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Our mission is to create a world without infectious disease
We are a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent
serious infectious diseases. Infectious diseases are one of the leading causes of death worldwide and can cause trillions of dollars of direct and indirect economic burden each year as evidenced by the current coronavirus disease 2019, or COVID-19, pandemic. We believe that now is the time to apply the recent and remarkable advances in immunology to combat infectious diseases. Our approach begins with identifying the limitations of the immune system
in combating a particular pathogen, the vulnerabilities of that pathogen and the reasons why previous approaches have failed. We then bring to bear powerful technologies that we believe, individually or in combination, will lead to effective
We have assembled four technology platforms, focused on antibodies, T cells, innate immunity and small interfering ribonucleic
acid, or siRNA, through internal development, collaborations and acquisitions. Our current development pipeline consists of product candidates targeting severe acute respiratory syndrome coronavirus 2, or SARS-CoV-2, the virus that causes COVID-19, hepatitis B virus, or HBV, influenza A, human immunodeficiency virus, or HIV, and tuberculosis, or TB. For SARS-CoV-2, VIR-7831, a
SARS-CoV-2- neutralizing monoclonal antibody, or mAb, is planned to start a Phase 2/3 clinical trial program in August 2020
and we anticipate initial clinical data to be available before the end of the year. VIR-7832, a vaccinal
SARS-CoV-2-neutralizing mAb, is planned to initiate a Phase 2 clinical trial later this year.
VIR-2703, a SARS-CoV-2-targeting siRNA, is in preclinical studies. For HBV, VIR-2218, an HBV-targeting siRNA, is currently in an ongoing Phase 2 clinical trial. Initial Phase 2 data have demonstrated substantial, durable, and dose dependent reduction
of hepatitis B virus surface antigen, or HBsAg, and VIR-2218 has been generally well-tolerated. We recently initiated a Phase 2 clinical trial to combine VIR-2218 with
pegylated interferon-alpha, or PEG-IFN- , an approved immune modulatory agent. In addition, we recently initiated a Phase 1 clinical trial for VIR-3434, an HBV-neutralizing mAb. For influenza A, VIR-2482, a mAb designed for the prevention of influenza A, is currently in a Phase
1/2 clinical trial and has been generally well-tolerated. For HIV, VIR-1111, an HIV T cell vaccine based on HCMV, is planned to initiate a Phase 1 trial in the second half of this year. We have built an
industry-leading team that has deep experience in immunology, infectious diseases and product development. Given the global impact of infectious diseases, we are committed to developing cost-effective treatments that can be delivered at scale.
Our Technology Platforms
current technology platforms are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. We are using our platforms to advance our current product candidates and generate additional
product candidates for multiple indications.
Antibody Platform: We have established a robust method for capitalizing on unusually
successful immune responses naturally occurring in people who are protected from, or have recovered from, infectious diseases. We identify rare antibodies from survivors that have the potential to treat and prevent rapidly evolving and/or previously
untreatable pathogens via direct pathogen neutralization and immune system stimulation. The fully-human antibodies that we discover may also be modified to enhance their therapeutic potential. We have applied these methods to identify mAbs for a
range of pathogens including Ebola, HBV, influenza A and influenza B virus, SARS-CoV-2, RSV and malaria, and bacterial pathogens, including clostridium difficile, Staphylococcus aureus, Klebsiella pneumoniae, and Acinetobacter
T Cell Platform: We are exploiting the unique immunology of human cytomegalovirus, or HCMV, a commonly occurring virus in humans,
as a vaccine vector to potentially treat and prevent infection by pathogens refractory to current vaccine technologies. This approach is based on fundamental observations made in non-human primates, or NHPs,
with rhesus cytomegalovirus, or RhCMV. We believe that this platform may also have applicability beyond infectious diseases, to areas such as cancer.
Innate Immunity Platform: Moving beyond more traditional approaches that are used to evoke adaptive immunity or that directly target pathogens,
where the development of resistance can occur, we plan to target host proteins as a means of creating host-directed therapies with high barriers to resistance. We believe that by leveraging the power of innate immunity, we can create medicines that
break the one-drug-for-one-bug paradigm to produce one-drug-for-multiple-bugs.
siRNA Platform: We are harnessing the power of siRNA to inhibit pathogen replication, eliminate key host factors necessary for pathogen survival
and remove microbial immune countermeasures. Our collaboration with Alnylam Pharmaceuticals, Inc., or Alnylam, includes VIR-2218 for HBV, VIR-2703 for SARS-CoV-2 and up to seven additional programs for infectious diseases.
Development Pipeline
Our current product candidates are summarized in the chart below:
The substantial impact of viral outbreaks and the need for global preparedness have been highlighted by the current COVID-19 pandemic. As of June 19, 2020, the virus had spread to 188 countries,
there were over 8.5 million recorded infections and over 450,000 recorded deaths. We have moved rapidly to address this global health challenge. Our focus is on treating and preventing SARS-CoV-2, as well as potential future coronavirus outbreaks. To do so, we are taking multiple approaches: antibodies (VIR-7831 and
VIR-7832), siRNA (VIR-2703), applying our innate immunity platform to identify cellular host genes necessary for virus replication, and vaccines. We anticipate that the
initial registration populations for our product candidates will include those at high risk of contracting COVID-19 and those in need of treatment for COVID-19.
VIR-7831 and VIR-7832 are SARS-CoV-2-neutralizing mAbs. For VIR-7831, we plan to submit an Investigational New Drug
Application, or IND, and thereafter commence a Phase 2/3 clinical trial program in August 2020. VIR-7832 is planned to initiate a Phase 2 clinical trial later this year. Both VIR-7831 and VIR-7832 are based on a parent antibody, S309, which was derived from samples previously gathered for research on
pan-coronavirus-neutralizing mAbs. S309 has demonstrated high affinity and avidity for the SARS-CoV-2 spike protein and the
ability to potently neutralize SARS-CoV-2 in multiple live-virus cellular assays. S309 binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also commonly known as SARS ), indicating that the epitope is highly
conserved. We believe the conservation of this epitope will make it more difficult for escape mutants to develop and result in a high barrier to resistance. S309 also exhibits potent effector function in vitro, potentially allowing the engagement
and recruitment of immune cells to kill off already infected cells. VIR-7831 and VIR-7832 have both been engineered with LS mutations within the Fc region of
the mAbs, for the purpose of increasing lung tissue bioavailability and extending their half-life. VIR-7832 has been further engineered with XX2 mutations in the Fc region of the mAb to potentially
allow it to function as a T cell vaccine. We anticipate initial clinical data from our Phase 2/3 trial of VIR-7831 to be available before the end of the year.
Our Phase 2/3 trial program for VIR-7831 will be comprised of the following:
To accelerate the progress of VIR-7831 and VIR-7832, we have signed a number of collaboration agreements to aid in their manufacture and potential commercialization. Specifically, we are collaborating on clinical manufacturing with WuXi Biologics (Hong Kong)
Limited, or WuXi, and Biogen Inc., or Biogen. We are collaborating on commercial manufacturing with WuXi and Samsung Biologics Co., Ltd., or Samsung, and we anticipate commercial supply of approximately 10-15 million doses in 2021, depending on
titer, yield and dose amount. And we are collaborating on potential commercialization with WuXi for greater China and GlaxoSmithKline plc, or GSK, for all other countries. See the section titled Recent SARS-CoV-2 Activities for a description of these and other collaborations.
VIR-2703 is an inhaled SARS-CoV-2-targeting siRNA for which we are conducting
preclinical studies that are expected to be completed by the end of 2020. In vitro, VIR-2703 has demonstrated the ability to significantly reduce
SARS-CoV-2 live virus replication. It is designed to degrade the viral genome, leading to inhibition of viral protein synthesis and blocking the production of infectious
virus. It targets a nucleic acid sequence in the SARS-CoV-2 genome that is highly conserved amongst currently available viral sequences and is also conserved in SARS-CoV-1. VIR-2703 leverages Alnylam s latest advances in lung delivery of siRNAs and is the first development candidate
selected in our expanded collaboration with Alnylam for SARS-CoV-2 and other coronaviruses.
HBV: Approximately 290 million people globally are chronically infected with HBV and
approximately 900,000 of them die from HBV-associated complications each year. There is a significant unmet medical need for more effective therapies that lead to life-long control of the virus after a finite
duration of therapy, which is the definition of a functional cure. For a registrational trial to demonstrate a functional cure, the formal endpoint accepted by the U.S. Food and Drug Administration, or the FDA, is undetectable HBsAg, defined as less
than 0.05 international units per milliliter, or IU/ml, as well as HBV DNA less than the lower limit of quantification, in the blood six months after the end of therapy.
We are developing VIR-2218 and VIR-3434 for the functional
cure of HBV. Each of these product candidates has the potential to stimulate an effective immune response and also has direct antiviral activity against HBV. We believe that a functional cure for HBV will require an effective immune response, in
addition to antiviral activity, based on the observation that severe immunosuppression can reactivate HBV disease. While monotherapy with VIR-2218 and VIR-3434 may
provide a functional cure in some patients, we believe combination therapy will be necessary for a functional cure in many patients. We are planning trials that combine VIR-2218 and VIR-3434, which we believe have the potential to act in concert by removing potentially tolerogenic HBV proteins and stimulating new HBV specific T cells. We also recently initiated a trial that combines VIR-2218 with PEG-IFN- and are evaluating additional combinations with other immunotherapy agents and direct acting antiviral
agents. We anticipate that the initial registration population for these product candidates will be patients chronically infected with HBV.
VIR-2218 is a subcutaneously administered
HBV-targeting siRNA that is currently in a Phase 2 clinical trial. By targeting a conserved region of the HBV genome, it is designed to inhibit the production of all HBV proteins: X, polymerase, S, and
core. Suppression of HBV proteins, particularly HBsAg, is hypothesized to remove the inhibition of T cell and B cell activity directed against HBV, allowing VIR-2218 to potentially result in a
functional cure. VIR-2218 was the first siRNA in the clinic to include Alnylam s ESC+ technology, which has the potential to enhance the therapeutic index. In total, 37 healthy volunteers have received VIR-2218 and 12 healthy volunteers have received placebo. In addition, 24 patients with chronic HBV on nucleotide/nucleoside reverse transcriptase inhibitors, or NRTIs, have received VIR-2218, and eight patients with chronic HBV on NRTIs have received placebo. The data suggest that VIR-2218 is generally well-tolerated in healthy volunteers given as a
single dose up to 900 mg and in patients given as two doses of 20 mg, 50 mg, 100 mg or 200 mg each dose. The data also demonstrate substantial, dose dependent reductions in HBsAg in patients at doses ranging from 20 mg
to 200 mg, which are durable at the higher doses for at least six months. We recently initiated a Phase 2 combination trial of VIR-2218 and PEG-IFN- , and
anticipate initial clinical data to be available in 2021.
The trial design for the Phase 2 combination trial of VIR-2218 and
PEG-IFN- is shown below:
VIR-3434 is a subcutaneously
administered HBV-neutralizing mAb currently in a Phase 1 clinical trial. By targeting a conserved region of HBsAg, it is designed to block entry of all 10 genotypes of HBV into liver cells called hepatocytes
and reduce the level of virions and subviral particles in the blood. We have also engineered VIR-3434 to have an extended half-life and to potentially function as a therapeutic T cell vaccine for chronic HBV
infection. These modifications are intended to enhance its potential to result in an HBV functional cure. We anticipate clinical data from our Phase 1 trial will enable us to initiate a Phase 2 clinical trial of
VIR-3434 in combination with VIR-2218 in 2021.
Influenza: On average, each year the influenza virus infects 5% to 10% of the world s population and results in an estimated 500,000
deaths. In the 2017-2018 flu season, it is now estimated that 61,000 people died from influenza in the United States alone. Influenza vaccines have historically had limited success, with an average efficacy of 40%. This limited efficacy results from
incomplete coverage against seasonal strains and the lack of an effective immune response in many individuals after receiving the vaccine. We are developing VIR-2482 as a universal prophylactic for influenza A
and have designed it to overcome both limitations of flu vaccines, which we believe will lead to meaningfully higher levels of protection. We anticipate that the initial registration population for VIR-2482
will be individuals at high risk of influenza A complications, such as the elderly with chronic lung disease or congestive heart failure.
VIR-2482 is an intramuscularly administered influenza
A-neutralizing mAb currently in a Phase 1/2 clinical trial. In vitro, VIR-2482 has been shown to cover all major strains of influenza A that have arisen since the
1918 Spanish flu pandemic. We believe that VIR-2482 has the potential to provide superior protection to flu vaccines and be able to be used year after year because it has broad strain coverage as opposed to
the limited strain coverage generated by vaccines. We also believe that it provides passive immunity rather than relying on a person to generate active immunity via a functional immune response, an ability that is known to decline with age. VIR-2482 has been engineered to increase lung tissue bioavailability and to extend its half-life so that a single intramuscular dose has the potential to last the entire flu season, which is typically five to six
months long. VIR-2482 is estimated to have a half-life of 58 days based on preliminary data. VIR-2482 has been generally well-tolerated in the approximately 100 healthy volunteers dosed in the Phase 1
portion of the clinical trial. We anticipate initiating the Phase 2 portion of the clinical trial in the northern hemisphere in the fourth quarter of 2020, followed by a second northern hemisphere season if necessary. Data from an interim analysis
of the first flu season of the Phase 2 clinical trial are anticipated to be available in the first half of 2021.
HIV: Each year there are
approximately 1.8 million new cases of HIV and approximately 1.0 million HIV-related deaths globally. Current prevention approaches such as behavioral modification and pharmacological intervention
have had only a modest effect on HIV transmission globally, leaving a high unmet medical need for a safe and effective vaccine for the billions of individuals who are or may become sexually active. VIR-1111 is
a proof of concept HIV vaccine designed to elicit a type of immune response that is different from other vaccines. We anticipate the initial registration population for our eventual HIV vaccine will be individuals at high risk of contracting HIV.
VIR-1111 is a subcutaneously administered HIV T cell vaccine based on HCMV for
which we plan to submit an IND in the second half of 2020 and thereafter commence a Phase 1 clinical trial. VIR-1111 has been designed to elicit T cells that recognize HIV epitopes that are different from
those recognized by prior HIV vaccines and to stimulate a different and specific type of T cell immune response to HIV, known as an HLA-E restricted immune response. An
HLA-E restricted immune response has been shown to be associated with protection of NHPs from simian immunodeficiency virus, or SIV, the NHP equivalent of HIV. VIR-1111
is a vaccine designed solely to establish proof of concept in a Phase 1 clinical trial to determine whether the unique immune response observed in NHPs can be replicated in humans.
TB: Globally, nearly two billion people are latently infected with TB, and each year there are
approximately 10 million new active cases of TB and approximately 1.6 million TB-related deaths. There is a high unmet medical need for a safe and effective vaccine that prevents active pulmonary TB
in adolescents and adults, as they represent the key sources of TB transmission and are the primary contributors to overall disease burden. VIR-2020 is a vaccine designed to provide a type of immune
response that is different from other vaccines and lead to meaningful levels of protection from active TB. We anticipate that the initial registration population for VIR-2020 will be people at high risk of