Dec. 25 at 3:23 AM
$VXRT
A Christmas Miracle
I’m so excited that I’m sitting here writing this post on Christmas Eve.
The Sanofi deal is a marriage made in heaven for us.
It's a monumental development, and the implications are massive, including two bombshells in this post that I think you're going to love.
________________________
Vaxart had to know Sanofi was coming, as Dynavax would have had to disclose, given deals like this take months.
Disclosure is generally required only when discussions reach a point where:
• There is agreement on price or structure, or
• A transaction is reasonably probable, and
• The impact would be material to investors
Re: the announcement on Christmas Eve Day…is Sanofi trying to fly under the radar of the US government, who blew it by not purchasing the rights to Covid, thus allowing a non-U.S. entity to get first access to VAAST, even though HHS funded our trial? Does RFK even understand what he’s sitting on?
The big attraction for Sanofi is thought to be Dynavax's experimental shingles vaccine, which could be a rival to GSK's blockbuster Shingrix jab.
A shingles vaccine in a pill? According to AI, it’s possible.
Sanofi got our Covid vaccine as a throw-in (at least from the media/market perception), while our platform continues to fly under the radar.
Meanwhile, the odds for Sanofi pulling the trigger on our Avian flu just skyrocketed.
Did Vaxart pull the r/s because they knew Sanofi was coming?
I’m going to take a little credit here, because I called Sanofi several years ago. I was all over Sanofi, so much so that I went back today to read some of my quotes that I had forgotten. Here they are, in no particular order:
“I’m calling it here. It’s Sanofi, folks. Could be GSK as well. There are way too many connections for it to be otherwise. Where there’s smoke, there’s fire. The smoke is coming out of my ears right now.”
“Sanofi (based in Paris) is the largest company in the world devoted entirely to vaccines, currently pumping billions into new plants in Toronto, Singapore, and France, and they just completed a new flu plant in Pennsylvania.”
“Sanofi’s M&A unit has spent billions acquiring dozens of firms. Are we on their radar?”
“Speaking to Fox News after our influenza challenge study with Sanofi in 2018, Fauci described our challenge study with Sanofi as 'encouraging' and 'potentially important…it will be important to determine how the vaccine performs with natural infection in the community.”
“I’ve always wondered why Sanofi would agree to a challenge study with a little no-name bio. They had everything to lose and nothing to gain, unless there was a caveat if their product was outperformed, they would have first dibs at getting in bed with us. When BP goes up against a small bio and gets beat, wouldn’t they want to join forces with a disruptive platform? Surely they can see the writing on the wall? They could have had us for next to nothing.”
JJ: Which is exactly what occurred. Deals in the bio sector are all about relationships and trust. There’s a lot of repeat business within the same firms. Old friends. And friends are like whiskey. The older, the better.
“Sanofi And GSK’s protein-based vaccine was tested as a booster dose for people who had previously had two doses of an mRNA or adenovirus vaccine. The booster dose was found to increase neutralizing antibodies 18-fold to 30-fold across different vaccine platforms and age groups.”
Will Sanofi and GSK consider their antigens using VAAST down the road?
"Multiple employees from Sanofi have like us on LI."
Sanofi connections:
1. Vaxy and Sanofi are research partners with Stanford.
2. Sanofi/Vaxy/Gates/VisMederi/CEPI/Stanford connections.
3. Plotkin is the former CEO (under a previous name) and now a consultant for Sanofi.
4. The flu challenge (if you can’t beat’em, join’em)
5. Sean not mentioning their name anymore.
6. Our GC was a VP at Sanofi for eight years. From the PR when he was hired: “Mr. Berg and his legal team counseled on product launches and supported internal and external collaborative efforts that led to the development of an innovative early pipeline...”
7. Sanofi has a facility in Miami, where Vaxy HQ and Edward Berg are relocating. (Dated)
8. Thomas Ghignone, former Head of Legal at Sanofi, liked Vaxart for years and liked Berg with his comment, “Congrats Ed. Best wishes.”
“When you combine Sanofi’s goal to dominate the vaccine landscape, along with our technology, and all the links I’ve listed above, a Sanofi/Vaxart collaboration/acquisition would not be a surprise.”
“Sanofi doesn’t have an alternative delivery program even though the new facilities they’re building include multiple platforms for multiple ways of administering vaccines.”
“Sanofi, ALT, J&J, AZN, and CureVac have either dropped their alternative delivery programs or have had major issues.”
“Sanofi produces 10 billion pills a year in India.”
“Sanofi’s goal is to dominate vaccine manufacturing, aggressively moving forward building diverse vaccine manufacturing platforms.”
“Sean is presenting ‘Novel Immune Correlates of Protection Against Influenza Infection’ at the Universal Influenza Vaccines 2022 Conference in September at Oxford. Vaxart is a sponsor. Why would Sean take a few days out of his schedule to fly across the pond when mgt. has said the focus is on Covid and Noro? And why would Vaxart pay to be a sponsor?”
“I’ve always loved Paris in the spring time.”
“Sanofi is the largest manufacturer in the world for flu vaccines, and their influenza shots are the largest contributor to their vaccine sales.”
“Sanofi’s current antigen for flu ended on Thursday. Now, new antigens. But from whom? Since they have to change antigens every so often, wouldn’t it be easier and quicker with a pill that is cross-reactive?”
“Sanofi attended Sean’s presentation in 2014 and asked him about the flu.”
“We have a Clinical Bio Operations Manager working in Paris."
“The U.S. has a stockpile of more than 100 million doses of the smallpox vaccine ACAM2000, an older shot originally produced by Sanofi. But it carries a high risk of side effects. Why wouldn’t Sanofi want to update with a pill with a better safety profile?”
Could a new oral smallpox-type vaccine be made?
AI: Yes, researchers could:
• Use non-replicating viral vectors
• Use specific smallpox antigens (not live virus)
• Combine them with an oral delivery platform (like enteric-coated tablets)
@Tellurider posted a MUST-READ today on Sanofi’s manufacturing prowess.
Wow.
Excerpts:
“Imagine having thirty-four mini-factories at your fingertips, each one ready to pivot like pieces of a sophisticated LEGO platform—able to be combined, reshuffled, and/or upgraded easily, enabling fast, scalable, and adaptable manufacturing.”
“While traditional sites are locked into manufacturing one product—or one class of products—for months or years, Modulus can manufacture up to four different vaccines or biologics simultaneously and significantly reduces production changeover times between any pre-validated technology platforms to as little as one week, while the industry standard remains several months.”
JJ: One week!
“Modulus represents a win-win-win innovation in the field of biopharma manufacturing.”
“More than just a factory, it redefines healthcare delivery with flexibility and speed, enabling us to meet the evolution of our pipeline, as well as adapt to the pressing needs of public health—all while delivering on our sustainability commitments.”
From Sanofi’s website:
Phase 2 is carried out in a small number of patients approximating 200.
Phase 3 trials can have patient numbers ranging from 500 to 1000…to satisfy regulators that the drug is fit for use as a treatment by the general population.
So they can ram Covid through quickly.
But here’s the blockbuster news, according to AI:
Sanofi can run a Phase 3 outside the U.S.
It’s common practice to run Phase 1/2 in the U.S., followed by Phase 3 in Europe, Asia, or multiple regions simultaneously.
This is routine for a company like Sanofi.
And here's the BOMBSHELL: If we deliver positive Sentinel data, then Sanofi can use that data to support COMPLETION of Phase 2.
This is normal. Sentinel cohorts are explicitly designed to inform go/no-go decisions.
So Sanofi could go straight from our Sentinel trial into a Phase three.
This is what AI is telling me.
So what we have is incredible synergy: The speed and flexibility of our platform, combined with Sanofi’s amazing flexibility and fastest production changeover times in the industry, needing a P3 of only 1000, with tens of billions in ammunition, along with deep connections globally with regulatory agencies, Sanofi’s goal of dominating the vaccine landscape, and the possibility of Sanofi going straight from our Sentinel trial into a Phase three.
Holy toledo.
BARDA, then Dynavax, now Sanofi, and sentinel data on the horizon.
If you’re not bullish, I don’t know what to tell you.
“Great moments are born from great opportunity. And that’s what you have here, tonight, boys. That’s what you’ve earned here tonight.”
Folks, we’ve earned this, our own Sanofi Christmas present.
I LOVE Sanofi.
Merry Christmas!
