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


Our vaccine COVID-eVax has been described within Covidx initiative, together with other ongoing European projects aimed at fighting SARS-Cov-2 pandemics.
Covidx platform provides the public with up-to-date and accurate information about in innovative therapeutic and diagnostic products against COVID-19. This project is aimed at displaying the European response to COVID-19, by mapping the landscape of relevant projects and their progress.


Read about: COVID-eVAx on covidX


Takis collaborates in the “TraZimab” project coordinated by Menarini Biotech and financed by Lazio Innova. The project put together three important local organizations - Menarini Biotech, Takis and OPBG (Bambin Gesù Pediatric Hospital - for the development of an innovative treatment against invasive aspergillosis based on CAR-T technology.

Takis has for years been at the forefront of research into innovative biotechnological therapies against invasive aspergillosis - a respiratory infection that affects 200,000 people a year worldwide with a mortality between 25% and 80%, particularly in immunocompromised patients. Researchers are developing TraZimab, a monoclonal antibody directed against a molecular target of the disease-causing fungus - Aspergillus fumigatus. TraZimab binds to a zinc transporter expressed on the cell surface of Aspergillus and essential for its sustenance.

The only treatment option to date are fungicides, which however have side effects on the liver and kidneys and are only partially effective due to the growing spread of fungi resistant to traditional drugs. The TraZimab project responds to the need to develop alternative therapeutic approaches: funding will allow to generate a large-scale and highly innovative treatment based on CAR-T engineered with the genetic sequence of the antibody.

CAR-T prepared in the laboratory and then injected into patients would be able to specifically recognize and neutralize the cells of the fungus. “We are proud to contribute to this project – says Emanuele Marra, Director of Infectious Diseases Area at Takis” – “this is a potentially more effective strategy than traditional therapies and with fewer side effects”.


Takis per il progetto TraZimab contro l’aspergillosi invasiva

Takis collabora al progetto “TraZimab” coordinato da Menarini Biotech e finanziato da Lazio Innova. Il progetto vede la partecipazione di tre importanti realtà del territorio – Menarini Biotech, Takis e OPBG (Ospedale Pediatrico Bambin Gesù – per la messa a punto di un trattamento innovativo contro l’aspergillosi invasiva basato sulla tecnologia CAR-T.

Takis è da anni in prima linea nella ricerca di terapie biotecnologiche innovative contro l’aspergillosi invasiva – una infezione respiratoria che colpisce 200.000 persone l’anno in tutto il mondo con una mortalità tra il 25% e l’80%, in particolare nei pazienti immunocompromessi. I ricercatori di Takis stanno sviluppando TraZimab, un anticorpo monoclonale diretto contro un bersaglio molecolare del fungo che causa la malattia – Aspergillus fumigatus. TraZimab si lega a uno specifico trasportatore dello zinco espresso sulla superficie delle cellule di Aspergillus e fondamentale per il suo sostentamento.

L’unica opzione di trattamento ad oggi sono i fungicidi, che però hanno effetti collaterali su fegato e reni e una efficacia solo parziale a causa della crescente diffusione di funghi resistenti ai farmaci tradizionali. Il progetto TraZimab, finanziato da Lazio Innova, risponde alla necessità di sviluppare approcci terapeutici alternativi: lo scopo è quello di portare sul mercato un trattamento altamente innovativo a base di CAR-T ingegnerizzati con la sequenza genetica dell’anticorpo.

I CAR-T preparati in laboratorio e poi iniettati nei pazienti sarebbero in grado di riconoscere e neutralizzare in maniera specifica le cellule del fungo. “Siamo orgogliosi di contribuire a questo a progetto” – ha dichiarato Emanuele marra, Direttore dell’area Malattie Infettive di Takis – “Si tratta di una strategia potenzialmente più efficace delle terapie tradizionali e con meno effetti collaterali”.