The stock price of Vir Biotechnology Inc (NASDAQ: VIR) increased by over 5% during intraday trading today. Investors are responding positively to Vir Biotechnology announcing new data from its robust hepatitis B virus (HBV) clinical trial program, including results from an ongoing Phase 2 clinical trial of VIR-2218, results from an ongoing Phase 1 clinical trial of VIR-3434 and preclinical data evaluating both investigational compounds as monotherapy and in combination. And the data was presented in one oral and two poster presentations at the International Liver Congress (ILC) 2022, the Annual Meeting of the European Association for the Study of the Liver (EASL).
In summary, the data presented at ILC demonstrated that a six-dose regimen of VIR-2218 provided greater and more durable reductions in hepatitis B surface antigen (HBsAg) than a two-dose regimen, with all participants achieving a >1 log10 IU/mL reduction during the trial. Phase 1 results evaluating VIR-3434 showed that a single dose (6 mg, 18 mg, 75 mg or 300 mg) resulted in a rapid reduction of HBsAg, with the largest and most durable response noted with the 300 mg dose. Finally, preclinical in vivo data demonstrated that the combination of both investigational compounds resulted in greater HBsAg reductions than either compound alone.
As part of its ongoing efforts to advance its broad HBV portfolio, Vir is expecting to dose the first patient in Part B of the Phase 2 MARCH (Monoclonal Antibody siRNA Combination against Hepatitis B) trial evaluating VIR-2218 in combination with VIR-3434 for 24 and 48 weeks, and in combination with interferon, by the end of June. And previously reported results from Part A demonstrated that VIR-3434 combined with VIR-2218 provided an additional 2 log decline in HBsAg loss over the 3 log decrease with VIR-2218 alone. No drug-related safety signals were observed. The additional data from Part A are expected later this year. However, with clinical trial sites in Ukraine and Moldova, the Company is continuing to monitor the war in Ukraine for any potential impact on timing.
The additional milestones expected in the second half of 2022 include:
Additional data from the Phase 2 trial of VIR-2218 in combination with PEG-IFN-.
Initial data from the Phase 2 trial led by Brii Biosciences evaluating VIR-2218 in combination with BRII-179, an investigational T cell vaccine, for the potential treatment of chronic HBV infection.
The initiation of a Phase 2 platform trial of VIR-2218 in combination with VIR-3434 in viremic patients (THRIVE/STRIVE sub-protocols), with initial data expected in the second half of 2023.
The initiation of a Phase 2 trial of VIR-2218 in combination with VIR-3434 for the treatment of chronic hepatitis D virus (HDV) infection, with initial data expected in 2023.
The company also expects to report initial data from the Phase 2 trial evaluating various combinations of VIR-2218, selgantolimod (GS-9688), Gilead Sciences investigational TLR-8 agonist, and nivolumab, an approved PD-1 inhibitor, as a potential cure regimen for chronic HBV infection in the first half of 2023.
KEY QUOTE:
The data presented at the International Liver Congress 2022 continue to indicate that our therapeutic strategy of combining an antiviral with an immunomodulator to restore immunologic control in patients with chronic HBV is additive and offers the potential for a functional cure. As we continue to evaluate VIR-2218 and VIR-3434, we are encouraged by the potential of these two investigational medicines alone and in combination. These data, alongside the anticipated initiation of Part B of the MARCH trial by the end of June, are important milestones in our broad HBV portfolio for which we expect multiple data readouts throughout 2022 and 2023.
Carey Hwang, M.D., Ph.D., Virs senior vice president, clinical research, head of chronic infection
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Vir Biotechnology (VIR) Stock: Why It Increased Over 5% Today - Pulse 2.0
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