INOVIO Pharmaceuticals Inc (NASDAQ: INO) is rocketing in the market this morning after announcing that it will move forward with its mid-stage study of its COVID-19 vaccine. The news comes shortly after BioNTech (NASDAQ: BNTX) and Pfizer (NYSE: PFE) announced positive results from their COVID-19 vaccine trial and Moderna Inc (NASDAQ: MRNA) announced even better results from its trial.
With such positive news coming out of recent COVID-19 vaccine clinical trials, investors are expecting to see more of the same out of INO, leading to dramatic gains in the market this morning. Here’s what’s going on:
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INO Stock Gains On Coming COVID-19 Vaccine Clinical Trial
In the press release, INOVIO announced that it has received clearance from the United States Food and Drug Administration to move forward with the Phase 2 segment of its planned Phase 2/3 clinical trial of INO-4800. INO-4800 is the company’s COVID-19 vaccine candidate.
The Phase 2/3 clinical trial is called INNOVATE, an acronym for INOVIO INO-4800 Vaccine Trial for Effciacy. It will be a randomized, blinded, placebo-controlled safety and efficacy trial of the vaccine candidate in adults in the United States.
INO said that the trial will be funded by the United States Department of Defense in coordination with the Office of the Assistant Secretary of Defence for Health Affairs and the Defense Health Agency.
INO explained that the Phase 2 segment of the trial will evaluate safety, tolerability, and immunogenicity of the potential COVID-19 vaccine. The vaccine will be provided to participants in a two-dose regimen, in a three-to-one randomization to receive either INO-4800 or placebo for each dose.
the company said that the study will address three age ranges. These include 18-50 years old, 15-64 years old, and 65 years and older.
In a statement, Dr. J. Joseph Kim, President at INO, had the following to offer:
I am extremely proud of the INOVIO team, which has been working tirelessly to develop a safe and effective vaccine in the fight against the COVID-19 pandemic. Initiation of our Phase 2 trial marks a pivotal milestone for INO-4800. We are especially pleased to continue our partnership with the DoD to advance the development of INO-4800 for active duty service members and civilian personnel and are grateful for the Department’s continued confidence in our technology to combat COVID-19.
INO-4800’s key differentiators are the safety and tolerability data we have observed thus far, as well as its excellent thermostability profile – making it possible to manufacture at scale and transport without frozen cold chain requirements. INO-4800 also maintains the ability to be safely re-administered and is differentiated by its ability to stimulate both CD4+ and CD8+ T cell responses.
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This Is Huge News
Recently, INOVIO Pharmaceuticals stock took a hit in the market after announcing that the FDA placed a clinical hold on its Phase 2/3 trial. However, with today’s news, the issues have been resolved for the Phase 2 segment, and the company is moving forward.
As it moves forward with the Phase 2 segment, INO will be working to cure the FDA’s concerns with the Phase 3 segment, for a seamless transition from Phase 1 to Phase 2.
While some are concerned that the vaccines from BNTX, PFE, and MRNA will hit the market first, limiting the opportunity, that’s not likely the case. While these vaccines are ahead in clinical trials, and will likely hit the market first, there’s a long-term opportunity surrounding COVID-19 vaccines.
The fact of the matter is that vaccination against the virus isn’t likely to last forever. Like the flu, I believe that consumers will find themselves seeking annual vaccinations in order to provide adequate long-term protection against the virus.
With recent news, the vaccine candidate at INO is likely to be the third to hit the market, following BNTX, PFE, and MRNA in 2020 commercialization. Ultimately, this will provide a tremendous opportunity, should all go well in the clinical trial, making INO stock one to watch closely.
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