Vir Biotechnology Advances Hepatitis and Oncology Programs, Announces Q3 2024 Results
核心洞察
Vir Biotechnology reported positive Phase 2 SOLSTICE data in chronic hepatitis delta (搜索), showcasing high virologic response rates with tobevibart and elebsiran.
The company anticipates presenting end-of-treatment data from the Phase 2 MARCH Part B trial for chronic hepatitis B (搜索) at AASLD 2024.
Vir plans to share initial clinical data from its dual-masked T-cell engagers (VIR-5818, VIR-5500, VIR-5525) in oncology in Q1 2025.
Vir Biotechnology, Inc. (Nasdaq: VIR) has provided a corporate update and reported its financial results for the third quarter ended September 30, 2024, highlighting advancements in its hepatitis and oncology programs. The company is focusing its efforts on infectious diseases and oncology, aiming to deliver significant impact for patients.
Hepatitis Programs Show Promise
Preliminary data from the Phase 2 SOLSTICE study, evaluating tobevibart (VIR-3434) both as a monotherapy and in combination with elebsiran (VIR-2218) for chronic hepatitis delta (搜索) (CHD), was presented at the European Study of the Liver (EASL) Meeting in June 2024. The data demonstrated high rates of virologic response and ALT normalization after 12 and 24 weeks of treatment, with no treatment-related serious adverse events observed. The combination therapy has received Fast Track Designation from the U.S. FDA, and Vir is working to advance it into a pivotal development program.
Additional data from the SOLSTICE trial, including 24-week clinical data and further data for patients on study beyond 24 weeks, will be presented at the upcoming American Association for the Study of Liver Diseases (AASLD) meeting in November 2024. The trial assesses the combination of tobevibart and elebsiran administered every four weeks, and tobevibart monotherapy administered every two weeks.
For chronic hepatitis B (搜索) (CHB), Vir plans to share end-of-treatment data from the Phase 2 MARCH Part B trial at the AASLD meeting. The MARCH-B trial is evaluating the safety, tolerability, and antiviral activity of tobevibart and elebsiran, plus peginterferon alfa-2a in approximately 30 participants, and approximately 50 participants treated with tobevibart and elebsiran. Further data assessing a potential functional cure is expected in the second quarter of 2025.
Oncology Pipeline Bolstered by T-Cell Engager Programs
Vir's oncology pipeline has been significantly strengthened through an exclusive worldwide license agreement with Sanofi for three clinical-stage masked T-cell engagers (TCEs). These include VIR-5818 (HER2 (搜索)-targeted), VIR-5500 (PSMA (搜索)-directed), and VIR-5525 (EGFR (搜索)-targeted). Initial clinical data for these programs is anticipated in the first quarter of 2025.
VIR-5818 is currently in a Phase 1 basket study as a monotherapy and in combination with pembrolizumab, targeting multiple tumor types, including metastatic breast cancer (搜索) and metastatic colorectal cancer (搜索). VIR-5500 is undergoing a Phase 1 dose escalation study in metastatic castration-resistant prostate cancer (搜索). VIR-5525 has a cleared Investigational New Drug Application (IND) from the U.S. FDA, and a Phase 1 basket study is planned across several solid tumor indications, including metastatic head and neck squamous cell carcinoma, metastatic adenocarcinoma, squamous non-small cell lung cancer, and metastatic colorectal cancer.
The PRO-XTEN masking technology is designed to keep the TCEs inactive until they reach the tumor microenvironment, potentially reducing off-tumor toxicity and improving efficacy and tolerability.
Financial Highlights and Corporate Updates
As of September 30, 2024, Vir Biotechnology had approximately $1.19 billion in cash, cash equivalents, and investments. Third quarter 2024 R&D expenses were $195.2 million, including $8.9 million of non-cash stock-based compensation expense. The increase was primarily driven by $102.8 million of the Sanofi upfront payment being recognized as in-process research and development expense.
Jason O’Byrne was appointed as Executive Vice President and Chief Financial Officer, effective October 2, 2024.
Vir will host a virtual investor event in November 2024, following the AASLD conference, to provide detailed updates on its hepatitis programs. A second event in the first quarter of 2025 will share initial clinical data for the masked T-cell engager programs.