatitis delta and patients with chronic hepatitis B. Annuncio • Feb 13
Vir Biotechnology, Inc. to Report Q4, 2024 Results on Feb 26, 2025 Vir Biotechnology, Inc. announced that they will report Q4, 2024 results After-Market on Feb 26, 2025 Annuncio • Jan 31
Vir Biotechnology, Inc. Announces Executive Changes On January 24, 2025, Vir Biotechnology, Inc. announced that Ann (Aine) M. Hanly, Ph.D., the Company’s Executive Vice President and Chief Technology Officer, will be leaving the Company on February 26, 2025. The Company has appointed Maninder Hora, Ph.D. to the role of Executive Vice President and Chief Technical Operations Officer, effective February 27, 2025, and Dr. Hora will assume Dr. Hanly’s responsibilities. Annuncio • Jan 08
Vir Biotechnology Announces Encouraging Safety and Efficacy Data in Ongoing Dose Escalation Trials for Dual Masked T-Cell Engagers VIR-5818 in Solid Tumors and VIR-5500 in mCRPC Vir Biotechnology, Inc. is presenting initial Phase 1 data from two of its dual-masked T-cell engagers (TCEs): VIR-5818, targeting a variety of HER2-expressing solid tumors; and VIR-5500, targeting PSMA in metastatic castration-resistant prostate cancer (mCRPC). Data show encouraging preliminary safety and efficacy profiles with no dose-limiting cytokine release syndrome (CRS), maximum tolerated dose (MTD) not yet reached as dose escalation continues, and early clinical response signals observed in heavily pretreated participants. These initial results provide clinical support for Vir Biotechnology’s in-licensed PRO-XTEN™ masking technology, which is designed to enable the selective activation of TCEs in the tumor microenvironment, mitigating damage to healthy cells and reducing toxicity. Despite availability of HER2-targeting therapies, there remains a significant unmet need for treatments with novel mechanisms of action to improve tolerability and extend survival. Currently, no HER2-directed immunotherapies are approved for solid tumors. The preliminary safety and efficacy data of VIR-5818 support the tumor-specific activation of PRO-XTENTM dual-masked TCEs and the potential of this technology to broaden the therapeutic index of TCEs. VIR-5818 is being evaluated in a Phase 1 clinical trial (NCT05356741) designed to study its safety and pharmacokinetics alone, and in combination with pembrolizumab, in participants with a variety of HER2-expressing cancers, including breast and colorectal cancer (CRC). The study has enrolled 79 heterogeneous and heavily pretreated participants in monotherapy cohorts. Early efficacy data indicate that 50% (10/20) of participants receiving VIR-5818 doses =400 µg/kg experienced dose-dependent tumor shrinkage across multiple HER2-positive tumor types. This includes participants who had received up to 9 prior lines of therapy. Strong anti-tumor activity was observed in a subset of participants with HER2-positive CRC who have exhausted standard of care. In this subset, confirmed partial responses (cPRs) were seen in 33% (2/6) of participants at early doses, and one patient continued in cPR for more than 18 months as of the data cut-off. Preliminary safety data demonstrate that VIR-5818 is generally well-tolerated, with minimal grade 1 or 2 CRS (20% and 10%, respectively) and no grade 3 or greater CRS observed in any of the 79 participants across doses up to 1000 µg/kg. Most treatment-emergent adverse events (TEAEs) were low grade, reversible and manageable. The MTD has not yet been reached. Preliminary pharmacokinetics and safety data indicate low systemic unmasking of the TCE, suggesting tumor-specific activation. Dual masking results in a half-life of approximately 6 days, which may enable a less frequent dosing regimen. As a result, Vir Biotechnology is currently evaluating a Q3W dosing regimen. Prostate cancer is the second most diagnosed cancer in men1. Despite advancements, there is still a significant unmet need for efficacious, well-tolerated treatments that can extend survival and improve quality of life. VIR-5500 is being evaluated in a Phase 1 clinical trial (NCT05997615) designed to assess its safety, pharmacokinetics, and preliminary efficacy in participants with mCRPC. The study has enrolled 18 participants with significant disease burden who have received 3 to 6 prior lines of therapy. Early efficacy data show encouraging signs of prostate-specific antigen (PSA) responses, and PSA reductions were observed in 100% (12/12) of participants after an initial dose =120 µg/kg. PSA50 response was confirmed in 58% (7/12) of participants receiving a first dose =120 µg/kg. Preliminary data show a promising safety profile, with no dose-limiting toxicities observed up to 1000 µg/kg without prophylactic corticosteroids. Safety findings showed minimal grade 1 or 2 CRS (17% and 11%, respectively) and no grade 3 or greater CRS at any dose. Most TEAEs were low grade. No hearing loss has been reported, suggesting safety benefits of dual masking in preventing on-target, off-tumor toxicities. Dose escalation is ongoing, and the MTD for VIR-5500 has not yet been reached. Preliminary pharmacokinetics and safety data indicate tumor-specific activation with minimal unmasking outside the tumor. The dual-masked TCE shows a desirable half-life of 8-10 days, which is enabling Vir Biotechnology to evaluate a Q3W dosing regimen. The safety and tolerability profile observed for VIR-5500 in ongoing dose escalation, together with the observed signs of early anti-tumor activity at low doses, may enable a wide therapeutic index. Annuncio • Dec 13
Vir Biotechnology, Inc. Receives FDA Breakthrough Therapy Designation and Ema Prime Designation for Tobevibart and Elebsiran in Chronic Hepatitis Delta Vir Biotechnology, Inc. announced that tobevibart and elebsiran have received U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation and European Medicines Agency (EMA) Priority Medicines (PRIME) designation for the treatment of chronic hepatitis delta (CHD). The designations are supported by compelling positive safety and efficacy data from the Phase 2 SOLSTICE trial, from which the Company recently presented new data at AASLD The Liver Meeting in San Diego, U.S. Vir Biotechnology's Phase 3 ECLIPSE registrational program evaluating tobevibart and Elebsiran in CHD will commence in the first half of 2025. CHD is a chronic, progressive liver disease caused by the hepatitis delta virus1 and is the most severe form of chronic viral hepatitis2. FDA Breakthrough Therapy designation aims to expedite the development and regulatory reviews of investigational therapies for serious conditions that demonstrate promising preliminary clinical evidence and potential improvement over existing therapies. EMA PRIME designation is granted to investigational medicines that target conditions with unmet medical needs for which no treatment option exists, or where they can offer a major therapeutic advantage over existing treatments. It fosters early exchange with the EMA to facilitate robust data collection, high-quality marketing authorization applications and expedited evaluations so that medicines can reach patients earlier. These designations follow FDA Fast Track designation and EMA Committee for Orphan Medicinal Products (COMP) positive opinion on orphan drug designation received earlier this year. Annuncio • Nov 19
Vir Biotechnology, Inc. Presents Positive Chronic Hepatitis Delta Clinical Trial Data and Announces Initiation of Phase 3 Registrational Program Vir Biotechnology, Inc. announced positive results from the SOLSTICE Phase 2 clinical trial evaluating tobevibart alone, or in combination with elebsiran, in people with chronic hepatitis delta (CHD). The most-advanced and potential first-of-its-kind investigational human monoclonal antibody and siRNA combination dosed monthly achieved 100% virologic response and rapid hepatitis delta virus (HDV) RNA suppression. HDV RNA below the lower limit of quantification (These data were presented in an oral session at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting, in San Diego, CA. Based on these results, and following a recent meeting with the FDA, Vir Biotechnology plans to initiate the Phase 3 registrational ECLIPSE program in the first half of 2025 to further evaluate the combination of tobevibart and elebsiran for the treatment of CHD. CHD is a chronic inflammatory liver disease caused by HDV. It is the most severe form of chronic viral hepatitis and on average, people living with CHD will progress to cirrhosis and liver failure within 5 years. There is no approved treatment in the United States. The objective of therapy is to clear the virus, and combination therapy offers the potential to do so by tackling the viral lifecycle through multiple mechanisms. Primary Endpoint Analysis from the Phase 2 SOLSTICE TrialClinical trial participants were randomized to receive tobevibart 300 mg monotherapy every two weeks (n=33) or a combination of tobevibart 300 mg and elebsiran 200 mg every four weeks (combination de novo arm, n=32). In addition, the participants from previous tobevibart or elebsiran monotherapy cohorts could rollover to receive the combination of tobevibart 300 mg and elebsiran 200 mg every four weeks (combination rollover, n=13). Rates of virologic suppression were evaluated at Week 24, and further assessed at Weeks 36, 48 and 60 in those participants that had reached each timepoint. Further monitoring will continue up to 192 weeks. Rapid and Sustained Virologic Suppression – 100% of participants across combination arms achieved an HDV RNA =2 log10 decrease or below limit of detection (LOD) at Week 24, and this rate was sustained over time in all participants at Weeks 36 (22/22) and those in the rollover cohort that reached Week 60 (5/5). HDV RNA TND was achieved in 41% (13/32) of participants across combination arms at Week 24 and this rose to 64% (14/22) at Week 36. By week 60, this had risen further with 80% (4/5) of participants in the rollover cohort having achieved no detectable viral RNA. Approximately 90% of participants receiving the combination achieved reductions in hepatitis B surface antigen (HBsAg) values below <10 IU/mL at Week 24, with sustained responses at later time points. This indicates suppression of the key biologic mechanisms that HDV requires for viral replication. ALT Normalization – Alanine aminotransferase (ALT) decreased in most participants between Day 1 and Week 24 and normalized in 47% (15/32) of participants in the combination de novo cohort and 56% (5/9) in the rollover cohort by Week 24. These rates were sustained at Week 36. Combined Endpoints – The protocol defined combined endpoint of HDV RNA decrease = 2 log10 compared to baseline or HDV RNA below LOD and ALT normalization at Week 24 was observed in 47% (15/32) of participants in the combination de novo arm. The more stringent composite endpoint of HDV RNA TND and ALT normalization was achieved in 19% (6/32) of participants in the combination de novo arm at Week 24, which increased to 27% (6/22) by Week 36. This trend was reflected in the combination rollover cohort in which 33% (3/9) of participants achieved this endpoint at Week 24 and 40% (2/5) at Week 60. Rates of HDV RNA suppression and ALT normalization were similar between non-cirrhotic and cirrhotic participants across combination arms. Safety Profile – The safety profile of tobevibart and elebsiran is consistent with previous studies. Treatment-emergent adverse events (TEAEs) were generally mild or moderate and transient across all treatment groups, with influenza-like illness being the most common event. No ALT flares were observed. There were no study-related discontinuations in the combination arms, and no treatment-related severe adverse events (SAEs) were reported. Phase 3 Registrational ECLIPSE ProgramFollowing a meeting with the FDA, Vir Biotechnology finalized the design of the Phase 3 registrational clinical program, ECLIPSE, which evaluates the tobevibart and elebsiran combination in people living with CHD. This program, which will commence in the first half of 2025, will include three randomized, controlled trials designed to evaluate the combination therapy in comparison to deferred treatment or bulevirtide. All studies will enroll both cirrhotic and non-cirrhotic participants. ECLIPSE 1 and 2 are Phase 3 trials designed to provide the registrational efficacy and safety data needed for submission to global regulatory agencies. ECLIPSE 3 is a Phase 2b trial designed to provide important supportive data, particularly in Europe, to help establish appropriate pricing and reimbursement in key markets. ECLIPSE 1 will assess the efficacy and safety of tobevibart and elebsiran compared to deferred treatment in regions such as the U.S. where bulevirtide is not available or its use is limited. ECLIPSE 2 will evaluate the efficacy and safety of switching to tobevibart and elebsiran in people with CHD who have not achieved viral suppression with bulevirtide therapy. ECLIPSE 3 is a Phase 2b head-to-head trial to evaluate tobevibart and elebsiran compared with bulevirtide in bulevirtide-naïve patients. Annuncio • Nov 15
Vir Biotechnology, Inc. Announces Positive End-Of-T Treatment Results for Tobevibart and Elebsiran Combinations in Chronic Hepatitis B from the March Study at AASLD The Liver Meeting Vir Biotechnology, Inc. 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-IFNa), 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. Chronic hepatitis B (CHB) is a long-lasting, inflammatory liver disease caused by the hepatitis B virus (HBV). 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. Complications from CHB may include liver cirrhosis, liver failure and liver cancer. Although CHB can be treated, there is no cure. Participants in the trial received tobevibart and elebsiran alone (doublet regimen) or in combination with PEG-IFNa (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-IFNa 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. 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. Annuncio • Oct 18
Vir Biotechnology, Inc. to Report Q3, 2024 Results on Oct 31, 2024 Vir Biotechnology, Inc. announced that they will report Q3, 2024 results on Oct 31, 2024 Annuncio • Jul 19
Vir Biotechnology, Inc. to Report Q2, 2024 Results on Aug 01, 2024 Vir Biotechnology, Inc. announced that they will report Q2, 2024 results After-Market on Aug 01, 2024 Annuncio • Jun 27
Vir Biotechnology, Inc. Receives FDA IND Clearance and Fast Track Designation for Tobevibart and Elebsiran for the Treatment of Chronic Hepatitis Delta Infection Vir Biotechnology, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application and granted Fast Track designation for the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta infection. Tobevibart, an investigational monoclonal antibody, and elebsiran, an investigational small interfering ribonucleic acid, are currently being evaluated in the Company’s Phase 2 SOLSTICE hepatitis delta clinical trial, with complete 24-week treatment data on track to be reported in the fourth quarter. The FDA’s Fast Track designation is intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The World Health Organization considers hepatitis delta to be the most severe form of chronic viral hepatitis due to more rapid progression towards liver cancer and liver-related death. It is estimated that at least 12 million people are living with chronic hepatitis delta globally. In June, the Company announced preliminary Phase 2 SOLSTICE trial data which suggests treatment with tobevibart alone or in combination with elebsiran was generally well tolerated and participants achieved high rates of virologic response at weeks 12 and 24, durable virologic response through 48 weeks, and high rates of ALT normalization. The complete 24-week treatment data is expected in the fourth quarter. The Company is working to expedite the initiation of its next study, the ECLIPSE trial. The open-label, randomized, controlled ECLIPSE trial is designed to support potential registration and will evaluate the safety and efficacy of a monthly-administered subcutaneous injection of tobevibart and elebsiran using the current standard of care therapy as a comparator. About the Phase 2 SOLSTICE Trial: The SOLSTICE trial (NCT05461170) is evaluating the safety, tolerability and efficacy of tobevibart and elebsiran for the treatment of people living with chronic hepatitis delta. One cohort is evaluating the combination of tobevibart and elebsiran dosed every 4 weeks with a second cohort evaluating tobevibart monotherapy every 2 weeks. Approximately 50% of participants have compensated cirrhosis. Tobevibart is an investigational subcutaneously administered antibody designed to inhibit entry of hepatitis B and hepatitis delta viruses into hepatocytes, neutralize both hepatitis B virus and hepatitis delta virus virions, and to reduce the level of virions 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. Elebsiran is an investigational subcutaneously administered 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. Vir believes it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially could result in an increased therapeutic index. Elebsiran is the first asset in the Company’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical trials. Annuncio • Jun 06
Vir Biotechnology, Inc. Announces New Preliminary Data from its Phase 2 SOLSTICE Hepatitis Delta Clinical Trial Evaluating tobevibart, an Investigational Monoclonalantibody, and Elebsiran Vir Biotechnology, Inc. announced new preliminary data from its Phase 2 SOLSTICE hepatitis delta clinical trial evaluating tobevibart, an investigational monoclonal antibody, and elebsiran, an investigational small interfering ribonucleic acid, for the treatment of people living with chronic hepatitis delta. Preliminary data from the Phase 2 trial show treatment with tobevibart alone or in combination with elebsiran was generally well tolerated and participants achieved high rates of virologic response at weeks 12 and 24, durable virologic response through 48 weeks, and high rates of ALT normalization. Preliminary data from the six participants reported on at the 2023 American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® demonstrated sustained virologic response: These participants received 12 weeks of either tobevibart or elebsiran monotherapy and then rolled over into combination therapy. All 6 participants remain on treatment. At the time of the analysis, 5 out of the 6 participants had reached 48 weeks of combination therapy and 1 had reached 40 weeks of combination therapy. All 6 participants showed sustained virologic response at time of last visit 100% (6 of 6) achieved HDV RNA < limit of detection (LOD) or = 2 log10 IU/mL decrease from baseline 50% (3 of 6) achieved ALT normalization 50% (3 of 6) achieved the combined endpoint Furthermore, 100% (6 of 6) achieved HDV RNA < the lower limit of quantification (LLOQ), 100% (6 of 6) achieved HDV RNA < LOD, and 83% (5 of 6) achieved HDV RNA target not detected (TND) The majority of adverse events were Grade 1-2 and transient in nature with no reported serious adverse events, no ALT flares and no Grade 2 or higher elevations in liver function tests (LFTs) were observed. Preliminary de novo combination of tobevibart + elebsiran (monthly dosing) data demonstrated rapid and high rates of virologic suppression and ALT normalization: Week 12: Among 27 participants 100% (27 of 27) achieved HDV RNA < LOD or = 2 log10 IU/mL decrease from baseline 44% (12 of 27) achieved ALT normalization 44% (12 of 27) achieved the combined endpoint Furthermore, 52% (14 of 27) achieved HDV RNA < LLOQ, 37% (10 of 27) achieved HDV RNA < LOD, and 15% (4 of 27) achieved HDV RNA TND Week 24: Among 11 participants 100% (11 of 11) achieved HDV RNA < LOD or = 2 log10 IU/mL decrease from baseline 64% (7 of 11) achieved ALT normalization 64% (7 of 11) achieved the combined endpoint Furthermore, 100% (11/11) achieved HDV RNA < LLOQ, 91% (10 of 11) achieved HDV RNA < LOD, and 55% (6 of 11) achieved HDV RNA TND Similar rates of virologic suppression and ALT normalization were observed in participants who are non-cirrhotic (n=6) and those with compensated cirrhosis (CPT-A, n=5). The majority of adverse events were Grade 1-2 and transient in nature with no treatment-related serious adverse events, no ALT flares and no Grade 2 or higher elevations in LFTs were observed. Preliminary tobevibart monotherapy (twice monthly dosing) data demonstrated high rates of virologic suppression and ALT normalization: Week 12: Among 26 participants 73% (19 of 26) achieved HDV RNA < LOD or = 2 log10 IU/mL decrease from baseline 54% (14 of 26) achieved ALT normalization 38% (10 of 26) achieved the combined endpoint Furthermore, 27% (7 of 26) achieved HDV RNA < LLOQ, 19% (5 of 26) achieved HDV RNA < LOD, and 8% (2 of 26) achieved HDV RNA TND Week 24: Among11 participants 55% (6 of 11) achieved HDV RNA < LOD or = 2 log10 IU/mL decrease from baseline 64% (7 of 11) achieved ALT normalization 55% (6 of 11) achieved the combined endpoint* Furthermore, 55% (6 of 11) achieved HDV RNA < LLOQ, 46% (5 of 11) achieved HDV RNA The majority of adverse events were Grade 1-2 and transient in nature with no serious adverse events, no ALT flares and no Grade 2 or higher elevations in LFTs were observed. Annuncio • May 30
Vir Biotechnology, Inc. Appoints Mark D. Eisner as Executive Vice President and Chief Medical Officer, Effective June 3, 2024 Vir Biotechnology, Inc. announced that Mark D. Eisner, M.D., M.P.H. will join the company as Executive Vice President and Chief Medical Officer (CMO), effective June 03, 2024. Dr. Eisner will be a part of the company’s Executive Management Team and will report directly to Marianne De Backer, M.Sc., Ph.D., MBA, Vir’s Chief Executive Officer. Dr. Eisner comes from Sonoma Biotherapeutics, Inc., where he most recently held the position of CMO. In this role, he led all development functions which included biometrics, regulatory, clinical science, clinical operations, drug safety, and pharmacology. Prior to his most recent tenure with Sonoma Biotherapeutics, Dr. Eisner served as CMO at FibroGen where he led all development functions, which included being the Head of China clinical development and clinical operations. Dr. Eisner has also been with Genentech nearly 11 years and served as their Senior Vice President of Global Head of Product Development Immunology, Infectious Disease and Ophthalmology and was accountable for late-stage clinical development of many products including strategy, clinical trials and budget. He brings to Vir deep immunology and infectious disease expertise with clinical development experience. Dr. Eisner has an impressive track record of leading teams during times of strategically evolving portfolios. Dr. Eisner completed his A.B. degree in human biology at Stanford University and his M.D. degree at the University of Pennsylvania School of Medicine. He also has an M.P.H. focusing on epidemiology from the University of California Berkeley, School of Public Health. He has an impressive list of publications and patents, honors and awards, and services for professional organizations. Annuncio • Apr 21
Vir Biotechnology, Inc., Annual General Meeting, May 29, 2024 Vir Biotechnology, Inc., Annual General Meeting, May 29, 2024, at 09:00 Pacific Standard Time. Agenda: To elect the Board of Directors’ four nominees for director named herein to hold office until the 2027 Annual Meeting of Stockholders, and until their successor is duly elected and qualified, or until their earlier death, resignation or removal; to approve, on an advisory basis, the compensation of the Company’s named executive officers; to ratify the appointment by the Audit Committee of the Board of Directors of Ernst & Young LLP as the Company’s independent registered public accounting firm for fiscal year ending December 31, 2024; and to consider other matters. Annuncio • Apr 12
Vir Biotechnology, Inc. to Report Q1, 2024 Results on May 02, 2024 Vir Biotechnology, Inc. announced that they will report Q1, 2024 results After-Market on May 02, 2024 Annuncio • Mar 05
Vir Biotechnology Completes Enrollment of Phase 2 Chronic Hepatitis Delta SOLSTICE Trial Ahead of Schedule Vir Biotechnology, Inc. announced that its Phase 2 SOLSTICE clinical trial evaluating the safety, tolerability and efficacy of tobevibart and elebsiran for the treatment of people living with chronic hepatitis delta (CHD) virus has completed enrollment of its current cohorts one month earlier than anticipated. This includes over 60 participants in two additional cohorts – one evaluating tobevibart given every 2 weeks and the other evaluating the combination of tobevibart and elebsiran given every 4 weeks. Initial data are expected in the second quarter of 2024. Of the participants dosed, approximately 50% have compensated cirrhosis. In the second quarter, the Company expects to report additional 12-week treatment data on 30 participants (15 per regimen) and 24-week treatment data on 20 participants (10 per regimen). Additional 24-week treatment data for all participants is expected in the fourth quarter of 2024. SOLSTICE is a Phase 2 multi-center, open-label trial designed to evaluate the safety, tolerability, and efficacy of tobevibart and elebsiran in adult participants (age 18 to 69) with CHD infection receiving nucleot(s)ide reverse transcriptase inhibitor therapy. Depending on the cohort, trial participants are receiving multiple doses of tobevibart and elebsiran as either monotherapy or in combination administered via subcutaneous injection for up to 88 weeks. The primary endpoints of the trial are the proportion of study participants achieving either a = 2log10 decrease in HDV RNA compared to baseline or HDV RNA less than the limit of detection and normalization of alanine transaminase (ALT) at Week 24. Annuncio • Feb 21
Vir Biotechnology, Inc. Announces Phil Pang Will Step Down as Chief Medical Officer Vir Biotechnology, Inc. announced that Executive Vice President, and Chief Medical Officer, Phil Pang, M.D., Ph.D., has decided to leave the company at the end of March 2024 to spend more time with his family. Annuncio • Feb 02
Vir Biotechnology, Inc. to Report Q4, 2023 Results on Feb 22, 2024 Vir Biotechnology, Inc. announced that they will report Q4, 2023 results on Feb 22, 2024 Annuncio • Oct 31
Vir Biotechnology, Inc. Appoints Jennifer Towne, Ph.D., as Executive Vice President and Chief Scientific Officer Vir Biotechnology, Inc. announced the appointment of Jennifer Towne, Ph.D., as Executive Vice President and Chief Scientific Officer, effective November 6, 2023. Dr. Towne will be responsible for leading the Company’s research function from basic research through scale-up manufacturing and the introduction of drug candidates to clinical trials. She will report to Vir’s Chief Executive Officer Marianne De Backer, M.Sc., Ph.D., MBA, and will join the Company’s Executive Management Team. Dr. Towne joins Vir from The Janssen Pharmaceutical Companies of Johnson & Johnson, where she spent nine years holding immunology research leadership roles of increasing responsibility within Research and Development. In her most recent role as Senior Vice President, Immunology Discovery and External Innovation, she was responsible for advancing disease understanding and development of innovative therapeutics across autoimmune and inflammatory diseases as well as for bringing the most promising early innovation into Janssen to support the immunology portfolio. Prior to Janssen, Dr. Towne held a variety of scientific roles during her 13 years at Amgen. During the course of her career, Dr. Towne led the development of 16 drug candidates from preclinical research to IND and clinical development. Dr. Towne earned her Ph.D. from the Department of Molecular Genetics, Biochemistry, and Microbiology at the University of Cincinnati College of Medicine in Cincinnati, Ohio. She also holds a bachelor’s in biochemistry and a bachelor’s in biology from the Department of Chemistry and Department of Biology at Whitworth University in Spokane, WA. Annuncio • Oct 12
Vir Biotechnology, Inc. Announces Multiple Abstracts Highlighting New Chronic Hepatitis B and Hepatitis Delta Data Accepted for Presentation at AASLD’s the Liver Meeting® 2023 Vir Biotechnology, Inc. announced that eight abstracts highlighting new data from its chronic hepatitis B (CHB) and chronic hepatitis delta (CHD) clinical programs have been accepted for presentation at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting®, taking place in Boston, MA, from November 10-14, 2023. These include seven poster presentations, one of which is a late-breaking poster, and one late-breaking oral presentation. Chronic hepatitis B (CHB) infection remains an urgent global public health challenge associated with significant morbidity and mortality. Approximately 300 million people around the world are living with CHB, and approximately 900,000 of them die from associated complications each year. These patients are significantly underserved by existing therapies with low functional cure rates, lifelong daily therapy and/or poor tolerability. Vir is working to achieve a functional cure for the millions of people with CHB around the world through its broad and differentiated portfolio. Chronic hepatitis delta (CHD) infection occurs as a simultaneous co-infection or super-infection with chronic hepatitis B. An estimated 12 million people globally are infected with CHD, representing approximately 5% of those infected with CHB. CHB-CHD co-infection is considered the most severe form of chronic viral hepatitis due to more rapid progression toward hepatocellular carcinoma and liver-related death. VIR-2218 (BRII-835) is an investigational subcutaneously administered hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) that Vir believes has the potential to stimulate an immune response and have direct antiviral activity against hepatitis B virus and hepatitis delta virus. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially could result in an increased therapeutic index. VIR-2218 is the first asset in the Company’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical trials. VIR-3434 (BRII-877) is an investigational subcutaneously administered antibody designed to block entry of hepatitis B and hepatitis delta viruses into hepatocytes and to reduce the level of virions and subviral particles in the blood. VIR-3434, which incorporates Xencor’s Xtend™ and other Fc technologies, has been engineered to potentially function as a T cell vaccine against hepatitis B virus and hepatitis delta virus, as well as to have an extended half-life. VIR-3434 was identified using Vir’s proprietary monoclonal antibody discovery platform. Annuncio • Oct 07
Vir Biotechnology, Inc. to Report Q3, 2023 Results on Nov 02, 2023 Vir Biotechnology, Inc. announced that they will report Q3, 2023 results on Nov 02, 2023 Annuncio • Oct 06
Biomedical Advanced Research and Development Authority Awards Funding to Vir Biotechnology, Inc. to Support Development of Antibody Platform Technologies for Global Infectious Disease Threats Vir Biotechnology, Inc. announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ (HHS) Administration for Strategic Preparedness and Response (ASPR), has awarded Vir approximately $50 million in new funding to advance the development of novel monoclonal antibody (mAb) candidates and delivery solutions to widen the applicability of mAbs in COVID-19 and in pandemic preparedness and response. The new funding will support research and development of novel alternative mAb delivery technologies that have the potential to revolutionize mAb delivery by increasing expression relative to existing technologies. Such delivery could widen the breadth of administration options and shorten development and manufacturing timelines. $40 million of the total funds is part of ‘Project NextGen,’ an initiative by the HHS to advance a pipeline of new, innovative vaccines and therapeutics for COVID-19 and will support the development of VIR-7229 through Phase 1 in the context of developing alternative mAb delivery technologies. The Phase 1 trial is expected to be completed in the second half of 2025. $10 million of the total funds falls under support from the Division of Chemical, Biological, Radiological and Nuclear (CBRN) medical countermeasures of BARDA which will support the discovery of new mAbs against a second pathogen of pandemic potential in the context of further advancing alternative mAb delivery technologies. The new investment falls under Vir’s existing Other Transaction Authority (OTA), a multi-year contract BARDA awarded Vir in 2022. This OTA allows for a potential total investment of up to $1 billion to support Vir’s development of future pandemic influenza mAbs as well as the potential development of up to 10 emerging infectious disease or CBRN medical countermeasure candidates. The balance of the potential funding is subject to BARDA exercising up to 12 options in further support of the development of pre-exposure prophylactic antibodies for the prevention of influenza illness or supporting medical countermeasures for other pathogens of pandemic potential. Vir is also receiving approximately $11 million in additional BARDA funding that will be applied to wind down activities for the BARDA-supported Phase 2 PENINSULA trial evaluating the investigational prophylactic mAb VIR-2482 for the prevention of symptomatic influenza A illness. These programs have been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under OT number: 75A50122C00081. Annuncio • Sep 22
Vir Biotechnology, Inc. Announces That Johanna Friedl-Naderer, the Company’s Executive Vice President and Chief Operating Officer, Will Be Leaving the Company on September 29, 2023 On September 20, 2023, Vir Biotechnology, Inc. announced that Johanna Friedl-Naderer, the Company’s Executive Vice President and Chief Operating Officer, will be leaving the Company on September 29, 2023. The Company does not intend to fill the Chief Operating Officer role, and Mrs. Friedl-Naderer’s responsibilities will be overseen by other members of the Company’s management team.