Benzinga | May 6, 2021 08:15AM EDT

Applied DNA Sciences Announces A booster Injection Delivered 30 Days After Prime Vaccination Elicited An Average Boost In SARS-CoV-2 Neutralizing Antibodies By 'Over 5-Fold'

- Manufactured by an enzyme and without bacteria, LinearDNA vaccine candidate is virus-free, plasmid-free DNA -

- Vaccine candidate induced neutralizing titers in 100% of trial cohort -

- Based on positive study results, companies plan to accelerate clinical trial with commercial minks -

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 a booster injection delivered 30 days after the prime vaccination elicited an average boost in SARS-CoV-2 neutralizing antibody (NAb) levels (titers) by over 5-fold, with every member of the trial cohort producing NAbs. The antibodies produced by the members of the feline cohort were tested against functional SARS-CoV-2 virus of the D614G lineage. The D614G mutation is present in most variants. Testing showed that neutralizing titers were detected in feline sera with a geometric mean titer for the cohort of 398. The average NAb titer results post-booster exceeded the three- to four-fold enhancement previously predicted by the Company. The Company expects to have cellular immunity data for the feline cohort in the coming weeks.

Dr. James A. Hayward, president and CEO, Applied DNA, said, "These data are very exciting because they are produced with infectious, functional virus. While no direct comparison is possible, we believe the immune response elicited by the feline cohort is competitive with the immune responses elicited by currently authorized COVID-19 vaccines. The LinearDNA vaccine candidate, produced by scalable PCR-based manufacturing, yields an extremely pure product, was freeze-dried, shipped without refrigeration, and contains no excipients. We believe these results hold great promise for the potential of LinearDNA vaccines for COVID-19 and other diseases in animals (cats, dogs, ferret, minks) and humans."

Based on the positive results, the Company plans to initiate a near-term clinical trial for the LinearDNA vaccine candidate in commercial minks to address the ongoing crises in this industry caused by mink's susceptibility to COVID-19 (in both farm and wild environs) and their ability to transmit new variants to the human population. The Company is seeking a commercial partner for its go-to-market strategy.

Dr. Luigi Aurisicchio, chief executive officer and chief scientific officer, Evvivax and Takis Biotech, commented, "We are very pleased by the quality of these results and believe that continued development of the vaccine candidate is quite justified. We will continue our collaboration and we are hopeful for success in the marketplace."

Concluded Dr. Hayward, "The vaccine prime and booster study provides the first proof in a higher-order animal of the functional ability and efficacy of LinearDNA. We believe the data from this clinical trial will clear the path to commerce and the eventual application of a LinearDNA platform for human use."