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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

15 February 2020 – Watch Takis on the Italian news TGR Officina Italia

The Italian TV programme TGR Officina Italia has dedicated a television report about Takis and our research activities to develop a vaccine against Covd-19. We announced our commitment as soon as the genetic sequences of the new Coronavirus became accessible and we have currently 10 researchers of ours working on various aspects of vaccine development.

Luigi Aurisicchio, CEO of Takis and Evvivax, and Emanuele Marra, Director of Infective Diseases Area at Takis, described our genetic vaccination approach and estimated at least one year time for the vaccine to be used in humans.

They also described Takis other research activities in the field of precision oncology and monoclonal antibody production and mentioned our team of young and talented researchers. Proud for that!

Enjoy watching the interview: TGR Officina Itakia – Alla ricerca del vaccino

 

12 February 2020 - TAKIS has applied to European funding initiative to develop a Vaccine and Therapeutics against COVID-19

12 February 2020 . Takis has applied to the European Call: “Advancing knowledge for the clinical and public health response to the 2019-nCoV epidemic” with the project

EUIMMUnCoV: The European Immunotherapy Platform against 2019-nCoV”.

EUIMMUnCoV project aims at developing novel and effective gene-based vaccines that activate the immune response against 2019-nCoV by means of innovative genetic strategies based on gene engineering and a multi-purpose and efficient device based on the mechanism of in vivo electroporation mediated gene transfer (EGT) which is already present in the hospitals of most European Countries. The same technology will be used to generate diagnostic and therapeutic antibodies able to block 2019-nCoV replication and propagation. Very importantly, EUIMMUnCoV will characterize host immune response against the virus, thus generating new knowledge important to identify new biomarkers.

If funded, Takis will coordinate a consortium made of 5 public/private partners:

  • IGEA (Italy)
  • Meditox (Czeck Republic)
  • National Institute for Infectious Diseases (INMI) Spallanzani (Italy)
  • Medical University of Vienna (Austria)
  • Immunitrack (Denmark)

More information: Advancing knowledge for the clinical and public health response to the 2019-nCoV epidemic

9 February 2020 – Takis vaccine against 2019-nCov Coronavirus mentioned on Italian TV channel RAI 3

Emanuele Marra, Director of infectious diseases area and Fabio Palombo, Director of Immunology and Vaccine area at Takis appeared on the Italian TV programme “Mezz’ora in più” by Lucia Annunziata.

They described Takis and Evvivax research to develop a genetic vaccine against 2019-nCov Coronavirus delivered by our DNA-electroporation platform. As soon as the genetic sequences of the new Coronavirus became available, our researchers started to work on the vaccine. They were able to design a genetic vector in few days that is now going to be tested in rodents and then in humans.

Watch the full interview: Mezz’ora in più – Coronavirus la corsa contro il tempo