The main work performed and results for the first reporting period are summarised in the next points:
- We have implemented a FTO and Patent Analysis. As a result, we have recognised the need for extending patent applications to more countries;
- We successfully found an alternative provider of animal health laboratories since our original provider was no longer available due to unforeseen knock-on effects caused by Covid-19. This is the main reason why we are 12 months behind schedule. An amendment of the GA was requested and approved at the beginning of the second period for extending the project duration these 12 months;
- We have accomplished the preparation of 1,000 vials of Master Seed (MS) and 50 vials up to passage MS+5 (250 WS vials) of the BGV1 vaccine candidate. These cultures were prepared under GMP conditions and using Transmissible Spongiform Encephalitis (TSE) certified material;
- We have carried out a several assays to optimise the BGV1 scale up production in different condition. As a general result, we have assessed that the BGV1 production performance is comparable to that of the current reference vaccine Rev1, making BGV1 affordable to be produced at industrial level as a firm industrial competitor to Rev1.
- We have prepared and submitted the paperwork to obtain authorisations to perform the experiments with Genetically Modified Organisms (GMOs), veterinary medicinal products and animal experiments, according to Directive 2009/41/EC, Directive 2001/82/EC and RD 53/2013, respectively.
- The project has obtained accreditation for GLP (Good Laboratory Practices) procedures, as well as GLP certificates for immunologic (Rose Bengal and indirect ELISA-R/LPS) and molecular (different PCR) analysis, a comprehensive system that guarantees validity of the results obtained.
- We continued our vaccine scale-up and piloting within vaccine homologation and marketing requirements.
- We have performed regular analysis of our competitors. For the EIB Investment Fund, we have prepared a Due Diligence report that contains a detailed analysis of our competitors.
- We have performed preliminary experiments to determine the genetic and phenotypic stability of BGV1. The findings represent a proof of principle of BGV1 stability.
- The first groups of ewes have been vaccinated with BGV1 or unvaccinated (controls). Immunological, bacteriological and molecular assays have been carried out, confirming the promising properties of BGV1 vaccine candidate. However, the efficacy trials were not completed, due to a failure in pregnancies for this animal trial in 3Q2021.
- After this trouble, the beneficiary’ feasibility was put in compromise, as that was the last chance the beneficiary had to perform the efficacy trial in sheep with the resources provided by the EIC.
- But fortunately, despite a difficult financial scenario, the beneficiary signed in June 2022 an agreement named “MATERIAL TRANSFER AGREEMENT AND FIRST RIGHT OF REFUSAL ON BGV1 VACCINE CANDIDATE” (or MTA) with a world leader Brucella vaccine manufacturer; An excellent partner with proven track record, who guaranteed to the beneficiary cutting-edge BSL3 facilities for animal experimentation, plus an expert team and an Industrial partner to perform all the remaining trials not only for sheep (main objective of this EIC Accelerator project), but also for cattle, which achievement was planned one year after this EIC Accelerator project termination. It is worth to mention that this fundamental support will be funded by this industrial partner, bringing about a feasible solution to the difficulties the beneficiary found in the developing of the EIC Accelerator project regarding BSL3 facilities availability after Covid-19 and funding.
- This agreement detailed also the conditions of an eventual sublicense of BGV1 in case those efficacy animal trials were successful, thus accomplishing the WP5 (licensing) goals once the efficacy trials are successfully completed.
- We have renewed our Corporate Image and we are ready for a communication campaign, subject to those efficacy trials completion.
- We have maintained contacts with key veterinary pharmaceutical companies and laboratories interested in our vaccine technology, which condition for an eventual sublicense of BGV1 required those efficacy trials positive results on beforehand. Having signed the above-mentioned MTA, this industrial partner will have a first right of refusal on BGV1 vaccine candidate, thus getting a remarkable competitive advantage in exchange of the work plan agreed in this contract.
