Powering the Immune System to Transform Lives
Our Therapeutic Focus Areas
Chronic Hepatitis Delta
Chronic hepatitis delta is considered the most severe form of chronic viral hepatitis, and on average, people living with the disease will progress to cirrhosis and liver failure within five years.1 Currently, there is no approved treatment in the United States, and therapeutic options are limited globally.
Vir Biotechnology is working to develop a chronic suppressive therapy to help address this significant unmet medical need. Our ongoing Phase 2 SOLSTICE trial is evaluating tobevibart alone or in combination with elebsiran as a potential treatment regimen for people living with chronic hepatitis delta. Tobevibart in combination with elebsiran is advancing into a Phase 3 registrational clinical program called ECLIPSE.
Tobevibart is an investigational neutralizing monoclonal antibody that has been engineered for immune engagement. Elebsiran is an investigational small interfering RNA (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 CDC https://www.cdc.gov/hepatitis/hdv/hdvfaq.htm
Chronic Hepatitis B
Around the world, approximately 254 million people live with chronic hepatitis B.1 Complications from chronic hepatitis B include cirrhosis and liver cancer, and the World Health Organization estimates that 1.1 million people died from viral hepatitis B in 2022.1 Although treatment options are available, they don’t eliminate the risk of disease progression.2
The rate of functional cure (lifelong control of the virus after a finite duration of treatment) with current approved treatments is 3%-7%.3-6 Our goal is to raise the bar with a new treatment option for chronic hepatitis B with a greater functional cure rate that may decrease the risk of developing end-stage liver disease complications like progression to cirrhosis, liver transplant and even death.
Our approach uses a combination regimen of antivirals and immunomodulators, including our investigational antibody, tobevibart, and siRNA, elebsiran.
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.
1 WHO Global Hepatitis Report 2024
2 CDC Hepatitis B Basics | Hepatitis B | CDC
3 European Association for the Study of the Liver. J Hepatol. 2017;67:370–398.
4 Kim GA, et al. Gut 2014; 63(8):1325-32.
5 Konerman MA, Lok AS. Clin Liver Dis 2016;20(4):645-665.
6 Liang TJ, et al. Hepatology 2015; 62(6):1893-908.
Oncology
One in five people worldwide develop cancer during their lifetime.1 Although medicine has made tremendous strides in cancer prevention and treatment, cancer still remains the second-leading cause of death globally and is the leading or second-leading cause of premature death (before age 70 years) in 112 countries.2 As the burden of cancer continues to grow, so does the need for new therapeutic options for patients.
Over the past 30 years, our understanding of cancer has increased dramatically. Today, we know many of the key drivers of this disease, down to the genetic and molecular levels.3
HER2, EGFR and PSMA, are three examples of molecules well-known to play a key role in cancer. These molecules are over-expressed in a variety of solid tumors, such as breast cancer, colorectal cancer and prostate cancer, making them attractive targets for cancer therapy. Current cancer therapies targeting these molecules have shown promise, but there remains a high need for more efficacious and better-tolerated treatments options.
We are advancing three investigational assets that leverage the PRO-XTEN™ masking technology with T-cell engagers targeting HER2, EGFR or PSMA. The PRO-XTEN™ masking technology is designed to keep the T-cell engagers inactive until they reach the tumor microenvironment, where tumor-specific proteases can cleave off the mask and activate the T-cell engager leading to killing of cancer cells. By driving the activity exclusively to the tumor microenvironment, we aim to limit the toxicity of these agents and potentially increase their efficacy and tolerability.
1 International Agency for Research on Cancer, WHO - Cancer Topics – IARC (who.int), accessed August 2024
2 American Cancer Society – Global Cancer Facts, 5th Edition - Global Cancer Facts & Figures-5th Edition
3 Understanding Cancer - NIH Curriculum Supplement Series - NCBI Bookshelf
HIV
More than 40 years since the start of the epidemic, HIV remains one of the world’s most serious public health challenges. It is estimated that close to 40 million people worldwide are living with HIV, including 1.4 million children.1 In 2023 alone, 1.3 million people worldwide were estimated to have acquired HIV.1
At Vir Biotechnology, we seek to address this elusive virus through the pursuit of an HIV cure, with support from the Bill & Melinda Gates Foundation.
Our approach is to utilize broadly neutralizing antibodies that have been modified with our Fc technology to enhance the immune system’s T-cell response to the virus. Broadly neutralizing antibodies are known to recognize and prevent a range of variants of HIV from infecting cells, which given the diversity of HIV strains worldwide and the virus’ history of generating viral resistance, we believe will be key to finally achieving a much-awaited cure.
Additional programs
We are currently in discussions with potential partners to out license several other Vir Biotechnology programs, including for influenza, COVID-19 and human papilloma virus (HPV).
Influenza
The World Health Organization considers influenza, commonly known as flu, as the next most likely pandemic threat. Each year, nearly a billion people around the world get sick from flu,1 resulting in approximately six million hospitalizations and up to 600,000 deaths worldwide.2
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 immunocompromised,3 due to the body’s inability to mount a response to vaccines.
Our investigational 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.
1 https://www.who.int/news/item/14-10-2022-influenza-in-the-northern-hemisphere-is-back
2 Luliono et al., Lancet. “Estimates of global seasonal influenza-associated respiratory mortality: a modelling study”, 2018 Mar 31;391(10127):1285-1300.
3 Restivo et al., Hum Vaccin Immunother., 2018; 14(3): 724-735
COVID-19
Sotrovimab, our investigational monoclonal antibody (mAb) treatment for COVID-19, was identified by our proprietary antibody platform and engineered for immune engagement. It was delivered in just 15 months during the pandemic and has benefited numerous people around the world.
VIR-7229 is our investigational next-generation COVID-19 antibody, optimized for 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 has been 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.
Pre-Cancerous HPV Lesions
Human papilloma virus (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 cancers.1
At Vir Biotechnology, 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 treat the current disease but also clearing underlying infection to prevent disease recurrence locally or in other areas of the body.
1 https://www.cancer.gov/about-cancer/causes-prevention/risk/infectious-agents/hpv-and-cancer