BioNTech—the virtual company with a virtual moral compass

What do we know about BioNTech?

Forty years in the industry, and I only heard of BioNTech in 2018. Then, I noticed on LinkedIn (am since ejected) that a lawyer I had worked with in 2007 on client supply agreements, then at Morrison & Forrester (MoFo), had gone to work for them. I thought no more of it, other than to wonder why he would move to such a tiny company.

Anyway, I thought now to dig in a little deeper on their website.

Top of the collaborator list is the Bill & Melinda Gates Foundation, saying:

“In September 2019, we entered into a partnership with the Bill & Melinda Gates Foundation to develop HIV and tuberculosis programs based on our proprietary mRNA vaccine technology. The investment was the largest equity investment made by the Foundation’s Strategic Investment Fund to date.  The collaboration comprises identification and pre-clinical development of vaccines and immunotherapies for these infectious diseases and strives to provide affordable access to world-class medicines in developing countries. The collaboration may also be extended to other infectious disease indications.”

The other collaborators are nearly all wall-to-wall mRNA exponents, hmmm.

What does BioNTech’s history tell us?

The website has this to say:

Based on profound scientific know-how, we are ushering in a new era of immunotherapy

2008

BioNTech is founded by Prof. Ugur Sahin, M.D., Prof. Özlem Türeci, M.D., and Prof. Christoph Huber, M.D., to develop and produce treatments for individualized cancer immunotherapy. (Seed round 180m USD) 

2012

Start of the first Phase 1 clinical trial with RNA immunotherapy in melanoma, today known as our FixVac approach

2013

Start of the first Phase 1 clinical trial with RNA Immunotherapy in melanoma – the first trial of an individualized immunotherapy (iNeST) in humans.

[Note from Hedley: The aim of a Phase 1 study is to prove safety in human volunteers. They are not intended to prove any kind of efficacy; also, it doesn’t say if the studies were finished, only that they started. If they had been proven safe, you’d expect them to say it!]

2014-2018

Strategic collaborations across the pipeline (Bayer Animal Health, Genentech, a member of the Roche Group, Genmab, Siemens, Sanofi, Regeneron, Genevant, Pfizer, University of Pennsylvania) 

2018

Completion of 270 million USD Series A financing round.

2019

BioNTech becomes a publicly traded company on the NASDAQ Global Select Market under the ticker symbol BNTX.

2020

Beginning of “Project Lightspeed” to quickly develop a safe and effective vaccine to address the emerging SARS-CoV-2 pandemic. The Pfizer-BioNTech COVID-19 vaccine is the first vaccine to receive emergency use authorization following a worldwide Phase 3 trial 

2020

Publication of first peer-reviewed paper for the COVID-19 vaccine candidate BNT162b1

2020

Establishment of BioNTech Manufacturing Marburg to produce COVID-19 vaccine, which became one of the largest mRNA manufacturing facilities in 2021

What can we take away from this?

In 2014, with nothing more than safety studies (Phase 1) started in melanoma, BioNTech struck numerous deals through 2014 - 2018:

“Strategic collaborations across the pipeline (Bayer Animal Health, Genentech, a member of the Roche Group, Genmab, Siemens, Sanofi, Regeneron, Genevant, Pfizer, University of Pennsylvania)” 

Excuse me, why would all these companies do business with BioNTech—they had nothing of proven value, diddly squat, in the pipeline. In normal times, going to these companies with just two safety studies in the bag would be a certain route out the door onto the pavement (sidewalk for our US colleagues).

Then suddenly, in 2020, BioNTech buys a large manufacturing plant in Marburg from Novartis:

BioNTech to Acquire GMP Manufacturing Site to Expand COVID-19 Vaccine Production Capacity in First Half 2021

• Facility will become one of the largest mRNA manufacturing sites in Europe and the third site in the BioNTech manufacturing network in Germany expected to produce BNT162 for global supply

• Expected to be fully operational in the first half 2021 with an annual production capacity up to 750 million doses of potential COVID-19 vaccine

• Rapid transition expected due to well-established biotechnology drug substance and drug product manufacturing equipment as well as an experienced team

• BioNTech will take over the entire site with currently approximately 300 employees, enabling a rapid transition to BNT162 production upon transaction closing

Now we really are in fantasy land!

Only ever having procured material for Phase 1 clinical trials in melanoma, using contract manufacturers, BioNTech takes on a full scale, commercial manufacturing plant!!! It also seems it had another two manufacturing plants that have appeared from nowhere.

Hopefully, you are taking in the impossibility of what has happened here.

The senior management team

Now we move on to the senior team that appear to have achieved this miraculous outcome:

From Discovery to Delivery – Meet our Senior Team

What can I say?—this is what is known in the industry as ‘virtual pharma’. That means they are a very small team managing contractors across the entire drug lifecycle—preclinical, clinical and quality.

Project Lightspeed crops up a lot in the bios, and about half of them appear to have been parachuted in from 2017 onwards. No evidence of experience in manufacturing for clinical trials and commercial supply amongst them.

James Ryan, bottom right, is the business contact I mentioned at the beginning. He is indeed an expert in negotiating the intricacies of supply agreements with multiple (probably hundreds in this case) of parties involved.

That’s it for now, I’ll leave you ponder the virtual moral compass piece.