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18 March 2020 – Takis on Italian TV program “Porta a porta” about Covid-19 vaccine

Our CEO Luigi Aurisicchio has been invited in Skype connection to the Italian TV program “Porta a porta” conducted by Bruno Vespa.

He has described our effort to develop a genetic vaccine against Covid-19 and given an overview of the next critical steps after the Italian Ministry of Health has approved the first tests on pre-clinical models. Clinical trial on humans may start by the end of this year.

Watch the video: https://youtu.be/qyOHTB5csqI

Rome, 17 March 2020 - Takis, a biotech company in Castel Romano, Rome, announces that it is ready to test its Covid-19 vaccine on pre-clinical models

Rome, 17 March 2020 - Takis, a biotech company in Castel Romano, Rome, announces that it is ready to test its Covid-19 vaccine on pre-clinical models.

The authorization comes from the Ministry of Health and represents the first step in bringing the vaccine to human use.

Takis researchers are the only ones in Italy and the first in Europe to access this phase of the experimentation.

Download PDF Italian Version

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As early as the end of January, the Company had announced that it wanted to make a Coronavirus vaccine. In recent weeks, our Country has become one of the most affected by the Covid-19 epidemic, making the search for effective vaccines and therapies even more urgent. Today, Takis researchers reaffirm their commitment and that of Italian Research, making available their expertise in the field of vaccines and immunology. The first results of the pre-clinical trial will be available already in April. “This is a demonstration of how a group of good researchers has decided to accept a very difficult challenge and to roll up their sleeves, managing to quickly identify the best strategies for developing a vaccine and starting preclinical tests. The challenge has begun, "said Emanuele Marra, Director of the area of infectious diseases and Partner of Takis.

Takis' product is a genetic vaccine, which contains only a fragment of DNA: it is safe and induces a strong response from the immune system. It is based on a technology called electroporation, which consists of the injection into the muscle followed by a very short electrical impulse which facilitates its entry into the cells and activates the immune system. The development of our vaccine is now preparing to enter a very important phase, that of pre-clinical experimentation, which will provide preliminary data on its efficacy and tolerability and which will be carried out in part thanks to the collaboration of the Spallanzani Institute in Rome, which will conduct experiments on cells to test the vaccine's ability to block virus replication.
"The information obtained from these initial studies will not only serve as a basis for vaccine development but will be extremely useful for creating immunization tools for the generation of neutralizing monoclonal antibodies." Giuseppe Roscilli, Director of the Monoclonal Antibody Development Area and Takis partner said.

"If the results are satisfactory, the vaccine could already be tested on humans in Autumn." - said Luigi Aurisicchio, Founder and Administrator of Takis. "Takis is the only company in Italy to have reached this point. Objective achieved thanks to the dedication of our researchers and without any type of external financing. But now Takis needs the collaboration of the institutions and anyone who is able to contribute, for this purpose we ask that to establish an open dialogue with national and European agencies in order to speed up the next steps towards clinical trials. Also for this reason, in recent days in the absence of public funding for Research, we have launched a crowdfunding campaign that aims to quickly collect the amount necessary to access the next stages of vaccine development, i.e. large-scale vaccine preparation and the execution of the clinical study. "
Takis represents an Italian excellence and is the demonstration of how important it is to invest in scientific research to preserve people's health. Hopefully, Italy will understand it soon.

For the Crowdfunding campaign: https://www.gofundme.com/f/il-vaccino-italiano-contro-covid1

A Crowdfunding initiative to speed up COVID-19 Vaccine development

Takis scientists are absolutely committed to find solutions to COVID-19 epidemic as soon as possible and are investing time and resources to move forward. However, the next steps up to humans will be much more expensive and being a small Biotech, we must necessarily stop. At this stage, speed is essential: we have already designed the next studies and estimated the costs. We will need approximately 2 millions, which will be used for large-scale vaccine preparation, for studies required by regulatory agencies and for the clinical study.

Spallanzani Institute and Takis can make a huge contribution to dealing with this incredible health emergency. Of course, a vaccine would be essential to protect the population at greatest risk, such as the elderly, cancer patients and healthcare professionals. For this, we are looking for funding that can help us develop the vaccine. Our goal is therefore to get as soon as possible to test the Italian vaccine against COVID-19 in humans and help the whole community to cope with this complicated health and economic situation.

We at Takis are really doing our best, we have openly declared our commitment and we will keep our promise, if we are given the opportunity. We must also see this as an opportunity to learn how to deal with future emergencies. Help us to make the Vaccine in the shortest possible time.

For donations: https://www.gofundme.com/f/il-vaccino-italiano-contro-covid19

2 March 2020 - Applied DNA Sciences Updates on COVID-19 Collaboration with Takis Biotech, 4 Preclinical LinearDNA™ Vaccine Candidates Designed

– Applied DNA Expected to Enter Large-Scale Production of Candidates in March; Preclinical Testing in Animals by Takis Biotech Anticipated to Begin in Calendar Q2 2020 -

– Candidates Inspired by the Sequence of Viral Spike Protein; Designed to Prevent Entry of Coronavirus into Human Host’s Cells -

Download PDF Italian Version

STONY BROOK, N.Y., and ROME, ITALY, Italy -  March 2, 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, and Takis Biotech (“Takis”), a company focused on the development of cancer vaccines, and founded by scientists from Merck Research Laboratories, announced today that the design of 4 DNA vaccine candidates that will be produced for preclinical animal testing via the Company’s proprietary PCR-based DNA manufacturing systems.

 

The companies’ announcement follows their statement on February 7, 2020 to announce an expanded Joint Development Agreement (JDA) between the Company’s majority-owned subsidiary, LineaRx, Inc. and Takis Biotech to include the preclinical development of a PCR-produced LinearDNA™ vaccine against COVID-19.

 

Applied DNA Sciences Updates on COVID-19 Collaboration with Takis Biotech, 4 Preclinical LinearDNA™ Vaccine Candidates Designed  

“Since expanding our JDA to include the pursuit of a COVID-19 vaccine, the virus has appeared on almost every continent. We expect delivery of the 4 preclinical constructs from Takis in this month. Within weeks of arrival we expect to immediately scale up PCR-based production of each vaccine candidate and ship them back to Takis who will determine each vaccine’s relative abilities to provoke an immune response in vaccinated mice,” stated Dr. James A. Hayward, president and CEO of Applied DNA and LineaRx.

The two firms have designed 4 preclinical vaccines on the basis of the “Spike” protein structure (the proteins responsible for the “crown” on the virus surface, and from whence its name derives). It is the Spike protein that enables uptake of the coronavirus, by binding to specific receptors on the host cells. One of the 4 candidate vaccines is the entire spike gene; the remaining 3 are variants based upon epitope mapping (identifying the likely antigenic portions of the protein) and assembling the corresponding parts of the ‘S’ gene into a new synthetic LinearDNA gene, and codon optimization (to ensure the new LinearDNA vaccine genes are efficiently expressed as proteins, once the genes have been delivered to a small percentage of the nuclei of the patient’s muscle cells.) Additionally, Applied DNA has proprietary means, which are the subject of pending patent applications, for genetic ensembles that increase the expression, folding efficiency and compartmentalization of proteins that can be built into the putative vaccine constructs if the results obtained in animal studies warrant this consideration.

Continued Dr. Hayward, “Our patented and proprietary platform for the production of linear DNA (LinearDNA™) not only empowers rapid development and large-scale production, but we believe it has the potential to yield a safe and effective vaccine with fewer risks than other currently utilized DNA production platforms. 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 LinearDNA is the rapidity at which a putative vaccine can be revised to accommodate mutational drift.”

Dr. Luigi Aurisicchio, CEO and CSO of Takis Biotech, stated: “Our original collaboration under the JDA on a pan cancer vaccine that will soon enter trials for the treatment of companion animals has already proven the ability of PCR-produced LinearDNA to induce powerful immune responses in animal models.  For the induction of antibodies that can neutralize COVID-19, it is essential to use reliable, effective technologies that can be quickly adapted in the face of shifting pathogens, and we believe that is the advantage that Applied DNA’s platform affords us over traditional vaccine development and other modern DNA-based vaccines. This global emergency requires a swift response.”

Under the terms of the amended JDA, Takis will use the scaled-up LinearDNA synthetic genes for each of the four putative vaccines to inoculate mice, whose sera will be tested for the presence of antibodies that bind to the purified Spike proteins. Those positive candidates that bind to Spike will be tested for their ability to neutralize COVID-19 by preventing uptake of the virus in cells in culture and in animal models.

The potential advantages posed by PCR-produced LinearDNA vaccines, as opposed to the circular DNA obtained from more traditional plasmid sources, 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 LinearDNA vaccine, the absence of any bacterial contaminants and the fact that the vaccine gene is effective without insertion into the patient’s genome.

Applied DNA and Takis makes clear that no commercial partner to take the coronavirus vaccine to market has been identified nor is there any indication that the Company’s applications to develop countermeasures would be approved by regulators.

About Takis Biotech.

Takis is a Biotech Company created by a group of scientists from Merck Research Laboratories (MRL). The group has more than 15 years of experience and an established track record in drug discovery in Oncology and is recognized for the conception and implementation of a number of innovative technologies. One of the main assets of Takis is the expertise in in vivo electro-gene-transfer, which can be used for a variety of clinically useful applications, from vaccine development to somatic gene therapy. Takis pipeline include 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.

Visit www.takisbiotech.it for more information.

About Applied DNA Sciences, Inc.

Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping, diagnostics and pre-clinical nucleic acid-based therapeutic drug candidates.

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list. Common stock listed on NASDAQ under the symbol APDN.

LinearDNA™ is a trademark of Applied DNA Sciences, Inc

Forward-Looking Statements

The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to the possibility of a failure to make timely payment on its outstanding secured convertible notes and resulting enforcement by noteholders of remedies on collateral which includes substantially all of Applied DNA’s assets, its history of net losses, limited financial resources, limited market acceptance, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partners product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 12, 2019 and our subsequent quarterly report on Form 10-Q filed on February 6, 2020, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.

 

investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, This email address is being protected from spambots. You need JavaScript enabled to view it.

program contacts: Brian Viscount, Applied DNA, 631-240-8877, This email address is being protected from spambots. You need JavaScript enabled to view it.

web: www.adnas.com

twitter: @APDN

15 February 2020 – Takis is the only Italian company listed in the WHO Covid-19 vaccines roadmap

A WHO (World Health Organization) meeting took place on 11-12 February to map out companies and academic groups that have announced Covid-19 development programs.

Takis is the only Italian company and among the few European ones on the WHO roadmap. Most of the other companies and research groups in the list are from China and U.S.

On the 27th of January we have announced our commitment for the development of innovative genetic vaccines against the Chinese Coronavirus. On the 7th of February we signed an agreement with the U.S. company Applied DNA Sciences. We are currently working together on our vaccine program.

Very proud to represent Italian research in the race for the Coronavirus vaccine!

Look at the list: COVID-19 vaccine development programs