UK is testbed for mass vaccination with gene therapies, leading to global rollout
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The first clue
The first clue was confirmed when I had an email from Jonathan Gilthorpe about a Swedish investigative reporter wanting to interview me on GMP.
Jonathan is fully awake and we exchange occasional emails as things pop out the woodwork.
I’d been concluding, by dot joining, that the UK was the epicentre of the SARS-CoV2 injections rollout, but the description ‘testbed’ brought instant clarity.
Of course, if they could get away with it in one country with a very ‘friendly’ Regulatory Authority, it would then be EMA, FDA and all around the rest of the world…
…and here, in the UK, we have the extremely friendly, even ‘enabling’ Regulatory Authority, MHRA.
We spoke about this a few days ago, as below:
The crux of this is that MHRA changed its Regulations to allow gene therapies, and other advanced medicinal products, to be manufactured without the safety umbrella of there being a proper Quality Management System in place. Dangerous stuff!!!
It takes me back to 2013
For reasons I can’t explain, my mind flashed back to 2013, when I first worked in the gene therapy arena, under the umbrella of my company PharmaFlow.
Then, I consulted to a contract development and manufacturing organisation (CDMO) for gene therapies, named Oxford Biomedica (OXB). The job was on a UK Government funding call, titled the Advanced Manufacturing Supply Chain Initiative (AMSCI) Round 3.
The feedback UKs Office for Life Sciences received was that in the two previous rounds of AMSCI, no life sciences companies were successful. The reason given was they were using a scientific mindset for a challenge that required an engineering and production systems approach. The Office for Life Sciences asked if I could find a company to submit a bid, and steer them through to a successful conclusion.
To cut a long tale short – I found a company and the bid was successful: Oxford BioMedica Wins Significant Funding via a Competitive Award from UK Government’s Advanced Manufacturing Supply Chain Initiative.
You won’t find PharmaFlow on the announcement, even though I had personally recruited Cranfield University and Heart of England NHS Foundation Trust!
That’s often the way I suppose. I felt betrayed at the time, and even more so when they dropped me from the project and fired the Director of Manufacturing who I had been working closely with. That’s business, as they say!
The important bit
Anyway, this is the important bit. That was the last contact I had with the company, but UK Government stayed very much engaged, as I’ve now realised:
Chief Secretary to the Treasury visits Oxford BioMedica
The Office for Life Sciences were hugely impressed by the potential for gene therapies manufactured by OXB in the UK, especially when OXB signed a £100 million agreement with Novartis to supply the viral vector for Kymriah (which they were developing while I was there):
Kymriah approved - royalties to OXB assured
OXB then went on to develop and manufacture the adenovirus vector (Kymriah is a lentiviral vector, very similar) for AstraZeneca:
https://www.oxb.com/news-media/press-release/oxford-biomedica-signs-supply-agreement-astrazeneca-expand-manufacturing
It begins: “Kymriah (tisagenlecleucel/CTL019), for which Oxford BioMedica (OXB) provides the key lentiviral vector component, has been approved by the FDA for the treatment of patients up to 25 years of age with refractory/relapsed (second or later relapse) B-cell acute lymphoblastic leukaemia (ALL). Novartis has announced that the price for the one-off treatment will be $475k (c £370k), an increase over our previous assumption of £300k”
Kymriah has significant side effects of Cytokine Release Syndrome and neurological toxicities, which appear (to the unqualified me) as similar to the AZ side-effects being reported.
Why am I saying all this?
…because the evidence that the UK IS the testbed for gene therapy-based products (especially mRNA) is extremely persuasive.