Vir Biotechnology Updates Positive Data from SOLSTICE Phase 2 Trial
Ahead of Vir Biotechnology presenting at the J.P. Morgan Healthcare Conference on Wednesday, January 14, at 3:45 p.m. PT, Vir Biotechnology yesterday provided key program updates, including new "positive" data from the ongoing SOLSTICE Phase 2 trial in chronic hepatitis delta. Participants receiving the combination therapy of tobevibart, an investigational neutralizing monoclonal antibody, and elebsiran, an investigational small interfering RNA, 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 stated. 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 being evaluated in prostate cancer, will be shared in an oral presentation at the 2026 American Society of Clinical Oncology 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. 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," said Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, Vir Biotechnology.
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- Market Potential: The global oncology therapy market is projected to reach $668 billion by 2034, and Oncolytics Biotech is seizing investment opportunities through execution-focused registration study designs in this rapidly growing sector.
- Leadership Enhancement: Oncolytics Biotech appointed John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics, both bringing extensive experience in late-stage oncology trial execution and regulatory strategy to advance the company's registration-directed programs in gastrointestinal cancers.
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Oncolytics Biotech Strengthens Leadership for Oncology Trials
- Market Potential: The global oncology therapy market is projected to reach $668 billion by 2034, creating significant investment opportunities for Oncolytics Biotech as it capitalizes on execution-ready platforms in this rapidly growing sector.
- Leadership Strengthening: Oncolytics Biotech appointed John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President of Biostatistics, both bringing extensive experience in late-stage oncology trial execution and regulatory strategy, which is expected to accelerate the company's registration-directed programs in gastrointestinal cancers.
- Breakthrough Efficacy Data: The company reported that pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite stable metastatic colorectal cancer patients, significantly exceeding the historical benchmark of 6-11% for chemotherapy alone, laying a strong foundation for future clinical applications.
- FDA Study Design Approval: Oncolytics Biotech has secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, marking the imminent launch of the only immunotherapy registration trial currently planned for this challenging therapeutic area, further solidifying its market position.
Norgine Expands Hepatology and Specialty Offerings with Exclusive Licensing Deal with Vir Biotechnology
Norgine's Licensing Agreement: Norgine has entered an exclusive licensing agreement with Vir Biotechnology to commercialize the combination of tobevibart and elebsiran for chronic hepatitis delta treatment in Europe, Australia, and New Zealand, addressing a significant unmet medical need.
Financial Terms and Responsibilities: The agreement includes an initial payment of EUR 55 million to Vir Biotechnology, with potential milestone payments totaling up to EUR 495 million, while Norgine will handle all commercialization activities and share clinical development costs.
Vir Biotechnology Partners with Norgine, Secures €55 Million Initial Payment
- Initial Payment: Vir Biotechnology will receive an initial reimbursement of €55 million upon closing the deal with Norgine, significantly enhancing the company's liquidity and extending its financial runway into Q4 2027.
- Milestone Rewards: The agreement includes up to €495 million in clinical, regulatory, and sales milestone payments, reflecting Norgine's confidence in the market potential of Vir's products, which could substantially enhance Vir's competitive position.
- Cost Sharing: Norgine will contribute approximately 25% of external development costs for the ongoing ECLIPSE registrational program, alleviating financial pressure on Vir while accelerating clinical trial progress and strengthening their partnership.
- Innovative Treatment: The combination of tobevibart and elebsiran is viewed as a potentially first-of-its-kind therapy for chronic hepatitis delta, with the successful enrollment completion of ECLIPSE 3 providing critical data to support access and reimbursement in Europe and other key markets.
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SOLSTICE Trial Results: The SOLSTICE trial showed that 66% of participants with chronic hepatitis delta achieved undetectable HDV RNA after 48 weeks of treatment with the combination of tobevibart and elebsiran, with a favorable safety profile and no severe adverse events reported.
ECLIPSE Program: The ECLIPSE registrational program is underway to further evaluate the combination therapy, with topline data expected in the first quarter of 2027, aiming to address the unmet needs in chronic hepatitis delta treatment.
Significance of Findings: Achieving undetectable HDV RNA is crucial for better outcomes in chronic hepatitis delta patients, and the combination therapy has shown promising results in reducing hepatitis B surface antigen levels and normalizing ALT levels.
Regulatory Recognition: The combination therapy has received Breakthrough Therapy and Fast Track designations from the FDA, as well as Priority Medicines and orphan drug designations from the EMA, highlighting its potential as a significant treatment option.
Vir Biotechnology Reveals Phase 2 Data at AASLD The Liver Meeting® and in NEJM, Showcasing High Undetectable HDV RNA Rates and Positive Safety Profile for Tobevibart & Elebsiran Combination
SOLSTICE Trial Results: The Phase 2 SOLSTICE trial showed that 66% of chronic hepatitis delta participants achieved undetectable HDV RNA after 48 weeks of treatment with the combination of tobevibart and elebsiran, with a favorable safety profile and no severe adverse events reported.
ECLIPSE Program: The ECLIPSE registrational program, which includes three randomized trials evaluating the combination therapy, is currently underway, with topline data expected in the first quarter of 2027.
Significance of Findings: Achieving undetectable HDV RNA is crucial for better outcomes in chronic hepatitis delta patients, and the combination therapy has shown promising results in reducing hepatitis B surface antigen levels and normalizing ALT levels.
Regulatory Recognition: The combination therapy has received Breakthrough Therapy and Fast Track designations from the FDA, as well as Priority Medicines and orphan drug designations from the EMA, highlighting the urgent need for effective treatments in chronic hepatitis delta.
Oncolytics Biotech Strengthens Leadership Amid Oncology Market Surge
- Market Potential: The global oncology therapy market is projected to reach $668 billion by 2034, and Oncolytics Biotech is seizing investment opportunities through execution-focused registration study designs in this rapidly growing sector.
- Leadership Enhancement: Oncolytics Biotech appointed John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics, both bringing extensive experience in late-stage oncology trial execution and regulatory strategy to advance the company's registration-directed programs in gastrointestinal cancers.
- Breakthrough Efficacy Data: The company reported that pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite stable metastatic colorectal cancer patients, significantly surpassing the historical 6-11% response rate for chemotherapy alone, indicating its potential in difficult-to-treat populations.
- FDA Study Design Approval: Oncolytics Biotech has secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, marking the imminent launch of the only immunotherapy registration trial currently planned for this disease, further solidifying its market position.
Oncolytics Biotech Strengthens Leadership for Oncology Trials
- Market Potential: The global oncology therapy market is projected to reach $668 billion by 2034, creating significant investment opportunities for Oncolytics Biotech as it capitalizes on execution-ready platforms in this rapidly growing sector.
- Leadership Strengthening: Oncolytics Biotech appointed John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President of Biostatistics, both bringing extensive experience in late-stage oncology trial execution and regulatory strategy, which is expected to accelerate the company's registration-directed programs in gastrointestinal cancers.
- Breakthrough Efficacy Data: The company reported that pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite stable metastatic colorectal cancer patients, significantly exceeding the historical benchmark of 6-11% for chemotherapy alone, laying a strong foundation for future clinical applications.
- FDA Study Design Approval: Oncolytics Biotech has secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, marking the imminent launch of the only immunotherapy registration trial currently planned for this challenging therapeutic area, further solidifying its market position.
Norgine Expands Hepatology and Specialty Offerings with Exclusive Licensing Deal with Vir Biotechnology
Norgine's Licensing Agreement: Norgine has entered an exclusive licensing agreement with Vir Biotechnology to commercialize the combination of tobevibart and elebsiran for chronic hepatitis delta treatment in Europe, Australia, and New Zealand, addressing a significant unmet medical need.
Financial Terms and Responsibilities: The agreement includes an initial payment of EUR 55 million to Vir Biotechnology, with potential milestone payments totaling up to EUR 495 million, while Norgine will handle all commercialization activities and share clinical development costs.
Vir Biotechnology Partners with Norgine, Secures €55 Million Initial Payment
- Initial Payment: Vir Biotechnology will receive an initial reimbursement of €55 million upon closing the deal with Norgine, significantly enhancing the company's liquidity and extending its financial runway into Q4 2027.
- Milestone Rewards: The agreement includes up to €495 million in clinical, regulatory, and sales milestone payments, reflecting Norgine's confidence in the market potential of Vir's products, which could substantially enhance Vir's competitive position.
- Cost Sharing: Norgine will contribute approximately 25% of external development costs for the ongoing ECLIPSE registrational program, alleviating financial pressure on Vir while accelerating clinical trial progress and strengthening their partnership.
- Innovative Treatment: The combination of tobevibart and elebsiran is viewed as a potentially first-of-its-kind therapy for chronic hepatitis delta, with the successful enrollment completion of ECLIPSE 3 providing critical data to support access and reimbursement in Europe and other key markets.
Vir Biotechnology Reveals Phase 2 Data at AASLD The Liver Meeting® and in NEJM, Showing High Undetectable HDV RNA Rates and Positive Safety Profile for Tobevibart and Elebsiran Combination
SOLSTICE Trial Results: The SOLSTICE trial showed that 66% of participants with chronic hepatitis delta achieved undetectable HDV RNA after 48 weeks of treatment with the combination of tobevibart and elebsiran, with a favorable safety profile and no severe adverse events reported.
ECLIPSE Program: The ECLIPSE registrational program is underway to further evaluate the combination therapy, with topline data expected in the first quarter of 2027, aiming to address the unmet needs in chronic hepatitis delta treatment.
Significance of Findings: Achieving undetectable HDV RNA is crucial for better outcomes in chronic hepatitis delta patients, and the combination therapy has shown promising results in reducing hepatitis B surface antigen levels and normalizing ALT levels.
Regulatory Recognition: The combination therapy has received Breakthrough Therapy and Fast Track designations from the FDA, as well as Priority Medicines and orphan drug designations from the EMA, highlighting its potential as a significant treatment option.
Vir Biotechnology Reveals Phase 2 Data at AASLD The Liver Meeting® and in NEJM, Showcasing High Undetectable HDV RNA Rates and Positive Safety Profile for Tobevibart & Elebsiran Combination
SOLSTICE Trial Results: The Phase 2 SOLSTICE trial showed that 66% of chronic hepatitis delta participants achieved undetectable HDV RNA after 48 weeks of treatment with the combination of tobevibart and elebsiran, with a favorable safety profile and no severe adverse events reported.
ECLIPSE Program: The ECLIPSE registrational program, which includes three randomized trials evaluating the combination therapy, is currently underway, with topline data expected in the first quarter of 2027.
Significance of Findings: Achieving undetectable HDV RNA is crucial for better outcomes in chronic hepatitis delta patients, and the combination therapy has shown promising results in reducing hepatitis B surface antigen levels and normalizing ALT levels.
Regulatory Recognition: The combination therapy has received Breakthrough Therapy and Fast Track designations from the FDA, as well as Priority Medicines and orphan drug designations from the EMA, highlighting the urgent need for effective treatments in chronic hepatitis delta.
