Why the FDA’s Inquiry of Inovio Is More Critical Than You Think

Throughout this crisis we call the novel coronavirus, I’ve generally had a positive view on Inovio Pharmaceuticals (NASDAQ:INO). Initially, I was very impressed with the science behind its DNA-based vaccine. Additionally, INO stock is levered to significant supply chain and logistics attributes that simply don’t exist for many other competing vaccine candidates. Most importantly, DNA vaccines can be rapidly produced and do not require frozen storage.

the inovio (INO) logo covered up by pills and a syringe
Source: Ascannio / Shutterstock.com

So I was a little bit annoyed when I was informed that my September article featuring the pros and cons of INO stock included a scientific inaccuracy. Specifically, I was told that the World Health Organization and Food and Drug Administration have been in concurrence for several years that DNA vaccines do not negatively impact the host genome through integration events.

What triggered this response? I suggested that “a lingering concern about this process is that insertion of foreign DNA may impact the host genome, causing cells to become cancerous.” I got this information from researcher Kishwar Hayat Khan, whose work was published by the National Institutes of Health.

However, the person that emailed me insisted that I was essentially wrong – international health agencies had a consensus on the safety of DNA vaccines. Still, my own research contradicted this claim. For instance, another report published by the NIH in 2014 stated:

Among the risks that WHO, FDA, and EMA lists for the use of DNA vaccines is the hazard of integration into recipient’s chromosomal DNA with the resulting risk of insertional mutagenesis or spreading of antibiotics resistance genes.

Asking Around

To be fair, the position of the WHO based on its “Expert Committee on Biological Standardization” published in August 2020 indicates, “Integration of the vector into the DNA of the vaccinee [sic] is not observed.” Nevertheless, much of the research to back this claim appears to use very dated scientific reports.

To get to the bottom of this regarding INO stock, I did something that I never did before: I contacted the FDA. Specifically, I asked the federal agency if it was true that it reached a consensus with the WHO regarding DNA vaccines’ potential risk for unfavorable host-genome integration.

Coincidentally, shortly after my email, the FDA announced that it halted Inovio’s planned later-stage trial for its Covid-19 vaccine due to questions it wanted to ask.

Is INO Stock in Trouble?

The timing of the halted trial is pure coincidence. Honestly, I wasn’t looking for trouble. I’m human. Sometimes, I make mistakes. But when I do, I take responsibility and correct them. But in this case, I did not believe that I made an error because I was citing medical research published by government sources.

Interestingly, I have received no further challenges about the possible risk that DNA vaccines may have cancer risks. Indeed, if anybody should look themselves in the mirror, it’s Inovio!

For example, I don’t like it when the company puts on its website that its DNA vaccines “Carries no potential toxicity from plasmid vector.” That’s an absolute statement. But in science, there is no such thing as an absolute statement.

Thus, Inovio should not be talking about no potential toxicity. Rather, it should address gradations of safety profiles dependent on multiple patient factors. Then, the company should address them as low, medium, or high risk, with supporting clinical data.

Not the Only Issue

That’s not the only instance. On another section of the company’s website, it states, “INOVIO’s DNA medicines do not interfere with or change in any way an individual’s own DNA.”

Again, we have another absolute statement. Scientifically, Inovio is suggesting that its vaccines have no host-genome integration risk. Where is the supporting clinical documentation for this 100% safety profile statement?

It’s no wonder why the FDA questioned Inovio, imposing a dark cloud on INO stock! You cannot make astounding statements like that without demonstrating scientific, peer-reviewed evidence.

Sure enough, I asked for this information from Inovio and I have yet to hear back. Unfortunately, this lack of transparency makes me a bit queasy about INO stock.

Transparency Should Be King During the Pandemic

One of the reasons why the American people are upset about President Donald Trump is his downplaying of the pandemic. In a way, it appears as if the White House thinks the American people are too stupid to make rational decisions if they were given too much information.

Well, I don’t think the president has the right to withhold critical information on the assumption of poor collective choices. I mean, who the heck do these politicians think they are?

It’s the same reason why I’m upset at the broader biotechnology and pharmaceutical industry. In August, National Geographic wrote a stunning and in my opinion, irresponsible article about mandatory Covid-19 vaccinations. Here’s a doozy from the article:

People who express hesitancy about a potential COVID-19 vaccine often say their top worry is safety, which raises concerns that some Americans could shy away from inoculation. But if a COVID-19 vaccine is proven safe, “I think the majority of people will want it,” [New York University’s School of Medicine bioethicist Arthur Caplan] says. “And if the majority of people want it, you won’t have to mandate it—they’ll be looking for it.”

I believe this is an irresponsible viewpoint because it implies that vaccines can be proven absolutely safe. Again, there is no such thing as proof in science. Instead, the responsible language would be if a vaccine demonstrated a high probability of safety based on clinical data, then and only then should a vaccine be presented to the public.

Another Point About Vaccines

As well, the American people should decide for themselves if they want to take a Covid-19 vaccine. This is where I vehemently disagree with former Vice President Joe Biden, who left open the possibility of a national vaccine mandate.

That is un-American. You need to give the people transparency about what they are taking and the ability to decline for whatever reason.

Similarly, it’s why I’m turning skeptical about INO stock. I don’t appreciate it when biotech firms make absolute statements without providing the basis/evidence. And that’s especially the case when the medical literature acknowledges the risk of host-genome integration.

Do DNA Vaccines Cause Cancer?

This brings our discussion back to the original contentious issue: do DNA vaccines cause cancer?

The God’s honest truth is that I don’t know. However, it’s important to note that I never stated that DNA vaccines absolutely cause cancer. That would be grossly irresponsible on my end because I don’t have the evidence.

Intellectually honest medical researchers cite the possibility of negative health outcomes via DNA vaccines. This platform, by its nature, involves our cell’s nucleus, where our DNA resides. Hence, the term, DNA-based vaccine. That’s backed up by another report published by the NIH. It states, “In case of DNA vaccines, after their internalization the DNA needs to translocate to the nucleus for transcription, followed by translation in the cytoplasm.”

To provide some contrast, consider the case of Moderna (NASDAQ:MRNA), which utilizes messenger RNA vaccines. According to Nature.com, “The core principle behind mRNA as a technology for vaccination is to deliver the transcript of interest, encoding one or more immunogen(s), into the host cell cytoplasm where expression generates translated protein(s) to be within the membrane, secreted or intracellularly located.”

This makes perfect sense as mRNA naturally resides in the cytoplasm. Theoretically, the risk of mRNA-based vaccines integrating into the host genome should be low. From what I understand, companies like Moderna can confirm this through fluorescently tagging their mRNA vaccines to ensure that they stay in the cytoplasm.

Human Genome and Viruses

Furthermore, I would like to point InvestorPlace readers to information provided by the National Institute of General Medical Sciences, which states in part:

When viruses infect us, they can embed small chunks of their genetic material in our DNA. Although infrequent, the incorporation of this material into the human genome has been occurring for millions of years. As a result of this ongoing process, viral genetic material comprises nearly 10 percent of the modern human genome.

In other words, human evolution demonstrates the precedent of viruses integrating into their host genome’s DNA. Therefore, it is very much possible for DNA-based vaccines to likewise integrate into their host genome.

How likely is this risk? Again, this is not a question that I should answer but the target biotech firm which is making claims of efficacy and safety. That’s why transparency is crucial.

Tread Carefully with Inovio Shares

Having gone through the science behind INO stock, the risks posed by DNA vaccines does not necessarily make shares a sell. At the most cynical level, Biden could win the White House and his administration could mandate Covid-19 vaccines.

Moreover, let’s say that the FDA greenlights Inovio’s DNA-based vaccine. In this hypothetical case, INO stock will likely skyrocket for two reasons: a) it received regulatory approval and b) DNA vaccines feature logistical advantages, as I mentioned near the top.

Given that other vaccine candidates from AstraZeneca (NASDAQ:AZN) and Johnson & Johnson (NYSE:JNJ) encountered setbacks that paused their clinical trials – as well as the therapeutic candidate from Eli Lilly (NYSE:LLY) – it’s possible that Inovio is still in the running. Frankly, you can’t ignore its ability to scale up rapidly and its relative ease of administration.

The Question for Investors

So, INO stock is definitely not out of contention. But that’s really not the question, is it? Instead, the question you should be asking is how probable is it that Inovio will be one of the candidates chosen to vaccinate the American people (and possibly other nationals)?

Here again, I simply don’t know. But if pressed to answer, I would say that Inovio does not feature enough advantages to convincingly lead the pack. Yes, its vaccine offers logistical advantages but it most likely will be a two-dose regimen. That would hamper distribution efforts while Johnson & Johnson’s vaccine candidate is designed to be a one-and-done affair.

I suppose that because this is the new normal, anything is possible. Acknowledging this, I’m not opposed to a speculative bet on INO stock, just in case. However, if that’s your approach, please realize the risks involved, which are plentiful.

On the date of publication, Josh Enomoto did not have (either directly or indirectly) any positions in the securities mentioned in this article.

A former senior business analyst for Sony Electronics, Josh Enomoto has helped broker major contracts with Fortune Global 500 companies. Over the past several years, he has delivered unique, critical insights for the investment markets, as well as various other industries including legal, construction management, and healthcare.

Article printed from InvestorPlace Media, https://investorplace.com/2020/10/why-fda-inquiry-very-critical-ino-stock/.

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