Vaccine Manufacture From The U.K. to Brazil And Saudi Arabia
By Louis Garguilo, Chief Editor, Outsourced Pharma
Why is Professor Thomas Rademacher’s U.K-based vaccine-creating biotech so important that Saudi Arabia has predicated the establishment of the Kingdom’s first vaccine manufacturing facility on the company?
Among the many aspects to the answer, CEO and Co-Founder Rademacher says this deal between Emergex Vaccines Holding Limited (Emergex), and the Vaccine Industrial Company (VIC), a part of the Kingdom of Saudi Arabia’s Vision 2030 to boost the biopharma sector, “highlights how clinical-stage biotechs continue to strategize to become more efficient and effective regarding their drug development and manufacturing outsourcing.”
Royal Details
On October 5, 2023, Emergex, a clinical-stage vaccine developer fighting global infectious diseases, announced it signed a Memorandum of Understanding (MOU) with VIC of Saudi Arabia for a collaboration to advance Emergex’s novel T cell-priming immune set-point candidates against designated infectious diseases.
Currently, Saudi Arabia has an entirely nascent market, and has established VIC to position itself as a future global biotech hub to “localize the biotechnology industry and harness novel technologies.”
Under the terms of the MOU, VIC intends to take an equity stake in Emergex, subject to Saudi NIH support of Phase II/III clinical trials of Emergex's T cell-priming candidates for Dengue, Coronavirus, Influenza, Yellow Fever, and potentially other indications.
VIC has a first-negotiation right to new candidates proposed by Emergex, and would have exclusive rights to marketing and distribution of potential licensed products.
A component of the deal is fill-and-finish activities for potential licensed products, with Emergex’s assistance for technology transfer – which includes the construction of a manufacturing facility, which we’ll detail soon.
To kick off our all-encompassing discussion, Rademacher thought it useful to review Emergex’s first government-affiliated collaboration – with Brazil – as background for this Saudi deal, and his wider thoughts on the vaccine-development industry.
So we’ll start there, and move through subjects such as:
- evolving outsourcing models for vaccine developers;
- shortcomings of the mRNA vaccines for Covid; and
- the (re-)emergence of T cell vaccines
The Rademacher Review
Professor Rademacher, MD, PhD, CEO and co-Founder of Emergex, is a historic and prolific biotech entrepreneur and vaccine advisor to governments.
He is Emeritus Professor of Molecular Medicine at University College London (UCL), and considered a founder of biotech in the early 1980s (when he was focused on recombinant proteins, monoclonal antibodies and glycobiology).
Rademacher has over 200 publications and 50 patents. He was a founder of the field of glycobiology and the Glycobiology Institute in Oxford. He co-founded Oxford GlycoSciences, the first-ever Oxford University biotech spinout, which in 1998 listed on the London Stock Exchange and reached a market capitalisation of £1.7 billion (roughly U.S. $2 billion in today’s valuation). After moving to UCL, Rademacher founded several more biotech spin-outs.
We could go on, but let’s move to his current company, and the Saudi precursor deal he’d like to talk about before initially.
Emergex is privately held, and headquartered in Oxfordshire, Abingdon, UK, with R&D facilities in Milton Park, UK, an operating subsidiary in Doylestown, Pennsylvania. In 2022, it acquired a GMP manufacturing facility in Fremont, CA. The company currently employs just under 40 individuals full time.
The technology pioneered at Emergex involves the development of a range of fully synthetic CD8+ T cell-priming immune set-point candidates. Emergex has two candidates for which Phase 1 clinical studies have been completed, and a host of other pre-clinical programs in its pipeline.
In that 2022 acquisition, Emergex acquired intradermal and patch drug-delivery technology and manufacturing equipment from Zosano Pharma.
“The first major commercial deal we did was with the Brazilian government,” says Rademacher, with Fiocruz (the Oswaldo Cruz Foundation, a scientific institution for research and development in biological sciences under the Brazilian Ministry of Health, located in Rio de Janeiro) and the Brazilian National Health Service.
“What they decided is – and Brazil is an important global vaccine producer – we basically provide a new pipeline of future vaccines, including for dengue, flu, Covid, chikungunya and others. The deal structure is they strategically invest in Emergex, and they pay for all the clinical trials, which of course is extremely important.”
The other vital component of this deal is that Emergex will eventually perform a tech transfer, ultimately bringing manufacturing capabilities for its vaccine platform in-country.
Emergex will supply all the vaccines initially, but “in the course of time” tech transfer manufacturing locally, first by establishing a fill-and-finish facility in Brazil (“No easy task,” says Rademacher) while Emergex continues to provide drug product.
“That deal was for all of Brazil, South America, and Central America except Mexico. It's massive,” says Rademacher, and it is similar to the Saudi deal.
The Saudi government started on its path of drug independence a few years ago, by creating a company called Saudi Bio. It’s the first and only biomanufacturing facility in the country, focused currently on bringing insulin production locally.
Notable, Novo Nordisk did a deal to tech transfer some technology into that facility, which appears to be near operational at this writing. Sanofi and others have worked with the Saudi government as well.
Where’s The Material?
With all this as segue, Rademacher is ready to dive into the Saudi-deal details. Those will come in our following editorial.
We’ll leave off for the moment with the answer to a leading question that brings us back to our bailiwick of outsourcing development and manufacturing.
How will Emergex initially provide the growing quantities of drug substance/product that will be needed in Brazil and now Saudi Arabia?
Rademacher says that will require a precise and tactical use of internal resources – starting with the facility Emergex purchased recently and mentioned above – coupled with the “training” and tactical utilization of “at least one contract development and manufacturing organization [CDMO] to augment output.”
The CDMO Emergex has already engaged with is Ardena, an organization with facilities in Belgium, the Netherlands, Spain and Sweden. Rademacher says they are quite “trained up, have made some clinical batches already, and are ready to scale up.”
More on that relationship, the Saudi deal, a fill-finish discussion, and some provocative thoughts on the mRNA response to COVID, in our next editorials.
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Also see:
Part 2: Creating T Cell Vaccines In The Sands ; Part 3: Beyond (And Better Than) mRNA: T Cell Vaccines