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.
Trade with 70% Backtested Accuracy
Analyst Views on VIR
About VIR
About the author
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.
