Last month, BHH member Sequentia Biotech, a Spanish bioinformatics company and NextBiomics, a biotech company involved in the research and development of Next Generation Probiotics and a spin-off of the Federico II University of Naples, announced the filing of a patent application for a bacterial vaccine against Covid-19.
“By engineering the probiotic Escherichia Coli Nissle 1917 expressing the SARS-CoV-2 Spike protein, it was possible to obtain an innovative model of immunization against Covid-19 by stimulating the intestinal immune system,” says Giovanni Sarnelli (professor of Gastroenterology at the Federico II University, NextBiomics’ CEO and co-founder).
“The NextBiomics vaccine is similar to others that have been already authorized (Pfizer, Moderna, AstraZeneca, Reithera, Johnson & Johnson) in that it stimulates the immune response against the Spike protein that the Coronavirus uses to infect cells, but it differs from them because it uses a probiotic bacterium as a vector, which is already on the market and being widely used for other purposes”. This feature differentiates NextBiomics’ vaccine from all the others in that it does not require an injection, plus it does not use a viral vector such as Adenovirus, which in rare cases has been associated with severe adverse reactions and exploits the intrinsic capacity of Escherichia Coli Nissle 1917 to modulate the immune response.
“The preclinical data conducted on a mouse model shows that the administration of engineered Escherichia Coli Nissle 1917 for 5 days a week, for a total of 17 weeks, was able to significantly stimulate the immune response with the production of circulating IgM and IgG antibodies, and without any side effects or adverse effects being documented. The ability of the vaccine to significantly stimulate the production of IgA at the mucosal level (both intestinal and bronchial), guaranteeing de facto further protection against COVID-19 infection, is an even more interesting feature of the technology,” adds Giuseppe Esposito, Professor of Pharmacology at the Sapienza University of Rome, scientific director and NextBiomics’ co-founder.
Mr. Sarnelli continues: “The design and scientific phases were accompanied by a fruitful experimental and strategic design activity in collaboration with Sequentia Biotech, a Spanish company with deep expertise in genomics and microbiomics.” Walter Sanseverino (CEO at Sequentia Biotech and NextBiomics’ co-founder) traces the future development of the probiotic vaccine: “The epidemiological data and the evolution of the SARS-COV-2 pandemic indicates that citizens will have to continue to undergo the recall vaccination. The strength of our approach is to make this process faster, with the advantage of oral administration that does not require trained personnel and health facilities or vaccination centers. This reduces the costs of management, distribution (it is not necessary to maintain deep refrigeration conditions) and pressure on health facilities, and makes the whole process a lot more simple and efficient.”
Mr. Sanseverino continues: “Moreover these advantages, combined with the high safety of the system, the simplicity and low costs of the production processes, with factories for the large-scale production of probiotics are already present all over the world, make our vaccine a valid alternative to those already on the market. We are having conversations with several pharmaceutical companies so that they can access our invention and our experimental data to carry out the clinical trials to make it possible to take the new vaccine to the market.”
Francesco Campobasso, NextBiomics‘ CFO, is enthusiastic about the patent: “This milestone, which is added to the other New Generation Probiotics already patented by our team, allows us to accelerate our development line for the release of annual broad-spectrum versions for mutated variants of Covid-19 that may appear over time.”