The Institute of Experimental Medicine achieved international prominence early in the 20th century, when Nobel Prize winner Pavlov worked with dogs to establish the central nervous system basis of conditioned reflexes. The IEM has developed a broad-based research capacity in many areas of biology and medicine.
In 1956 the IEM’s Department of Virology, under Academician Anatoly Smorodintsev, developed live vaccines against polio and in 1959 against measles. These vaccines and derivatives of them were used throughout Russia. After years of research in these and other areas of viral infection the Department turned its attention to influenza. They were able to develop an attenuated i.e. weakened form of the influenza virus which would serve as the basis for a safe, live influenza vaccine.
In 2001 the IEM entered into a Commercialisation Agreement with BioDiem Ltd, whereby worldwide rights (outside of Russia and the CIS) to the proprietary LAIV technology were granted to BioDiem in exchange for a royalty payment.
Prof Larisa Rudenko, the Head of the Dept of Virology at the IEM is a director of BioDiem. Prof Rudenko is a world expert in live attenuated influenza vaccine technology working closely with the CDC and WHO and other world-recognised influenza groups.
BioDiem contributes to the WHO’s Global Pandemic Influenza Action Plan by licensing the WHO to transfer an egg-based live attenuated influenza virus (LAIV) vaccine production technology to developing country manufacturers.
The agreement is a non-exclusive licence designed to support wider distribution of the LAIV influenza vaccine in developing countries. Whereas public sector usage is royalty-free, royalties flow to BioDiem from private sector sales. BioDiem has authorised the Institute of Experimental Medicine (IEM) and the Centers for Disease Control and prevention (CDC) to supply LAIV reassortants to the WHO for use by its sublicencees. The vaccines developed through the WHO program are manufactured using eggs. WHO has issued sublicences to the LAIV technology to three entities: the Serum Institute of India (SII), the Government Pharmaceutical Organization in Thailand (GPO), and Changchun BCHT Biotechnology Co. in China (BCHT).
In 2014 the Serum Institute of India launched its seasonal influenza vaccine, called Nasovac-S™, in India. This vaccine is a result of the WHO collaboration using BioDiem’s technology and follows on from the SII launch of Nasovac for swine flu prevention in 2010. BioDiem receives royalty payments on sales of vaccines in the private market.
Facilitated by a grant from the WHO, work has been completed on a new laboratory fit-out at the Institute of Experimental Medicine to allow the Institute to handle highly pathogenic influenza (HPAI) strains e.g. H5N1 (avian or bird flu). Any material generated will be made available for use in developing countries under the World Health Organization’s Global Pandemic Influenza Action Plan to Increase Vaccine Supply.
In August 2009 the Institute of Experimental Medicine (IEM), the originator of BioDiem’s Live Attenuated Influenza Virus (LAIV) technology, entered into a development and collaboration agreement with the PATH, an international non-profit organization to develop prototype pandemic LAIVs for use in developing countries. The aim of this collaboration is to speed the development of live attenuated influenza vaccines that can be a safe, low-cost, and highly effective method for enabling real-time response against an influenza pandemic which is likely to hit developing countries hardest.
This agreement has seen preclinical and clinical study use of BioDiem’s cold-adapted master donor LAIV virus bearing avian or human influenza virus genes from viruses with pandemic potential. PATH has provided financial and technical support to the Institute of Experimental Medicine and third party contractors to complete this important public health work.
PATH has also sponsored recent large clinical trials of LAIV in young children to assess safety and efficacy. The results of these are expected to be available in 2015.
The aim of the Cooperative Research and Development Agreement (CRADA) between BioDiem and the US Center for Disease Control and Prevention (CDC) was to develop a vaccine candidate against the H5N1 avian influenza based on BioDiem’s technology. Preclinical studies to assess the infectivity, immunogenicity and protective efficacy of the H5N1 LAIV versus the standard inactivated influenza vaccine have been successfully completed. The results support the value of the LAIV vaccine technology in protection against the H5N1 virus. In particular it was demonstrated that the cell-based manufacturing method, which allows rapid scale up in the case of a pandemic, produced successful results and that the LAIV vaccine provided greater cross-protection against variants of the H5N1 virus than the inactivated vaccine. This feature could be extremely advantageous in the event of an avian flu outbreak. Also in such a situation, access to chicken eggs could be compromised and so the ability to manufacture flu vaccine rapidly in mammalian cells would give an advantage. Previous published work has demonstrated the efficacy of cell-produced LAIV vaccine vs. egg-produced vaccine in ferret studies.
BioDiem has strong ties to the world-class research institutions of Australia, which have assisted in the research and development of BioDiem’s portfolio. These partners include: