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Business Wire
9 hours 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.
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.
Yahoo
27-02-2025
- Business
- Yahoo
Vir Biotechnology Inc (VIR) Q4 2024 Earnings Call Highlights: Strategic Advances Amid Financial ...
R&D Expenses: $507 million in 2024, down from $580 million in 2023. G&A Expenses: $119 million in 2024, down from $174 million in 2023. Net Loss: $522 million in 2024, compared to $615 million in 2023. Net Cash Consumption: Approximately $532 million in 2024. Cash Position: $1.1 billion in cash equivalents and investments at the start of 2025. Employee Count: 408 employees at the end of 2024, down from 587 at the end of 2023. Warning! GuruFocus has detected 5 Warning Signs with VIR. Release Date: February 26, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Vir Biotechnology Inc (NASDAQ:VIR) has made significant progress in its oncology and infectious disease programs, positioning itself at the forefront of innovative therapies. The company is preparing to initiate its Eclipse Phase 3 program for hepatitis Delta in the first half of the year, supported by multiple regulatory designations. Vir Biotechnology Inc (NASDAQ:VIR) has secured worldwide rights to the Pro extend platform, providing a strong foundation for future growth in both oncology and infectious diseases. The company's financial position is strong, with a cash runway extending into mid-2027, allowing for continued investment in key programs. Vir Biotechnology Inc (NASDAQ:VIR) has successfully reduced operating expenses and cash burn, reflecting a disciplined approach to capital allocation. The company's forward-looking statements involve substantial risks and uncertainties, which could impact clinical development programs and future results. Current treatment options for hepatitis Delta are limited, especially in the US where there are no approved therapies. The company is reliant on partnerships for the commercialization and development of its hepatitis B program. Vir Biotechnology Inc (NASDAQ:VIR) has undergone restructurings and site closures, which could impact operational efficiency. The company reported a net loss of $522 million for 2024, highlighting ongoing financial challenges despite cost-saving measures. Q: Can you elaborate on the mechanism for the cleavage of the T-cell engager and its efficiency in the tumor microenvironment? A: Mika Derynck, Executive Vice President, Therapeutic Area Head Oncology, explained that the Pro extend masking technology used in their T-cell engagers is efficiently cleaved in the tumor microenvironment. This is evidenced by the activity observed in both the HER2 and PSMA programs, which show tumor-specific cleavage without significant peripheral toxicity. The technology is also used in an approved hemophilia drug, demonstrating its efficiency in a high protease environment. Q: What additional steps are needed to start the Eclipse trial for hepatitis Delta, and what is the estimated timing for enrollment completion? A: Mark Eisner, Executive Vice President and Chief Medical Officer, stated that they are on track to initiate the Eclipse program in the first half of the year. The team is working urgently to start the trials, and they expect efficient patient recruitment due to the high unmet need in hepatitis Delta and compelling phase 2 data. Q: What are the go/no-go criteria for the hepatitis B program, and what would be attractive to a potential development partner? A: Mark Eisner mentioned that they are looking for a 30% functional cure in the triplet therapy and 20% in the doublet, based on KOL interactions. These criteria are considered clinically meaningful, and they plan to partner the program after obtaining functional cure data. Q: Given the strong safety profile in phase one studies of other programs, do you see a read-through to 5,525, and will you escalate doses more aggressively? A: Marianne De Backer, CEO, indicated that learnings from previous programs will inform the 5,525 study. Mark Eisner added that EGFR is broadly expressed in normal tissue, making it a rigorous test for their dual masking technology. They expect to be efficient in conducting the study, leveraging insights from earlier programs. Q: What gives you confidence that higher doses of 5,500 will produce deeper, more durable PSA responses? A: Mark Eisner explained that the PSMA program is still in early dose escalation, showing compelling early signs of efficacy and safety. They anticipate deeper and more sustained efficacy as they escalate the dose, supported by the platform's validated ability to unmask molecules in the tumor while maintaining a high safety profile. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
