4 March 2021 – The first volunteer tested Takis vaccine COVID-eVax

Luca Rivolti, 21, is the first volunteer who tested the vaccine against COVID-19 developed by Takis and Rottapharm biotech. The clinical trial has just started at the San Gerardo hospital in Monza and Luca was the first of 80 healthy volunteers who will be vaccinated in the coming weeks / months. He has had no significant side effects so far and will receive the second dose of the vaccine by the end of March.

We thank him and all the volunteers for their valuable contribution to the Italian fight against the pandemic.

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March 1, 2021 - The first healthy volunteers received the initial dose of the DNA vaccine against COVID-19 (COVID-eVax) designed by Takis and developed in collaboration with Rottapharm Biotech in Italy: it is the first DNA vaccine to reach the clinical stage in Europe.

Phase 1 will involve 80 healthy volunteers divided into 4 groups with different doses administered with or without booster, while Phase 2 will reach up to 240 subjects on the most promising doses.

The phase I/II clinical study of the first european DNA vaccine against Covid-19 has started today in Italy

The DNA vaccine represents an innovation compared to other technological platforms already available, such as those with messenger RNA or viral vectors. "DNA allows us to avoid the cold chain in storage and transport," said Luigi Aurisicchio, CEO and Scientific Director of Takis. "Due to its characteristics, the production of the antigen is prolonged over time and the vaccine could work well already in the first cycle. Furthermore, if necessary, the administration can be repeated several times for a more solid immune response, also thanks to the use of the electroporation technique developed by another Italian company, IGEA, which facilitates the entry of DNA into muscle cells and it also acts as an adjuvant, thus stimulating immunological processes ".

A vaccine therefore developed entirely in Italy and which also makes use of a prestigious consortium of Italian clinical centers for Phase 1 and Phase 2 of the clinical trial. In fact, the National Cancer Institute IRCCS Pascale Foundation in Naples, the National Institute of Infectious Diseases Lazzaro Spallanzani in Rome and the San Gerardo Hospital in Monza in collaboration with the University of Milan-Bicocca are participating in the study. The three clinical centers are involved in all study activities, but each has greater responsibility for one of the three main aspects of the trial.

The San Gerardo Hospital in Monza is responsible for the treatment of the first subjects in each dose and therefore for the verification of the preliminary results: the first administration took place today in the Phase 1 Research Center directed by Prof. Marina Cazzaniga, medical oncology scientist at the University of Milan-Bicocca. "The vaccine promotes the production of a very specific portion of the "Spike" protein, which the virus uses to bind to human cells" underlines Prof. Paolo Bonfanti, Director of the Infectious Diseases Unit of ASST Monza and associate professor of Infectious Diseases at the University of Milano-Bicocca “and against which, therefore, the body will trigger the immune response”.

Pascale Institute in Naples plays a decisive role in expanding the number of subjects for each dose, in order to consolidate the results. "Among other things" explains Prof. Paolo Ascierto, Director of the Unit of Melanoma, Oncological Immunotherapy and Innovative Therapies of the Pascale Institute in Naples, "the DNA vaccine can be easily and quickly modified to take into account the variants of the virus that are becoming prevalent or that may appear in the future ”.

Finally, the Spallanzani Institute in Rome is responsible for all laboratory tests that document the immune response and therefore the potential efficacy. In fact, the vaccine performed very well in laboratory tests, evoking a strong humoral and cellular immune response, which will now be confirmed in humans.

"With COVID-eVax we are demonstrating the ability of Italian Research in generating innovative solutions against the pandemic and we have asked for the collaboration of important Italian development centers" concludes Aurisicchio "We have found in Rottapharm Biotech a partner for the initial investment and support in clinical development, but financial intervention by Italian and European institutions is now required on a technology that could prove useful not only against COVID-19, but also on a series of other therapeutic indications, starting with cancer vaccines " .

For more information:

Takis

Dr Luigi Aurisicchio (CEO/CSO)

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Rottapharm Biotech

Dr. Federica Girolami (Business Development, Scientific Liaison and Drug Safety Director)

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Takis

Takis is a biotechnology company created by a group of scientists formerly from Merck Research Laboratories (MRL) and it is located in Rome (Italy). The group has more than 15 years of experience and proven expertise in drug discovery in Oncology and is recognized for the design and implementation of a number of innovative technologies, including that of DNA gene therapy. One of Takis’s core assets is its experience with electroporation, a technology that can be used for a variety of clinically useful applications, from vaccine development to somatic gene therapy. Takis' pipeline includes four cancer vaccine candidates based on this technology. Takis is also actively involved in the generation of humanized monoclonal antibodies for use in oncology and infectious diseases, including COVID-19.

For more information on the company, visit www.takisbiotech.it

Rottapharm Biotech

Rottapharm Biotech is a research company dedicated to the discovery and development of innovative drugs. It is located in Monza (Italy) The company expertise in research and development includes medicinal / computational chemistry for small molecules, a proprietary platform for the generation and selection of new monoclonal antibodies and the development of other biological drugs and advanced therapies, the validation of new molecular targets, the pharmacological, pharmacokinetic, toxicological and pharmaceutical characterization of new drug candidates; the design and conduct of innovative clinical trials. The company strategy is to develop its own pipeline independently and then seek partnerships with pharmaceutical companies, as well as investing in alliances on innovative projects of other biotech companies or university spin-offs.

For more information on the company, visit www.rottapharmbiotech.com

 

24 February 2021 – Takis ranked first in Regione Lazio

Takis ranked first in the call “Emergenza Coronavirus ed Oltre” in the event “L’innovazione oltre l’emergenza” organized by Regione Lazio in order to illustrate the main innovative projects in the fight against COVID-19 and for recovery in the post-pandemic scenario.

Takis won with a project for the generation of knowledge and the development of reagents and tools to identify SARS-Cov-2 variants.

Thanks to this contribution, we will be able to test the effectiveness of our COVID-eVax against the coronavirus variants.

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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