Engineered Veterinary Vectored Immunotherapy and Vaccines: EVVIVAX

-          All 11 vaccinated felines produced neutralizing antibody titers against all three variants -

-          A SARS-Cov-2 challenge trial with mink is set in August -

STONY BROOK, N.Y. & ROME, ITALY - June 7, 2021 - (BUSINESS WIRE)-Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, and its program development partner, Evvivax, S.R.L. (“Evvivax”), today announced results from an in vitro neutralization study of sera from the trial cohort comprised of 11 domestic felines vaccinated with the Applied DNA-Evvivax LinearDNA™ COVID-19 vaccine candidate against the B.1.1.7 (U.K.), P1 (Brazil), and B.1.526 (New York) SARS-CoV-2 variants. This study extends the previously announced induction by the vaccine candidate of neutralizing antibodies against functional virus of the D614G lineage and showed that all 11 vaccinated felines produced neutralizing antibody titers against all three variants.

The study showed neutralizing antibody titers against B.1.1.7 were not significantly impacted, while neutralizing antibody titers against P1 and B.1.526 were reduced as expected and consistent with other CDC-reported data on vaccine-induced antibody neutralization against these variants1. The Company believes these expected reductions in viral neutralization titers against P1 and B.1.526 are unlikely to lead to a significant reduction in the effectiveness of the vaccine candidate against these variants in domestic felines and other veterinary applications, such as farmed mink.

“The LinearDNA-based COVID-19 vaccine has a unique molecular design in the face of steadily evolving variants. In targeting the receptor-binding region of SARS-CoV-2 that is crucial for viral entry into host cells, we expect high levels of protection against current and future variants with this vaccine,” said Dr. Luigi Aurisicchio, CEO/CSO of Evvivax S.R.L.

Dr. James A. Hayward, president and CEO of Applied DNA, said, “These data are very encouraging and reinforce our belief that our LinearDNA COVID-19 vaccine candidate will be protective against existing and emerging variants. We plan to initiate a SARS-CoV-2 challenge trial with mink in August of this year where we hope to demonstrate the protective nature of our LinearDNA vaccine candidate against COVID-19 for subsequent commercial application.”

Footnote:
1
https://www.cdc.gov/coronavirus/2019-ncov/variants/variant-info.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fcases-updates%2Fvariant-surveillance%2Fvariant-info.html

About Applied DNA Sciences

Applied DNA is commercializing LinearDNA™, its proprietary, large-scale polymerase chain reaction (“PCR”)-based manufacturing platform that allows for the large-scale production of specific DNA sequences.

The LinearDNA platform has utility in the nucleic acid-based in vitro diagnostics and preclinical nucleic acid-based drug development and manufacturing market. The platform is used to manufacture DNA for customers as components of in vitro diagnostic tests and for preclinical nucleic acid-based drug development in the fields of adoptive cell therapies (CAR T and TCR therapies), DNA vaccines (anti-viral and cancer), RNA therapies, clustered regularly interspaced short palindromic repeats (CRISPR) based therapies, and gene therapies. Applied DNA has also established a COVID-19 diagnostic and testing offering that is in the early stages of commercialization and is grounded in the Company’s deep expertise in DNA.

The LinearDNA platform also has non-biologic applications, such as supply chain security, anti-counterfeiting and anti-theft technology. Key end-markets include textiles, pharmaceuticals and nutraceuticals, and cannabis, among others.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN,’ and its publicly traded warrants are listed on OTC under ticker symbol ‘APPDW.’

Applied DNA is a member of the Russell Microcap® Index.

About Evvivax

Evvivax, whose name is derived from Engineered Veterinary Vectored Immunotherapy and Vaccines, is a spin-off of Takis Biotech (www.takisbiotech.it). Evvivax pursues the discovery and development of innovative Therapeutic Veterinary Cancer Vaccines based on proprietary viral vectors and DNA platform technologies. Evvivax frontline candidates are two therapeutic cancer vaccines for canine tumors: Tel-eVax and Erb-eVax. Evvivax aims at translating scientific breakthrough achievements in Cancer Immunotherapy into marketed innovative products in Veterinary and subsequently in Human Oncology. More recently, Evvivax has moved to developing innovative vaccines against zoonotic diseases, including a vaccine against COVID-19 for pets.

Visit www.evvivax.com for more information.

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, 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 partner’s therapeutic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration (U.S. FDA), U.S. Department of Agriculture (USDA) or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final or conditional approval from the U.S. FDA, USDA or equivalent foreign regulatory agencies, the unknown outcome of any applications or requests to U.S. FDA, USDA or equivalent foreign regulatory agencies, the unknown ability to manufacture the vaccine candidates in large quantities, the fact that the safety and efficacy of the vaccine candidates has not yet been established, the unknown ability of the vaccine candidates to generate revenue or profit for Applied DNA, the fact that there has never been a commercial drug product utilizing PCR-produced DNA technology approved for therapeutic use, 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 17, 2020 and Quarterly Reports on Form 10-Q filed on February 11, 2021 and May 13, 2021 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.

Contacts

For Applied DNA:
Investor contact: Sanjay M. Hurry, 917-733-5573, 
This email address is being protected from spambots. You need JavaScript enabled to view it.
Program contact: Brian Viscount, 631-240-8877, 
This email address is being protected from spambots. You need JavaScript enabled to view it.
Web: 
www.adnas.com
Twitter: @APDN

For Evvivax:
Corporate/Investor contact: Luigi Aurisicchio, Evvivax, +39-0650576077, 
This email address is being protected from spambots. You need JavaScript enabled to view it.
Program contact: Antonella Conforti, +39-0650576077, 
This email address is being protected from spambots. You need JavaScript enabled to view it.
Web: 
www.evvivax.com
LinkedIn: Evvivax

 

Cat pixbay Evvivax Vaccine LinearDNA

Realizzato da un'azienda italiana, sperimentazione in Usa

Ha dato un risultato positivo la sperimentazione di fase 1 del vaccino anti Covid-19 per i gatti, realizzato dall'azienda italiana Evvivax e testato negli Stati Uniti in collaborazione con l'azienda americana Applied DNA Sciences. "In tutti gli animali trattati abbiamo osservato la formazione di anticorpi neutralizzanti dopo una singola somministrazione di un DNA sintetico lineare e a fine aprile potremo vedere i risultati della seconda iniezione", ha detto all'ANSA Luigi Aurisicchio, amministratore delegato e direttore scientifico delle aziende biotech Takis ed Evvivax.

"È un risultato - ha proseguito - molto positivo, che valida la tecnologia alla base del vaccino. Il disegno molecolare è lo stesso messo a punto dalla Takis per il vaccino destinato all'uomo e in fase di sperimentazione con un'altra azienda italiana, la Rottapharm Biotech". Il risultato ottenuto nei gatti "è la prima vera dimostrazione di principio che un vaccino genetico contro il virus SarsCoV2 basato sulla tecnica sull'elettroporazione del DNA stimola risposta immunitaria ", ha osservato Aurisicchio riferendosi alla tecnica che consiste nell'iniettare nel muscolo la dose del vaccino, seguita un brevissimo impulso elettrico che facilita l'ingresso del vaccino nelle cellule per attivare il sistema immunitario.

Si sperimenta un vaccino anti Covid nei gatti alla luce sia dei casi di contagio fra gatti e uomini finora osservati, sia dei casi di contagio con le varianti emergenti osservati nei gatti e in altre specie animali, tra cui i topi: "vale a dire che si potrebbe generare un serbatoio naturale, indipendentemente dai progressi della vaccinazione nell'uomo".

Il prossimo passo sarà misurare gli anticorpi generati nei gatti dopo il richiamo e si prevede inoltre di sperimentare il vaccino sui visoni, nei quali il virus Sars-CoV2 si diffonde molto facilmente, al punto di avere causato epidemie che hanno portato all'abbattimento di molti animali negli allevamenti.

Cat pixbay Evvivax Vaccine LinearDNA

Fonte: Ansa

- Vaccine Candidate Well Tolerated and Effective in Cohort -

- Strong Neutralizing Antibody Titer Elicited Across Cohort -

STONY BROOK, N.Y. and ROME, ITALY – April 12, 2021 – Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, and its program development partner, Evvivax, S.R.L. (“Evvivax”), today announced positive preliminary Phase I clinical trial results for a LinearDNA™ COVID-19 vaccine candidate (the “vaccine candidate”) in adult domestic felines. Results following administration of a single prime dose of the vaccine candidate on day 1 in late February indicate that the LinearDNA vaccine candidate is well-tolerated by the cohort. A SARS-CoV-2 neutralization assay was conducted by the Cornell University Animal Health Diagnostic Center at the College of Veterinary Medicine 20 days after prime dose delivery to establish the immune response of all cohort members. The results of the neutralization assay yielded high titers of SARS-CoV-2 neutralizing antibodies (NAb) from all cohort members. Follow-on NAb assay results after administration of the vaccine candidate booster are expected to be available in late April 2021. Based on the initial promising NAb titers after a single prime dose of the LinearDNA vaccine candidate, the companies intend to extend the evaluation of neutralizing antibodies in select cohort members through September 2021 to determine the durability of the immune response.

Applied DNA and Evvivax

Dr. Diego Diel, D.V.M., M.S., Ph.D., Associate Professor of Virology at the Cornell University College of Veterinary Medicine’s Department of Population Medicine and Diagnostics, who performed the NAb assay, stated, “The levels of neutralizing antibodies elicited in the vaccinated cats after only a single prime dose are compelling. Based on these preliminary data, it seems like this vaccine candidate has the potential to be effective in cats and perhaps other COVID-19-susceptible animals such as ferrets and minks.”

Dr. Joseph Impellizeri, DVM, DACVIM (O), MRCVS, veterinary oncologist at Guardian Veterinary Specialists (GVS) in Brewster, N.Y., and Trial Supervising Investigator for the study, said, “Administration of the vaccine candidate via electroporation was well-tolerated with no adverse events in the normal healthy feline volunteers. Preliminary findings with antibody production at this level are very encouraging and support the continued development of the vaccine candidate.”

Dr. James A. Hayward, president and CEO, Applied DNA, said, “We are excited to present these preliminary results of our first proof-of-concept clinical study for a LinearDNA-based vaccine that seeks to prevent cats from acting as a potential reservoir of SAR-CoV-2 that might eventually find its way to humans. We would expect a further three- to four-fold increase in titer levels post-booster vaccination from the already high average titer levels generated by the prime vaccination.

“There is increasing concern globally as new variants, including B.1.1.7, have been found1 in domestic pets in both the UK and the US. While there is no evidence of transmission from pets to their owners, the rate of testing pets for COVID-19 is too low to estimate infection rates. Hence, the Company believes that preparations for a pet vaccine are wise. The data we have generated to date also lays the foundation for the application of the vaccine candidate to additional mammals, such as commercially farmed mink, where there is a clear commercial need both domestically and abroad that is made more urgent by the rise of coronavirus variants.”

Dr. Luigi Aurisicchio, chief executive officer and chief scientific officer, Evvivax and Takis Biotech, commented, “Cats, mink, and ferrets share a receptor for the virus that is very similar to the human receptor that SARS-CoV-2 uses to infect humans. In 2020, minks were infected following exposure from infected humans where it mutated, and people then transmitted it back into the human population. Known as ‘Cluster 5’, this SARS-CoV-2 mink-associated variant devastated the farmed mink industry, particularly in the EU and is also present in the U.S. More recently, cats have been shown to be susceptible to certain variants that pose greater threats to humans, including B.1.1.7. This clinical trial can help develop a productive path forward to the benefit of cat, mink, and humans.”

Phase I is a single-center clinical trial designed to evaluate domestic feline immune response, safety, and tolerability of the vaccine candidate with a cohort of 11 healthy, client-owned domestic felines and conducted at GVS. The LinearDNA vaccine candidate is administered intramuscularly via gene electrotransfer of primer and booster 28-35 days apart. The vaccine candidate has previously demonstrated antibody and T-cell responses at low doses of LinearDNA in preclinical mouse models. Applied DNA has manufactured a complete supply of the vaccine candidate in a lyophilized (freeze-dried) form that is shelf-stable at room temperature (zero cold chain requirement) with no loss of potency once resolubilized with water.

On the assumption that the Phase I endpoint is met, Applied DNA and Evvivax are expected to initiate Phase II that will involve the placement of seroconverted vaccinated non-client-owned cats among infected cats, with the primary endpoint being the percent of vaccinated cats that resist infection. In addition, the two companies expect to initiate a Phase I/II clinical trial using the LinearDNA vaccine candidate in minks upon the receipt of all necessary regulatory approvals.

Concluded Dr. Hayward, “The study marks the first clinical trial to evaluate our proprietary PCR-produced LinearDNA platform that offers the advantages of speed and ease of manufacture in adapting vaccines to match variants and with room temperature stability. We believe the data from this clinical trial is an important stepping-stone on the path to the eventual application of a LinearDNA platform for human use.”

Footnote:

1 Grimm, David. “Major Coronavirus Variant Found in Pets for First Time.” Science, March 19, 2021. https://www.sciencemag.org/news/2021/03/major-coronavirus-variant-found-pets-first-time.

About Applied DNA Sciences
Applied DNA is commercializing LinearDNA™, its proprietary, large-scale polymerase chain reaction (“PCR”)-based manufacturing platform that allows for the large-scale production of specific DNA sequences.

The LinearDNA platform has utility in the nucleic acid-based in vitro diagnostics and preclinical nucleic acid-based drug development and manufacturing market. The platform is used to manufacture DNA for customers as components of in vitro diagnostic tests and for preclinical nucleic acid-based drug development in the fields of adoptive cell therapies (CAR T and TCR therapies), DNA vaccines (anti-viral and cancer), RNA therapies, clustered regularly interspaced short palindromic repeats (CRISPR) based therapies, and gene therapies. Applied DNA has also established a COVID-19 diagnostic and testing offering that is in the early stages of commercialization and is grounded in the Company’s deep expertise in DNA.

The LinearDNA platform also has non-biologic applications, such as supply chain security, anti-counterfeiting and anti-theft technology. Key end-markets include textiles, pharmaceuticals and nutraceuticals, and cannabis, among others.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN,’ and its publicly traded warrants are listed on OTC under ticker symbol ‘APPDW.’

Applied DNA is a member of the Russell Microcap® Index.

About Evvivax
Evvivax, whose name is derived from Engineered Veterinary Vectored Immunotherapy and Vaccines, is a spin-off of Takis Biotech (www.takisbiotech.it). Evvivax pursues the discovery and development of innovative Therapeutic Veterinary Cancer Vaccines based on proprietary viral vectors and DNA platform technologies. Evvivax frontline candidates are two therapeutic cancer vaccines for canine tumors: Tel-eVax and Erb-eVax. Evvivax aims at translating scientific breakthrough achievements in Cancer Immunotherapy into marketed innovative products in Veterinary and subsequently in Human Oncology. More recently, Evvivax has moved to developing innovative vaccines against zoonotic diseases, including a vaccine against COVID-19 for pets.

Visit www.evvivax.com for more information.

FOR APPLIED DNA
Investor contact: 
Sanjay M. Hurry, Applied DNA Sciences, 917-733-5573, This email address is being protected from spambots. You need JavaScript enabled to view it.
Program contact: Brian Viscount Applied DNA Sciences, 631-240-8877, 
This email address is being protected from spambots. You need JavaScript enabled to view it.

FOR EVVIVAX
Corporate/Investor contact: 
Luigi Aurisicchio, Evvivax, +39-0650576077, This email address is being protected from spambots. You need JavaScript enabled to view it.
Program contact: Antonella Conforti, +39-0650576077, 
This email address is being protected from spambots. You need JavaScript enabled to view it.
Web: 
www.evvivax.com
LinkedIn: Evvivax

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.

Applied DNA and Evvivax LinearDNA Covid 19 vaccine

The clinical trial utilizes a PCR-produced LinearDNA COVID-19 vaccine candidate initially developed by Applied DNA and Takis Biotech, the parent company of Evvivax, for human use. The human vaccine candidate yielded strong antibody and T-cell responses at low doses of LinearDNA in mouse models. If the veterinary vaccine candidate demonstrates effectiveness against active disease in cats, the two companies intend to apply for a USDA Animal and Plant Health Inspection Service (APHIS) conditional license (9 CFR 102.6) to enable commercial veterinary sales for domestic felines. The American Veterinary Medical Association lists approximately 58.4 million cats living in households in the United States in 20181.

Phase I initiation follows the completion of a second and final round of preclinical testing overseen by Evvivax at an independent third-party testing laboratory on a lyophilized (freeze-dried) form of the vaccine candidate administered in the clinical trial. Phase I is being conducted in Brewster, N.Y. by Veterinary Oncology Services at Guardian Veterinary Specialists (GVS), a multi-specialty veterinary hospital, with a primary endpoint of demonstrating the safety and immunogenicity (detection of neutralizing antibodies and T-cell response) of the vaccine candidate in negative, client-owned felines.

On the assumption that the Phase I endpoint is met, Applied DNA and Evvivax are expected to initiate Phase II that will involve the placement of seroconverted vaccinated non-client-owned cats among infected cats, with the primary endpoint being the percent of vaccinated cats that resist infection. On the assumption that primary endpoints of the two Phases of the clinical trial are met, Applied DNA and Evvivax are expected to apply for APHIS conditional license.

“The start of our veterinary clinical trial puts us on a path to potential future commercial sales of our vaccine candidate while also serving a significant step in the positioning and validation of DNA produced on our LinearDNA manufacturing platform as an alternative to plasmid-produced DNA,” said Dr. James A. Hayward, president and CEO, Applied DNA. “Perhaps our greatest concern should be that the SARS-CoV-2 virus can mutate within an animal population before jumping back to people, possibly in a form that renders current vaccines less effective or makes the virus more transmissible. We hope that a safe and effective LinearDNA COVID-19 vaccine can help mitigate this risk as it relates to domestic felines.”

Concluded Dr. Hayward, “We believe that our LinearDNA platform has certain advantages over existing nucleic acid-based vaccines such as the speed and simplicity of production, the potential of high levels of expression, the simplicity of design, and stability during shipment without the need for refrigeration. Beyond vaccines, we believe our platform applies to a host of other cutting edge therapeutic modalities, including CAR T, mRNA, and AAV.”

Dr. Luigi Aurisicchio, chief executive officer and chief scientific officer, Evvivax and Takis Biotech, commented, “It is of concern when you have a disease that can go from people to animals and then back to people again. This has recently happened with minks, who are highly susceptible to the infection and with serious consequences to their health. Domestic felines are a known COVID-19 reservoir and can transmit the virus to other felines. This clinical trial will help us determine an efficacious path forward while expanding the genetic approach to other zoonotic diseases and cancer vaccines.”

Trial Supervising Investigator and Diplomate of the American College of Veterinary Internal Medicine, Dr. Joseph Impellizeri of GVS, stated, "We are hopeful that the information obtained through this initial trial will create a pathway for better understanding of the feline role for prophylactic immunotherapy against COVID-19."

To learn more about LinearDNA, Applied DNA’s large-scale polymerase chain reaction (PCR)-based manufacturing platform, click: https://www.linearxdna.com/

 

Footnote:
1 https://www.avma.org/resources-tools/reports-statistics/us-pet-ownership-statistics

 

About Applied DNA Sciences

Applied DNA is commercializing LinearDNA™, its proprietary, large-scale polymerase chain reaction (“PCR”)-based manufacturing platform that allows for the large-scale production of specific DNA sequences.

The LinearDNA platform has utility in the nucleic acid-based in vitro diagnostics and preclinical nucleic acid-based drug development and manufacturing market. The platform is used to manufacture DNA for customers as components of in vitro diagnostic tests and for preclinical nucleic acid-based drug development in the fields of adoptive cell therapies (CAR T and TCR therapies), DNA vaccines (anti-viral and cancer), RNA therapies, clustered regularly interspaced short palindromic repeats (CRISPR) based therapies, and gene therapies. Applied DNA has also established a COVID-19 diagnostic and testing offering that is in the early stages of commercialization and is grounded in the Company’s deep expertise in DNA.

The LinearDNA platform also has non-biologic applications, such as supply chain security, anti-counterfeiting and anti-theft technology. Key end-markets include, textiles, pharmaceuticals and nutraceuticals, and cannabis, among others.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN’, and its publicly traded warrants are listed on OTC under ticker symbol ‘APPDW’.

Applied DNA is a member of the Russell Microcap® Index.

 

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, 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 partner’s therapeutic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration (U.S. FDA), U.S. Department of Agriculture (USDA) 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, USDA or equivalent foreign regulatory agencies, the unknown outcome of any applications or requests to U.S. FDA, USDA or equivalent foreign regulatory agencies, the unknown ability to manufacture the vaccine candidates in large quantities, the fact that the safety and efficacy of the vaccine candidates has not yet been established, the unknown ability of the vaccine candidates to generate revenue or profit for Applied DNA, the fact that there has never been a commercial drug product utilizing PCR-produced DNA technology approved for therapeutic use, 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 17, 2020, and Form 10-Q filed on February 11, 2021 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.

 

About Evvivax

Evvivax, whose name is derived from Engineered Veterinary Vectored Immunotherapy and Vaccines, is a spin-off of Takis Biotech (www.takisbiotech.it). Evvivax pursues the discovery and development of innovative Therapeutic Veterinary Cancer Vaccines based on proprietary viral vectors and DNA platform technologies. Evvivax frontline candidates are two therapeutic cancer vaccines for canine tumors: Tel-eVax and Erb-eVax. Evvivax aims at translating scientific breakthrough achievements in Cancer Immunotherapy into marketed innovative products in Veterinary and subsequently in Human Oncology. More recently, Evvivax has moved to developing innovative vaccines against zoonotic diseases, including a vaccine against COVID-19 for pets. Evvivax is currently seeking investors for further expanding the collaboration with ADNAS and other Institutions.

Visit www.evvivax.com for more information.

Investor contact: Sanjay M. Hurry, Applied DNA Sciences, 917-733-5573, This email address is being protected from spambots. You need JavaScript enabled to view it.

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

Web: www.adnas.com; www.linearxdna.com

Twitter: @APDN

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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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