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7 February 2020 - Takis, LineaRX and Applied DNA Science collaborate for Development of a Linear DNA Vaccine Candidate Against Wuhan Coronavirus 2019-nCoV

7 February 2020 - Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”) a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing for product authenticity, traceability solutions, nucleic acid-based biotherapeutic development, and liquid biopsies for cancer diagnostics, announced today and in a late-day Investor Call yesterday, that it has expanded its existing Joint Development Agreement (JDA) with Takis Biotech to include the preclinical development of a linear DNA vaccine against 2019-nCoV, the new coronavirus that originated in Wuhan, China, infecting more than 28,000 and killing hundreds in just weeks. The advantages posed by PCR-produced linear DNA for this challenge include the speed of production, the absence of antibiotics and their resistance genes, the purity of the DNA, the simplicity of design, the powerful immunogenicity proved in a prior linear DNA vaccine, the absence of any bacterial contaminants and the fact that the vaccine gene is effective without insertion into the patient’s genome.

The virus expanded its hosts to humans and has been declared a public health emergency by the World Health Organization (WHO) and by the U.S. Department of Health and Human Services (HHS). LineaRx, Inc. (“LineaRx”) is the majority-owned subsidiary of Applied DNA focused on the therapeutic and diagnostic applications of the Company’s large-scale PCR platform that is protected by multiple issued and pending patents.

“We have a patented and proprietary platform for the production of linear DNA that empowers rapid development and large-scale production that we believe will yield a safe and effective vaccine with fewer risks than other DNA production platforms,” said Dr. James Hayward, president and CEO of both Applied DNA and LineaRx. “As is typical for RNA viruses, coronaviruses mutate at rapid rates that require constant surveillance.  We believe that one of the many benefits of PCR-produced linear DNA is the rapidity at which a putative vaccine can be revised to accommodate mutational drift.”

Dr. Luigi Aurisicchio, CEO/CSO of Takis, stated, “Our collaboration under the JDA on genetic technologies has already shown the ability to induce powerful immune responses in animal models using linear DNA.  To induce antibodies that can neutralize 2019-nCoV, it is essential to use reliable, effective technologies, that can be quickly adapted in the face of shifting pathogens. This global emergency requires a swift response.”

The companies are also developing a cancer vaccine that has shown rapid tumor clearance in test animals as reported this last September. Clinical trials using the linear DNA form of the cancer vaccine in companion animals are being planned. The Company has also participated in collaborative submissions for competitive contracts to develop related genetic countermeasures to protect American warfighters.

The collaborating teams have already begun the design and optimization of a synthetic gene that when delivered to muscles, should enable the temporary production of a designed antigen that could provoke an immune response against the virus. We expect to have linear DNA ready for testing within the next 60 to 90 days. Once the optimized gene is assembled, the Company will produce quantities of the linear DNA prototype vaccine at large scale for tests in mice. Prior evidence indicates that genes made of linear DNA reside only temporarily within the muscle cell nucleus, long enough to provoke an immune response, and is eventually cleared without genomic integration.

29 January 2020 – Takis vaccine against 2019-nCov Coronavirus on La Stampa

Luigi Aurisicchio, CEO/CSO of Takis and Evvivax, declared in an interview on La Stampa newspaper that our genetic vaccine against 2019-nCov Coronavirus may be ready in about 4 months for use by humans, while the preliminary tests on rodents may be completed in about 4 or 5 weeks.

Read the full article: Nei laboratori dove si studia il coronavirus: “Il vaccino? Ci vogliono almeno quattro mesi”

 

 

Takis and Evvivax developing a 2019-nCoV Coronavirus vaccine

Rome, 27 January 2020 - Takis and Evvivax, two biotechnology companies present in the science park of Castel Romano, Rome announce their commitment for the development of innovative vaccines against 2019-nCoV, the new coronavirus originating in Wuhan, China. To date, the virus has caused 81 deaths and over 2,800 known infections and is rapidly expanding in various countries.


"This is a worldwide emergency to which Takis researchers can and must contribute" - says Luigi Aurisicchio, CEO / CSO of the two companies - "We will immediately make available our skills gained for the development of vaccines against Cancer and other infectious diseases to fight the spread of this coronavirus ". Takis and Evvivax have developed vaccines based on genetic technologies capable of inducing powerful immune responses. "Our technologies are based on genetic engineering techniques and on the use of viruses and DNA fragments that can be used both for gene therapy and for vaccination" - says Emanuele Marra, Director of the Infectious Diseases Area at Takis. “To obtain antibodies capable of neutralizing pathogens, it is essential to use particularly effective technologies. At Takis, thanks to genetic vaccination, we have generated dozens of antibodies capable of neutralizing viruses and pathogenic bacteria "- continues Giuseppe Roscilli, Antibody Area Director. "In various clinical studies conducted in Italy and the USA, our veterinary vaccines have induced a powerful immune response and prolonged the survival of dogs with cancer, which like us humans develop it with high frequency. Even against zoonoses, that is, infectious diseases that are transmitted from animals to humans and vice versa, we can use the same type of approach. "- declares Dr. Antonella Conforti, Director at Evvivax.

Genetic vaccination is therefore the basis for the development of the 2019-nCoV vaccine at Takis. “Coronavirus biology and the availability of the 2019-nCoV genome sequence are all the information we need for vaccine design. The development of the methods and the experimentation will be fundamental to get to human clinical trials as soon as possible "- says Fabio Palombo, Immunology and Cancer Vaccines Area – NeoMatrix Director.

"Thanks to the experience of our scientists, Takis and Evvivax are technologically competitive at an international level and can make their contribution to this Health emergency with the internal resources currently available. However, scientific research requires important investments and it is essential to obtain financing and / or collaborations with large companies as soon as possible that allow us to develop the 2019-nCoV vaccine as quickly as necessary. "- concludes Luigi Aurisicchio.
The race against the virus has started.

For more information: www.takisbiotech.it and www.evvivax.com


Visualization of 2019-nCoV with Transmission Electron Microscopy.

Negative-stained 2019-nCoV particles are shown in Panel A, and 2019-nCoV particles in the human airway epithelial cell ultrathin sections are shown in Panel B.

 

Trazimab as a new promising approach to treat invasive Aspergillosis

Takis is proud to announce very promising results achieved with Trazimab, a monoclonal antibody against a new target expressed by Aspergillus fumigatus, a fungus which causes Aspergillosis, a rare and deadly disease.

 

There has been in increase in the number of projects for the development of biotech drugs against infections caused by the fungus Aspergillus: that is a promising field of research, with Takis company at the forefront. This is thanks to an experienced team of researchers who are dedicated to identifying new molecular targets against which to develop the drugs of the future. The next goal for Takis is the production of Trazimab, a monoclonal antibody for the treatment of Aspergillus infections. The new therapeutic approach could prove to be effective in particular against invasive pulmonary aspergillosis, a respiratory infection that is affecting more and more people around the world and for which current drugs are likely to be inadequate.

Among the infections caused by fungi of the genus Aspergillus, invasive aspergillosis is perhaps the most relevant, with 200,000 cases per year worldwide and a mortality rate that despite treatments remains between 25% and 80%. Whereas it does not affect immunocompetent individuals, invasive aspergillosis is extremely dangerous, even lethal for immunocompromised individuals.

 


There are many immunosuppressed patients, for example those taking immunosuppressive drugs following a transplant or those undergoing chemotherapy or radiotherapy to treat cancer. For these people, the only hope of treatment, until recently, were antifungal drugs, in particular azoles. But they are no longer enough, because of the onset of multi-resistant strains both in clinical settings and in the environment due to the abuse of fungicide in agriculture. They are increasingly widespread and require the development of innovative therapeutic strategies.
The hope against Aspergillus fumigatus today comes from biotechnology. Within the Trazimab project funded by the Campania region, Takis is developing biotechnological drugs against Aspergillus, such as monoclonal antibodies. This represents a potential alternative to traditional therapy, which in addition to dealing with the widespread phenomenon of drug-resistance, is also associated with important side effects on the kidneys and liver. Thanks to decades of experience in the production of antibodies and in vivo studies, the Takis team aims to transform the treatment of invasive aspergillosis with an innovative antibody, directed against a still unexplored molecular target, which promises to open a new way in the fight against Aspergillus.
Monoclonal antibodies are today one of the most avant-garde therapeutic approaches for the treatment of cancer, but their use is beginning to extend also to infectious diseases. This is thanks to their ability to recognize specific molecular targets with extreme precision, reducing side effects and maximizing efficacy. “We believe that the development of Trazimab could be a great opportunity for the use of monoclonal antibodies for a disease, such as Invasive Pulmonary Aspergillosis, in which small molecules still represent the gold standard” said Emanuele Marra, Director of Infectious diseases at Takis,“I also consider that the methodology used for the development of this antibody could facilitate the production of specific antibodies against fungal proteins and not just saccharide components”

2 December 2019 - Takis second Biotech in Europe at EIT Health Catapult Final!

Takis second Biotech in Europe at EIT Health Catapult Final!

Takis second Biotech in Europe at EIT Health Catapult Final


Paris, 2 December, 2019 – NeoMatrix, a neoantigen-based cancer vaccine based on Precision Immunology has been awarded second among the best Biotech companies in Europe. The journey started this summer, when a though selection of 150 companies led to a list of 7 finalists.

“The EIT Health Catapult competition was a great experience and most importantly validated NeoMatrix concept and business model” said Dr. Fabio Palombo, Director of NeoMatrix. “We have all the tools to make our dream real: provide new cures to cancer patients.”

“This is an fantastic recognition of our work and our ideas” said Luigi Aurisicchio, CEO/CSO. “We are more and more motivated to move forward NeoMatrix to clinical trial. In Paris we had the opportunity to meet many other stakeholders, learn each other and above all to establish a great network for future collaborations. ”
Are you ready to be "catapulted" in the Future of Cancer Therapy?

For more information please see our NeoMatrix web page

Check out all EHC finalists at: FINALISTS EHC 2019 – BIOTECH HEALTH Category

2-3 December 2019 - PARIS - European EIT Health Biotech Final: Forza Takis and Forza Italia!

NeoMatrix Personalized Cancer Vaccine Program at EIT Health Final in Paris, 2-3 December 2019

NEOMATRIX

Takis among the 7 European Finalists at EIT Health Summit


Paris, 2 December, 2019 – Takis, an Italian Biotech Company leader in Gene Therapy, Cancer Vaccines and generation of monoclonal antibodies is proud to announce its participation at the

eit Healt Summit 2019

the place where collective ideas transform the future of healthcare.

Takis S.R.L. will present NeoMatrix, a neoantigen-based cancer vaccine, as a proof-of-concept of personalized immunology. NeoMatrix starts from tumor biopsy  and gets to the manufacturing of a personalized cancer vaccine in 5 weeks.

“We are proud to have been selected among the finalists in this important European competition. Not only as Takis Biotech, but also as the only Italian company among incredible companies with brilliant ideas and teams able to create new opportunities for patients” said Luigi Aurisicchio, CEO/CSO.

“We know that immune system has a key role in fighting cancer” said Dr. Fabio Palombo, Leader and Champion of NeoMatrix. “Thanks to a deep knowledge of cancer immunobiology and cutting-edge vaccination technologies we have now the tools to provide precision therapies to human patients able to complement current standard of care.”

Stay tuned for the competition!

 

For more information please see our NeoMatrix web page

Check out all EHC finalists at: FINALISTS EHC 2019