Engineered Veterinary Vectored Immunotherapy and Vaccines: EVVIVAX

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STONY BROOK, N.Y. – September 16, 2020 - Applied DNA Sciences, Inc. (NASDAQ: APDN) (“Applied DNA” or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables in vitro diagnostics, preclinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting and anti-theft technology, today announced that it and Evvivax, S.R.L., a spin-out of Takis Biotech focused on engineered veterinary immunotherapy and vaccines, are expected to initiate a veterinary clinical trial of one of the Company’s five LineaDNA™ vaccine candidates upon approval of the clinical plan by the U.S. Department of Agriculture. The goal of the vaccine trial is to evaluate the vaccine candidate as a strategy for the prevention of SARS-CoV-2 (COVID-19) (a zoonotic disease) infections in companion felines of humans. The clinical trial will seek to understand the immune response in cats by utilizing a vaccination strategy of interest in people that could yield valuable data for both cats and humans.
In addition to curbing feline SARS-CoV-2 infections, the vaccine may have a secondary benefit of preventing transfer of the SARS-CoV-2 virus from cats to their human owners. While no such transfer has been formally documented to date, there is still much that is unknown about the disease and its transmission across species. The vaccine trial also serves the additional purpose of generating data on larger animals required as part of the Company’s preclinical development work on its vaccine candidates for potential human development.

2020 09 16 Cat Trial FINAL Applied DNA Takis Evvivax

Veterinary COVID-19 Trial Design
The clinical trial is a New York State-based, single-center trial that intends to enroll 30 healthy domestic feline companion animals and follow them for six months. The study will evaluate domestic feline immune response, safety, and tolerability of the LineaDNA vaccine candidate, which will be injection once per month at 1mg/month for the first three months of the trial. Dosing will be administered intramuscularly via gene electrotransfer utilizing electroporation technology. The primary endpoint is to determine evidence of antibody and T-cell response in the companion felines.
The trial will take place at Guardian Veterinary Specialists in Brewster, N.Y., under the supervision of Dr. Joseph Impellizeri, DVM, DACVIM (O), MRCVS from Veterinary Oncology Services, LLC (link). Applied DNA and Evvivax will co-sponsor the trial. Applied DNA's participation is approximately $100,000, and the Company will supply a quantity of the linear DNA vaccine candidate.

Rationale for COVID-19 Linear DNA Vaccine Candidate for Veterinary Use
In an article titled ‘Susceptibility of ferrets, cats, dogs, and other domesticated animals to SARS-coronavirus 2’ published in Science Magazine on May 29, 2020, the authors of the article conducted research that found that “in cats the virus replicated in the nose and throat and caused inflammatory pathology deeper in the respiratory tract, and airborne transmission did occur between pairs of cats”1. According to the CDC, roughly 60% of human infectious diseases are zoonotic, such as rabies, Lyme disease, West Nile virus, and MERS, among others. Globally and in the United States, COVID-19 positive cats have been reported in small numbers. The World Organization for Animal Health (OIE) indicates that “infection of animals with COVID-19 virus meets the criteria of an emerging disease2.”

Applied DNA’s LineaDNA vaccine candidates for COVID-19 have previously demonstrated evidence of production of antibody and T-cell responses at low doses of linear DNA in preclinical mouse models. The Company believes that linear DNA vaccines have inherent advantages over conventional DNA and RNA vaccines: they contain only the desired therapeutic DNA sequence with reduced risk of antibiotic resistance and genomic integration; they hold the advantages of speed and scalability when manufactured by the Company’s LinearDNA manufacturing platform; they are manufactured at high levels of purity and with very simple means of production; they are much more stable during storage and shipments than RNA-based vaccines which is a practical advantage during a worldwide deployment.
Dr. James A. Hayward, president and CEO of Applied DNA, stated, “Animal health offers an efficient regulatory path with the U.S Department of Agriculture that serves as a second avenue through which to potentially commercialize our linear DNA COVID-19 vaccine development work while having the ancillary benefit of progressing our human related preclinical development work with the  data generated from this domestic cat study. Because animals and people can both be affected by this zoonotic virus, and with much of the world’s COVID-19 efforts centered on humans with very little known about its effects on our closest companions with whom we share our homes, we believe it prudent to pursue this avenue for the therapeutic benefit of animals and humans alike.
“The collaboration between Applied DNA and Takis/Evvivax is a natural outgrowth of cooperation between the companies that has its roots in the field of cancer research with the development of a linear DNA telomerase (anti-cancer) vaccine that was progressed to COVID-19 vaccine development work. We now seek to apply the same linear DNA vaccine candidates, whose results in small animal models echo the effectiveness announced by some of the COVID-19 vaccines already in human trials, to a veterinary vaccine candidate.”
Commenting on the collaboration, Dr. Luigi Aurisicchio, Chief Executive and Scientific Officer of Takis Biotech and Evvivax, said, “The holy grail would be to prevent COVID-19 as opposed to waiting for it to start and then treating it. The implications of success of this cat study would be quite large, both for cats and people.”

1 https://science.sciencemag.org/content/sci/368/6494/1016.full.pdf
2 https://www.oie.int/en/scientific-expertise/specific-information-and-recommendations/questions-and-answers-on-2019novel-coronavirus/

STONY BROOK, N.Y. – September 16, 2020

pdf icon Download final press release

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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

Coronavirus 2019 nCoV with Transmission Electron Microscopy
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.

 

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Tumor Reduction Demonstrated In Vivo Using Two Linear DNA Vaccines in Animal Models

Tumor Reduction

STONY BROOK, N.Y., September 19, 2019 – Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA”), a leader in large-scale PCR-based DNA manufacturing, announced today that LineaRx, Inc. (“LineaRx”), its majority-owned subsidiary focused on next-generation biotherapeutics, and its collaborators Takis/Evvivax have completed pre-clinical animal studies of two vaccine candidates produced with linear DNA. Tests of both vaccines in mouse models demonstrated their ability to eliminate tumors in vivo, and to potentially prevent initial occurrence.

Evvivax S.R.L. designed a synthetic gene sequence to produce immunity in companion animals, directed against the protein telomerase (TERT), which is overexpressed in 85% of all mammalian cancers, whereas Takis S.R.L. designed a neoantigen-based cancer vaccine (TK), as a proof-of-concept of personalized immunology. For the studies, the TERT and TK based vaccines were produced in linear DNA form by LineaRx. Here is a summary of the recently completed studies performed in vivo:

Previous results from Phase 1 of the collaboration’s Joint Development Agreement (JDA) confirmed immunogenicity in mice that were vaccinated with linear DNA against the human protein telomerase. The results reported herein are from the Phase 2 of the JDA using mice implanted with murine colon cancer.
In the prophylactic use of the telomerase vaccine, wherein vaccination is done before addition of tumor cell lines to the mice, transplanted tumors were cleared within 10 days.
In the therapeutic application using either TERT or TK linear DNA vaccine application, cancer cells were introduced and allowed to grow before administration of the vaccine. The successful reduction of total tumor mass was accomplished in conjunction with antibodies that targeted PD-1 and CTLA4. These antibodies, known as Checkpoint Inhibitors, are commonly used in oncology strategies that rely upon immunotherapy. In this setting the tumor cells were reduced significantly within 30 days.
The strategy of the Takis TK neoantigen vaccine uses unique multiple-target antigenic epitopes that have been identified from the tumor of a human patient. The linear DNA can utilize the genes for several of the most effective universal antigens such as TERT, or neoantigens that are more personalized to the patient.

“We know that immune system has a key role in fighting cancer” said Dr. Luigi Aurisicchio, CEO of Takis/Evvivax. “Thanks to a deep knowledge of cancer immunobiology and cutting-edge vaccination technologies we have now the tools to provide new therapies to our pet friends and human patients.”

For more information please see the Press Release from Applied DNA Sciences adnas

 

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 University Hospital for Companion Animals

Our CEO/CSO Luigi Aurisicchio flew to Copenaghen to present promising results about electrochemotherapy at the University Hospital for Companion Animals.

Electrochemotherapy (ECT) is an approved and efficacious treatment for local control of cutaneous and subcutaneous tumor nodules, although less effective against distant or inaccessible metastasis.

In addition, preliminary evidences suggest that ECT can activate the immune system. We therefore investigated the synergic effect of ECT and DNA Electro-Gene Transfer (DNA-EGT) in both mice and dogs by means of a clinically validated device for Veterinary electroporation called Vet-ePorator. In particular, we explored the combination of our vaccine Erb-eVax and ECT in dogs with metastatic breast cancer or osteosarcoma, with excellent results in terms of both tumor control and immune response against Tumor Associated antigens.

Our findings provide new data on tumor immunobiology and most importantly improve the efficacy of ECT and may open up novel immunotherapeutic approaches.

We are pleased to share these data that summarize the best of our technology and make a significant impact on patients’ survival and quality of life.

 

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Flyer A4 Meeting Vitares 2019 Bn

Evvivax is glad to sponsor the first Vitares Annual Congress, which is also the first Italian One Health meeting focusing on Cancer Immunotherapy.

This meeting brings together Basic research, Veterinary and Human Medicine Scientists involved in the field of Immunology, Oncology and Education, aiming at creating networks of collaboration. Internationally renowned scientists from Italy and abroad will provide the State of the Art and present their most recent data in a highly stimulating scientific environment.

Public health initiatives such as One Health demonstrate the growing awareness of the fact that animal and human health are strongly interconnected with each other and with the environment. Zoonotic pathogens and Cancer represent a direct hazard to Veterinary and Human Health”, said Luigi Aurisicchio, CEO/CSO at Takis and president at Vitares.

Looking forward to meeting you in Rome!

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