CAMBRIDGE, Mass.--(BUSINESS WIRE)--Visterra, Inc. today announced that it will present new preclinical data on VIS410, a novel monoclonal antibody in development for treatment of hospitalized patients with influenza A, at the 2nd International Meeting on Respiratory Pathogens, at the Grand Copthorne Waterfront Hotel in Singapore, on March 7 - 9, 2018. The meeting is being conducted by the International Society for Influenza and Other Respiratory Virus Diseases (ISIRV).
Visterra is a clinical-stage biotechnology company that uses its novel Hierotope® platform to identify unique disease targets and to design and engineer precision antibody-based biological medicines against such targets that are not adequately addressed with conventional approaches.
The data presented demonstrate in vitro neutralizing activity by VIS410 against currently circulating seasonal influenza A, and binding and antiviral activity against newly emergent H7N9 strains, which are deadly avian influenza A strains that have infected humans. In addition, findings will be presented from two models based on data from the previously completed VIS410 human challenge study and published data. The first model describes serum concentrations of VIS410 observed in the VIS410 human challenge study and its impact on viral load. The second model predicts clinical efficacy of VIS410 at doses under study by Visterra for treatment of hospitalized influenza A patients, in combination with oseltamivir.
“We look forward to participating in this important conference and sharing these new and encouraging in vitro data of VIS410 binding and antiviral activity against newly emergent H7N9 strains. While great strides have been made in China in curtailing the current wave of human H7N9 infections, this virus and other emergent avian influenza A strains continue to present ongoing pandemic potential of grave concern,” said David Oldach, MD, Chief Medical Officer of Visterra. “The modeling data indicate the potential for VIS410 efficacy at doses currently under evaluation. We continue to advance VIS410 in the clinic and are conducting a Phase 2b global clinical trial of VIS410 in combination with oseltamivir versus oseltamivir alone in hospitalized patients with influenza A.”
The data will be presented in three posters:
Title: VIS410, a Broad-Spectrum, Anti-Influenza A Monoclonal
Antibody in Clinical Development Demonstrates Activity against Recent
Vaccine, Seasonal, and H7N9 Strains of Influenza
Abstract Number:
ARP0032
Presenter: David Oldach, MD, Chief Medical Officer,
Visterra
Presentation Times: 5:45 pm – 7:30pm, Wednesday,
March 7; 5:30 pm – 7:30 pm, Thursday, March 8
Title: Population Pharmacokinetic and Viral Dynamic Modeling of
VIS410, a Monoclonal Antibody against Influenza A Virus in a Human
Challenge Model
Abstract Number: ARP0025
Presenter:
Patrick Smith, PharmD, Chief Scientific Officer, Consulting Services,
Certara
Presentation Times: 5:45 pm – 7:30pm, Wednesday,
March 7; 5:30 pm – 7:30 pm, Thursday, March 8
Title: Model-based Clinical Efficacy Prediction and Study Design
Support for VIS410, a Novel Neutralizing mAb, in Combination with
Oseltamivir, in Hospitalized Patients with Influenza A
Abstract
Number: ARP0028
Presenter: Patrick Smith, PharmD, Chief
Scientific Officer, Consulting Services, Certara
Presentation
Times: 5:45 pm – 7:30pm, Wednesday, March 7; 5:30 pm – 7:30 pm,
Thursday, March 8
About VIS410
VIS410 is Visterra’s monoclonal antibody designed and engineered to target all known strains of influenza A and is being developed as a single-dose administration for the treatment of hospitalized patients with influenza A. VIS410 is directed against a specific epitope, called the Hierotope, on hemagglutinin, which is a surface protein of influenza viruses used for binding and entry into cells. VIS410 is designed to prevent fusion of the influenza virus with host cell membranes by binding to hemagglutinin and thereby terminating the viral replication cycle. Visterra is currently completing a Phase 2a clinical trial of VIS410 in ambulatory patients with influenza A, with funding through contract number HHSO100201500018C from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. In addition, Visterra is currently conducting a Phase 2b clinical trial of VIS410 in hospitalized patients with influenza A.
About Influenza
Influenza is an infectious disease that causes illness in humans worldwide with symptoms that range in severity from mild to life-threatening. The majority of seasonal influenza infections result in mild illness; however, some infections result in severe disease, which may result in rapidly progressive pneumonia, respiratory failure and death. Severe disease is more commonly observed in high-risk groups, including infants, pregnant women, the elderly, patients with underlying medical conditions, and patients with disease- or treatment-related immunosuppression. According to the CDC, approximately 35 million people suffer from influenza infections in the United States each year, resulting in as many as 710,000 hospitalizations and as many as 56,000 deaths. The World Health Organization reports that globally there are as many as five million severe influenza cases annually, leading to as many as 500,000 deaths. In addition to seasonal infections, epidemics that spread across countries and continents, or pandemics, are caused by influenza strains that have a high rate of human-to-human transmission and, if the strain causes severe disease, may lead to a high mortality rate.
About Visterra
Visterra is a clinical-stage biopharmaceutical company focused on applying its novel Hierotope® platform to identify unique disease targets and to design and engineer precision antibody-based biological medicines against such targets that are not adequately addressed with conventional approaches. Visterra’s technology is uniquely capable of engineering biological medicines for infectious diseases that provide broad coverage across viral strains, including mutated strains, and in the case of endogenous targets, selectively modify the activity of targets that have limited surface area, are hard to access, have dynamic structures, and/or are similar to other proteins in the body that should be avoided. VIS410 is a monoclonal antibody in development as a single-dose administration for the treatment of hospitalized patients with influenza A, regardless of the viral strain. The company’s other product candidates are VIS649, a monoclonal antibody in development for the treatment of IgA nephropathy, VIS513, a monoclonal antibody in development as a single-dose administration for the treatment of dengue, and VIS705, an antibody-drug conjugate being developed as a single-dose curative therapy, engineered to kill all strains of the deadly Pseudomonas aeruginosa bacteria. In addition, Visterra has applied its Hierotope platform to develop novel modifications to the Fc region of an antibody, to enhance half-life by as much as ten-fold while maintaining and often improving effector function. These capabilities, called ViStar™ antibody Fc engineering, support the development of long-acting monoclonal antibodies for the extended protection in infectious diseases and less frequent administration in chronic diseases. For more information, visit www.visterrainc.com.
