Periodic Reporting for period 1 - BGV1 (New vaccine for a paradigm shift in Brucellosis)
Reporting period: 2018-12-01 to 2019-05-31
EU INDUSTRIAL AND SOCIETAL PROBLEMS:
Brucellosis is consistently ranked as the world’s most common and widespread zoonotic disease, meaning that it normally exists in animals but it can also infect humans. In livestock, it causes devastating production losses in low-income countries accounting in more than €3bn per year. In humans, there are 500,000 new cases annually requiring long-term hospital treatment and with devastating complications in pregnant women.
Brucellosis is endemic in most Asia, Africa and LATAM and is prevalent in the EU Mediterranean regions. Between 2009-2014, Europe spent more than €270m in control and eradication programs mainly in Italy, Greece, Portugal and Spain. Only around 20 developed countries have eradicated the disease but, in a global world with international trading, people travelling all around the world and potential threat of bioterrorism, outbreaks may take place anywhere. As a vaccine for humans does not exist, the most rational approach for preventing human brucellosis is the control and elimination of the infection in animals. It requires an integrated approach involving vaccination programs and/or ‘Test & Slaughter’ of infected animals, among other measures. However, existing vaccines have four main problems: 1) They are unsafe for pregnant, lactating animals and male adults; 2) They interfere with the standard diagnostic tests, causing the DIVA problem (to differentiate between infected and vaccinated animals); 3) In case of infecting humans, existing vaccines are resistant to antibiotics of choice for treating Brucellosis in human beings; 4) As a result, existing vaccines require complex management systems and costly diagnostic techniques that are not appropriate for developing countries; in Europe, control programs are based on tests for animal check-ups and compensation to farmers for slaughter of the infected animals, with vaccination prohibited or highly restricted to areas with higher prevalence of Brucellosis (as example, see programs implemented in Greece).
OUR SOLUTION:
GreenVac developing the first vaccine against Brucella melitensis in small ruminants that overcomes the main drawbacks of existing vaccines and will be safe and viable for use in all countries across the developing world. Our vaccine has been developed by the team of Prof. Maria-Jesus Grilló, a world leading authority on brucellosis and partner in GreenVac. BGV1´s main innovations are: 1) BGV1 is avirulent for animals, 2) BGV1 eliminates or minimises the DIVA problem (to Differentiate between Infected and Vaccinated Animals) and does not interfere with diagnostic tests, 3) the vaccine has very low potential transmissibility and, in case of infection, it could be treated in combination with standard antibiotics, and 4) it has the potential to be a non-specific vaccine that is effective in different animals (e.g. sheep, goats and cattle) and for more than one Brucella strain. The BGV1 vaccine fulfils all the requirements, exhibiting a safe profile with an enhanced protective efficacy, no residual virulence and no serodiagnostic interference.
Brucellosis is consistently ranked as the world’s most common and widespread zoonotic disease, meaning that it normally exists in animals but it can also infect humans. In livestock, it causes devastating production losses in low-income countries accounting in more than €3bn per year. In humans, there are 500,000 new cases annually requiring long-term hospital treatment and with devastating complications in pregnant women.
Brucellosis is endemic in most Asia, Africa and LATAM and is prevalent in the EU Mediterranean regions. Between 2009-2014, Europe spent more than €270m in control and eradication programs mainly in Italy, Greece, Portugal and Spain. Only around 20 developed countries have eradicated the disease but, in a global world with international trading, people travelling all around the world and potential threat of bioterrorism, outbreaks may take place anywhere. As a vaccine for humans does not exist, the most rational approach for preventing human brucellosis is the control and elimination of the infection in animals. It requires an integrated approach involving vaccination programs and/or ‘Test & Slaughter’ of infected animals, among other measures. However, existing vaccines have four main problems: 1) They are unsafe for pregnant, lactating animals and male adults; 2) They interfere with the standard diagnostic tests, causing the DIVA problem (to differentiate between infected and vaccinated animals); 3) In case of infecting humans, existing vaccines are resistant to antibiotics of choice for treating Brucellosis in human beings; 4) As a result, existing vaccines require complex management systems and costly diagnostic techniques that are not appropriate for developing countries; in Europe, control programs are based on tests for animal check-ups and compensation to farmers for slaughter of the infected animals, with vaccination prohibited or highly restricted to areas with higher prevalence of Brucellosis (as example, see programs implemented in Greece).
OUR SOLUTION:
GreenVac developing the first vaccine against Brucella melitensis in small ruminants that overcomes the main drawbacks of existing vaccines and will be safe and viable for use in all countries across the developing world. Our vaccine has been developed by the team of Prof. Maria-Jesus Grilló, a world leading authority on brucellosis and partner in GreenVac. BGV1´s main innovations are: 1) BGV1 is avirulent for animals, 2) BGV1 eliminates or minimises the DIVA problem (to Differentiate between Infected and Vaccinated Animals) and does not interfere with diagnostic tests, 3) the vaccine has very low potential transmissibility and, in case of infection, it could be treated in combination with standard antibiotics, and 4) it has the potential to be a non-specific vaccine that is effective in different animals (e.g. sheep, goats and cattle) and for more than one Brucella strain. The BGV1 vaccine fulfils all the requirements, exhibiting a safe profile with an enhanced protective efficacy, no residual virulence and no serodiagnostic interference.
Our key objective for this SME Inst Phase-1 Feasibility Study was to verify the technical, clinical, practical and commercial viability of our vaccine. We wanted to prove that our solution is superior to current status quo on the market and provides a superior performance and health and economic benefits. Therefore, we conducted the following activities:
1. Regulation and product development feasibility: We have validated the improve safety of the vaccine in pregnant ewes. We have prepared the detailed protocols in line with OIE guidelines and principles for future safety and efficacy studies. We already got the authorisations by the Spanish Agency of Medicines and Medical Devices (AEMPS) to use BGV1 as Product for Clinical Veterinary Research.
2. Market and Commercialisation feasibility study: We have carried out a full market research study by revising target regions, animal segments and commercialisation channels. Our plan is to reach a successful licensing agreement with an animal health company for the global commercialization of BGV1 vaccine after the end of the project. We have identified comparable business cases in the veterinary market that we have used as reference. We already contacted some of the key players in the brucellosis vaccines market to present our preclinical results with very promising results.
3. Economic and financial feasibility study and Business Plan: We have revisited the competitors analysis (including pricing), investment required for our strategy and economic viability. We have formulated the complete business plan including targeted market segments/countries, pricing, risk assessment, mitigation & contingency plan, communication plan, budgeting & economic forecasting.
1. Regulation and product development feasibility: We have validated the improve safety of the vaccine in pregnant ewes. We have prepared the detailed protocols in line with OIE guidelines and principles for future safety and efficacy studies. We already got the authorisations by the Spanish Agency of Medicines and Medical Devices (AEMPS) to use BGV1 as Product for Clinical Veterinary Research.
2. Market and Commercialisation feasibility study: We have carried out a full market research study by revising target regions, animal segments and commercialisation channels. Our plan is to reach a successful licensing agreement with an animal health company for the global commercialization of BGV1 vaccine after the end of the project. We have identified comparable business cases in the veterinary market that we have used as reference. We already contacted some of the key players in the brucellosis vaccines market to present our preclinical results with very promising results.
3. Economic and financial feasibility study and Business Plan: We have revisited the competitors analysis (including pricing), investment required for our strategy and economic viability. We have formulated the complete business plan including targeted market segments/countries, pricing, risk assessment, mitigation & contingency plan, communication plan, budgeting & economic forecasting.
The currently available vaccines against Brucellosis have some serious safety drawbacks mainly due to residual virulence for animals and humans and due to certain antibiotic resistance and therefore their use is relatively limited. Compared with the State of the Art (SoA), our BGV1 vaccine fulfils and supersedes all the requirements needed, exhibiting a safe profile with an enhanced protective efficacy with no residual virulence and serodiagnostic interference. Our last results during the Feasibility Study have confirmed the safety of the vaccine in pregnant ewes.. This push GreenVac to conttinue developing BGV1 against Brucellosis as it has the potential of allowing, for the first time, mass vaccination of any animal at any time (including pregnant and lactating animals), which is a radical paradigm shift in Brucellosis control and eradication. In addition, as BGV1 does not interfere with diagnostic tests, it also simplifies the implementation of effective & easy-to-adhere vaccine management systems in developing countries to control and eradicate Brucellosis. Targeting all of the animal herd, BGV1 will reach 3.73 bn animals and produce up to €3.8bn in benefits to our users. It will avoid Brucella impacts on animals, such as reduced animal fertility, abortion, poor weight gain, and a substantial decline in milk production.
Our vaccine will reinforce the EU Prevention principle on Animal Health (“Animal Health Law”, 2016) by supporting the EU challenge towards the implementation of effective programs to achieve disease prevention, limiting the impact of disease outbreaks when they do occur, and protecting the welfare of animals. Moreover, BGV1 will contribute to the objectives of the One Health Initiative: One World, One Health, One Medicine, dedicated to improve the lives of all species—human and animal—through the integration of human medicine, veterinary medicine and environmental science. GreenVac will have the potential to reinforce the European aspiration to be a global health provider leader as an original signee of the UN - Global Health Cooperation agreement.
GreenVac is now prepared to address and implement the findings of our Feasibility Study during a SME Ins Phase 2 project ensuring a successful commercialisation of the BGV1 vaccine.
Our vaccine will reinforce the EU Prevention principle on Animal Health (“Animal Health Law”, 2016) by supporting the EU challenge towards the implementation of effective programs to achieve disease prevention, limiting the impact of disease outbreaks when they do occur, and protecting the welfare of animals. Moreover, BGV1 will contribute to the objectives of the One Health Initiative: One World, One Health, One Medicine, dedicated to improve the lives of all species—human and animal—through the integration of human medicine, veterinary medicine and environmental science. GreenVac will have the potential to reinforce the European aspiration to be a global health provider leader as an original signee of the UN - Global Health Cooperation agreement.
GreenVac is now prepared to address and implement the findings of our Feasibility Study during a SME Ins Phase 2 project ensuring a successful commercialisation of the BGV1 vaccine.