Vir Biotechnology Presents New Data on VIR-2482, the Company’s Investigational Monoclonal Antibody for the Prevention of Influenza A, at IDWeek 2020

Rhea-AI Summary

Vir Biotechnology has released data on VIR-2482, a monoclonal antibody aimed at preventing influenza A. The preclinical and Phase 1 studies reveal promising results, including broad neutralizing capability against historical strains and a prolonged half-life that supports potential once-per-season dosing. Notably, elderly patients with comorbidities are at high risk for severe influenza complications, with hospitalization rates between 19%-44% and associated costs of $4,122-$8,181 per patient. This underscores the need for effective prevention strategies, which VIR-2482 may fulfill.

Positive

• VIR-2482 shows broad neutralizing potential against all major influenza A strains from the last century.
• Phase 1 data indicates that VIR-2482 is well tolerated and may allow for once-per-season dosing due to its extended half-life.
• Preclinical studies demonstrated that VIR-2482 significantly reduced morbidity and mortality in mouse models.

Negative

• None.

– Preclinical data show VIR-2482 has broad neutralizing potential against
all major strains of influenza A from the last 100 years –

– Extended half-life observed in Phase 1 demonstrates potential for once-per-season dosing –

– Claims-based analysis highlights the high hospitalization rates and elevated costs among high-risk elderly patients, reinforcing need for new approaches to prevention –

SAN FRANCISCO, Oct. 21, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ: VIR), a clinical-stage immunology company focused on treating and preventing serious infectious diseases, today announced the presentation of preclinical and Phase 1 data demonstrating the broad neutralizing ability, high-level effector function, extended half-life and tolerability of VIR-2482 in the prevention of influenza A. The Company also released new health economics outcomes research, which shows that elderly adults with comorbidities suffer more severe consequences of influenza. The data will be presented at IDWeek 2020, which takes place virtually Oct. 21-25.

“Despite widespread influenza vaccination, the elderly in the U.S. have a high risk of hospitalization and incur significantly higher healthcare costs,” said Phil Pang, M.D., Ph.D., chief medical officer of Vir Biotechnology. “The data presented at IDWeek quantify the magnitude of the urgent need for a universal influenza A-neutralizing monoclonal antibody with high efficacy. The data also suggest that VIR-2482, because of its broad influenza A strain coverage, potency and prolonged half-life, has the potential to be the first neutralizing monoclonal antibody to address this large unmet need.”

The two abstracts accepted for poster presentation include:

• Preliminary, blinded pharmacokinetic and safety data from the first-in-human, randomized, placebo-controlled Phase 1 study, which demonstrate that intramuscular dosing of VIR-2482 was well tolerated among healthy volunteers at doses up to 1,800mg (Abstract #631). The preliminary pharmacokinetic profile also shows a prolonged half-life, which could enable once-per-season dosing.
  
  
• Preclinical data, which show that VIR-2482 has broad binding and neutralizing potential against all major strains of influenza A, including pandemic strains, from the last 100 years (Abstract #1231). Additionally, VIR-2482 administered prophylactically 24 hours prior to lethal doses of influenza significantly reduced morbidity and prevented mortality in mouse models.
  

A separate claims-based analysis accepted for oral presentation demonstrates the significant health and economic impact of influenza A on elderly patients (>65 years old) with comorbidities (Abstract #86). According to an analysis of insurance claims data from the IQVIA PharMetrics^® Plus database (October 1, 2013, to March 1, 2019), 19%-44% of elderly influenza patients were hospitalized within 30 days of diagnosis compared to 3%-13% of non-influenza patients. Associated healthcare costs ranged from $4,122-$8,181 per patient in the month after diagnosis, with the highest attributable costs observed among elderly patients with congestive heart failure, stroke or chronic pulmonary disease. The health and economic implications of this analysis demonstrate the ongoing need among high-risk elderly groups for additional protection against influenza.

VIR-2482 Scientific Research Presented at IDWeek 2020

Poster Presentations

• Preliminary safety and pharmacokinetic profile of VIR-2482: a monoclonal antibody for the prevention of influenza A illness
  Abstract #: 631
  Lead author: Sager J

• VIR-2482: A potent and broadly neutralizing antibody for the prophylaxis of influenza A illness
  Abstract #: 1231
  Lead author: Pizzuto MS
  

Oral Presentation

• Health resource burden of influenza among the elderly with underlying conditions in the United States
  Abstract #: 86
  Date: Wednesday, October 21, 2020
  Time: 7 a.m. ET
  Lead author: Reyes CM
  

About VIR-2482 
VIR-2482 is an intramuscularly administered influenza A-neutralizing monoclonal antibody. In vitro, it has been shown to cover all major strains of influenza A that have arisen since the 1918 Spanish influenza pandemic. VIR-2482 is designed as a universal prophylactic for influenza A. It has the potential to overcome the limitations of current influenza vaccines and lead to meaningfully higher levels of protection due to its broad strain coverage and because it does not rely on an individual to create their own protective antibody response. VIR-2482 has been half-life engineered so that a single dose has the potential to last the entire influenza season, which is typically five to six months long.

About Vir Biotechnology
Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting hepatitis B virus, influenza A, SARS-CoV-2, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio. 

Vir Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “potential,” “may,” “will,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “goal,” “intend,” “candidate,” “continuing,” “developing” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the potential benefits of VIR-2482, including its ability to broadly neutralize against all major strains of influenza A, its high-level effector function and binding capability and its extended half-life, the potential of VIR-2482 in treating high-risk, elderly patients, the potential of VIR-2482 as a universal prophylaxis for influenza A and the health and economic implications of influenza A on elderly patients. Many factors may cause differences between current expectations and actual results including unexpected safety or pharmacokinetic data observed during preclinical or clinical studies, challenges in treating influenza A, difficulty in collaborating with other companies or government agencies, and challenges in accessing manufacturing capacity. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

FAQ

What are the key findings about VIR-2482 presented by Vir Biotechnology?

Vir Biotechnology's presentation highlighted VIR-2482's broad neutralizing potential against influenza A strains and its long half-life, suggesting once-per-season dosing.

How does VIR-2482 impact elderly patients at risk of influenza A?

The data indicates that elderly patients with comorbidities experience high hospitalization rates and significant healthcare costs due to influenza A, reinforcing the need for effective treatments like VIR-2482.

What is the hospitalization rate for elderly influenza A patients according to the analysis?

The analysis indicates that 19%-44% of elderly influenza patients are hospitalized within 30 days of diagnosis.

What are the potential benefits of VIR-2482 based on the presented research?

VIR-2482 is designed to offer potent protection against influenza A, potentially filling the gap left by existing vaccines and providing a universal prophylactic strategy.

When was the data on VIR-2482 presented?

The data on VIR-2482 was presented during IDWeek 2020 from October 21-25.