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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - RAPID (RNA particles for Preparedness against Infectious Diseases)

Teaser

Summary

In the past two decades, the world has experienced a remarkable increase in the frequency and size of viral epidemics. These events have exemplified that conventional vaccine development trajectories take too much time. This showed from the poor control of recent epidemics (Ebola, Zika, influenza) and epizootics (Bluetongue, Schmallenberg, influenza).

BunyaVax builds unprecedented technology for cost-effective and rapid development of vaccines against newly emerging viruses. The platform can be a valuable tool in quickly controlling the spread of new virus strains among populations.

The BunyaVax RNA particle technology combines inherent safety with strong efficacy. A unique characteristic of the RNA platform is that it allows for â€˜plug and playâ€™ application. Any gene, for example from the influenza virus, can be plugged into the RNA particle genome to generate a potent vaccine. The platform can stably express a broad variety of viral antigens. Due to this characteristic, BunyaVax can create a range of new vaccines. A major advantage is that development and manufacturing can be completed in a timeframe of 16 weeks which is at least twice as fast as current methods.

The BunyaVax technology is in a stage of proven efficacy in sheep. RAPID is designed to prepare for partnerships with vaccine manufacturers and/or venture capital firms and to lay the foundation for broad application of the vaccine platform. Key steps for upscaled production levels will be taken. Ultimately, this will allow BunyaVax to forward the technology to a stage in which industry can use it to develop vaccines for controlling veterinary and human infectious disease outbreaks at an earlier stage than currently possible.

The project pointed out that BunyaVax can indeed scale up it\'s production process. Furthermore, it resulted in fine-tuning of the business strategy and development of a detailed business plan.

Work performed

In the project, the following work has been performed:

1. Demonstrating the feasibility of medium-to-large scale vaccine production. At project start BunyaVax vaccines could be produced robustly under research conditions at small to medium scale. One of the key requirements for future commercial application, in addition to proven safety and efficacy in relevant animal models, is the ability to manufacture vaccine batches at a relevant clinical scale within a timeframe of eight weeks. BunyaVax has evaluated state-of-the-art technology for large scale production of vaccine batches and found that it\'s production process can indeed be upscaled. BunyaVax will now take steps to develop the process at larger scale.

2. Developing a detailed business plan. Firstly, extensive market research was performed - resulting in a detailed overview of the vaccine industry, recent deals, interests and positions of key players in the market and an analysis of infectious diseases and their unmet needs. The findings were used to develop a detailed business plan. The resulting document now includes an overview of the company, team, strategy, technology platform, product pipeline, market, strategic partnerships, intellectual property, product development plan, risks, milestones and financial plan. The business plan will be used to attract VC and to direct business efforts.

Final results

For most emerging-virus vaccines, the main obstacle is not the effectiveness of conventional approaches but the need for more rapid development and large-scale deployment. This showed from the poor control of recent epidemics and epizootics. The development of more potent and versatile vaccine platforms is therefore urgently needed. Plug and Play vaccine technologies have emerged over the last 4 years as promising alternatives to conventional vaccine technologies. Whereas the majority of early work in this field focused on cancer applications, now the potential of these vaccines to protect against a wide variety of emerging infectious diseases is becoming clear.

BunyaVax develops one of the most promising Plug and Play vaccines. In fact, BunyaVax has been the first to open up the possibility of generating bunyavirus-based RNA vaccines, a route never explored before, but with great potential. The first generation of BunyaVax RNA particles was developed already in 2010, but recent innovations in transfection methodologies have rendered the technology economically viable.

Before start of the RAPID project, BunyaVax has shown that its RNA particle technology can be used to protect mice from a lethal dose of influenza and to protect sheep from a lethal infection of Rift Valley Fever.

During the RAPID project, BunyaVax focussed on (1) proving that upscaled vaccine production is feasible and economical and (2) on preparing a solid business plan. Now that the milestones have been reached, BunyaVax is in a position in which partnerships with vaccine manufacturers can be explored and (2) additional funding can be attracted to finance follow up studies. Ultimately, BunyaVax aims to make the technology widely available for generating vaccines for infectious diseases with large unmet needs.