Lipoxen And Cambridge Biostability Limited: Positive Data for Revolutionary Influenza Vaccine

Published: Apr 30, 2009

Lipoxen plc (AIM:LPX) (“Lipoxen” or “the Company”), a bio-pharmaceutical company specialising in the development of high value differentiated biologicals, vaccines and siRNA delivery, and Cambridge Biostability Ltd (CBL), the developer of temperature stable vaccines and biopharmaceuticals, are pleased to announce that they have achieved positive preclinical results for the delivery of a novel and enhanced influenza vaccine based on the combination of Lipoxen’s novel vaccine delivery system ‘ImuXen’ and CBL’s proprietary VitRIS stabilisation platform.

The study results show that ImuXen increases the effectiveness of influenza vaccine materials by approximately 30-fold. In addition, the VitRIS formulation enhances the efficacy of the vaccine a further 4-fold. As a combined product, the VitRIS-preserved ImuXen formulation has the potential to achieve a projected 10-fold advantage in vaccine production rates, addressing the greatest potential need for seasonal and pandemic influenza vaccines for existing and newly emerged flu viruses.

Highlights of the results:

• ImuXen shown to increase the effectiveness of influenza vaccines by approximately 30-fold

• VitRIS formulation enhances the efficacy of the vaccine by a further 4-fold

• Potential to radically increase output of vaccine doses from existing manufacturing facilities - projected 10-fold advantage in vaccine production rates

• No requirement for 'cold-chain' of refrigerated trucks, warehouses and fridges

The study, which was undertaken by Lipoxen and CBL with analysis of blood samples conducted by Retroscreen Virology Ltd in London, was set up to determine the capability of Lipoxen’s ImuXen technology, in combination with CBL’s VitRIS stabilisation technology, to create a stable vaccine formulation that would increase antibody production against an H1N1 Influenza virus which was supplied by the UK National Institute for Biological Standards and Control (NIBSC), the Government body responsible for safeguarding and advancing public health by assuring the quality and safety of biologicals. Data from the study was independently reviewed by Professor Will Irving, a Consultant Virologist at Nottingham University's Queen’s Medical Centre and a leading UK virologist who has worked on influenza for over 15 years.

Lipoxen, in association with CBL and with funding from the Technology Strategy Board (formerly the DTI), have created a novel water-free influenza vaccine formulation, that will be heat and freeze stable and will not require refrigeration during transport, storage and distribution.

Lipoxen’s ImuXen technology entraps regular flu vaccine material (killed virus particles) into the Company’s proprietary liposomes to provide an enhanced antibody response compared to a regular vaccine formulation. CBL’s VitRIS technology enables the liposomes to be dried and stabilised within microscopic particles of sugar glass which can then be suspended in a user-friendly biocompatible oil. The thermostable liquid vaccine is then ready for immediate injection and has the added advantage that it can be used for long term stockpiling.

The results of the study give clear indication that Lipoxen’s vaccine technology coupled with CBL’s formulation techniques, not only provide a significantly enhanced vaccine response but also a dramatic advantage in increased vaccine production rates. This advantage addresses the greatest need of seasonal and pandemic influenza vaccines based on newly emerged flu viruses, such as the recent swine flu outbreak.

Following the study results, Lipoxen have selected a lead vaccine candidate and are currently conducting stability studies at elevated temperature in partnership with CBL.

Lipoxen and CBL are also in discussion with major vaccine manufacturers with a view to licensing the new technology package for pandemic and seasonal influenza vaccines.

Commenting on the announcement, M. Scott Maguire, CEO of Lipoxen, said:

“This new very positive data on a novel flu vaccine candidate comes at a critical time for the World particularly in light of the current potential for a swine flu outbreak where the death toll is climbing daily and the spread of disease is an enormous current global threat. These results show that we have the technology to develop a novel flu vaccine candidate suitable for pandemic planning. Our vaccine candidate offers the advantages of enhanced immune response, fast and high volume production as well as no requirement for a cold-chain, all ideal characteristics in planning for further pandemic situations. Based on the results we are encouraged to believe that it would also work for the new swine flu 2009 strain since an earlier human derived H1N1 strain was used in the studies reported today. We look forward to working with CBL to maximise the commercial potential of this flu vaccine candidate.”

Also commenting on this announcement, Dr David Moss, Director of Research at Cambridge Biostability, said: “We are delighted that our VitRIS technology has allowed the development of a thermo-stable, instantly injectable vaccine against influenza. Thermostability, the removal of reliance upon the cold chain, coupled with the fact that the vaccine needs no reconstitution prior to injection are two major steps forward in the development of the next generation of vaccines and other biologics aimed at both the developing and developed world markets.”

Adding to this, Professor of Virology Will Irving, an independent Consultant Virologist at Nottingham University's Queens Medical Centre, said:

“This new influenza vaccine formulation has generated some very exciting data. The potential to generate protective antibody responses whilst using surprisingly low doses of antigen is a major potential breakthrough - in the H5N1 vaccine field, published data suggest that prohibitively large doses of antigen may be needed in order to generate protective responses. The novel delivery vehicle, showing stability at ambient temperatures, will also be a huge benefit, allowing delivery of vaccine in situations which otherwise would experience great difficulties in achieving successful transport and storage of traditional vaccine preparations.”

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