“The antibodies covered by these patents are designed to block critical functions of the influenza virus necessary for infection or replication,” said Wayne P. Fitzmaurice, iBio’s vice president of intellectual property. “Current public health strategies for influenza include annual preventative vaccination and the use of small molecule drugs for treatment in some cases. However, because vaccines do not always prevent disease, and drug-resistant influenza strains pose increased risk, there is a global need for new, more effective biologics such as these antibodies to treat influenza infection.”
According to BCC Research, the global influenza market will grow at 8% CAGR from $4 billion in 2013 to nearly $6 billion in 2018. Efforts continue by government agencies and disease prevention organizations to support and fund research and development programs, and pandemic prevention.
“We expect increasing commercial and government interest in the development of therapeutic antibodies and vaccines to prevent or treat influenza outbreaks,” stated Robert Erwin, iBio’s president. “Our iBioLaunch platform technology is ideally suited for vaccines and antibodies, and provides the efficiency and flexibility for simultaneous development of both types of products.”
iBioLaunch technology has previously been used for the development and successful phase 1 clinical evaluation of vaccine candidates targeting H1N1 influenza and avian H5N1 influenza. Additional infectious disease applications of the technology are in development including a transmission blocking vaccine for malaria in a phase 1 clinical trial and a National Institutes of Health sponsored program for an antibody against anthrax.
The first newly allowed patent application, “Human Neuraminidase Antibody and Methods of Use Thereof,” includes claims for a monoclonal antibody against the influenza neuraminidase protein. Antibodies based on this invention are potential therapeutic agents against influenza, including highly pathogenic H5N1 strains resistant to drugs such as oseltamivir (marketed as Tamiflu), and one such proprietary antibody, which is based upon iBio’s iBioLaunch technology, has demonstrated safety and therapeutic efficacy in highly predictive animal models infected with a variety of influenza types, including H5N1.
The second allowed patent application, “Influenza Hemagglutinin Antibodies, Compositions, and Related Methods,” includes claims to an isolated monoclonal antibody or antigen-binding fragment that binds hemagglutinin (the viral protein that binds to susceptible cells as the first step in virus entry and infection) and where the antibody has a specified composition of matter. Interfering with hemagglutinin activity blocks further spread of the virus in the body. This invention is applicable to a wide range of influenza strains including the most dangerous types.
Both allowed patent applications are based on inventions developed by scientists at the company’s research and technology collaborator, the Fraunhofer USA Center for Molecular Biotechnology and are owned by iBio. These inventions are part of the company’s broader portfolio which includes additional antibodies and technology for efficient production of antibodies in green plants.
iBio develops and offers proprietary products and product licenses, based on its proprietary iBioLaunch and iBioModulator platforms, providing collaborators full support for turn-key implementation of its technology for protein therapeutics and vaccines.