iBio, Inc. has announced that the company is proceeding with development of an antibody candidate as a therapeutic against influenza, including highly pathogenic H5N1 strains resistant to drugs such as oseltamivir (marketed as Tamiflu). This 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 influenza antibody was discovered by scientists at Fraunhofer USA Center for Molecular Biotechnology (Fraunhofer) and is a part of Bio’s successful antibody research collaboration with Fraunhofer. Prior to the discovery of this influenza antibody product candidate, the collaboration has produced rituximab and palivizumab biosimilar candidates.
“We are pleased to further expand our antibody product candidate pipeline, particularly with an important proprietary candidate,” said Robert Kay, chairman and CEO of iBio. “This development continues our strategy to grant royalty-bearing licenses of iBioLaunch technology to others for development of their products using our platform, as we recently announced with Caliber Biotherapeutics for their anti-cancer monoclonal antibody candidate, while we continue to bring forward our own product candidates for self-development and eventual partnership with others.”
The iBioLaunch platform is a proprietary, transformative technology for development and production of biologics using transient gene expression in unmodified green plants. Advantages over other systems may include: success with proteins difficult or impossible to produce with other methods; broad applicability to biologics, including therapeutic proteins and vaccines; production time measured in weeks instead of months or more. Additional benefits may include a surge capacity for remedial action against bioterrorism and pandemic disease including influenza; product entry that is unconstrained by traditional process patents, and significantly lower capital and operating costs for comparable production.
Influenza virus infection is a common infectious disease that often causes mild symptoms but can lead to severe symptoms and death. Influenza epidemics occur yearly, causing three to five million cases of severe illness, and about 250,000 to 500,000 deaths worldwide. Although the common strains of influenza constitute a significant public health concern, more dangerous influenza strains have emerged periodically leading to pandemics that kill millions of people. The high mutation rate of influenza viruses leads to the frequent emergence of new strains and also to the development of resistance to antiviral drugs. An effective antibody-based influenza drug based on iBio technology has the potential to effectively treat such drug-resistant infections as well as complex and advanced infections.
The use of monoclonal antibodies for the treatment of a wide variety of diseases and illnesses has emerged as one of the most important contributions of biotechnology to clinical medicine. A few dozen antibody products generate global annual sales of about $50 billion, and several hundred new product candidates are in clinical trials for many medical applications. Rituximab is an antibody drug approved for treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, and other diseases, generating annual sales in excess of $6 billion. Palivizumab is an antibody drug used to prevent serious lung infections caused by the respiratory syncytial virus, producing annual worldwide sales of nearly $1 billion.
iBio develops and offers product applications of its iBioLaunch and iBioModulator platforms, providing collaborators full support for turn-key implementation of its technology for both proprietary and biosimilar products.
Fraunhofer USA CMB, a division of Fraunhofer USA, Inc. is a not-for-profit research organization whose mission is to develop safe and effective vaccines targeting infectious diseases and autoimmune disorders.