The experimentation of the all-Italian anti Covid-19 vaccine has started, conceived by Takis of Castel Romano (Rome) and developed in collaboration with Rottapharm Biotech of Monza. Here are the accounts and shareholders of the Takis company
While the first generation of Covid-19 vaccines has been approved by the European and Italian health authorities, the clinical trial of the vaccine by Italian biotech Takis, developed with the Monza-based company Rottapharm, started yesterday. In addition to that of Reithera, COVID-eVax is added to the list of Italian vaccine candidates.
TESTING OF THE TAKIS VACCINE BEGINS
The experimentation of the all-Italian anti Covid-19 vaccine has started, conceived by Takis of Castel Romano (Rome) and developed in collaboration with Rottapharm Biotech of Monza. The first healthy volunteer of the 80 scheduled for phase 1 was vaccinated today in the San Gerardo hospital in Monza, one of the three Italian centers that, in collaboration with the University of Milan-Bicocca. He is involved in clinical trials with the National Cancer Institute Pascale Foundation of Naples and the National Institute of Infectious Diseases Lazzaro Spallanzani of Rome and the San Gerardo Hospital of Monza.
HOW WILL THE PHASES OF THE EXPERIMENTATION BE
Phase 1 of the trial, on 80 healthy volunteers divided into 4 groups with different doses administered with or without booster, "will be attached to phase 2: as soon as we have the information on the most promising doses we will proceed immediately with the second dose, probably in the end. September and early October on a further 240 patients. So we will move on to phase 3 ”, Luigi Aurisicchio, CEO and Scientific Director of Takis, told Ansa.
HOW THE TAKIS VACCINE IS MADE
Called Covid-eVax, the vaccine is all Italian and in laboratory tests it caused a strong immune response both of the antibody and cellular type. It is based on a new technology compared to that of the vaccines available so far and which can be easily updated to combat the variants, moreover “it allows to avoid the cold chain in storage and transport”, notes Aurisicchio. It is in fact a DNA vaccine: to stimulate the immune reaction it uses a fragment of DNA that is injected into the muscle and promotes the production of a specific portion of the Spike protein, the main weapon that the SarsCoV2 virus uses to enter human cells; the efficiency of the process is increased by the electroporation technique, which favors the passage of DNA into the cells thanks to light and short electrical stimuli. The latter technique was developed by another Italian company, the Igea di Carpi.
THE THREE CLINICAL CENTERS
The three clinical centers are involved in all the activities of the study, Takis notes, but each has greater responsibilities on one of the three main aspects of the trial: the San Gerardo di Monza, where today the first administration in the Phase Research Center took place. 1 directed by Marina Cazzaniga, of the University of Milano-Bicocca, is responsible for the treatment of the first subjects of each dose and for the verification of the preliminary results; the Pascale in Naples has a decisive role in expanding the number of subjects for each dose, in order to consolidate the results;
Spallanzani in Rome is responsible for all laboratory tests that document the immune response and therefore the potential efficacy.
AIFA'S FREE GO
Aifa, the Italian Medicines Agency, has recently given the green light to the phase I and II clinical study , which will be carried out at the national cancer institute Irccs Pascale in Naples, the national institute on Spallanzani infectious diseases in Rome and the San Gerardo hospital in Monza in collaboration with the University of Milan Bicocca. All the details.
THE PRECLINICAL STUDIES
The vaccine has been successfully subjected to preclinical studies. "The preclinical results have demonstrated the safety of the vaccine and its effectiveness in inducing a powerful immune response, both antibody and cellular against the virus", declared in recent days Emanuele Marra, director of the infectious diseases department, and Giuseppe Roscilli, director of the department of generation and production of monoclonal antibodies, of Takis.
And on these first data, Aifa has given the green light in recent days to the phase 1 and phase 2 clinical trials of the drug. “The authorization of Aifa represents the first important step for the development of DNA technology against covid-19 but also for other pathologies”, underlined in recent days Luigi Aurisicchio, CEO and scientific director of Takis.
The vaccine developed by Takis and Rottapharm is also economical and does not require storage at particularly low temperatures. "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".
The vaccine was developed by Takis, a biotechnology company based in Rome, which has been active for over 10 years in the discovery of drugs and vaccines.
The company is 65% controlled by Rita Mancini. 28% is owned by Luigi Aurisicchio, CEO and scientific director of the company. The remaining 7% is divided equally between Emanuele Marra and Giuseppe Roscilli.
THE NUMBERS OF TAKIS
Takis closed 2019 with a total value of production equal to € 2,488,883, a clear increase compared to the € 1,937,803 recorded in 2018. The profit doubles, or almost, to € 406,861 (compared to 219,878 in 2018), against production costs of 672,404 euros.
Rottapharm Biotech also collaborated in the development and preclinical study of the Italian Covid vaccine, born as a spinoff of Rottapharm Madaus, a pharmaceutical multinational, founded in the 1960s by the doctor and researcher Luigi Rovati, now controlled by the American Myland and previously (since 2014 ) by the Swedes from Meda.
At the time of the sale of Rottapharm Madaus, however, Rottapharm Biotech, a Research & Development center, became an independent company that is part of the Fidim group, led by Lucio Rovati, and controlled 99.9% by Spadif Trust and 0.01% % from Sirefid Spa.
THE NUMBERS OF FIDIM
Fidim, in 2019, recorded a total production value of 1,051,566 euros, a slight decrease compared to 1,102,340 euros. The company is in the red for 191,496,939 euros, with total costs of 13,334,150.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/takis-e-rottapharm-tutto-sulle-societa-biotech-del-vaccino-anti-covid-italiano/ on Mon, 01 Mar 2021 14:24:14 +0000.