The experimentation of innovative anti covid vaccines, effective against the virus and its variants, does not stop. Among these there is one "made in Italy". Is called COVID-eVax ed è l’unico in sperimentazione clinica in Europa basato sul Dna. Ideato dalla società biotecnologica Takis Biotech based in Castel Romano in Lazio and developed in collaboration with Rottapharm Biotech of Monza and important Italian academic institutions.

How is the COVID-eVax vaccine born?

The Takis research company, founded in 2009, specializes in genetic vaccines for cancer patients and the development of therapies based on monoclonal antibodies. With the pandemic breakthrough and the need to develop an anti-covid vaccine, Takis has launched a crowdfunding initiative to support research to test a vaccine in its own laboratories. The goal was achieved and thanks to the collaboration of Rottapharm Biotech of Monza and the work of a group of Italian researchers, with experience abroad in the development of innovative drugs, Covid-eVax was born. 

Takis Biotech laboratory group

Covid-eVax 

It is an innovative anti-covid vaccine based on a synthetic DNA technological platform produced in the laboratory. 

Results Phase I of experimentation

According to the results of Phase I tests at theSan Gerardo Hospital of Monza,National Cancer Institute IRCCS Pascale of Naples and the Clinical Research Center of Verona, in collaboration with i VisMederi laboratories in Siena, the COVID vaccine-eVax was "well tolerated" with the induction of an immune response up to 90% of the volunteers. Despite the promising preliminary data, the experimentation in the last year has stopped compromising the immediate availability of the vaccine. 

To find out more we interviewed Luigi Aurisicchio, founder and CEO of Takis. 

Luigi Aurisicchio - COVID-eVav vaccine administration gun

What are the benefits of the COVID vaccine-eVax?

By its nature, COVID-eVax has a number of important benefits, including: Immunogenicity: the vaccine is able to induce both antibodies and cell-type responses; Stability: DNA is a potentially stable molecule for a long time at room temperature, which allows for shipping and storage without a cold chain. Therefore, the technology is suitable for use in low-income countries;Calling up the answer: COVID-eVax can be used to invoke the immune response induced by other SARS-CoV-2 vaccines, based on different technologies.

What critical issues did you encounter in the development phase?

The criticalities are related to the fact that it is not a simple injection, but the administration is linked to the use of a device, the electroporator, which requires training from the vaccinator. 

It's called COVID-eVax where for eVax we mean electric vaccine. How is it administered?

The vaccine is administered by electroporation, which consists of an intramuscular injection followed by the delivery of short, low-voltage electrical pulses that induce a strong immune response against the antigen. The procedure allows for the efficient transfer of DNA across the cell membrane without toxic effects on cells and tissues. Several studies have shown that electroporation greatly improves gene expression and has already been evaluated in phase I-III clinical trials, showing promising results in terms of safety, tolerability, gene expression levels and immunogenicity. Electroporation is based on Cliniporator ™ technology developed by IGEA, an Italian company from Carpi, and already marketed for use in electrochemotherapy in cancer patients. Local application of electrical impulses improves the release of chemotherapy into cancer cells leading to therapeutic effects. In Europe, 224 medical devices are already available in major hospitals. In partnership with IGEA, we have developed a special gun (Gene gun) which allows the administration of the vaccine and the delivery of the electrical impulse, which we used for the clinical study.

It is a "precision" vaccine based on DNA, different from those already available with messenger mRNA and adenoviral vector. How does it work?

COVID-eVax is a precision vaccine that targets the RBD region of the Spike protein which is critical for viral infection and antibodies that bind to this region have been shown to effectively neutralize the virus. For this reason, it is supposed to minimize the risk of unwanted side effects seen for other vaccines. Furthermore, COVID-eVax can be administered multiple times, without inducing neutralizing antibodies against the vaccine itself, as can happen with viral vector vaccines. Plasmid DNA is produced in bacteria, then extracted and purified, without using amplified viral vectors in mammalian cells. Compared to RNA, its administration avoids the use of other ingredients (liponanoparticles, adjuvants, etc.). This allows for shorter production times, less expensive processes, easier transportation and storage, and potentially a better safety profile.

Covid-19 variants

The DNA platform is very flexible, does it also work against variants?

Laboratory data show that our vaccine as it is works very well against known variants. However, the genetic design of COVID-eVax can be easily adapted to mutations in case of virus evolution and immune escape. In fact, we already have vaccines ready against all the variants that have emerged in recent months, including Delta. Furthermore, we have developed a prediction and monitoring system, called COVID-miner which allows to determine in advance a variant that shows a selective advantage over others.

Can it be used for many other diseases, including cancer?

Yes of course. The technology was developped from our experience in Immuno-Oncology and thanks to COVID-19 we had the opportunity, albeit with difficulty, to bring it to the clinic. We have learned a lot and plan to develop cancer vaccines. But this platform, which we have called X-eVax, where X stands for "antigen X" could be used in many other areas of prevention and therapy within a national pandemic plan, for example. 

Trial

Takis Biotech laboratory

80 volunteers participated in phase I of the Covid-eVax trial. What were the first results on safety and immunogenicity?

The vaccine proved to be safe, with very few minor side effects. Furthermore, most of the volunteers developed antibodies and cellular response, which is very important for rapid resolution of the disease and elimination of virus-infected cells.

According to the first results of the tests, the Covid-eVax vaccine it resulted "well tolerated" with the induction of an immune response up to 90% of the volunteers, but the experimentation in the last year has stopped compromising the immediate availability of the vaccine. Where is it today? When will Covid-eVax be available?

I cannot answer this question today. It is clear that the investments required for Phase 2 and 3 and for commercialization cannot be made by two small companies such as Takis and Rottapharm Biotech. Support from the State or the European Commission is essential to continue the development of the COVID-eVax vaccine, but more generally of the vaccine platform. It would be important for our country to capitalize on this experience so as not to be unprepared in the near future and to have an asset available immediately.

The value of Italian excellence in international research

The Italian vaccine Covid-eVax was born from a crowdfunding initiative in support of research initiated by Takis and thanks to the work of a group of Italian researchers with experience abroad in the development of innovative drugs. 

Takis Biotech laboratory

How important is it to invest in scientific research and how much is it to enhance Italian excellence in Italy and in the world?

Italian research has always been at the forefront in various fields, for example in immunology, gene and cell therapy, both academically and privately. The factors that made it possible are certainly not of an economic nature: Italian researchers are brilliant, resourceful, have skills to sell and are able to adapt to structural deficiencies. All this despite the fact that Italy is still a country that believes little in research, investing a share equal to 1,39% of GDP. Doing research in Italy is really difficult and unfortunately many brains go abroad where they are given great opportunities. Another great lack is the absence of Technology Transfer, that is the possibility of translating the discoveries of university researchers into commercial development opportunities that can create new jobs and finance the research itself in a virtuous circle. In this context, the biotechnology sector can make a great contribution with public / private partnerships. Investments in innovation are the fundamental engine of the economic growth of a developed country and SMEs also in the Biotech field must be strengthened by the Italian system.

Covid-19 vaccines: the stages

How were the vaccines made? What were the stages?

This was explained by the Director General of Prevention of the Ministry of Health, Gianni Rezza.

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