FDA gave chimeric antigen receptor (CAR) T-Cell therapy 'breakthrough designation' in 2014 - the Route to Genetic Engineering

What followed was the greatest crime against humanity in the history of the World - Let them prove me wrong!

Going to keep this short, but not sweet

There is no way to sweeten this bitter pill I am going to unveil for you here. The subtitle of this post opens the analysis:

“What followed was the greatest crime against humanity in the history of the World - Let them prove me wrong!”

It begins with chimeric antigen receptor (CAR) T-Cell therapy (CAR-T). In 2014, FDA assigned CAR-T therapy 'breakthrough designation - drugs that have been granted breakthrough status are given priority review.

The first CAR -T therapy was approved by FDA just 3 years later, in 2017. Not quite working at the “speed of science,” but not far off. The brand name of the product was Kymriah, marketed by the Swiss giant Novartis. It was reported in Fierce Pharma:

Novartis, still struggling with Kymriah manufacturing, is providing some out-of-spec doses to patients who ask

“Novartis released some new data on CAR-T drug Kymriah this month that it hopes will improve the uptake of the drug. But Novartis also continues to wrestle with manufacturing issues that have kept some doses from meeting specifications, a problem that is also hampering Kymriah sales.”

“The drugmaker says it is working on a list of improvements to the process but acknowledges that some doses are still not meeting specifications, a problem that Liz Barrett, CEO of Novartis Oncology, outlined earlier this year to shareholders.”

Worrying side effects began to emerge

Along with the manufacturing issues, worrying side effects began to be reported. This is today’s Kymriah package insert. Side effects of Cytokine Release Syndrome and Neurological Toxicities…accompied by cancers…

I worked on the Kymriah supply chain in 2013

Kymriah uses a lentiviral vector to deliver gene modified cells into the patient. The drug substance is manufactured by Oxford BioMedica, based in Oxford, UK. I was an external consultant on the early-stage supply chain, which was still very much experimental, in a regulatory terrain that was still evolving and incredibly immature. That was in 2013.

You can imagine my surprise when I saw this Press Release announcing the supply agreement signed on approval, in 2017!

“The agreement builds on the collaboration announced between the Group and Novartis in October 2014 and anticipates the commercial launch of CTL019 later this year.”

“Under the terms of the agreement which includes minimum offtake requirements, Oxford BioMedica could potentially receive in excess of $100 million from Novartis over the next three years. This amount includes a $10 million upfront payment, various performance incentives and bioprocessing and development services. The supply agreement is for three years, extendable to five years subject to the agreement of both parties.”

I can categorically confirm the impossibility of such a timeline being achievable, based on my expert opinion which I would be glad to express in front of a judge anywhere in the world…

Then this:

FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety probe

“As many have feared, the FDA’s investigation into secondary T-cell cancers following treatment with existing CAR-T therapies is poised to lead to a classwide black box warning.

For all six commercial CAR-T therapies, the FDA is requiring label updates to include T-cell malignancies in the boxed warning section of each product’s label, according to the agency’s separate notification letters dated Jan. 19 to Bristol Myers Squibb, Gilead Sciences’ Kite Pharma, Johnson & Johnson and Novartis. A black box warning is the most serious safety alert on a medication’s label.”

This gave Big Pharma a massive problem

Given that most of the world’s drugs are now out of patent, either generic of over-the-counter, the patent monopoly that creates blockbuster drugs was proving hard sustain. Not just hard, but virtually impossible.

They thought the CAR-T drugs for rare diseases were going to be the answer when Kymriah launched in 2017. However, the massive price tags, and the manufacturing supply chain complexity and associated risks to patient safety, dealt a massive blow to the other CAR-T therapies following on.

The prospect of a black box warning was something not to be relished by Big Pharma executives or their investors.

THIS IS THE KICKER:

They decided to take the gene modified cell therapy technology used for CAR-T, and rebrand it as ‘vaccinations.’

The Oxford BioMedica drug substance for Kymriah was converted to an adenovirus vector for AstraZeneca.

See screen shot evidence (screen shot because some of the website news has been taken down) here:

Suddenly, blockbuster revenues were once again flooding in…

… What followed was the greatest crime against humanity in the history of the World

More to come on this topic…