Latest news with #ECLIPSE
Business Wire
2 days ago
- Business
- Business Wire
Vir Biotechnology Successfully Initiates all Trials in 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 ECLIPSE 3. All three trials in the Company's registrational ECLIPSE program for chronic hepatitis delta (CHD) have now been initiated. ECLIPSE 3 is a Phase 2b trial designed to compare the combination of tobevibart and elebsiran to bulevirtide treatment in patients with CHD. ECLIPSE 3 will provide important supportive data to help establish access and reimbursement in key markets. "We believe our registrational ECLIPSE program will validate the potential of our combination of tobevibart and elebsiran to establish a new standard of care in both newly diagnosed and previously treated patients with chronic hepatitis delta.' 'People living with chronic hepatitis delta urgently need new options to treat their disease,' said Marianne De Backer, Ph.D., MBA, Chief Executive Officer, Vir Biotechnology. 'With the strong foundation of our previous data and the proven expertise of our team, we believe our registrational ECLIPSE program will validate the potential of our combination of tobevibart and elebsiran to establish a new standard of care in both newly diagnosed and previously treated patients with chronic hepatitis delta.' 'We are encouraged by the high rates of viral suppression demonstrated by the combination of tobevibart and elebsiran in our Phase 2 SOLSTICE study,' said Mark Eisner, M.D., M.P.H., Chief Medical Officer, Vir Biotechnology. 'Taken together, our ECLIPSE trials are designed to demonstrate the potential of our tobevibart and elebsiran combination therapy, including breadth of response and dosing convenience. These are key aspects for improving patients' quality of life and supporting long-term treatment adherence in real-world settings.' CHD is an area of significant unmet medical need, with no approved treatments in the U.S. and limited options globally. 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 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 potential of the combination of tobevibart and elebsiran has been recognized by Breakthrough Therapy and Fast Track designations from the U.S. Food and Drug Administration (FDA), along with Priority Medicines (PRIME) and orphan drug status from the European Medicines Agency (EMA). These designations support the expedited development of treatments for serious diseases where there is a significant unmet medical need. About the ECLIPSE Registrational Program ECLIPSE is a registrational program to evaluate the safety and efficacy of tobevibart in combination with elebsiran in patients with chronic hepatitis delta (CHD). 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 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, and both trials are currently recruiting. 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 3 plans to enroll participants who have never received bulevirtide for the treatment of CHD. Participants will be randomized 2:1 to receive the combination of tobevibart and elebsiran or bulevirtide. The primary endpoint in ECLIPSE 3 measures hepatitis delta virus (HDV) RNA at the lower limit of quantification target not detected, HDV RNA TND (defined as HDV RNA = 0 IU/mL), at Week 48. 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 July 2025 2 CDC What is Hepatitis D - FAQ | CDC, accessed July 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 establish a new standard of care in both newly diagnosed and previously treated patients with CHD; Vir Biotechnology's clinical development plans and expectations for the ECLIPSE Phase 3 registrational program, including protocols for and enrollment into ongoing and planned clinical studies, target endpoints and data readouts; Vir Biotechnology's strategy and plans; and any assumptions underlying any of the foregoing. Many factors may cause differences between current expectations and actual results, including, without limitation: unexpected safety or efficacy data or results observed during clinical studies or in data readouts, including the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; challenges in accessing manufacturing capacity; clinical site activation rates or clinical enrollment rates that are lower than expected; the timing and outcome of Vir Biotechnology's planned interactions with regulatory authorities, as well as general difficulties in obtaining any necessary regulatory approvals; successful development and/or commercialization of alternative product candidates by Vir Biotechnology's competitors, as well as changes in expected or existing competition; geopolitical changes or other external factors; and unexpected litigation or other disputes. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. The actual results may vary from the anticipated results, and the variations may be material. 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
31-07-2025
- 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.
Fashion Value Chain
28-06-2025
- Entertainment
- Fashion Value Chain
Versace Eyewear Spring-Summer 2025: Bold & Iconic
Versace unveils its Spring-Summer 2025 Eyewear Core Collection, echoing the house's high-glam aesthetic and maximalist attitude. Designed for those who embrace boldness and individuality, the lineup features sun and optical frames in iconic shapes, rich color palettes, and standout brand signatures—from sculpted logos to Medusa embellishments. SIGNATURE LINE Versace's Signature styles are defined by geometric and classic shapes in acetate, each enhanced by gold Versace logos on wide temples: VE4487: A sharp, low-profile design in five statement colorways, including opal lilac and transparent burgundy. VE4492U: Oversized square frames with sculpted angles and a range of earthy and vivid shades. VE4489U: Sleek unisex frames with bold 3D metal lettering. VE3374U: Elegant, rectangular optical frames in Havana, black, and transparent tones. AVANTI LINE Paying tribute to Versace's '90s archives, Avanti features the Medusa framed in a 'V': VE2284: A pilot shape with wraparound rivets and bold gradient lenses. VE1307: A geometric pilot with metal Medusa décor—luxurious and masculine. ECLIPSE CAPSULE Avant-garde and sculptural, Eclipse plays with futuristic shapes and Medusa iconography: VE2280: Elliptical wraparound mask-style sunglasses with metal accents. VE4485: Feminine and oversized with gradient mirrored lenses and Medusa-inset metal ovals. VE3372U: Bold cat-eyes in burgundy, Havana, and transparent pink with soft curves and angular definition. MEDUSA BUTTERFLY SERIES A showstopper range that blends sparkle with structure: VE2282: Glamorous square metal frames with butterfly and Medusa details, including a premium gold-plated variant with real rose gold mirror lenses. Prices start at INR 18,290, available at Sunglass Hut, LensCrafters, and select optical stores.
RNZ News
22-06-2025
- General
- RNZ News
How Debbs Murray found freedom and safety
Debbs Murray has spent more than two decades working tirelessly in the family violence sector, for refuge, and various government and non-government agencies including the police. She is the founder of ECLIPSE family violence services based in Waikato, through which thousands of frontline family harm prevention workers have been trained. The training focusses on helping practitioners build greater understanding of the complexity of family violence and coercive control - and why so many victims don't or can't get out. But through all of that advocacy over 20 years, Debbs has never really shared her own experience in writing, of the seven years she was in a relationship marked by severe family violence and absolute coercive control. She's now written a book about her extraordinary journey - and that of her four children. It's aimed at anyone experiencing family violence and their loved ones who want to help. Photo: supplied
Yahoo
02-06-2025
- Business
- Yahoo
National Comprehensive Cancer Network (NCCN) Updates Colorectal Cancer Screening Guidelines to Include Shield Blood-Based Screening
First national guideline recommendation for Shield paves the way for improved patient access and additional major guideline inclusions NCCN guidelines point to landmark ECLIPSE Study showing efficacy of Shield Shield is FDA-approved for adults age 45 or older at average risk for colorectal cancer PALO ALTO, Calif., June 02, 2025--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the National Comprehensive Cancer Network (NCCN) has included the Shield blood test in its updated colorectal cancer (CRC) screening guidelines. The Shield test detects CRC signals in the bloodstream from DNA that is shed by tumors, called circulating tumor DNA (ctDNA). The updated NCCN CRC Screening Guidelines reflect the addition of Shield with a recommendation for testing every three years. "With a simple blood draw, Shield provides a more convenient and pleasant screening option for the millions of eligible Americans who are forgoing their recommended screening for colorectal cancer," said AmirAli Talasaz, Guardant Health co-CEO. "This major guideline inclusion from the National Comprehensive Cancer Network is just the first for Shield, and we believe a pivotal step for more patients to benefit from this test." In its guideline update, the NCCN pointed to Guardant's landmark ECLIPSE (Evaluation of ctDNA LUNAR Assay in an Average Patient Screening Episode) study evaluating the performance of Shield compared to a screening colonoscopy. One of the largest studies of its kind and published in the New England Journal of Medicine (NEJM), ECLIPSE demonstrated that the Shield blood test is highly effective in detecting CRC, with a sensitivity of 83 percent. About Shield Shield is a non-invasive, blood-based screening test that detects alterations associated with colorectal cancer in the blood. It is intended as a screening test for individuals at average risk for the disease, age 45 or older, and is not intended for individuals at high risk for colorectal cancer. The Shield test can be considered in a manner similar to guideline-recommended non-invasive CRC screening options and can be completed during any healthcare visit. A positive Shield result raises concern for the presence of colorectal cancer or advanced adenoma and the patient should be referred for colonoscopy evaluation. About Guardant Health Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit and follow the company on LinkedIn, X (Twitter) and Facebook. Forward-Looking Statements This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health's liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health's financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operation" and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2024, and in its other reports filed with or furnished to the Securities and Exchange Commission thereafter. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health's views as of any date subsequent to the date of this press release. View source version on Contacts Investor Contact: Zarak Khurshidinvestors@ Media Contact: Meaghan Smithpress@ 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
