Creating T Cell Vaccines In The Sands
By Louis Garguilo, Chief Editor, Outsourced Pharma
Like many nations, Saudi Arabia has been dependent on vaccines supply from other countries. That’s about to change.
Remarkably, it has a lot to do with a vaccine-creating biotech based in the U.K.
According to the CEO and Co-Founder of Emergex Vaccines Holding Limited, Professor Thomas Rademacher, the Saudi government intends to develop and produce a new generation of vaccines – predominantly based on Emergex’s platform for T cell-priming vaccines, which, avers Rademacher, “is the next step beyond mRNA vaccines.”
The Desert Deal
Rademacher was contacted by the Saudis, who had seen an earlier deal Emergex did with Brazil; they were interested in the company’s T-cell-vaccine development platform.
As part of Saudi Arabia’s Vision 2030 to boost the biopharma sector, the country created the Vaccine Industrial Corporation (VIC), which entered a three-part strategic deal with Emergex:
- Emergex provides VIC full distribution rights on vaccines co-created in Saudi Arabia, the Gulf Cooperation Council (GCC) states in the region, as well as Egypt and Morocco.
- The Saudi NIH pays for and manages clinical trials (starting with Phase 2) – a first for the Kingdom.
- If the above fall into place, the Saudis fund the construction of a vaccine facility, initially for fill-finish; eventually Emergex may outsource the full manufacture of vaccines to the Saudis.
According to Rademacher, the Saudi government is committed to building a state-of-the-art manufacturing facility (for the Emergex platform and legacy vaccines) and the facility has already been designed by a Swedish firm.
“The facility would be massive, and able to supply quantities of vaccine enough for all of the Middle East,” says Rademacher.
Initially, though, Emergex will supply bulk product to the Saudis fill-finish operations. In time, if demand exceeds the ability to keep up, Emergex will “pass on the silver,” as Rademacher says – the science and technology to create the entire vaccine.
A Form Of Outsourcing
“This is an advanced form of outsourcing for a biotech like ours,” Rademacher explains. “We ‘outsource’ this massive commercial market to a trusted partner.”
In truth, there may be no other way.
Going back to the first deal Emergex did with Brazil, all vaccines in that country go through the National Health Service; vaccines will also be centralized in Saudi Arabia.
“We are a part of that plot, and the mechanism by which it moves forward,” says Rademacher. “Once the Saudis get that facility up and running, there’s also a lot of off-patent vaccines [legacy vaccines] they can go ahead and make as well.”
“It’s a fantastic opportunity for them and us. And it's interesting how this ‘outsourcing model’ balloons. I just got off a call with people in other regions who have heard about this.”
Is Rademacher implying the Saudi’s grand plan was formed with his U.K-based vaccine development organization as a lynchpin?
It would be all the more amazing given the currently adequate but still modest manufacturing capacity Emergex has at its single, U.S.-based facility, and at one CDMO that’s been “brought up to speed” as a backup.
No hesitation in replying from Rademacher:
“We believe VIC was formed with us in mind. They convinced relevant parties we are the “new technology box that needed to be ticked” to set all their vaccine plans in motion.
Of course, the Saudis have already built out an expansive, $500 billion technology-smart city, called Noem.
“Someday in the future they may not necessarily use our resources,” says Rademacher, and that’s fine with him. “There are only so many vaccines we can do, and many are not high on our list.”
“On the other hand," he says, "if they want to continue to use us as resources, they will provide us labs and other support."
"But our view is that VIC was set up specifically to bring us in.”
That, to this editor, is quite amazing. And there’s an additional bonus for Emergex: The Saudis want to run clinical trials. “So we are already looking at a collaboration between Brazil and Saudi,” Rademacher says.
“We're coordinating the two regions, and they love it.”
Building A Facility
As mentioned in our first editorial, companies such as Novo Nordisk and Sanofi have worked with the Saudi government on vaccines, but importantly, no Big Pharma was interested in structuring an Emergex-like deal until after a facility was actually built, says Rademacher.
The potentiality remains “the building of this grand development fill-and-finish manufacturing facility,” he says. That becomes a reality if and when clinical trials with Emergex-technology-led T Cell vaccines commence in Saudi Arabia.
Rademacher is careful not to imply the massive facility would be constructed specifically for Emergex technology; it will handle “traditional types of vaccines” as well.
“The only rights they have initially with us is fill-and-finish, and their distribution rights,” says Rademacher. “However, we have indicated that if the market demands do exceed our ability to supply, then we will do a full tech transfer.”
“All our vaccines are made with what’s called a “core particle,” he explains. To that is added the specifics for the target pathogen. Emergex would supply the Saudis with “those bits and pieces” enabling them make the vaccine. “In other words, we give them the raw materials.”
Eventually, a final step: Emergex transferring “the knowhow for the core particle technology.”
“We’ve always looked at it this way,” says Rademacher. “If we ever got to the position where we couldn't adequately supply, then yes, please go ahead and do it!”
One CDMO Enough?
Surprising is Emergex’s capacity to be self-sufficient in supplying Brazil and the Saudis through, and potentially beyond, clinical trials, by (a) repurposing the facility the company purchased in Fremont, California (from the former Zosano Pharma Corporation in October 2022), and (b) utilizing a single Europe-based CDMO Rademacher at this time calls “a backup.”
The Fremont, Cal., GMP facility purchase included Zosano’s proprietary microneedle array patch (MAP) intradermal drug delivery system, plus manufacturing equipment designed for clinical and commercial manufacture, together providing Emergex with an innovative MAP delivery technology and "optimised manufacturing capability."
But is there enough capacity to supply drug substance on large-scale commercial levels?
“Listen,” Rademacher says,“if you get into the dengue world and other such vaccines, the number of vials you have to produce gets quite ridiculous. But for the vaccines Emergex is developing, today we have no problem.”
“We’re already producing up to a ten-million scale in-house, and our Fremont facility will allow for a magnitude expansion. And we can use our CDMO – they are capable of taking it to higher levels.”
For the foreseeable future, then, Emergex can remain both a biotech developing new vaccines and a supplier of those vaccines, backed up by a single CDMO partner.
Rademacher considers this the best of “outsourcing” strategies. Regarding those larger future quantity needs?
“Look at it this way, these are wonderful problems to have.”
And again, he sees outsourcing in one form or another as the solution.
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Also see:
Vaccine Manufacture From The U.K. to Brazil And Saudi Arabia