RegulationFast Track (United States), Orphan Drug (European Union), PRIME (European Union), Breakthrough Therapy (China), Breakthrough Therapy (United States)

Structure/Sequence

Sequence Code 565396725H

Source: *****

Sequence Code 565396727L

Source: *****

Clinical Trials associated with Tobevibart

NCT07142811

/ Active, not recruitingPhase 2

A Phase 2b Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy Versus Bulevirtide in Participants With Chronic HDV Infection (ECLIPSE 3)

A Study to Evaluate Tobevibart+Elebsiran versus Bulevirtide in Chronic HDV Infection

Start Date05 Aug 2025

Sponsor / Collaborator

Vir Biotechnology, Inc.

NCT07128550

/ RecruitingPhase 3

A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy in Participants With Chronic HDV Infection Not Virologically Suppressed With Bulevirtide (ECLIPSE 2)

This is a multicenter, open label, randomized Phase 3 clinical study to evaluate tobevibart + elebsiran in participants with Chronic HDV Infection not virologically suppressed with bulevirtide

Start Date30 Jul 2025

Sponsor / Collaborator

Vir Biotechnology, Inc.

NCT06903338

/ Active, not recruitingPhase 3

A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart + Elebsiran Combination Therapy in Participants With Chronic HDV Infection (ECLIPSE 1)

This is a multicenter, open label, randomized Phase 3 clinical study to evaluate the efficacy and safety of the combination of tobevibart + elebsiran for the treatment of chronic hepatitis delta in comparison to delayed treatment.

Start Date12 Mar 2025

Sponsor / Collaborator

Vir Biotechnology, Inc.

100 Clinical Results associated with Tobevibart

100 Translational Medicine associated with Tobevibart

100 Patents (Medical) associated with Tobevibart

Literatures (Medical) associated with Tobevibart

22 Jan 2026·NEW ENGLAND JOURNAL OF MEDICINE

A Phase 2 Trial of Tobevibart plus Elebsiran in Hepatitis D

Article

Author: Streinu-Cercel, Anca ; Agarwal, Kosh ; Santos, Desiree ; Chow, Sophia ; Bullard, Brianna L. ; Chattergoon, Michael A. ; Asselah, Tarik ; Gane, Edward J. ; Lu, Yimeng ; Kennedy, Patrick T. ; Lampertico, Pietro ; Correll, Todd ; Jucov, Alina ; Wedemeyer, Heiner ; Hwang, Carey ; Camus, Gregory ; Pilowa, Cara

BACKGROUND:

Both tobevibart (a monoclonal antibody) and elebsiran (a small interfering RNA) target hepatitis B virus surface antigen (HBsAg). Their efficacy and safety in the treatment of chronic hepatitis D virus (HDV) infection are unknown.

METHODS:

In this ongoing, phase 2, open-label trial, we randomly assigned participants to receive tobevibart plus elebsiran every 4 weeks or tobevibart monotherapy every 2 weeks. The primary end point was a combined response, defined by an HDV RNA level below the limit of detection or a decrease in the HDV RNA level of at least 2 log₁₀ IU per milliliter from baseline (virologic response) and normalization of the alanine aminotransferase (ALT) level, at week 24.

RESULTS:

At week 24, a combined response was observed in 47% of participants (15 of 32) who received tobevibart plus elebsiran and in 70% of participants (23 of 33) who received tobevibart, with a virologic response in 100% (32 of 32) and 82% (27 of 33), respectively, and normalization of the ALT level in 47% (15 of 32) and 76% (25 of 33). At week 48, a combined response was observed in 56% of participants (18 of 32) with tobevibart plus elebsiran and 61% of participants (20 of 33) with tobevibart; undetectable HDV RNA (also known as target not detected, or TND; no amplification during reverse-transcriptase-polymerase-chain-reaction assay) in 66% (21 of 32) and 48% (16 of 33), respectively; normalization of the ALT level in 56% (18 of 32) and 61% (20 of 33); and an HBsAg level below 10 IU per milliliter in 91% (29 of 32) and 21% (7 of 33). No ALT flares were observed in participants starting tobevibart and elebsiran simultaneously or receiving tobevibart monotherapy. Through week 48, a total of 81% of participants who received tobevibart plus elebsiran and 94% of those who received tobevibart had at least one adverse event, primarily influenza-like illness and chills.

CONCLUSIONS:

In this phase 2 trial, tobevibart plus elebsiran as well as tobevibart monotherapy decreased HDV RNA and ALT levels through week 48. Treatment with tobevibart plus elebsiran was associated with a high incidence of undetectable HDV RNA and of a decrease in the HBsAg level. (Funded by Vir Biotechnology; ClinicalTrials.gov number, NCT05461170.).

01 Jan 2026·JOURNAL OF HEPATOLOGY

Engineered monoclonal antibody tobevibart enhances HBsAg capture by Fc receptor-positive cells and activates HBV-specific T cells

Article

Author: Wong, Rachel ; Wang, Li ; Tay, Chin H ; Snell, Gyorgy ; Tracy, Karen E ; Corti, Davide ; di Iulio, Julia ; Giovannoni, Federico ; Marzi, Roberta ; Guarino, Barbara ; Lempp, Florian A ; Benigni, Fabio ; Arvin, Ann ; Schmid, Michael A ; Wedemeyer, Heiner ; Lanzavecchia, Antonio ; Sprugasci, Nicole ; Gane, Ed ; Peter, Alessia ; Stefanutti, Erin ; Vincenzetti, Lucia ; Agarwal, Kosh ; Havenar-Daughton, Colin ; Czudnochowski, Nadine ; Belnap, David M ; Gupta, Sneha V ; Cloutier, Daniel ; Rosen, Laura E ; Errico, John M ; Deshpande, Sharvari ; Momin, Amin ; Yuen, Man-Fung ; Chen, Yi-Pei ; Seu, Lillian

BACKGROUND & AIMS:

Effective immune targeting is likely essential for achieving functional cure of chronic hepatitis B (CHB). Tobevibart, a human monoclonal antibody against hepatitis B surface antigen (HBsAg), neutralizes HBV and HDV. This study aimed to characterize the effects of the engineered GAALIE Fc of tobevibart on HBV immune responses.

METHODS:

We studied tobevibart and its equivalent, HBC34^∗-GAALIE, in vitro using electron microscopy, reporter cells, and primary human or mouse immune cells to assess dynamics of HBsAg reduction, dendritic cell (DC) activation, and T-cell stimulation. Tobevibart-mediated binding of HBsAg to immune cells was also evaluated in a phase I clinical trial in patients with CHB.

RESULTS:

The GAALIE Fc of tobevibart increased binding to activating FcγRs, decreased binding to inhibitory FcγRIIb, mediated gain of function in FcγR signaling in immune complexes with HBsAg, and increased binding of HBsAg to neutrophils and monocytes in vitro compared to wild-type Fc. Similarly, administration of 300 mg tobevibart in patients with CHB resulted in binding of HBsAg to these cells in vivo, concurrent with a reduction in circulating HBsAg. In vitro, immune complexes of HBC34^∗-GAALIE and HBsAg activated human DCs significantly more than HBC34^∗-wild-type. These DCs presented antigen and stimulated HBsAg-specific human T cells. Similarly, HBC34^∗-GAALIE augmented HBsAg-specific CD4⁺ T-cell responses from mice transgenic for human FcγRs.

CONCLUSIONS:

We demonstrate that tobevibart combines the advantages of potent neutralization of HBV and HDV with FcγR-mediated reduction of HBsAg and enhancement of T-cell responses. It is currently under clinical investigation, alone and in combination with other agents, for the treatment of chronic hepatitis delta and to induce functional cure of CHB.

CLINICAL TRIAL:

VIR-3434-1002, phase 1, ClinicalTrials.gov identifier NCT04423393.

IMPACT AND IMPLICATIONS:

Chronic infection with HBV or co-infection with HDV can cause severe liver disease and cancer. We have previously shown that the monoclonal antibody tobevibart potently neutralizes HBV and HDV. Here we demonstrate that the engineered Fc region of tobevibart effectively interacted with several immune cell types, potentially facilitating the rapid removal of damaging viral proteins from the circulation and activating T-cell responses that may control HBV infection long term.

01 Jan 2026·Nature Reviews Gastroenterology & Hepatology

SOLSTICE: tobevibart plus elebsiran for hepatitis D

Article

Author: Ray, Katrina

News (Medical) associated with Tobevibart

12 Jan 2026

·investors.vir.bio

Vir Biotechnology Provides Updates on Chronic Hepatitis Delta and Oncology Programs and Upcoming 2026 Clinical Milestones

– Positive, updated Phase 2 SOLSTICE data showed combination of tobevibart and elebsiran is well tolerated and achieved undetectable HDV RNA in 88% of chronic hepatitis delta participants evaluable at 96 Weeks of treatment – New Phase 1 data from PSMA-targeted PRO-XTEN® dual-masked T-cell engager VIR-5500 in prostate cancer to be presented at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium in February – Year-end 2025 cash and investments balance of approximately $781M1, with cash runway extended into Q4 2027 as a result of the Norgine licensing agreement and continued disciplined resource deployment SAN FRANCISCO--(BUSINESS WIRE)-- Vir Biotechnology, Inc. (Nasdaq: VIR) today 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. The Company also announced that safety and efficacy data from the Phase 1 trial of VIR-5500, its PSMA-targeted PRO-XTEN® dual-masked T-cell engager (TCE) being evaluated in prostate cancer, will be shared in an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium in February. “We are poised for a year of significant clinical progress where we will report initial topline data from our Phase 3 program in CHD, present substantive Phase 1 safety and efficacy data from our PSMA-targeted VIR-5500 TCE program and continue to advance our broader portfolio of PRO-XTEN® masked TCEs through dose escalation,” said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. “The latest data from our SOLSTICE Phase 2 trial evaluating tobevibart and elebsiran combination therapy in CHD are very promising, showing that monthly treatment with this combination therapy has the potential to achieve an undetectable viral load in a large number of patients, which could redefine the standard of care in CHD.” Vir Biotechnology will present at the 44ᵗʰ Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026, at 3:45 p.m. PT. The webcast and presentation will be accessible from the Company’s website under Events & Presentations. Recent Updates and 2026 Clinical Milestones Tobevibart and elebsiran combination therapy for CHD Data from the Phase 2 SOLSTICE trial to be presented at the 44ᵗʰ 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. By contrast, HDV RNA TND was achieved by 53% (17/32) of participants receiving tobevibart antibody monotherapy at Week 72 and 46% (11/24) in the subset of participants evaluated through Week 96. There were no grade 3 or higher treatment-related adverse events in the combination arm, and treatment emergent adverse events were generally mild to moderate and transient. Complete results at Week 96 will be presented at a future medical meeting. Previous positive Phase 2 SOLSTICE data at Week 48 were published in the New England Journal of Medicine.2 The registrational ECLIPSE program in CHD is ongoing, with ECLIPSE 1 and ECLIPSE 3 fully enrolled. Topline data from the ECLIPSE 1 trial is expected in the fourth quarter of 2026. Topline data from the ECLIPSE 2 and ECLIPSE 3 trials are expected in the first quarter of 2027. Last month, Vir Biotechnology granted Norgine Pharma UK Limited, an affiliate of Norgine, an exclusive license for the commercial rights to the combination of tobevibart and elebsiran for the treatment of CHD in Europe, Australia and New Zealand. Vir Biotechnology has retained all commercialization rights for tobevibart and elebsiran in the United States and other markets outside of the Greater China Territory.3 PRO-XTEN® dual-masked TCE immunotherapy portfolio PSMA-targeted PRO-XTEN® dual-masked TCE VIR-5500 is currently being evaluated as monotherapy and in combination with androgen receptor pathway inhibitors (ARPIs) for the first-line treatment of metastatic castration-resistant prostate cancer (mCRPC). Vir Biotechnology will share updated Phase 1 data at the 2026 ASCO Genitourinary Cancers Symposium in February. The Company previously shared preliminary data from the ongoing trial in January 2025 and will provide an update that includes safety and efficacy data of VIR-5500 monotherapy in the later-line mCRPC patients, including RECIST and PSA responses, durability and dose-response relationship. Vir Biotechnology is also currently enrolling patients in its Phase 1 dose escalation trials for VIR-5818 in HER2-expressing solid tumors and VIR-5525 in EGFR-expressing solid tumors. Phase 1 dose escalation response data for VIR-5818 are expected in the second half of 2026. Additionally, the Company is currently progressing a number of PRO-XTEN® masked TCEs in preclinical studies directed at clinically validated targets with potential applications across a variety of solid tumors, including lung, colorectal and bladder. All candidates have been discovered and optimized by leveraging Vir Biotechnology’s antibody and TCE discovery and engineering platform, which includes dAIsY™ (data AI structure and antibodY), a proprietary artificial intelligence engine, and the universal PRO-XTEN® masking technology. 2025 ending cash position (unaudited) and runway projection Cash, cash equivalents and investments were approximately $781 million as of December 31, 2025.1 As a result of the anticipated net cash benefits from the Norgine licensing agreement, and through continued financial discipline, the Company expects cash, cash equivalents and investments to fund operations into the fourth quarter of 2027. 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). ECLIPSE includes three randomized, controlled trials designed to evaluate the combination therapy in comparison to deferred treatment or bulevirtide. ECLIPSE 1 (NCT06903338) is a Phase 3 trial evaluating the safety and efficacy of tobevibart in combination with elebsiran compared to deferred treatment in the U.S. or other regions where bulevirtide use is limited. ECLIPSE 2 (NCT07128550) is a Phase 3 trial evaluating 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 (NCT07142811) is a Phase 2b head-to-head trial evaluating combination 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. About Tobevibart and Elebsiran Tobevibart is an investigational broadly neutralizing monoclonal antibody (mAb) 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 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. Tobevibart is administered subcutaneously, and it is currently in clinical development for the treatment of patients with chronic hepatitis delta. 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. Current data indicate 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. About Chronic Hepatitis Delta (CHD) CHD is the most severe form of chronic viral hepatitis4 and was recently classified as carcinogenic by the International Agency for Research on Cancer.5 People living with the disease rapidly progress to cirrhosis, liver failure6 and liver-related death.4 There are currently no approved treatments in the U.S., and options are limited in the European Union and globally. About VIR-5500, VIR-5818, VIR-5525 VIR-5500, VIR-5818 and VIR-5525 are investigational, clinical candidates currently being evaluated for the treatment of solid tumors. These assets leverage the universal PRO-XTEN® masking technology and target PSMA, HER2 and EGFR, respectively. TCEs are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. The universal 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 is designed to help drug candidates stay in the bloodstream longer in their inactive form, allowing them to better reach the site of action and potentially allowing less frequent 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. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a portfolio of preclinical programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology routinely posts information that may be important to investors on its website. Vir Biotechnology has exclusive rights to the universal PRO-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company. Footnotes and references: 1 These preliminary selected financial results are unaudited and subject to adjustment. The Company expects to report its final and complete fourth quarter and full-year 2025 financial results in late February 2026. 2 Asselah T, Chattergoon MA, Jucov A, et al. A Phase 2 Trial of Tobevibart plus Elebsiran in Hepatitis D. N Engl J Med. 2025 Nov 9.Online ahead of print. doi:10.1056/NEJMoa2508827. 3 People’s Republic of China, Hong Kong, Taiwan and Macau 4 National Institute of Diabetes and Digestive and Kidney Diseases. Hepatitis D. NIDDK. Published November 2024. Accessed September 2025. Hepatitis D - NIDDK (nih.gov). 5 Karagas, Margaret R et al., Carcinogenicity of hepatitis D virus, human cytomegalovirus, and Merkel cell polyomavirus, The Lancet Oncology, Volume 26, Issue 8, 994 – 995. 6 Center for Disease Control and Prevention. Hepatitis D FAQs. CDC. Published March 2020. Accessed September 2025. What is Hepatitis D - FAQ | CDC. 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. Forward-looking statements contained in this press release include, but are not limited to, statements regarding: Vir Biotechnology’s belief that 2026 will be a year of significant clinical progress for its CHD and oncology TCE programs; the therapeutic and commercial potential of Vir Biotechnology’s CHD program and Vir Biotechnology’s belief that the monthly treatment with the combination of tobevibart and elebsiran has the potential to achieve an undetectable viral load in a large number of patients, which could redefine the standard of care in 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 trials, target endpoints and data analyses or readouts (including the expectation of topline data for ECLIPSE 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 plans and expectations for the VIR-5500 and VIR-5818 Phase 1 programs, including protocols for and enrollment into ongoing and planned clinical trials, target endpoints and data analyses or readouts (including plans to share updated Phase 1 data for VIR-5500 at the 2026 ASCO Genitourinary Cancers Symposium in February 2026 and Phase 1 dose escalation response data for VIR-5818 in the second half of 2026); Vir Biotechnology’s cash balance (unaudited) and anticipated 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. You are cautioned not to place undue reliance on any scientific data presented or these forward-looking statements, which are based on Vir Biotechnology’s available information, expectations and assumptions as of the date of this press release. Other factors that may cause Vir Biotechnology’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir Biotechnology’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Vir Biotechnology assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Media CorporateComms@vir.bio Investors IR@vir.bio

Clinical ResultPhase 1Phase 2Phase 3License out/in

17 Dec 2025

·www.fiercebiotech.com

Norgine gets in on Vir\'s hepatitis D program with €550 European licensing pact

The two companies will share costs on Vir\'s ongoing studies, one of which will pit the candidate head-to-head against Gilead\'s approved offering.\n Vir Biotechnology is handing off certain commercial rights for its hepatitis D program to European specialty pharma Norgine in a licensing deal that’s worth up to €550 million ($645 million) and still leaves the untapped U.S. market to Vir.Norgine will shell out €55 million ($64 million) upfront for the prospective chronic hepatitis delta (hepatitis D or HDV) combo of Vir’s monoclonal antibody tobevibart and Alnylam-discovered siRNA elebsiran. The deal also puts Vir in line for up to €495 million ($581 million) in clinical, regulatory and sales milestones, plus tiered royalties from Norgine’s licensed sales territories in Europe, Australia and New Zealand.Vir, meanwhile, will retain all commercialization rights in the U.S. and other markets outside of the greater China territory, according to a Tuesday press release. The two companies will share clinical development costs for Vir’s ongoing Eclipse trial program, with Norgine responsible for about 25% of external costs going forward. With that, Vir expects to extend its cash runway through the last quarter of 2027. The company chose Norgine for its “ideal expertise and reach in key international markets” that could maximize the impact of the treatment, CEO Marianne De Baker, Ph.D., commented in the release.“This agreement advances our commitment to sustainably develop and commercialize the tobevibart and elebsiran combination treatment globally while advancing our innovative clinical pipeline,” Baker said.Mid-stage data from Vir’s HDV program has already shown that it could make for a considerable threat in the limited drug arena. Across 32 participants dosed in Vir’s phase 2 Solstice trial, 66% met and sustained rates of HDV RNA target not detected at 48 weeks, an endpoint that means no active HDV RNA was found in a blood sample. 90% of patients studied saw a reduction in hepatitis B surface antigen, which points to suppression for the core biological mechanisms required for HDV viral replication.CHD is the most severe form of chronic viral hepatitis and can only infect people if the hepatitis B virus is present. By combining tobevibart, a neutralizing monoclonal antibody, with the liver-directed hepatitis B surface antigen-reducing design of elebsiran, Vir looks to treat the disease by tackling its viral lifecycle through multiple mechanisms, Norgine explained in its own press release.Norgine, which has a “rich history in hepatology and specialty care,” highlights the deal as affirming its position as a “partner-of-choice for companies seeking a trusted collaborator in Europe, Australia and New Zealand,” CEO Janneke van der Kamp noted.Next up for the tobevibart-elebsiran pair is Eclipse 3, a phase 2b trial that pits the two head-to-head with Gilead’s bulevirtide. Bulevirtide, commercialized as Hepcludex in Europe, is one of the few treatments available for the disease. However, the drug hasn’t yet reached the U.S. due to an FDA complete response letter in 2022, leaving Vir and other prospective HDV drugmakers racing to be the first to unlock the U.S. market. Earlier this month, Mirum Pharmaceuticals showed that it also has its eye on the HDV prize with a $620 million buy of Bluejay Therapeutics and its HDV prospect, brelovitug. In a phase 2 study, brelovitug demonstrated 100% HDV RNA response plus improvements in liver enzyme levels.

$Norgine gets in on Vir\'s hepatitis D program with €550 European licensing pact$

Phase 2License out/inAcquisitionDrug ApprovalClinical Result

17 Dec 2025

·investors.vir.bio

Vir Biotechnology Grants Norgine Exclusive Commercial License to Chronic Hepatitis Delta Treatment Candidate in Europe, Australia & New Zealand, Including Global Cost Sharing Agreement for Ongoing ECLIPSE Clinical Development Program

– Vir Biotechnology to receive EUR 55 million initial reimbursement payment upon closing, and up to EUR 495 million in clinical, regulatory and sales milestones, along with tiered, mid-teen to high-twenties percent royalties on net sales – Companies to share clinical development costs for ongoing ECLIPSE registrational program with Norgine contributing approximately 25% of go-forward external costs – ECLIPSE 3, designed to support access and reimbursement in Europe and other key geographies, has completed enrollment SAN FRANCISCO--(BUSINESS WIRE)-- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the Company has granted Norgine Pharma UK Limited, an affiliate of Norgine, a leading European specialty pharmaceutical company, an exclusive license for the commercial rights to the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta (CHD) in Europe, Australia and New Zealand. Per the terms of the agreement, Vir Biotechnology will receive an initial reimbursement payment of EUR 55 million and is eligible to receive up to EUR 495 million in clinical, regulatory and sales milestones, and tiered, mid-teen to high-twenties percent royalties on net sales in Norgine’s licensed territory. Vir Biotechnology retains all commercialization rights for tobevibart and elebsiran in the United States and other markets outside of the Greater China Territory.1 In addition, clinical development costs for the ongoing trials in Vir Biotechnology’s ECLIPSE registrational program (ECLIPSE 1, 2 and 3) will be shared, with Norgine contributing approximately 25% of go-forward external costs. As a result of this agreement, Vir Biotechnology expects that current cash, cash equivalents and investments will be extended into the fourth quarter of 2027, based on the current operating plan. “We believe Norgine has the ideal expertise and reach in key international markets to maximize the impact of our investigational treatment for CHD,” said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. “People living with this devastating disease deserve efficacious, safe and convenient treatment options. This agreement advances our commitment to sustainably develop and commercialize the tobevibart and elebsiran combination treatment globally while advancing our innovative clinical pipeline.” The combination of tobevibart and elebsiran is a potentially first-of-its-kind therapy for the treatment of CHD, bringing together an investigational human monoclonal antibody and a small interfering RNA (siRNA) with the goal of disrupting the viral lifecycle through multiple mechanisms. The combination is currently under evaluation for the treatment of CHD in Vir Biotechnology’s ECLIPSE registrational program. Vir Biotechnology also confirmed completion of enrollment for ECLIPSE 3, a Phase 2b head-to-head trial to evaluate tobevibart and elebsiran compared with bulevirtide in bulevirtide-naïve patients. ECLIPSE 3 is designed to provide important supportive data to help establish access and reimbursement in Europe and other key geographies. Forty-eight week data from the Phase 2 SOLSTICE trial presented last month at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® and simultaneously published in the New England Journal of Medicine demonstrated that two thirds (66%, 21/32) of participants receiving a monthly dose of the combination of tobevibart and elebsiran achieved hepatitis delta virus (HDV) RNA target not detected (TND). Importantly, the combination regimen achieved a high proportion of TND in participants with cirrhosis and high baseline HDV RNA. The combination was well-tolerated, with no grade 3 or higher treatment-related adverse events and no treatment-related discontinuations. “We are excited to collaborate with Vir Biotechnology to advance care in CHD and improve patient access to this innovative therapy,” said Janneke van der Kamp, Chief Executive Officer, Norgine. “By combining our expertise in hepatology and specialty care with cutting-edge science from Vir Biotechnology, we are reinforcing our commitment to improving healthcare outcomes. Collaborations like this affirm Norgine’s position as a partner-of-choice for companies seeking a trusted collaborator in Europe, Australia and New Zealand.” The closing of this transaction with respect to certain jurisdictions outside the United States is subject to Norgine receiving regulatory approval from applicable authorities as may be required. About Tobevibart and Elebsiran 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 (CHD). 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 HBsAg. Current data indicate 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 CHD. The combination of tobevibart and elebsiran has been granted Breakthrough Therapy and Fast Track designations by the U.S. Food and Drug Administration (FDA), and Priority Medicines (PRIME) and orphan drug designations by the European Medicines Agency (EMA). About Chronic Hepatitis Delta (CHD) CHD is the most severe form of chronic viral hepatitis2 and was recently classified as carcinogenic by the International Agency for Research on Cancer.3 People living with the disease rapidly progress to cirrhosis, liver failure4 and liver-related death.2 There are currently no approved treatments in the U.S., and options are limited in the European Union and globally. 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. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a portfolio of preclinical programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology routinely posts information that may be important to investors on its website.

100 Deals associated with Tobevibart

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis D, Chronic	Phase 3	United States	Vir Biotechnology, Inc.	12 Mar 2025
Hepatitis D, Chronic	Phase 3	Canada	Vir Biotechnology, Inc.	12 Mar 2025
Hepatitis D, Chronic	Phase 3	Germany	Vir Biotechnology, Inc.	12 Mar 2025
Hepatitis D, Chronic	Phase 3	Moldova	Vir Biotechnology, Inc.	12 Mar 2025
Hepatitis D, Chronic	Phase 3	New Zealand	Vir Biotechnology, Inc.	12 Mar 2025
Hepatitis D, Chronic	Phase 3	Pakistan	Vir Biotechnology, Inc.	12 Mar 2025
Hepatitis D, Chronic	Phase 3	Romania	Vir Biotechnology, Inc.	12 Mar 2025
Hepatitis D, Chronic	Phase 3	Ukraine	Vir Biotechnology, Inc.	12 Mar 2025
Hepatitis D, Chronic	Phase 3	United Kingdom	Vir Biotechnology, Inc.	12 Mar 2025
Hepatitis B, Chronic	Phase 2	United States	Vir Biotechnology, Inc.	11 Jul 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05612581 (CTgov)	Phase 1/2	Hepatitis B, Chronic	33	TDF+VIR-3434 (STRIVE: Cohort 1a (VIR-3434 + TDF))	rwojlcyiyq(clwjvamqvr) = qxqnurvtmc xmakmtmfct (gduthbccrz, hmzglufihb - dwfyztmihz) View more	-	26 Nov 2025
				TDF+VIR-3434 (STRIVE: Cohort 2a (VIR-3434 + TDF))	rwojlcyiyq(clwjvamqvr) = yozmcteirq xmakmtmfct (gduthbccrz, tdqemjkvbk - xhlxkejxin) View more
NCT05461170 (Pubmed \| N Engl J Med)	Phase 2	Hepatitis D	65	Tobevibart plus Elebsiran	mrohxsdrxb(yepknbmvkw) = wvwnyclypo teaebyisgn (pizqkkdlpv ) View more	Positive	09 Nov 2025
				Tobevibart	mrohxsdrxb(yepknbmvkw) = jsourtrzbf teaebyisgn (pizqkkdlpv ) View more
NCT04856085 (MARCH, Company_Website) Manual	Phase 2	Hepatitis B, Chronic	83	Tobevibart + Elebsiran	uateyaluui(dwkvleiekf) = vgxmbxwdcc wnzgzyrjzt (bxxsvnpqob ) View more	Positive	09 May 2025
				Tobevibart + Elebsiran + PEG-IFNα	uateyaluui(dwkvleiekf) = fzlebvpwlf wnzgzyrjzt (bxxsvnpqob ) View more
NCT05461170 (SOLSTICE, EASL2024) Manual	Phase 2	Hepatitis D, Chronic	33	TobevibartTobevibart 300 mg plus ElebsiranElebsiran 200 mg	pnkbqnfoow(pmnqnyjuwk) = hmraurjqrp naivdsqjiu (rzzmbefjjq ) View more	Positive	01 Jun 2024
				Tobevibart 300 mg	pnkbqnfoow(pmnqnyjuwk) = wiaffnqgoe naivdsqjiu (rzzmbefjjq ) View more
NCT04856085 (MARCH, Biospace) Manual	Phase 2	Hepatitis B, Chronic	-	VIR-343+VIR-2218+peginterferon alpha	kjufgzynlf(jszwcbvica) = jdpzchggxa qscbxsvrnx (tevhymroxl ) View more	Positive	13 Nov 2023
				VIR-343+VIR-2218	kjufgzynlf(jszwcbvica) = jsrvbfawmf qscbxsvrnx (tevhymroxl )
phase 1 study (EASL2022)	Phase 1	Hepatitis B HBsAg \| HBeAg	-	VIR-3434 6 mg	kyavtydetx(ezktrgtgho) = Ten adverse events were reported, and all were grade 1 or 2 in severity. No clinically significant laboratory abnormalities or signs of immune complex disease were observed. oguzrkroyz (uhnrdzsrty )	Positive	25 Jun 2022
				VIR-3434 18 mg
EASL2021	Phase 1	Hepatitis B, Chronic	8	VIR-3434 6 mg	ncbgtkaxcr(tzkngbhbpc) = wzxoagoqvq znehsxfgtg (pjpiliiorz )	-	23 Jun 2021
NCT04423393 (GlobeNewswire) Manual	Phase 1	Hepatitis B, Chronic	8	VIR-3434	lgrkvsuhsn(mcsfipoumi) = uoznskjuha csmrhyimnc (qdfojegqsu )	Positive	26 Jan 2021
				Placebo	-

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