On April 12, 2021, Sequentia Biotech, a Spanish omics 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 the COVID-19 syndrome.

“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 NEXBIOMICS 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.

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. 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”

NextBiomics is a biotech company specialized in the design and development of drugs and
healthy molecules by using the enzymatic properties of bacteria, probiotics and
immunobiotics. It is a spin-off of the University of Naples Federico II and partner of
Sequentia Biotech.