Public Funding for Bigdna Ltd

This project aims to further the development of bacteriophage for targeted pharmaceutical applications. Bacteriophages, viruses of bacteria, have been modified to target specific cells types, and they offer the potential for the delivery of many pharmaceutical products and for a variety of purposes, including vaccines and gene therapy. The effects of host immune responses on the efficacy of these modified viral vector technologies will be assesed, and if detrimental, strategies will be explored to ameliorate such impacts.

BigDNA is a vaccine development company, using bacteriophages to deliver DNA vaccines. Arising as an additional output from a previous TSB SMART Proof of Concept project, the Company has identified a novel non-vaccine peptide-based cancer therapy which it believes may have significant clinical and commercial potential. This novel peptide combination has the potential to greatly increase clinical efficacy over existing therapies, and may offer a fast track route through to regulatory approval. BigDNA wishes to perform a full analysis of the intellectual property position surrounding this novel therapeutic, as well as a full commercial assessment of the opportunities available to such a product. This will also cover a detailed competitor and licensee analysis. If a positive Proof of Market analysis is obtained, then full technical development of this novel product can begin.

Bacteriophage (phage) offer the potential to deliver both protein and DNA vaccines within the same construct. They also promise extremely rapid development and manufacturing timescales, since the DNA vaccine cassette can be synthesised to express antigens for virtually any pathogen, literally within days following sequence identification. Phage are extremely robust, and can be delivered orally or in combination with other vaccines, and being particulate antigens, are naturally targeted to antigen presenting cells. BigDNA holds patents surrounding bacteriophage-based DNA and DNA/protein (chimeric) vaccines. To date, our focus has been on using bacteriophage lambda. The company now wishes to explore the potential for using phage M13 as an alternative vehicle for this technology. M13 is extremely well characterised with an excellent manufacturing base, and offers enormous technological potential. Phage-based DNA vaccine technology has been developed and patented by BigDNA in the UK, and has already attracted overseas investment, commercial collaborative R & D activity, and a licensing agreement with big pharma. This project aims to investigate the potential of a range of modifications designed to optimise and develop M13 as a platform for this purpose which should result in a vaccine platform and products capable of addressing a wide range of infectious diseases and cancers for which current vaccines either do not exist, or alternatively, cannot be developed in the rapid timescales likely required for pandemic disease indications.