Phase 1 testing was successfully completed of the Italian anti Covid-19 vaccine by Takis and Rottapharm Biotech, so much so that the immune response against the SARS-CoV-2 virus it is present in 90% of vaccinated people, but there are no funds to continue with the other two phases of the study. The vaccine, the first DNA to reach the clinical development stage in Europe, is however forced to a halt. At least for now. This was announced by the biotech companies themselves. To this difficulty is added that of very long times to assign the Green pass to the volunteers enrolled in the studio.
How the DNA vaccine works
That developed by Takis-Biotech is low on electroporation, technology developed in collaboration with the company Igea of Carpi: thanks to short electrical stimuli, it mediates the passage of DNA inside the cells and activates the immune system. Covid e-vax, then, it produces a rapid activation of the immune system through the introduction into the muscle of a fragment of DNA of the virus containing a portion of the Spike protein that triggers the production of antibodies
“Financing is needed”
“Even the existing vaccines, despite being developed by large companies, have required major interventions by their own countries, as is logical for vaccines against a pandemic”, he explains. Luigi Aurisicchio, CEO and scientific director of Takis. Phase 1 test results indicate that the Covid-eVax it was found to be “well tolerated” and “induced an immune response (antibody and / or cellular) at all doses tested (0.5, 1 and 2 milligrams, administered in double dose)”. The best response, the companies continue, “was observed in the group treated at higher dosage, with the induction of an immune response in up to 90% of the volunteers “.
The cellular response
“The preliminary results are favorable,” he said Lucio Rovati, president and scientific director of Rottapharm Biotech. “We believe that the data generated in this study are a validation of the efficacy of the new technological platform of DNA vaccines, different from those already available at Messenger RNA or a viral vector, and potentially useful also in different fields, such as for the treatment of some oncological pathologies “.
In addition to the problem of funding, however, there are difficulties in conducting the second part of the study in Italy due to the high number of vaccinated people. “Moreover, the profile of the immunological reaction, with a strong cellular response, is such that – observes Rovati – Covid-eVax should be tested as a third dose when the antibody response from the vaccines already available will decrease and in order to provide a strong boost to immune memory“. Thanks from the companies to the volunteers who participated in the study” for making themselves available to the research: a great act of generosity, especially at this time when there are other vaccines available “, Aurisicchio says, hoping that” it will reach them. the next few days the Green pass has not yet been obtained “.
Pregliasco: “We must continue”
The virologist Fabrizio Pregliasco spoke in Repubblica on the DNA vaccine and on the issue of funds: “Phase 1 is the first tested on humans, and acts as a filter – explains the virologist – 2 and 3 are those in which they are established, among other things, dosage and safety. They last on average 3-4 months. Provided, however, that they can be financially supported. It is a path that should be followed because we can still give a lot to fight this pandemic, which is testing us even today “.