A WORLD WITHOUT INFECTIOUS DISEASE
Vir Biotechnology, Inc.
EASL ILC 2021 Hepatitis B Data Call
June 25, 2021
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Forward-Looking Statements
Statements in this presentation that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding the expected success, cost, and timing of our research and clinical development plans and clinical trials, our goals with respect to the prophylaxis or treatment of COVID-19, HBV, influenza A and HIV, our objectives, strategy, technology platform and clinical trial designs, the potential benefits of our collaborations, and our ability to complete certain milestones. Words such as "believe," "anticipate," "plan," "expect," "intend," "will," "may," "goal," "potential" and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based on the beliefs of the management of Vir Biotechnology, Inc. (the "Company") as well as assumptions made by and information currently available to the Company. Such statements reflect the current views of the Company with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about the Company, including, without limitation, risks inherent in developing the Company's products and technologies, future results from the Company's ongoing and planned clinical trials such as unexpected data or clinical site activation rates or clinical trial enrollment rates that are lower than expected, difficulties arising from our collaborations, challenges in accessing adequate manufacturing capacity, the Company's ability to obtain adequate financing to fund its planned clinical trials and other expenses, statements related to regulatory authorizations and approvals, trends in the industry, changes in the competitive landscape, delays or disruptions due to the COVID-19 pandemic, the legal and regulatory framework for the industry, unexpected litigation or disputes and future expenditures. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The actual results may vary from the anticipated results and the variations may be material. Other factors that may cause the Company's actual results to differ from current expectations are discussed in the Company's filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. These forward-looking statements should not be taken as forecasts or promises nor should they be taken as implying any indication, assurance or guarantee that the assumptions on which such forward-looking statements have been made are correct or exhaustive or, in the case of the assumptions, fully stated in this presentation. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this presentation is given. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. The Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 for all forward-looking statements.
This presentation discusses product candidates that are under clinical study and which have not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of these product candidates for the use for which such product candidates are being studied.
The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of such products.
© 2021 Vir Biotechnology, Inc. | 2 |
Vir Clinical Development Pipeline
Antibody | siRNA | T cell | ||||||||||||
Disease | Product | Treatment/ | Pre-clinical | Phase 1 | Phase 2 | Phase 3 | Authorized | Collaborator | ||||||
Area | Candidate | Prophylaxis | ||||||||||||
Sotrovimab* | Treatment | U.S., EU† | ||||||||||||
Sotrovimab + | Treatment | ||
bamlanivimab | |||
COVID-19 | |||
Sotrovimab* | Prophylaxis | ||
VIR-7832 | Treatment | ||
VIR-2218 | Treatment | ||
VIR-2218 + | Treatment | ||
PEG-IFN-⍺ | |||
VIR-3434 | Treatment | ||
HBV | VIR-2218 + | Treatment | Planned 2H:2021 start |
VIR-3434 | |||
VIR-2218 + | Treatment | Planned 2H:2021 start | |
TLR81 + PD-12 | |||
VIR-2218 + | Treatment | ||
BRII-179 | |||
Influenza A | VIR-2482 | Prophylaxis | |
HIV | VIR-1111** | Prophylaxis |
*Sotrovimab (VIR-7831) IV formulation used in Phase 3 COMET-ICE trial; IM formulation currently in Phase 2 COMET-PEAK and COMET-TAIL trials, and pending in prophylaxis trial **Vaccine designed to establish proof of concept in Phase (Ph) 1 clinical trial to determine whether unique immune
response observed in non-human primates can be replicated in humans; ultimately, any candidates we advance as a potential HIV vaccine will require modifications to VIR-1111 before further clinical development.
1: GS-9688 | |
2: nivolumab | 3 |
† In the U.S., EUA received on 5/26/2021. In the EU, EMA |
positive opinion under Article 5(3) received on 5/21/2021.
Chronic HBV: Our Approach to Functional Cure
We believe that chronic HBV (CHB) is a viral disease resulting in immune dysfunction
We believe that chronic HBV infection results in immune dysfunction via the expression of a large amount of HBV antigens, which act to suppress the immune system
We believe a functional cure for CHB results from regaining immunologic control
We hypothesize that knocking down HBV antigens will
remove the block on the immune system, and in the setting of an immune
modulator, result in immune control
© 2021 Vir Biotechnology, Inc. | 4 |
Chronic HBV: HBV T cells become dysfunctional in infected mice
HBV T cell | HBV T cell |
Transgenic | Core-only |
HBV mouse | expressing mouse |
Isogawa M, et al. PLoS Pathog 2013; 9(7):e1003490
© 2021 Vir Biotechnology, Inc. | 5 |
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Vir Biotechnology Inc. published this content on 25 June 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 25 June 2021 15:08:07 UTC.