Saturday, December 26, 2020

Oh, patents! Inovio’s SARS CoV-2 DNA vaccine candidate (INO-4800) (1)

Copyright © Françoise Herrmann 

A deoxyribonucleic acid (DNA) vaccine delivers an engineered plasmid directly to a cell. A plasmid is a small double-stranded DNA molecule, which is engineered to code for a specific target antigen and able to replicate independently of chromosomal DNA. In the case of COVID-19, the Inovio plasmid was engineered to code for the spike antigen of the SARS Coronavirus-2. Thus, once transfected, by the introduction of an engineered DNA molecule, the cell is instructed to produce a specific (harmless) antigen in vivo. Production in vivo of a (harmless) antigen, against which the body, in turn, mounts an immune reaction.  An immune reaction, consisting in the production of T-cells and antibodies, henceforth also able to recognize the SARS CoV-2 spikes attached to the virus, and in significant enough quantities to block replication of the (harmful) virus, when a person is infected.

On December 24, 2020, Inovio published the results of Clinical Testing Phase I (on healthy human volunteers) of the Inovio SARS CoV-2 DNA vaccine candidate: INO-4800. Succinctly, the vaccine candidate was found 100% effective in triggering a strong immune response, in all 38 vaccinated subjects. The INO-4800 vaccine candidate also presented an excellent tolerability and safety profile (Tebas, et al., 2020). Funded by the Coalition for Epidemic Preparedness Innovations (CEPI), the Inovio (INO-4800) DNA vaccine candidate trials move on to Phase II of the Federal Drug Administration (FDA) approval process, for bringing drugs to market.

Compared to the Pfizer and Moderna mRNA COVID-19 vaccines, currently deployed in the US, Great Britain and Canada, the Inovio SARS CoV-2 DNA vaccine candidate is touted as having the advantage of requiring no refrigeration, at all.

The development of the Inovio SARS CoV-2 vaccine candidate, as well as future(1) Inovio COVID-19 treatments, rely on the prior development of the company's patented DNA vaccines, against the Middle East Respiratory Syndrome (MERS) coronavirus, the human papillomavirus (HPV) and influenza viruses, as well as on the development of  cancer tumor-fighting drugs, and the treatment of HPV-related diseases, using the company's proprietary DNA monoclonal antibody (dMAb™) biotechnology.

 The following sample patents, assigned to Inovio, cover various aspects of the subsumed biotechnologies.

  • US10016497 - MERS-CoV vaccine.
  • US10087240 - DNA antibody constructs and method of using same.
  • US10166288 - Vaccines having an antigen and interleukin-21 as an adjuvant.
  • US10226526 - Vaccines for human papillomavirus and methods for using the same.
  • US10232030 - Vaccines for human papillomavirus and methods for using the same.
  • US10398769 - Influenza nucleic acid molecules and vaccines made therefrom.
  • US10548971 - MERS-CoV vaccine.
The Youtube video below introduces Inovio's COVID 19 vaccine candidate. 


Note (1) Future Inovio drug development, for COVID 19, is under contract with the US Department of Defense (DoD), Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), and the Defense Advanced Research Projects Agency (DARPA).

References

CEPI - Coalition for Epidemic Preparedness Innovations https://cepi.net/ 

FDA - The Drug Development Process - https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process

Inovio Pharmaceuticals (Company website) www.inovio.com

Inovio DNA medicines technology https://www.inovio.com/dna-medicines-technology/

Pablo Tebas 1, ShuPing Yang 1, Jean D. Boyer 1, Emma L. Reuschel, Ami Patel, Aaron Christensen-Quick et al. (2020)  Safety and immunogenicity of INO-4800 DNA vaccine against SARS-CoV-2: A preliminary report of an open-label, Phase 1 clinical trial. EClinical Medicine – The Lancet, December 23w 2020.  DOI: https://doi.org/10.1016/j.eclinm.2020.100689  https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(20)30433-8/fulltext

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