A WORLD WITHOUT INFECTIOUS DISEASE - Vir Biotechnology, Inc - VIR Bio Overview
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A WORLD WITHOUT
INFECTIOUS DISEASE
Vir Biotechnology, Inc.
39th Annual J.P. Morgan Healthcare Conference
January 12, 2021
1
Legal disclaimers
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 our research and clinical development plans, expected timing of commencement of clinical trials, our goals with respect to the prophylaxis or treatment of SARS-CoV-
2/COVID-19, HBV, influenza A, tuberculosis and HIV, our manufacturing and commercialization plans, our objectives, strategy, technology platform and clinical trial designs, the
potential benefits of our collaborations, regulatory matters, market size and opportunity 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, 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
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Taking on the most serious infectious diseases
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Potential best-in-class Strong Near-term
technologies execution value drivers
Multiple mid- COVID-19 Phase 3 data
Dual-action
and late-stage COMET-ICE, ACTIV-3
antibodies
clinical compounds
Potential best-in-class HBV Phase 2 data
Differentiated VIR-2218 + PEG-IFN-⍺
siRNA therapies
COVID-19 antibodies
Programmable Proof-of-biology data
Leading program VIR-1111, VIR-7832, VIR-3434
T cell vaccines
for HBV functional cure
Multi-pathogen targeted Clinical starts
Flu A and HIV prevention VIR-2218 + VIR-3434,
small molecules
breaking new ground VIR-2218 + Gilead assets,
VIR-2482
© 2021 Vir Biotechnology, Inc. 3
2020: Delivering on multiple fronts
Identified potent, differentiated antibodies for COVID-19
Rapid response to Initiated two Phase 3 trials: early treatment and hospitalized patients
COVID-19 Established pan-coronavirus collaboration with GSK
Established POC for lead HBV candidate (siRNA)
Leading the way toward Initiated POC trial for antibody as a therapeutic T cell vaccine
HBV functional cure Initiated first POC combination trial for HBV functional cure
Continuing to advance
Completed Phase 1; confirmed potential for 1X/seasonal dosing for Flu A
our pipeline in Initiated Phase 1 trial of prophylactic T cell HIV vaccine
Influenza A and HIV
Significantly strengthened our balance sheet
© 2021 Vir Biotechnology, Inc. 42021: A transformational year ahead
With the potential to….
Deliver COVID-19 Seek regulatory approval and launch our first antibody
solutions Demonstrate that antibodies can stimulate T cell immunity
Deliver clinical milestones for potential best-in-class HBV portfolio
Lead the way toward Vir programs and new Gilead clinical collaboration
HBV functional cure • POC for siRNA + PEG-IFN-⍺ • Phase 2 initiation for siRNA + antibody
• POC for antibody • Phase 2 initiation for siRNA + Gilead assets
Continue to advance
Initiate POC trial for universal prophylaxis for Flu A
our pipeline in Generate first-in-human data for novel vaccine platform in HIV
Influenza A and HIV
…become a revenue-generating company
© 2021 Vir Biotechnology, Inc. 5Vir development pipeline Antibody siRNA T cell
Product Treatment/
Disease Area Pre-clinical Phase 1 Phase 2 Phase 3 Collaborator
Candidate Prophylaxis
Early treatment
VIR-7831
(Ambulatory)
Late treatment
VIR-7831
(Hospitalized)
COVID-19
VIR-7831 Prophylaxis
VIR-7832 Treatment
VIR-2218 Treatment
VIR-2218 +
HBV Treatment
PEG-IFN-⍺
VIR-3434 Treatment
Influenza A VIR-2482 Prophylaxis
HIV VIR-1111* Prophylaxis
*Vaccine designed to establish proof of concept in Phase (Ph) 1 clinical trial to determine whether unique immune *COVID-19: coronavirus disease 2019; HIV: human immunodeficiency virus;
response observed in non-human primates can be replicated in humans; ultimately, any candidates we advance as a © 2021 Vir Biotechnology, Inc. HBV: hepatitis B virus 6
potential HIV vaccine will require modifications to VIR-1111 before further clinical development.COVID-19: Ongoing need for effective antibody therapy
88 MM Vaccines are
Infections worldwide
not enough
1.9 MM Herd immunity will take time
Deaths worldwide
Vaccine hesitancy remains
274K
New cases per day (US) The virus is mutating
* John Hopkins University (Data as of 1/7/2021)
© 2021 Vir Biotechnology, Inc. 7COVID-19: A rapidly evolving pandemic
What we know now….
of circulating viruses ~ 88 million people infected*
< 0.4% have been sequenced ~ 305,717 sequenced viruses**
~5% of the world’s population
of the known sequences
75% come from only 4 countries
UK (45%) US (18%) Denmark (7%) Australia (5%)
What we still don’t know…
• Genetic structure and medical implications of SARS-CoV-2 mutants
• How virus will respond to immune pressure (i.e., seroprevalence ~10%***)
Why this matters: majority of clinical antibodies target the RBM†, which is highly variable
* John Hopkins University (Data as of 1/7/2021)
** GISAID (human seqs, low coverage excluded) (Data as of 1/3/2021)
© 2021 Vir Biotechnology, Inc. 8
*** www.serotracker.com
† RBM: Receptor Binding MotifCOVID-19: The South African variant…
January 5, 2021
“…appears to ‘obviate’ antibody drugs.”
– Dr. Scott Gottlieb
“…might have a negative impact on the
January 6, 2021
efficacy of some of the monoclonal
antibodies that are used.”
– Dr. Anthony Fauci
© 2021 Vir Biotechnology, Inc. 9VIR-7831: Binds to a site that is highly conserved
Scottish mutant VIR-7831 is
+ expected to retain
activity against all
UK mutant four variants
+
South African mutant The same cannot
be said for other
+
clinical-stage
Mink mutant antibodies
Month & Year
GISAID (human seqs, low coverage excluded)
>1018 aa (80% full length) © 2021 Vir Biotechnology, Inc. 10VIR-7831: A differentiated, dual-action antibody
Blocks virus entry
into healthy cells
+
Clears infected
cells
© 2021 Vir Biotechnology, Inc. 11VIR-7831: Potential best-in-class antibody
Improved lung Blocks viral entry
bioavailability3 into healthy cells
(neutralization)1,2
Dual-Action
Clears infected cells
Extended
Engineered to have by recruiting the
half-life1,2 potent and lasting immune system1,2
effects against
SARS-CoV-2 and
other CoVs*
Low dose High barrier to resistance;
allows for IM potential to address
formulations future pandemics2
* Sarbecoviruses.
1. Pinto D, et al. Nature. 2020;583:290–5;
2. Vir Biotechnology, Press release, 18 May 2020 (accessed November 13, 2020); © 2021 Vir Biotechnology, Inc. 12
3. Hope, IAS 2019- HIV & HBV Cure Forum, Mexico CityVIR-7831 and VIR-7832: A robust clinical program
Trial Population Primary Endpoint Milestones
Patients at high risk PHASE 3
Reduction in hospitalization
of hospitalization
and/or death Data
Early Treatment (VIR-7831) (e.g., obesity, diabetes, age >55) (1Q:2021)
Time to sustained recovery
PHASE 3
Mild, moderate, and higher- (i.e., discharged, home for
severity hospitalized patients 14 consecutive days) and/or Part 1 review
reduction in death (1Q:2021)
Hospitalized (VIR-7831)
PHASE 3
Uninfected individuals Prevent symptomatic
at high risk infection Start
Prophylaxis (VIR-7831) (2Q:2021)
Safety and tolerability of PHASE 1b/2a
Patients at high risk of
hospitalization (age >55)
VIR-7832; virologic comparison Start
Early Treatment of VIR-7831 and VIR-7832 (1Q:2021)
(VIR-7832/VIR-7831)
© 2021 Vir Biotechnology, Inc. 13Vir-GSK: A pan-coronavirus collaboration
Creating A Robust Coronavirus Portfolio For Impact Today and in the Future
Partnership benefits:
Scale and speed of
commercialization
Developing pan-corona
Manufacturing and supply antivirals using functional
genomics and antibodies
Data sciences, human
genetics
Accelerating development Developing
Medicinal chemistry of COVID-19 antibodies pan-corona vaccines
Future pandemic planning VIR-7831, VIR-7832
© 2021 Vir Biotechnology, Inc. 14HBV functional cure program
Our goal Achieve HBV functional cure* through combination therapy
Suppress Stimulate
Our approach the virus and enhance
the immune
system
• Inhibits virion production
VIR-2218 (siRNA)
Our core assets • Removes tolerogens
address both
• Prevents viral entry
VIR-3434 (mAb) • Removes tolerogens
• Acts as a T cell vaccine
*Functional cure: undetectable hepatitis B virus surface antigen (HBsAg), defined as less than
0.05 international units per milliliter, as well as HBV DNA less than the lower limit of quantification, © 2021 Vir Biotechnology, Inc. 15
in the blood six months after the end of therapy.Broadest HBV functional cure portfolio
Ongoing / Planned Combination Trials
VIR-2218
Potential Best-In-Class siRNA Currently in
PEG-IFN-⍺
as “backbone” of therapy Phase 2
VIR-3434 Start Phase 2
+
mAb trial in 2H:2021
GS-9688
TLR-8 Agonist
Start Phase 2
nivolumab trial in 2021
Substantial, Durable, and Dose Dependent
PD-1
Reduction of HBsAg through 36 weeks
BRII-179 Start Phase 2
T cell vaccine trial in 1H:2021
Note: current and planned trials are/will be conducted in patients with chronic HBV
on nucleotide/nucleoside reverse transcriptase inhibitors (NRTIs), which are standard of care treatment. © 2021 Vir Biotechnology, Inc. 16
PEG-IFN: pegylated interferon alpha.VIR-2482: Universal prophylaxis for Influenza A
Expected advantages of VIR-2482 Influenza Hemagglutinin (HA)
In vitro, covers all major strains of Influenza A
since the 1918 pandemic Most Vaccine-Induced
Antibodies
Does not rely on host immune system
to mount a response
IM administration (like the flu shot)
Extended half-life with potential for VIR-2482
1X/seasonal dosing
Variable amino acids
Start Phase 2 in 4Q:2021 Conserved amino acids
with expected POC data 1H:2022 Conserved epitope
© 2021 Vir Biotechnology, Inc. 17T cell platform progress
Culmination of a decade-long collaboration with
Oregon Health & Science University with support from the
Bill & Melinda Gates Foundation
“We are pleased to have initiated the first Phase 1 trial to
evaluate our T cell platform, which explores the potential for
immune-programmed vaccines to treat and prevent serious
infectious diseases like HIV.”
HIV vaccine candidate begins HIV Vaccine: Vir Biotechnology
first clinical trial in humans Announces First Patient Dosed
© 2021 Vir Biotechnology, Inc. 182021 anticipated catalysts
Catalyst Disease area Anticipated timing
VIR-7831 (mAb) Phase 3 (Early Treatment, COMET-ICE) data COVID-19 1Q:2021
VIR-7831 (mAb) Phase 3 (Hospitalized, ACTIV-3) part 1 review COVID-19 1Q:2021
VIR-7832 (mAb) Phase 1b/2a (Early Treatment, AGILE) start COVID-19 1Q:2021
VIR-7831 (mAb) Phase 3 (Prophylaxis) start COVID-19 2Q:2021
VIR-2218 (siRNA) Phase 2 one-year response durability data HBV 1H:2021
VIR-2218 (siRNA) + BRII-179 Phase 2 start HBV 1H:2021
VIR-2218 (siRNA) + VIR-3434 (mAb) Phase 2 start HBV 2H:2021
VIR-2218 (siRNA) + PEG-IFN-⍺ Phase 2 initial data HBV 2H:2021
VIR-2218 (siRNA) + GS-9688 + nivolumab Phase 2 start HBV 2021
VIR-2482 (mAb) Phase 2 start Influenza A 4Q:2021
VIR-2482 (mAb) Phase 2 POC data Influenza A 1H:2022
VIR-1111 (T cell) Phase 1 initial data HIV 2H:2021
© 2021 Vir Biotechnology, Inc. 19Vir Biotechnology
Significant near-term value drivers
Two Phase 3 COVID-19 read-outs for VIR-7831; seek approval and launch our potential
best-in-class antibody
Leading the way toward a functional cure for HBV
Advancing clinical pipeline in Influenza A and HIV
Even more potential value to be unlocked
Multi-pathogen targeted small molecules
Vaccinal antibodies
Immune programming
Our mission is to create a world without infectious disease
© 2021 Vir Biotechnology, Inc. 20You can also read
