Candidate: Linear DNA vaccine

Category: VAX

Type: To be based on PCR-produced linear DNA designed to induce antibodies that can neutralize SARS-CoV-2. Five preclinical vaccines have been designed based on the structure of the “Spike” protein, which enables uptake of the coronavirus by binding to specific receptors on the host cells.

Status: Applied DNA and Takis said May 4 the first injections of their DNA vaccine candidates produced neutralizing antibodies in test animals, in studies completed at the Lazzaro Spallanzani National Institute for Infectious Diseases in Rome. Initial results were obtained using plasmids to baseline results; Applied DNA’s linear DNA dose-response trials began in early May.

Applied DNA said March 24 that it filed a provisional patent application with the U.S. Patent and Trademark Office (USPTO) for its diagnostic assay under development for SARS-CoV-2—five days after announcing it had completed the design of the assay. The assay uses PCR-based detection of viral sequences that code for the Spike protein that is also the target of Applied DNA’s vaccine candidate partnered with Takis Biotech.

Rome-based Takis  won approval from the Italy’s Ministry of Health to begin a preclinical trial of Applied DNA’s COVID-19 vaccine candidate in March. Also that month, Applied DNA began large-scale production of four vaccine candidates , expanded to a fifth candidate a month later, via the company’s proprietary PCR-based DNA (“LinearDNA”) manufacturing systems.

“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 James A. Hayward, President and CEO of Applied DNA.

Applied’s majority-owned subsidiary LineaRx and Takis said in February they had formed a joint venture to develop the preclinical vaccine using PCR-based DNA manufacturing technology. The companies said advantages of their technology 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 linear DNA vaccine, the absence of any bacterial contaminants and the effectiveness of the vaccine gene without insertion into the patient’s genome.

COVID-19: 200 Candidates and Counting

To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:

FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.

DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data

KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.

TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.

GEN has also tagged the most common treatment types: