H2020 BoVLP-BVD Project: Development of a labeled polyantigenic virus-like particle vaccine (DIVA) against bovine viral diarrhea virus (BVDc)
- Type Project
- Status Filled
- Execution 2017 -2017
- Assigned Budget 50.000,00 €
- Scope Europeo
- Main source of financing H2020
- Project website BoVLP-BVD
The work conducted was aimed at exploring the economic viability of a novel bovine viral diarrhea virus (BVDV) vaccine with prospective attributes based on the characteristics of the virus-like particle (VLP) technology that will be used for its development. The exploration focused on three aspects:
1. Commercial viability: Is there an unmet need with a significant market, and does the prospective target product profile of Aquilon's vaccine meet it?
2. Technical feasibility: Is it possible to obtain a cost-effective industrial vaccine using Aquilon's VLP technology? and
3. Regulatory viability: Is the regulatory roadmap compatible with the timeframes and costs required for the project to be a reasonable investment opportunity, taking into account future technological and commercial risks?
1. Commercial viability: A thorough analysis of the current competitive environment and market size was conducted, confirming the need for a standalone broad-spectrum vaccine that would discriminate between infected and treated animals, thus facilitating the implementation of containment policies. The market size in the EU is estimated at around €600 million, with a conservative estimate of €30 million to €50 million in sales for the Aquilon vaccine.
2. Technical feasibility: The main challenge and necessary condition for the technical feasibility of the project was to define the antigens that would be combined in the virus-like particles to obtain testable vaccine prototypes. More than 25 different peptides derived from the main antigens of bovine viral diarrhea virus (BVDV) were analyzed using sera from infected animals to determine which antigens were naturally reactive (the assumption was that if infected animals had produced antibodies against a given peptide, it would be immunogenic once expressed on the surface of the vaccine particles). The results are very promising, as three highly reactive peptides have been identified that will be included in multiple copies in the virus-like particles (VLPs) to obtain defined, testable polyantigenic vaccine prototypes. The discovery of these peptides will allow for new patent applications for composition of matter, which will increase the commercial attractiveness of the project.
3. Regulatory feasibility: A regulatory roadmap was developed considering the vaccine and disease characteristics (recombinant, non-live, polyantigenic, labeled, yeast-based). The timelines and costs of the regulatory program (including production scale-up) are therefore available and can be integrated into a business plan projection to define the overall economic viability of the project.
Dissemination: At this stage, for confidentiality reasons, dissemination efforts are focused on describing the project objectives and the potential product profile on the corporate website, without going into technical details. Once the initial proof of concept of the prototype has been obtained and the patents have been filed, we will prepare confidential and non-confidential dossiers to share with potential partners. The discovery of immunoreactive antigenic determinants in bovine viral diarrhea (BVD) virus is a significant scientific contribution that will be integrated into scientific communications once the work is completed and the patents have been filed.
The need to reduce the use of antibiotics to combat diseases in livestock is widely accepted and is resulting in increased environmental, social, and legal pressure. Cost-effective vaccination as an alternative to antibiotic treatment has become the focus of most European industry and regulators. In cattle farming, one of the diseases with the greatest economic and environmental impact is Bovine Viral Diarrhea (BVD). This disease is the most common viral disease of cattle in Europe. Clinical symptoms are difficult to identify because they are highly variable or can also go unnoticed (subclinical disease). Despite this, BVD causes very high economic losses in all countries with developed cattle farming, making it a true "time bomb." For example, Animal Health Ireland estimates that the annual cost of BVD to the Irish shelter is €102 million.
The control and prevention of bovine viral diarrhea virus (BVDV) infections presents significant challenges. Viral genetic variation, persistent infections, and viral tropism for immune cells have complicated disease control strategies. However, vaccination has provided an effective tool to prevent acute systemic infections and increase reproductive efficiency through fetal protection. The current unmet need is for a broad-spectrum, cost-effective, and safe BVDV vaccine that avoids the potential risks associated with live attenuated vaccines (the current gold standard) and can distinguish between immunized and infected animals to facilitate integrated, campaign-driven approaches to combat the disease.
Aquilon's vaccine, based on proprietary virus-like particle technology, will be a recombinant, non-live, polyantigenic vaccine (covering both type 1 and type 2 infections) with labeling attributes (DIVA, Differentiation of Vaccinated from Infected Animals). In this context, the primary objective of this Phase I project was to confirm the technical, commercial, and regulatory feasibility of a novel non-live, polyantigenic, labeled, recombinant vaccine against bovine viral diarrhea virus (BVDV).
The results of the economic-benefit-risk analysis, which combines prospective regulatory costs and timescales, manufacturing scale and prospective cost of goods, technical feasibility, and commercial interest, indicate that the project represents a good investment opportunity that addresses a significant unmet veterinary need with a strong impact on society beyond the economics of the livestock industry.
In a context of general environmental, social, and legal pressure to reduce antibiotic use in livestock disease control, cost-effective vaccination has become the priority of most public, industrial, regulatory, and agri-food agencies. The development of new vaccines to prevent disease and, therefore, avoid the use of antibiotics or improve existing substandard vaccines is now a European and industrial priority.
Bovine viral diarrhea virus (BVDV) is a major infectious agent of cattle worldwide, affecting herd productivity and reproduction. BVDV has been and remains an endemic disease in all countries where systematic eradication and control programs have not been established. Under these conditions, approximately 50% of herds have or have had animals with persistent infection, and approximately 90% of cattle have been exposed to the virus at some point in their lives. BVDV infection has a significant economic impact, estimated at hundreds of euros per animal for a European herd of approximately 80 million animals. Modified live and inactivated vaccines have been available for more than 50 years; however, the incidence of bovine viral diarrhea virus (BVDV)-induced disease remains significant, confirming the need for improved vaccines.
Aquilón aims to develop a novel recombinant BVDV vaccine using proprietary virus-like particle technology. The vaccine will be polyantigenic, non-live, labeled to differentiate vaccinated from infected animals, and cost-effective from a manufacturing perspective. Before beginning the experimental phase of the project, Aquilón aims to confirm its commercial viability by precisely defining the target product profile and systematically exploring its market potential and prospective development costs/schedule to meet regulatory requirements. These studies are required for the formulation of a business plan, which will be the basic tool for deciding whether to invest in the project's future development.
The project's feasibility has been thoroughly explored through the Phase I instrument, and the conclusion is that the investment required to develop the vaccine is acceptable given the commercial and societal interest of the unmet veterinary need being addressed. The discovery of novel, surprisingly highly immunoreactive peptides during the technical evaluation allows for new patent applications and contributes relevant new knowledge to the field of BVD. The continuation of the project is guaranteed, with an expected commercialization period of 6 years and sales of between €30 and €50 million. The impact of the vaccine in countries where cattle farming is significant can be estimated in hundreds of millions of euros. Most importantly, the project will commercialize a tool to manage a highly relevant disease without the use of antibiotics and with an integrated and planned approach seeking eradication, based on the ability to discriminate between vaccinated and unvaccinated animals.
- AQUILON CYL SOCIEDAD LIMITADA (AQUILONCYL)
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