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Takis and Rottapharm Biotech announce the authorization of the clinical trial by the Italian Medicines Agency (AIFA) of COVID-eVax, the vaccine against COVID-19 designed by Takis and developed in collaboration with Rottapharm Biotech. The Phase I and II clinical trial can now start in February and will provide the first results on safety and immunogenicity about 3 months after the start of the trial.

Unlike other platforms already approved by the European Medicines Agency (EMA) such as mRNA and Adenoviral vectors, COVID-eVax is based on a DNA fragment injected into the muscle that promotes the production of a specific portion of the "Spike” protein, stimulating a strong immune reaction against the virus. The efficiency of the process is increased by the "electroporation" technique, which favors the passage of DNA inside the cells in a simple, rapid way and without side effects thanks to light and short electrical stimuli. Takis has been collaborating for years with another Italian company, IGEA, whose "electroporator" is already available throughout Europe. The three companies together are collaborating in the creation of an even more widespread system.

"The preclinical results have demonstrated the safety of the vaccine and its efficacy in inducing a powerful antibody and cellular immune response against the virus" stated Emanuele Marra, Director of the Infectious Diseases Department, and Giuseppe Roscilli, Director of the Generation and production of Monoclonal Antibodies at Takis. The phase I and II clinical study will be carried out at the National Cancer Institute IRCCS Pascale in Naples, the National Institute for Infectious Diseases Spallanzani in Rome and the San Gerardo Hospital in Monza in collaboration with the University of Milan-Bicocca.

"The authorization of AIFA represents the first important step in the development of DNA technology against COVID-19 but also for other diseases" said Luigi Aurisicchio, CEO and Scientific Director of Takis. “Among the important advantages, DNA is cheap, does not need complex formulations, can be produced on a large scale and does not need the cold chain. But above all, vaccination can be repeated over time to increase and maintain the immune response and its flexibility allows it to be easily adapted against the new variants of the virus that are emerging, should they become resistant to current vaccine therapies and therapeutic antibodies".

According to Lucio Rovati, President and Scientific Director of Rottapharm Biotech, "COVID-eVax is a vaccine that was born in Italy, is being developed in Italy with all Italian technologies, will be tested in Italy and, in case of success of clinical studies, will be produced in Italy thanks to a solid and highly competent consortium that is already working on the possible industrialization phase."

"The development of a synthetic DNA vaccine represents a further weapon for mass immunization and for the final victory over COVID-19", said Paolo Ascierto, Director of the Melanoma, Oncological Immunotherapy and Innovative Therapies Unit of the Institute Pascale of Naples and coordinator of the clinical study, together with Dr. Marina Cazzaniga and Prof. Paolo Bonfanti of the Milan-Bicocca University and Dr. Simone Lanini of the Spallanzani Institute in Rome.

COVID-eVax was born from the passion and expertise of an Italian Biotech and a team with great experience in the development of innovative drugs, but also from an important courageous investment. However, to make this vaccine and its promising technology available to everyone, the intervention of Public institutions will be necessary to capitalize on what we have learned from this pandemic", concluded Rovati.


Takis has been added to the European Malaria Fund portfolio.

The EU Malaria Fund is a public-private partnership between the European Union, international organizations, corporations and organized civil society, providing a new funding tool to address market failures in infectious diseases with a significant relevance to public health globally.

Every two minutes a child under the age of five dies of malaria. We will make our knowledge and expertise available in genetic vaccination platforms to help combat this complex disease. This is an exciting new challenge that we can't wait to get started.

Malaria-eVax is a multistage targeted vaccine against malaria.

Read more: Control Malaria – EU Malaria Fund

STONY BROOK, N.Y. and ROME, ITALY – March 2, 2021 - Applied DNA Sciences, Inc. (NASDAQ: APDN) (the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, and its program development partner, Evvivax, S.R.L. (“Evvivax”), today announced the initiation of Phase I of a two-phase clinical trial to evaluate a LinearDNA™ COVID-19 vaccine candidate for the feline veterinary market. The goal of the trial is to evaluate the vaccine candidate as a strategy for the prevention of SARS-CoV-2, the virus that causes COVID-19, in feline companions of humans that may mitigate the animals as a potential reservoir for infections in humans. If successful, the clinical trial will also serve as an important initial validation of LinearDNA, Applied DNA’s large-scale, PCR-based manufacturing platform, for vaccines.

Read more: Applied DNA and Evvivax Initiate Phase I of Clinical Trial

Luigi Aurisicchio, CEO of Takis, and Lucio Rovati, CEO of Rottapharm biotech, interviewed on the journal of SIMeF – Società Italiana di Medicina Farmaceutica.  

They talked about the contribution of Italian research to the race for a vaccine against Sars-Cov-2 and pointed out the strengths and critical issues of the vaccines under study, their production and clinical experimentation .

Italy is among the leading countries in the development of a vaccine. We believe that investments in innovation are fundamental engine of the economic growth of a developed country.


Read the interview here

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In January, the clinical trial of our DNA vaccine for Covid-19 - 100% made in Italy - will begin at the research center of the San Gerardo Hospital in Monza, with the Pascale Institute of Naples which coordinates the experimentation and collaboration of the Spallanzani in Rome.
Our technology differs from that of the vaccines that will be approved first. Such diversity can be an advantage for our candidate in terms of repeatability and duration of the immune response.

Look at the video on SKYTg24

WIth the first generation of vaccine against COVID-19 being investigated in clinical trials, vaccines able to fight the new emerging variants of the SARS-CoV-2 virus will be the next goal. Takis is preparing to the phase 1 clinical trial of the COVID-eVax vaccine, based on the genetic sequence of the SARS-CoV-2 virus circulating in China in early 2020. "Our vaccine has demonstrated an ability to neutralize Wuhan virus - said Luigi Aurisicchio, CEO and scientific director of the biotech company - and we expect approval to begin the Phase 1 clinical trial by regulatory agencies in December. Furthermore, the vaccine induces antibodies capable of blocking the variant of SARS-CoV-2 called G614D, now the most widespread in the world ".

The G614D variant gives the virus a selective advantage by making it more infectious, allowing it to bind better to the Ace2 receptor found on the surface of many organs, from the lungs to the heart. Takis is already working on other possible vaccines against the new emerging variants, including the one born in Australia (S477N) and those that appeared in outbreaks developed in mink farms.

"At the moment – said Aurisicchio - we know that minks develop a disease similar to that occurring in humans, we know that farms have facilitated the transmission of the virus from minks to humans and vice versa, but it is not yet known what advantages these mutations give to the virus”.

Read about: ANSA