June 15, 2020
Inovio: Pulling Out All The Stops For A COVID-19 Vaccine
By Michael D. Shaw
As most people are aware, the US is making a strong and aggressive push to develop a vaccine for COVID-19. It will take the utmost in planning, collaboration, and good fortune to roll this thing out in the proposed 12-18 months. One of the players involved is Inovio Pharmaceuticals, based in Plymouth Meeting, PA.
According to its mission statement, “The company is focused on rapidly bringing to market precisely designed and delivered DNA medicines to potentially treat and protect people from serious and life-threatening diseases associated with HPV, cancer, and infectious diseases.” Its core values are certainly inspiring…
- Be bold
- Act like an entrepreneur
- Be passionate
- Enjoy the journey
The idea of a “DNA Medicine” is that once inside the cell, the DNA plasmids enable the cell to produce the targeted antigen. The antigen is processed naturally in the cell and triggers the desired T cell and antibody-mediated immune response.
The company lists a number of firsts including:
- A DNA medicine to show potential for efficacy in glioblastoma multiforme (GBM), the most deadly brain cancer and one of the most aggressive cancers overall
- A DNA medicine to create anti-prostate cancer-specific T cells
- MERS (Middle East Respiratory Syndrome) vaccine to progress to Phase 2 clinical testing (INO-4700)
As to the applicability of DNA medicines to COVID-19, they can be designed and manufactured quickly, the products are stable and do not require frozen storage and transport, and they boast robust immune response as well as favorable safety and tolerability profiles. Moreover, Inovio’s success regarding the related MERS coronavirus is definitely a plus.
The company’s COVID-19 vaccine is called INO-4800 and on May 20, excellent preclinical study data was published.
Dr. J. Joseph Kim, Inovio’s President & CEO, said, “Inovio and our collaborators are working diligently to advance INO-4800 to help fight the current pandemic. We are planning to utilize these positive preclinical results along with our upcoming animal challenge data and safety and immune responses data from our Phase 1 studies to support rapidly advancing this summer to a large, randomized Phase 2/3 clinical trial.”
Sounds great, and full steam ahead, right? Well, there is a problem, although it is not with the technology or efficacy of INO-4800. As it happens, Inovio has filed a lawsuit against VGXI, a contract development and manufacturing organization, claiming that it does not have the manufacturing capacity to move its vaccine production forward. VGXI is a unit of GeneOne Life Science Inc. of South Korea. According to Inovio’s contract with VGXI, this should trigger an immediate technology transfer back to Inovio.
Per the lawsuit, by not doing so, VGXI violated its contract and has kept Inovio’s “vaccine and world health hostage, perhaps to squeeze more money from Inovio or because it’s having buyer’s remorse over its existing contract.”
“Inovio is seeking an emergency injunction against VGXI to ensure expeditious technology transfer of the manufacturing process for Inovio’s coronavirus vaccine, INO-4800, to Inovio and Inovio’s selected manufacturers,” said Jeff Richardson, a company spokesman. “The technology transfer is mandated by existing contract between Inovio and VGXI.” Richardson added that Inovio expects the contractual matter dispute with VGXI to be resolved shortly, and that the technology transfer will begin as planned.
There seems to be a troubling parallel here between key technology being hoarded by a Korean company and our reliance on Chinese pharmaceutical manufacturers. As one observer put it, a foreign company should not have veto power over America’s healthcare system and the development of a potential vaccine. This much is clear: Inovio has a potential COVID-19 vaccine. Nothing should stop the company from developing this product. Litigation wastes time and money–and lives.
More than that, Inovio has every right to find another contractor. Had this partnership functioned properly, Inovio would not be looking for a replacement. But, as a very talented engineer with whom I worked years ago once remarked, “Nothing’s easy.”