Applied DNA Sciences (APDN), Evvivax announce positive preliminary Phase I clinical trial results for a LinearDNA COVID-19 vaccine candidate

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.

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.

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