Vir Biotechnology, Inc. (Nasdaq: VIR) has released its corporate update and financial results for the third quarter ended September 30, 2024.
“This quarter marked a transformative period for Vir. We have strengthened our clinical pipeline with three promising dual-masked T-cell engagers in oncology and refined our focus within infectious diseases to maximize our impact on patient care. We are also excited to welcome Jason O’Byrne as our new CFO, who brings extensive financial leadership experience to our team,” stated Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer of Vir Biotechnology. “Looking ahead, we anticipate significant data in our hepatitis programs in the fourth quarter and are eager to share initial clinical data from our dual-masked T-cell engagers in the first quarter of 2025.”
Pipeline Programs
Chronic Hepatitis Delta (CHD)
Preliminary data from the Phase 2 SOLSTICE study for chronic hepatitis delta was presented at the European Association for the Study of the Liver (EASL) Meeting in June 2024. The results showed that tobevibart, both as a monotherapy and in combination with elebsiran, achieved high rates of virologic response and ALT normalization after 12 and 24 weeks of treatment, with no serious treatment-related adverse events reported. This combination therapy has received Fast Track Designation from the U.S. FDA, and the company is actively working to advance this regimen into pivotal development due to the promising virologic suppression rates. At the upcoming American Association for the Study of Liver Diseases (AASLD) “The Liver Meeting” in November 2024, additional data from the SOLSTICE trial will be presented, detailing 24-week clinical outcomes for both cohorts involved.
Chronic Hepatitis B (CHB)
The company plans to present end-of-treatment data from the Phase 2 MARCH Part B trial as a Late Breaking presentation at the AASLD meeting in November 2024. This trial evaluates the safety, tolerability, and antiviral activity of a triplet combination of tobevibart, elebsiran, and peginterferon alfa-2a in approximately 30 participants, as well as a doublet combination in around 50 participants. Further assessments regarding potential functional cures are expected to be shared in the second quarter of 2025.
Solid Tumors
- VIR-5818: This dual-masked HER2-targeted T-cell engager aims to minimize off-tumor toxicity, potentially enhancing dosage and efficacy for patients with HER2-expressing cancers. A Phase 1 basket study is ongoing, and initial clinical data is anticipated in the first quarter of 2025.
- VIR-5500: A dual-masked PSMA-directed T-cell engager is currently undergoing a Phase 1 dose escalation study to evaluate its safety and optimal dosing for metastatic castration-resistant prostate cancer, with initial clinical data expected in the first quarter of 2025.
- VIR-5525: This dual-masked EGFR-targeted T-cell engager has received Investigational New Drug (IND) clearance from the U.S. FDA, with plans to initiate a Phase 1 basket study across various solid tumor indications in the first quarter of 2025.
Preclinical Pipeline Candidates
Vir Biotechnology is advancing preclinical assets in partnership with GSK for respiratory syncytial virus and is pursuing an HIV cure in collaboration with the Bill & Melinda Gates Foundation.
