elebsiran (VIR-2218) and tobevibart (VIR-3434) - (SOLSTICE)

November 4, 2026: Vir Biotechnology (NASDAQ: VIR) provided a pipeline update highlighting upcoming catalysts in chronic hepatitis delta (CHD) and oncology.

For CHD, expanded Phase 2 SOLSTICE results for elebsiran plus tobevibart will be presented at AASLD The Liver Meeting 2026 on November 8. Topline data from the pivotal Phase 3 ECLIPSE 1 trial are expected in Q4 2026; the study compares monthly subcutaneous elebsiran/tobevibart versus deferred treatment in the U.S. or regions where bulevirtide use is limited. Topline data from ECLIPSE 2 and ECLIPSE 3 are expected in Q1 2027. The company said ECLIPSE 1/2/3 will support a comprehensive global filing package.

In oncology, the FDA granted Fast Track designation to VIR-5500/ASP6958, a PSMA-targeted PRO-XTEN dual-masked T-cell engager, for late-line metastatic castration-resistant prostate cancer. Vir said the program achieved proof of concept, and multiple pivotal trials are expected to begin in 2027. The Phase 1 study is evaluating monotherapy and combination therapy across six dose-expansion cohorts.

For VIR-5818, a HER2-targeted T-cell engager, Vir plans to add monotherapy backfill cohorts after FDA feedback to optimize dose and schedule; combination dose escalation with pembrolizumab is ongoing. VIR-5525, an EGFR-targeted T-cell engager, continues Phase 1 enrollment.

Vir also announced a Gilead collaboration for three novel PRO-XTEN candidates, including $90 million upfront cash/equity and potential milestones and royalties.