Powering the Immune System to Transform Lives
Our Therapeutic Focus Areas
Chronic Hepatitis Delta
Chronic hepatitis delta (CHD) is considered by the World Health Organization to be the most severe form of chronic viral hepatitis due to more rapid progression towards liver cancer and liver-related death1. Approximately 70% to 80% of people living with CHD will progress to cirrhosis within five to 10 years of diagnosis if left untreated2.
The estimated global prevalence of CHD ranges from 12 to 72 million, with the majority of cases remaining undiagnosed3-6.
Vir is working to develop a chronic suppressive therapy that helps address this significant unmet medical need. Our ongoing Phase 2 SOLSTICE trial is evaluating tobevibart (VIR-3434) alone, and in combination with elebsiran (VIR-2218), as a potential treatment regimen for people living with CHD.
Tobevibart is an investigational neutralizing monoclonal antibody that has been engineered for immune engagement. Elebsiran is an investigational siRNA that is designed to enable targeted delivery to the liver and to reduce Hepatitis B surface antigen, a protein which is required for the hepatitis delta virus life cycle.
1 WHO Hepatitis Delta Factsheet - https://www.who.int/news-room/fact-sheets/detail/hepatitis-d
2 CDC https://www.cdc.gov/hepatitis/hdv/hdvfaq.htm
3 Wedemeyer H, Manns MP. Epidemiology, pathogenesis and management of hepatitis D: update and challenges ahead. Nat Rev Gastroenterol Hepatol. 2010;7: 31–40. doi: 10.1038/nrgastro.2009.205
4 Miao Z, Zhang S, Ou X, Li S, Ma Z, Wang W, et al. Estimating the global prevalence, disease progression and clinical outcome of hepatitis delta virus infection. J Infect Dis. 2019. doi: 10.1093/infdis/jiz633
5 Stockdale AJ, Kreuels B, Henrion MYR, Giorgi E, Kyomuhangi I, de Martel C, et al. The global prevalence of hepatitis D virus infection: Systematic review and meta-analysis. J Hepatol. 2020;73: 523–532. doi: 10.1016/j.jhep.2020.04.008
6 Chen H-Y, Shen D-T, Ji D-Z, Han P-C, Zhang W-M, Ma J-F, et al. Prevalence and burden of hepatitis D virus infection in the global population: a systematic review and meta-analysis. Gut. 2019;68: 512–521. doi: 10.1136/gutjnl-2018-316601
Chronic Hepatitis B
Around the world, approximately 300 million people live with chronic hepatitis B (CHB), with 1.5 million new infections each year1. Complications from CHB include liver cirrhosis and liver cancer, which lead to greater than 800,000 deaths annually worldwide2.
The rate of functional cure (lifelong control of the virus after a finite duration of treatment) with current approved treatments is 3%-7%2-5. Our goal is to deliver the first treatment for CHB with 30% or greater functional cure rate. This further reduces the risk of debilitating disease progression.
Vir’s approach uses a combination regimen of antivirals and immunomodulators, including our investigational antibody tobevibart (VIR-3434), and siRNA elebsiran (VIR-2218).
Our ongoing Phase 2 MARCH Part B trial is evaluating 24 and 48 weeks of tobevibart and elebsiran together, with and without peginterferon alpha, to help us determine if we can achieve a functional cure.
1WHO Hepatitis B Factsheet - https://www.who.int/news-room/fact-sheets/detail/hepatitis-b
2European Association for the Study of the Liver. J Hepatol. 2017;67:370–398.
3Kim GA, et al. Gut 2014; 63(8):1325-32.
4Konerman MA, Lok AS. Clin Liver Dis 2016;20(4):645-665.
5Liang TJ, et al. Hepatology 2015;62(6):1893-908.
Influenza
The World Health Organization considers influenza the next most likely pandemic threat. Each year, nearly a billion people around the world get sick from flu1, resulting in approximately six million hospitalizations and up to 600,000 deaths worldwide2.
Despite the availability of vaccines, there remains a significant unmet patient need as vaccine effectiveness rates are lower among high-risk populations, including those who are immunocompromised3, due to the body’s inability to mount a response to vaccines.
Our investigational neuraminidase-targeting monoclonal antibody candidate VIR-2981 has shown in vitro potent activity against all major strains of influenza A and B viruses, both of which cause seasonal epidemics.
Our goal with VIR-2981 is to achieve a meaningful reduction of medically attended influenza illness, especially for those considered at high risk for severe illness, thus increasing their protection against influenza A and B.
1https://www.who.int/news/item/14-10-2022-influenza-in-the-northern-hemisphere-is-back
2Luliono et al., Lancet. “Estimates of global seasonal influenza-associated respiratory mortality: a modelling study”, 2018 Mar 31;391(10127):1285-1300.
3Restivo et al., Hum Vaccin Immunother., 2018; 14(3): 724-735
HIV
Over forty years since the start of the epidemic, HIV remains one of the world’s most serious public health challenges. Approximately 39 million people worldwide are living with HIV, including 1.2 million in the U.S. alone. In 2022 alone, 1.3 million people worldwide were estimated to have acquired an HIV infection1.
At Vir, we seek to address this elusive virus through the development of an HIV vaccine and an HIV cure, both with support from the Bill & Melinda Gates Foundation.
Prevention
Our differentiated approach to HIV prevention starts with our T cell-based viral vector platform. This platform utilizes human cytomegalovirus (HCMV) as a vector designed to enhance T cell immunity.
VIR-1388 is our novel investigational T cell vaccine candidate for the prevention of HIV and is currently in a Phase 1 clinical trial. VIR-1388 utilizes human cytomegalovirus (HCMV) as a vector, which is a weakened version of the virus designed to deliver the HIV vaccine material to the immune system without causing disease in the trial participants. Based on in vivo preclinical data, we hypothesize an HCMV-based vaccine may be able to “program” unique T cell responses against HIV.
We believe the type, breadth and sheer number of T cells that an HCMV-based vaccine may be able to elicit against HIV differentiates this vaccine approach, but we recognize that this is a very challenging field. If the initial immunogenicity clinical trial data support this unique T cell-based viral vector platform, we believe its potential application is broader than HIV or infectious disease – including oncologic applications.
Cure
To bring hope to the millions of people living with HIV, we are developing a cocktail of broadly neutralizing antibodies (bnAbs) that have been engineered to enhance T-cell responses. Given the diversity of HIV strains worldwide and the virus’ history of generating viral resistance, we believe a combination of at least two bnAbs is required to achieve a functional cure.
COVID-19
Sotrovimab, our investigational monoclonal antibody (mAb) treatment for COVID-19, was identified by our proprietary antibody platform and Fc engineered for immune engagement. We are very proud of the fact that it was delivered in just 15 months during the pandemic and has benefited numerous people around the world.
As new variants continue to emerge and with vaccination rates falling, there remains an unmet need for new therapies for COVID-19. VIR-7229 is our investigational next generation COVID-19 mAb that in development has demonstrated increased potency, breadth, and resistance to viral escape thanks to AI engineering and optimization. In preclinical studies, VIR-7229 has been shown to have high potency against a broad spectrum of variants.
The development of VIR-7229 through the end of Phase 1 is supported by the Biomedical Research and Development Agency (BARDA), part of the U.S. Department of Health and Human Services’ (HHS) Administration for Strategic Preparedness and Response (ASPR)*.
*The development of VIR-7229 has been supported in whole or in part with federal funds from the Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Number: 75A50122C00081.
RSV and hMPV
Respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) are leading causes of lower respiratory tract infections among infants, the immunocompromised and elderly populations. Globally, each year there are approximated 33 million RSV acute lower respiratory infections, resulting in approximately 3.6 million hospitalizations and approximately 100,000 deaths per year in children <5 yrs1. Additionally, there are approximately 14 million hMPV cases, resulting in approximately 643,000 hospitalizations and approximately 16,000 deaths in children <5 yrs2.
People with weakened immune systems, lung and heart disease, and infants are at greater risk for RSV and hMPV infections and complications. Our investigational monoclonal antibody candidate VIR-8190 is designed to significantly reduce the risk of acquiring both RSV and hMPV, two viruses that causes significant morbidity and mortality in infants and the immunocompromised, thus addressing a significant unmet need.
1You Li et al., Lancet. 2022 May 28; 399(10340): 2047–2064.
2Wang et al., Lancet. “Global burden of acute lower respiratory infection associated with human metapneumovirus in children under 5 years in 2018: a systematic review and modelling study” 2021 Jan; 9(1): E33-43
Pre-Cancerous HPV Lesions
Human Papillomavirus (HPV) infection can result in numerous health issues including high-grade squamous intraepithelial lesions (HSIL) which are often a precursor for various types of cancers such as cervical, vaginal, vulvar, anal, penile, and oropharyngeal.
Despite advances in vaccination and screening, HPV-associated cancers and conditions remain significant global health concerns. HPV causes an estimated 630,000 cancers worldwide each year, accounting for about five percent of all cancers1.
At Vir, we are leveraging our T cell-based viral vector platform to develop VIR-1949, an investigational therapeutic vaccine candidate that targets the underlying HPV virus with the goal of eliciting specific types of T cell responses against HPV for a long-lasting immune response. This is key to not only treating the current disease but also clearing underlying infection to prevent disease recurrence locally or in other areas of the body.
VIR-1949 is based on the HCMV vector and is Vir’s first preclinical pipeline candidate to expand our pipeline beyond infectious disease into viral-associated cancer.
1https://www.cancer.gov/about-cancer/causes-prevention/risk/infectious-agents/hpv-and-cancer