Latest news with #VirBiotechnology
Business Wire
a day ago
- Health
- Business Wire
Vir Biotechnology Initiates Second Pivotal Trial in Its Global ECLIPSE Registrational Program for Chronic Hepatitis Delta
SAN FRANCISCO--(BUSINESS WIRE)--Vir Biotechnology, Inc. (Nasdaq: VIR) today 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. ECLIPSE 2 is designed to provide the registrational efficacy and safety data needed for potential submission to global regulatory agencies, including agencies in the U.S. and Europe. 'Patients living with chronic hepatitis delta, a known cause of liver cancer, are waiting for effective options to change the course of their disease." Share 'Patients living with chronic hepatitis delta, a known cause of liver cancer, are waiting for effective options to change the course of their disease,' said Marianne De Backer, Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. 'We are excited about the rapid progress of our ECLIPSE program, which demonstrates our unwavering commitment to deliver a highly effective treatment for people living with chronic hepatitis delta.' 'We are encouraged by the transformational potential of tobevibart and elebsiran to rapidly drive the hepatitis delta virus to undetectable levels, as demonstrated by compelling data from our Phase 2 SOLSTICE clinical trial. We remain focused on advancing this investigational combination for chronic hepatitis delta with utmost urgency,' said Mark Eisner, M.D., M.P.H., Executive Vice President and Chief Medical Officer, Vir Biotechnology. CHD is the most severe form of chronic viral hepatitis, 1 with people living with the disease rapidly progressing to cirrhosis, liver failure 2 and liver-related death. 1 There are currently no approved treatments 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 Therapy and Fast Track designations, and by the European Medicines Agency (EMA) with Priority Medicines (PRIME) and orphan drug designations. 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), 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, is currently recruiting. 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 2 plans to enroll participants in regions where bulevirtide is approved for the treatment of CHD. Participants who fail to achieve virologic suppression (defined as failure to achieve HDV RNA TND) after a minimum 24 weeks of bulevirtide treatment will be randomized 2:1 to switch to the combination of tobevibart and elebsiran or continue receiving bulevirtide. The primary endpoint in ECLIPSE 2 measures HDV RNA at the lower limit of quantification target not detected, HDV RNA TND (defined as HDV RNA = 0 IU/mL), at Week 24. 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. 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 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 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 preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology routinely posts information that may be important to investors on its website. References: 1 WHO Hepatitis Delta Factsheet – Hepatitis D ( accessed June 2025 2 CDC What is Hepatitis D - FAQ | CDC, accessed June 2025 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: 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 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.
Yahoo
7 days ago
- Business
- Yahoo
First subject dosed in Phase I trial of Vir Biotechnology's VIR-5525
Vir Biotechnology has dosed the first subject in the non-randomised Phase I trial to assess VIR-5525, the investigational dual-masked T-cell engager (TCE) that targets epidermal growth factor receptor (EGFR). This trial marks a step in developing treatments for various solid tumours expressing EGFR with high unmet medical needs, including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), cutaneous squamous cell carcinoma (cSCC) and colorectal cancer (CRC). It is designed as the first-in-human open-label trial and will explore VIR-5525's pharmacokinetics, preliminary anti-tumour activity, and safety as a single agent and in conjunction with pembrolizumab. VIR-5525 utilises the PRO-XTEN masking technology, which aims to selectively activate TCEs within the tumour microenvironment, potentially decreasing toxicity to healthy cells. Vir Biotechnology CEO Marianne De Backer said: 'We are excited to bring our third PRO-XTEN dual-masked T-cell engager VIR-5525 to the clinic as we further our mission of transforming the lives of people living with hard-to-treat solid tumours. 'This achievement is a testament to Vir Biotechnology's commitment to advancing innovative therapies that address substantial unmet needs in oncology.' The latest announcement has triggered a $75m milestone payment to Vir as part of its exclusive global licence agreement signed with Sanofi last year for the PRO-XTEN platform and clinical-stage TCEs. Since the closing of the transaction, this expected milestone payment has been held as restricted cash and was not counted in the company's $1.02bn in cash, cash equivalents, and investments as of 31 March 2025. This payment is set to be identified as a research and development expense in the third quarter of this year. The company is also progressing with dose escalation for its other dual-masked TCEs, VIR-5818 and VIR-5500, targeting HER2-expressing solid tumours and PSMA in metastatic castration-resistant prostate cancer, respectively. In March 2025, Vir Biotechnology enrolled the first subject in the Phase III ECLIPSE registrational programme of tobevibart and elebsiran in those with chronic hepatitis delta (CHD). "First subject dosed in Phase I trial of Vir Biotechnology's VIR-5525" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
24-07-2025
- Business
- Business Wire
Vir Biotechnology 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
SAN FRANCISCO--(BUSINESS WIRE)--Vir Biotechnology, Inc. (Nasdaq: VIR) today 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. 1 Although EGFR-targeting therapies are available, they often face limitations due to the development of resistance mechanisms 2 and high toxicities associated with treatment. 3 'We are excited to bring our third PRO-XTEN™ dual-masked T-cell engager VIR-5525 to the clinic as we further our mission of transforming the lives of people living with hard-to-treat solid tumors,' said Marianne De Backer, Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. 'This achievement is a testament of Vir Biotechnology's commitment to advancing innovative therapies that address substantial unmet needs in oncology.' 'EGFR has been well characterized as a key oncogenic driver and a marker of poor prognosis in cancer. Traditional therapies have significant limitations, creating a substantial unmet need for highly efficacious and well-tolerated options,' said Mark Eisner, MD, MPH, Chief Medical Officer, Vir Biotechnology. 'VIR-5525 harnesses the anti-tumor power of T-cell engagers with a dual-masking approach designed to unlock an expanded therapeutic index. We look forward to evaluating the potential of this clinical candidate in our Phase 1 trial.' 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 excluded 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 showed compelling early clinical response signals and promising safety profiles for both clinical candidates in heavily pretreated patients. The Company is advancing multiple preclinical dual-masked TCEs against clinically validated targets with potential applications across a variety of solid tumors with high unmet need. These undisclosed candidates integrate the PRO-XTEN™ masking technology with novel TCEs discovered and engineered using Vir Biotechnology's antibody discovery platform and the Company's proprietary dAIsY™ (d ata AI s tructure and antibod y) artificial intelligence engine. About VIR-5525 T-cell engagers (TCEs) are powerful anti-tumor agents that can direct the immune system, specifically T-cells, to destroy cancer cells. VIR-5525 is an investigational dual-masked TCE currently being evaluated in an open-label, non-randomized Phase 1 clinical trial (NCT06960395) designed to assess the safety, pharmacokinetics and preliminary efficacy of VIR-5525 alone or in combination with pembrolizumab. VIR-5525 combines a bispecific EGFR and CD3 binding TCE with the PRO-XTEN™ masking technology. The PRO-XTEN™ masking technology is designed to keep the TCEs inactive (or masked) until they reach the tumor microenvironment, where tumor-specific proteases cleave off the mask and activate the TCEs, leading to killing of cancer cells by T-cells. By confining the activity exclusively to the tumor microenvironment, we aim to circumvent the traditionally high toxicity associated with unmasked 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 for less frequent dosing regimens. 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 preclinical portfolio of 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 PRO-XTEN™ masking platform for oncology and infectious disease. PRO-XTEN™ is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company. References: 1 Sigismund S, Avanzato D, Lanzetti L. Emerging functions of the EGFR in cancer. Mol Oncol. 2017 Nov 27;12(1):3–20. 2 Hrustanovic G, Lee BJ, Bivona TG. Mechanisms of resistance to EGFR targeted therapies. Cancer Biol Ther. 013 Jan 28;14(4):304–314. 3 Zhao Y, Cheng B, Chen Z, Li J, Liang H, Chen Y, Zhu F, Li C, Xu K, Xiong S, Lu W, Chen Z, Zhong R, Zhao S, Xie Z, Liu J, Liang W, He J. Toxicity profile of epidermal growth factor receptor tyrosine kinase inhibitors for patients with lung cancer: A systematic review and network meta-analysis. Crit Rev Oncol Hematol. 2021 Apr; 160:103305; Liu T, Jiang S, Teng X, Zhong L, Liu M, Jin Y, Dong M. A comparison of panitumumab and cetuximab in the treatment of KRAS wild-type metastatic colorectal cancer: a systematic review and meta-analysis. Immunopharmacol Immunotoxicol. 2023 Feb; 45(1):1-9. 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: the therapeutic potential of VIR-5525, both as a monotherapy and in combination with pembrolizumab, as a treatment for a variety of EGFR-expressing solid tumors in areas of high unmet need, and Vir Biotechnology's belief that VIR-5525 and the PRO-XTEN™ masking technology can circumvent the traditionally high toxicity associated with unmasked TCEs and unlock an expanded therapeutic index; Vir Biotechnology's preclinical and clinical development plans and expectations for its TCE assets, including protocols for and enrollment into ongoing and planned clinical studies, potential dosing regimens, target endpoints and data readouts; Vir Biotechnology's delivery and recognition of the $75 million milestone payment pursuant to the 2024 exclusive worldwide license agreement with Sanofi; 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; Vir Biotechnology's use of artificial intelligence and machine learning in its efforts to engineer next-generation proteins and in other research and development efforts; 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.
Business Wire
22-07-2025
- Business
- Business Wire
Vir Biotechnology to Provide Corporate Update and Report Second Quarter 2025 Financial Results on August 6, 2025
SAN FRANCISCO--(BUSINESS WIRE)--Vir Biotechnology, Inc. (Nasdaq: VIR), today announced that the Company will provide a corporate update and report financial results for the second quarter ended June 30, 2025, on August 6, 2025. The Company will host a conference call at 1:30 p.m. PT / 4:30 p.m. ET on August 6, 2025. The corporate update and financial results will be provided via a press release shortly after market close and will be accessible on the News page in the Investors section of the Vir Biotechnology website. Participants may access the conference call via webcast on the Events & Presentations page of the Vir Biotechnology website or via phone by dialing the U.S. toll free number +1 (888) 800-8770 or international number +1 (646) 307-1953, Conference ID: 7568777. A recorded version of the conference call will be available approximately two hours after the completion of the event and will be archived for 30 days. 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 preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology routinely posts information that may be important to investors on its website.
Globe and Mail
02-07-2025
- Business
- Globe and Mail
Hepatitis D Pipeline Appears Robust With 8+ Key Pharma Companies Actively Working in the Therapeutics Segment
DelveInsight's, ' Hepatitis D Pipeline Insight, 2025 ' report provides comprehensive insights about 8+ companies and 10+ pipeline drugs in Hepatitis D pipeline landscape. It covers the Hepatitis D pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Hepatitis D pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Discover the latest drugs and treatment options in the Hepatitis D Pipeline. Dive into DelveInsight's comprehensive report today! @ Hepatitis D Pipeline Outlook Key Takeaways from the Hepatitis D Pipeline Report In June 2025, Ribocure Pharmaceuticals AB announced clinical trial is to learn if drug RBD1016 works to treat chronic hepatitis D virus infection in adults. It will also learn about the safety of drug RBD1016. There will be 2 treatment groups - an active group (n=10) and a deferred active group (n=5), with participants allocated randomly. In the active group, participants will receive RBD1016. In the deferred active group, participants will receive 4 doses of placebo followed by deferred treatment with doses of RBD1016. In June 2025, Vir Biotechnology Inc. conducted 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. DelveInsight's Hepatitis D Pipeline report depicts a robust space with 8+ active players working to develop 10+ pipeline therapies for Hepatitis D treatment. The leading Hepatitis D Companies such as Vir Biotechnology, Inc./Alnylam Pharmaceuticals, Bluejay Therapeutics, Inc., Ribocure Pharmaceuticals AB, Assembly Biosciences, Shanghai HEP Pharmaceutical Co., Ltd., Huahui Health and others. Promising Hepatitis D Pipeline Therapies such as Brelovitug 300 mg, lonafarnib, Ritonavir, Bulevirtide, Peginterferon Alfa-2a (PEG-IFN alfa), hepalatide, Peginterferon Lambda-1a and others. Stay ahead with the most recent pipeline outlook for Hepatitis D. Get insights into clinical trials, emerging therapies, and leading companies with Hepatitis D @ Hepatitis D Treatment Drugs Hepatitis D Emerging Drugs Profile Tobevibart + Elebsiran: Vir Biotechnology/ Alnylam Pharmaceuticals Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen. It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes, and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart, which incorporates Xencor's Xtend™ and other Fc technologies, has been engineered to have an extended half-life and was identified using Vir Biotechnology's proprietary monoclonal antibody discovery platform. Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. Current data indicates that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. It is the first asset in Vir Biotechnology's collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical studies. Currently, this combination drug product is in Phase III stage of its development for the treatment of Hepatitis D. Brelovitug: Bluejay Therapeutics Brelovitug is an investigational, highly potent, pan-genotypic, fully human IgG1 mAb that targets the anti-HBsAg on both the HDV and the HBV. Brelovitug is designed to neutralize and remove hepatitis B and hepatitis D virions and deplete HBsAg-containing subviral particles, which gives brelovitug a potentially advantageous safety profile and makes it a potentially efficacious treatment for CHD, a condition with urgent unmet medical need. In addition, brelovitug has shown immunomodulatory functions in CHB patients, which may help to reconstitute antiviral immunity and contribute to functional cure for CHB when combined with other agents. Currently, the drug is in the Phase II/III stage of its development for the treatment of Hepatitis D. RBD1016: Ribocure Pharmaceuticals AB RBD1016 is a GalNAc-siRNA drug independently developed by Ribo based on its proprietary GalNAc-siRNA platform, targeting the X gene of hepatitis B virus. It inhibits all four HBV transcripts through the RNA interference mechanism, and can simultaneously inhibit HBV DNA replication, reduce cccDNA and integrate DNA derived HBsAg and other antigens. RBD1016 demonstrates well-tolerated safety profile in Phase I study including both healthy subjects and patients with CHB infection. RBD1016 shows a highly efficient long-acting effect of reducing the HBsAg in patients. Currently, the drug is in Phase II stage of its development for the treatment of Hepatitis D. The Hepatitis D Pipeline Report Provides Insights into- The report provides detailed insights about companies that are developing therapies for the treatment of Hepatitis D with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Hepatitis D Treatment. Hepatitis D Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Hepatitis D Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Hepatitis D market Explore groundbreaking therapies and clinical trials in the Hepatitis D Pipeline. Access DelveInsight's detailed report now! @ New Hepatitis D Drugs Hepatitis D Companies Vir Biotechnology, Inc./Alnylam Pharmaceuticals, Bluejay Therapeutics, Inc., Ribocure Pharmaceuticals AB, Assembly Biosciences, Shanghai HEP Pharmaceutical Co., Ltd., Huahui Health and others. Hepatitis D pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Hepatitis D Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Unveil the future of Hepatitis D Treatment. Learn about new drugs, Hepatitis D Pipeline developments, and key companies with DelveInsight's expert analysis @ Hepatitis D Market Drivers and Barriers Scope of the Hepatitis D Pipeline Report Coverage- Global Hepatitis D Companies- Vir Biotechnology, Inc./Alnylam Pharmaceuticals, Bluejay Therapeutics, Inc., Ribocure Pharmaceuticals AB, Assembly Biosciences, Shanghai HEP Pharmaceutical Co., Ltd., Huahui Health and others. Hepatitis D Pipeline Therapies- Brelovitug 300 mg, lonafarnib, Ritonavir, Bulevirtide, Peginterferon Alfa-2a (PEG-IFN alfa), hepalatide, Peginterferon Lambda-1a and others. Hepatitis D Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Hepatitis D Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Get the latest on Hepatitis D Pipeline Therapies and clinical trials. Download DelveInsight's in-depth pipeline report today! @ Hepatitis D Companies, Key Products and Unmet Needs Table of Contents Introduction Executive Summary Hepatitis D: Overview Pipeline Therapeutics Therapeutic Assessment Hepatitis D– DelveInsight's Analytical Perspective Late Stage Products (Phase III) Tobevibart + Elebsiran: Vir Biotechnology/ Alnylam Pharmaceuticals Drug profiles in the detailed report….. Mid Stage Products (Phase II/III) Brelovitug: Bluejay Therapeutics Drug profiles in the detailed report….. Early Stage Products (Phase I) Drug Name: Company Name Drug profiles in the detailed report….. Preclinical and Discovery Stage Products Drug Name: Company Name Drug profiles in the detailed report….. Inactive Products Hepatitis D Key Companies Hepatitis D Key Products Hepatitis D- Unmet Needs Hepatitis D- Market Drivers and Barriers Hepatitis D- Future Perspectives and Conclusion Hepatitis D Analyst Views Hepatitis D Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Yash Bhardwaj Email: Send Email Phone: 09650213330 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: NV Country: United States Website:
