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Inovio VGX-3100 HPV Data Adds To Conviction

Mar. 23, 2021 10:58 PM ETInovio Pharmaceuticals, Inc. (INO)37 Comments
William Meyers profile picture
William Meyers


  • Inovio reported positive Phase 3 VGX-3100 data.
  • In addition to treating cervical dysplasia, label expansion is likely.
  • DNA plasmid technology is poised to create a broad array of commercial therapies.

Pipette adding sample to petri dish with DNA profiles in background
Photo by Andrew Brookes/Cultura via Getty Images

Inovio Pharmaceuticals (NASDAQ:INO) is a clinical stage biotechnology company. It briefly captured investor attention in early 2020 when it announced it had a candidate for a Covid-19 vaccine, INO-4800. That propelled the stock price from

This article was written by

William Meyers profile picture
I provided stock and bond research and analysis to a small cap specialist investor, Lloyd Miller, from 2002 until his death in January 2018. For my own account I invest mainly in technology and biotechnology stocks. My technology and investment web site is openicon.com, where readers can view the notes I take to make decisions and to write articles for Seeking Alpha.

Analyst’s Disclosure: I am/we are long INO. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.

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Comments (37)

I haven’t seen any decent value evidence for VGX-3100 that would convince me insurers would cover it based on such modest efficacy.

Take 100 fully insured women with HSIL. Say insurers pay for 100 Qiagen diagnostic tests, and 70% come back as HPV-16/18+ (this percentage is actually declining quickly over time due to the introduction of Gardasil back in 2006). So far the cost of 100 diagnostic tests needs reimbursing.

Say all 70 HPV-16/18+ women go on to receive VGX-3100, ~ 17 will have their HSIL regress and will be spared surgical excision (of which ~8 would have happened naturally without any diagnostic test or treatment). The HSIL in 53 women will not respond to VGX-3100 and they’ll need surgical excision anyway. So for their insurers the whole exercise only increased costs without benefit.

The maximal gain per 100 women is 11 surgeries spared due to the vaccine, but at the cost of 100 diagnostic tests and 70 courses of VGX-3100 vaccination. The surgery we are talking about is not an expensive or complex one. It is closer to a removing a suspect mole, but clearly more uncomfortable and intimate. Definitely an unpleasant experience.

Even the best case scenario doesn’t account for women who are not afraid of a little discomfort and would sooner undergo the immediacy of surgical lesion excision rather than wait for months and have lots of appointments for tests and vaccines in the hope VGX-3100 (if they qualify) gives them a 1-in-4 chance of avoiding surgery.
@mechan1sm - "I haven’t seen any decent value evidence for VGX-3100 that would convince me insurers would cover it based on such modest efficacy."

Modest for a bunch, quite efficacious for a smaller bunch. Which is why they are looking for markers to tell them which women will fall into the quite efficacious group. Or didn't you know that?
@joel menkes can you point to any cases where biomarkers for immunotherapy response have been found beyond MSI-H/dMMR for PD-1 mAbs in non-viral cancers? Or should I just assume ‘you didn’t know that’ there aren’t any.

With these kind of patient numbers they simply will not find anything compelling, especially given that up to 50% of ‘responders’ will be women whose lesions would have resolved spontaneously.

INO-4800 is a scientific advance but does not represent a meaningful clinical advance at almost any price point. The efficacy is just too low. These sort of response rates are often acceptable for market approval in cancer, but this is a pre-cancerous lesion with an existing SoC treatment.

Do you ever wonder why Inovio hasn’t found a Big Pharma partner for HSIL despite getting a Ph3 readout? There is no market for it
@mechan1sm - "Or should I just assume ‘you didn’t know that’ there aren’t any."

Yeah, well, there weren't a lot of things until there were, were there? Or should i just assume you didn't you know that. If ino does come up with them, even in the face of your all knowing and all seeing self knowing they won't, the efficacy you cite as being just too low won't be just too low, will it.

Do they need a Big Pharma partner or is apollo sufficient? I've got auph as well (and a few others). Despite their getting approval for lupkynis they have, with the exception of the partnership with otsuka for certain countries ex-US, they continue to choose to go it alone. Some companies simply don't want big partners for some or all of their products. Or should i just assume you sit on ino's board and are privy to the board's inner thoughts?
TommyIrish profile picture
"Nearly 19 million more American adults – about a third of those now refusing to get vaccinated – would get vaccinated if they could take a pill instead of getting a shot, according to a poll conducted by Quadrant Strategies and commissioned by Vaxart, Inc. (VXRT)"

Most opinion polls are misleading and hypothetical ones especially like "would be in favor of someone else paying higher taxes if it created world peace" and such like. In this case the unspoken assumption is that both alternatives are as effective and safe.

The current AstraZeneca vaccine that the UK has been pumping into almost 50% of the UK population can't even get Emergency Use Authorization in the US and none of the vaccines have full approval. So Vaxart are miles away from getting ANY approval. By which time the operative question your doctor "may" ask you "Do you prefer an untested vaccine that may be less effective to one that is true and tested?".

Vaccination hesitancy will shrivel one it is clear that people that get the vaccine can get on with life without a face mask and other restrictions like not being allowed back in the office.
FDA Revolving door, ex-FDA chief, scott Gottlieb, just happens to now be on board of Pfizer(BioNtech partner) and trump covid czar Moncef Slaoui sat on Moderna board. Enough said. Now Inovio has many advantages over mRNA and protein vaccines (Novavax, JJ, and AZ). The thing many people are overlooking is the durability of protection. Currently approved vaccines last maybe 6 months at most, no one really knows. So your talking about vaccinating everyone multiple times per year. Good luck. Can’t even get my patients to adhere to their normal meds or get an annual flu shot. The current players have only humoral or B/cell antibody coverage and limited T-helper/Treg cell activity. This is where Inovio will prevail. DNA plasmids have a longer half-life and continue to be transcribed into mRNA than mRNA alone, and inovio DNA plasmids has more robust t/cell response. DNA plasmids can also code for larger sequences incorporating various protein targets as variants continue to emerge. Inovio strong!!
Release the hold of the Cellectra device (CROOKED FDA) and we shoot to the moon.
@Ukcats1332 - "Release the hold of the Cellectra device..."

Would've months ago if the world was still in need of a new vaccine to fight covid. The hold might never have been put on if there had been no competition as advanced as we were.
@joel menkes
Drivel, as usual from Mr. Executive.
As FDA knows more than you concerning this matter. If Inovio was as advanced as you stated, they would have been on the market long ago. FDA knows what they're doing. Case closed!!
Cheers my friend.
@Novavax Op Warp Speed - "Drivel."

I gotta say, you do know drivel, given your having practiced it every day and multiple times per. So where did you go wrong on this comment of yours? I've already related my experience with the fda on the bowel clearing pill vs the evil tasting glop that was being used back then, with the attempt to hold up approval being made by one member of the review panel. Who, as it turned out to be, was on the bod of the glop producing company. And here we have that other guy's fda, with that other guy promoting the vaccine development of a different company, and that other guy also being anti-asian for the sake of votes.

So please, don't give me your own drivel about who knows what concerning this matter. You worry about your own problems with nvax which on its way to fulfilling my prediction of 45 before long. And that's only a stop along the route downward.

"Inovio VGX-3100 HPV data adds to conviction."

I'll wait patiently on the sidelines until the final PH3 VGX-3100 data results are revealed. As the downside pressure on $INO pps will remain until then. Potential drop in shr price near $7 or lower is possible. I would think about acquiring a few shrs at a nicer entry level. At this time nothing is promised, that includes VGX-3100 data. Biotech games will be played, as players gonna play. Never a loser, unless or until one sells a loser. That's why patience is my best friend and ally. You either believe in the science platform or not. The rewards could arrive any day, as Novavax $NVAX proves and has done for my 15 yr investment. A huge payoff, on paper at this time. Anticipating more catalysts to drive the shrs even higher, as the MM's and Institutional investors play their games with the shr prices of many bio's at this time.
Inovio could surely have it's day in the spotlight also imho. Good luck and best to all.
Ciao my friends.
William Meyers profile picture
@Novavax Op Warp Speed Not an unreasonable attitude. There is always risk in biotech therapy development. Even with approved drugs, there is always the pricing and acceptance issue.
@William Meyers - "There is always risk in biotech therapy development."

He knows. He was a 15 yr long big loser with novavax until covid came along
@Novavax Op Warp Speed I would be interested in starting a position IF INO got to a $1 Billion market cap. I don't like the risk reward at $2 Billion and agree with author on a neutral view of INO at the current market cap.
excellent analysis
Congratulations INOVIO 💓💰
To the moon baby.... 🌜the world is ours... 🌎
munhoi profile picture
@6x7 bigelk yeah right, when
Abdul Rahman BH profile picture
William Meyers
Thanks for the article
I am very proud of INOVIO 🧬💯
Very fair evaluation, even though the baseless hold on INO 4800 Is in my opinion,an unjustified effort to stall Inovio!
William Meyers profile picture
@George C. Perez I have wondered why the FDA has been so slow dealing with Inovio's vaccine while rushing others with ties to the Trump admin, but have no definite proof of favoritism. If you do, feel free share a link to it.
@William Meyers Look I hate the fact that the FDA held us up. But "ties to the Trump admin?" What proof do you have of these wild accusations?
@Sig S. - "What proof do you have of these wild accusations?"

Nothing wild about it. Trump himself pushed the moderna vaccine from the moment he got the words from moderna's ceo at that conference of vaccine researchers he'd held. And then look who wound up where.

If Reveal 2 MITT lines up with Reveal 1 ITT, that would not result in a failed trial. Because the full P3 trial, Reveal 1 plus Reveal 2, will be a higher-powered trial than Reveal 1 alone (two-sided versus one-sided), the bar for statistical significance will be a p-value of 0.05 or less, not 0.025 or less like it was in Reveal 1. So if Reveal 2 MITT yields a p-value of roughly 0.029 like Reveal 1 ITT did, the overall MITT for the entire trial (Reveal 1 plus Reveal 2) will easily achieve statistical significance. Reveal 2 MITT would have to underperform Reveal 1 ITT significantly in order for the trial as a whole not to achieve statistical significance. The odds of success for the overall P3 data look good in my opinion. Thanks for the article, nicely done.
@circa1762 - "If Reveal 2 MITT lines up with Reveal 1 ITT,..."

Would or wouldn't that circumstance provide a strong suggestion that the initiative to look for the markers denoting a strong subgroup target for successful treatment is the right approach to take? If you can isolate that group, around 25-30% of the overall afflicted population, wouldn't that give a significant segment of the market to inovio? If that's all correct, anybody have a decent idea of what kind of revenue/profit could we estimate if we would get that much market share?
@joel menkes Yes, I think the biomarker test developed with Qiagen is the right approach regardless of Reveal 2 data. If you can tell 25-40% of the patient population that 3100 has a track record of treating women with their biomarker profile successfully, that should be a powerful motive for those women to choose treatment via 3100. As for revenue, it’s hard to predict with any accuracy since we don’t know yet what the pricing of 3100 will be upon approval, but my assumption, based on 20-40% of the patient population eventually taking 3100, is somewhere around the high tens of millions or low hundreds of millions in annual revenue. That alone would not turn Inovio into a profit-making machine, of course, but it would still represent a huge step by covering a significant chunk, or all, of the company’s current annual expenses. Inovio becomes substantially de-risked if and when that happens.
@circa1762 - "That alone would not turn Inovio into a profit-making machine, of course, but it would still represent a huge step by covering a significant chunk,..."

Thanks much, your take is very appreciated, looks very logical from all angles i can think of. Be well
carlomiami profile picture
Nice report, I believe INOVIO time to shine is coming this year.
@carlomiami I hope your right. Been hearing that for the last 5 years. lol Getting a little impatient. I made some nice gains in and out of the stock. Selling Calls/Puts. But it just seems they are always a bit short and/or a bit late.
@Sig S. I have no respect for shorts, I believe that there is not much humanity in them!
@George C. Perez - "...I have no respect for shorts,..."

They're like cigarettes; no useful beneficial purpose and if the money that surrounds them wasn't so large they wouldn't exist.
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