字幕表 動画を再生する
It was January 24 2020, BioNTech CEO Ugur Sahin knew
that Covid-19 was likely to become a global pandemic.
I did some calculations and calculated how many people were
infected. How many weeks how many people could have traveled,
how many people could be as symptomatic and every
calculation that I made clearly demonstrated. This is not any
more original outbreak, but the virus has already spread
worldwide.
Though it was over a month and a half before the World Health
Organization officially declared a pandemic, Sahin met with his
wife, BioNTech's co-founder and chief medical officer Özlem
Türeci, and together they agreed to redirect most of the
company's resources to developing a vaccine.
It was immediately clear to both of us that the technology we
had, which we had already clinically developed, could help
to ensure a rapid response.
Up until that point, BioNTech was primarily focused on
developing novel cancer treatments. The company was
little known internationally and had never brought a product to
market. They were still
a small, relatively unknown biotech company really working
on this cutting edge science.
The founders were confident in the potential of their mRNA
technology, which they knew could trigger a powerful immune
response. That confidence wasn't necessarily shared by the
broader medical community. No mRNA vaccine or treatment had
ever been approved before. But the couple's timely breakthrough
was actually decades in the making.
We understood that we would need to invest some time and it would
need innovations on different levels in order to make it
really work for vaccines and beyond. But the potential was
already clear there.
Sahin and Tureci, whose families both immigrated to Germany from
Turkey, met in the early 1990s, when they were working in the
cancer ward at a hospital in southwest Germany. Neither
envisioned a career in business.
During my time at medical faculties studying medicine, I
also started to do my PhD, which meant work in a laboratory. And
that actually caused a clash in my perception.
Tureci and Sahin both realized that while there was a little
they could offer terminal cancer patients in the ward, in the lab
they saw lots of potential for new treatments.
I was doing my lab work and understood that the immune
system could be a powerful weapon to fight cancer. And at a
certain time point, I realized that it's not only laboratory
work, but you have really to develop the therapies and you
need funding for that.
Out of desperation, I become became an entrepreneur and
founder companies because I understood that if you want to
use innovative research to develop medicines, you have to
do it yourself.
The couple had been studying messenger RNA or mRNA since the
late 1990s. The function of mRNA is essentially to teach
ourselves how to make specific proteins. But because mRNA is
very unstable and quickly degrades in the body, they knew
there was still a long way to go before it was ready for use in a
vaccine.
And at that time point, mRNA was used by a very small community.
So it was like a talent you see a young talent, you know all the
weaknesses and you know that you have to invest a lot of years to
make the technology mature.
So in the meantime, they co-founded their first company
Ganymed Pharmaceuticals in 2001. Ganymed used a more established
technology, monoclonal antibodies to treat stomach
cancer, and the couple sold the company for 1.4 billion in 2016.
It was Germany's biggest biotech deal ever. By that point, Sahin
and Tureci were already eigh years into their second ventur
BioNTech. When they founded th company in 2008, the couple fel
that they had improved th stability of mRNA enough t
focus on developin individualized cancer vaccine
So the biggest challenge in cancer treatment is that every
cancer is different, personalized or individualized.
Cancer vaccines are based on on getting the tumor off of the
patient and analyzing that tumor, then making a vaccine
which is tailored to the profile to the genetic profile of the of
the patient's tumor.
Unlike traditional vaccines, mRNA vaccines don't introduce a
weakened version of the virus into your body. Instead, the
mRNA instructs the body to make a specific virus protein that
will trigger an immune response and produce antibodies, which
can be used to fight off a cancer that's already growing,
or to protect against future COVID-19 infections. And while
traditional vaccines require scientists to collect and grow
large quantities of a virus, a process that can take months,
mRNA vaccines are much faster to produce. That's because they're
made from a DNA template in the lab, the sequence for which can
be shared electronically in an instant.
It's the most ancient information technology, which
means that the organism is prepared and has all the tools
to understand what you want to convey in terms of messages with
mRNA.
The vision and the scientific know how we're in place, but by
the beginning of 2020, BioNTech had still not gotten any of its
mRNA cancer vaccines approved for use in humans. The company
had never turned a profit. And when it IPO in 2019, it raised
about 100 million less than it had hoped for.
They were still a small, relatively unknown biotech
company, really working on this cutting edge science.
But the world was on the verge of changing. On the day when
Sahin realized that COVID-19 had already spread around the world,
few others were concerned. Europe had just reported its
first few Coronavirus cases, and Germany had not reported any
yet. But after Sahin and Tureci talked that morning in late
January, they immediately jumped into action.
On the weekend, we started to decide the vaccine sequences.
And on Monday, we met our teams explained them, this could
become a global outbreak and that we have the obligation to
do the best that we can do to come up with vaccine candidates.
And already on Tuesday, we had the full commitment of the whole
team to start the development of a new vaccine.
We are like in a military operation. The teams were
redirected. We never put our cancer programs at hold. So they
went on while those parts of our company who could really help
with COVID-19 project started step by step to pick up pace and
work on a project litespeed.
BioNTech knew that to successfully produce tests and
manufacture a Covid vaccine on a global scale, it would need a
bigger partner. The company had already partnered with Pfizer,
having worked with him since 2018, to develop an mRNA based
flu vaccine, which is currently in clinical trials. And so
naturally BioNTech turn to them.
We approach Pfizer in early February, which was very early
because no one really believed that there was a pandemic. And
as everyone else, our Pfizer colleagues did not really
believe that a pandemic vaccine would be needed.
And the response to that point from Pfizer was no. And I talked
with Pfizer CEO about this. And he was saying essentially at
that point early on, he was really focused on Pfizer's
operations in China, Pfizer's people in China, and he wasn't
yet thinking about developing a vaccine.
Undeterred, BioNTech initially went at it alone, developing not
just one but for vaccine candidates. The company started
preparing for phase one clinical trials in Germany, which would
test the vaccine in humans. By this time, others were starting
to catch on.
COVID-19 can be characterized as a pandemic. Dow is now down more
than 1100 points as moments ago, the who has formally declared
the Coronavirus, a global pandemic.
And now the extreme new measures in the US. Large events banned
in Washington State and San Francisco. As U.S. cases rise
over 1000. Less
than a week after the pandemic was declared Pfizer agreed to
work with BioNTech to help them scale up their clinical trials
production and distribution.
We had our first patient in on on April 23. It was the first
volunteer and in July, we started phase three clinical
trial. This was already in partnership with Pfizer, which
allowed us to move fast from the early stage of clinical
development to the to the latest stage of development.
So as they were starting phase one they were designing and
figuring out phase two as they were getting into phase two,
they were figuring out these massive phase three clinical
trials that they managed to start in the summer, and the FDA
and regulators globally were working on being incredibly
flexible.
Over 43,000 participants were enrolled in the company's phase
three trials, which measured how many vaccinated participants
contracted Covid compared to the unvaccinated placebo group.
Sahin and Tureci we're by no means certain that the vaccine
would work at all.
We knew that vaccine is able to activate the immune system, but
it didn't know whether the immune system is able to control
the virus. So as a scientist, my expectation was it would be
great if we have 70% efficacy. But I was also aware that if the
immune system is not able to control we might have just a
negative result and getting the call on Sunday evening and
hearing that we have 95% efficacy. This was
extraordinary, of course high much higher than than we had
expected.
And it brought this just amazing hope that we would be able to
start fighting back against this virus. And I think everybody who
got that news felt like their lives changed.
Over 1.75 billion doses of the Pfizer-BioNTech vaccine have
been delivered worldwide. And perhaps obviously BioNTech is
finally making money. With a market cap of nearly 60 billion,
the company made over $4.5 billion in profit in the first
two quarters of 2021. As the United States and European
Commission governments have entered into massive contracts
to buy hundreds of millions of doses. And BioNTech's stock has
seen a rise of over 500% since January of 2020.
In the second quarter alone, they brought in more than 5
billion euros in revenue. That compares to just about 40
million that they took it in the second quarter of last year. So
this has been a transformative year for BioNTech.
In August, the Pfizer-b vaccine became the first to gain full
FDA-approval, helping pave the way for a return to normal life.
But there's still a long way to go. Over half of the world
remains unvaccinated. And the virus is mutating into new, more
infectious variants like the Delta strain, which is ripping
through communities worldwide.
Our work on Covid is still a large part of our activities in
the company, obviously, because there is still a long path to go
until we have manufactured sufficient supply to ensure that
all those who want to be vaccinated and need to be
vaccinated get the vaccine.
In September, Pfizer submitted data to the FDA demonstrating
that a booster given six months after the second shot restores
immunity to 95%. Currently, the FDA has authorized boosters of
the Pfizer-BioNTech vaccine for certain vulnerable populations
such as those over 65.
My personal opinion is that we can't control the pandemic. And
we can't control this virus, if we don't enable that, that the
vast majority of the population stays immune.
And then there's the issue of kids. Currently, the
Pfizer-BioNTech vaccine is the only one authorized by the FDA
for use in children 12 and over though the two companies have
requested emergency authorization for ages five
through 11, after clinical trials showed positive results
when kids were given 1/3 of the normal dosage. But amidst their
ongoing Covid efforts, biontech has still found the time to
advance its oncology work.
Even during the pandemic, we have been able to initiate
multiple phase one clinical trials which meant bringing new
concepts, not only mRNA vaccines, but also other immune
therapies for the first time in human testing in cancer
patients. And we have also initiated advanced trials with
our cancer vaccines where we compare against standard of care
treatments.
We are of course excited to get the data and it could be as
exciting as COVID-19 efficacy data.
Sahin and Tureci emphasize that developing therapeutic cancer
vaccines which are administered after a patient has already been
diagnosed, are bound to be a much lengthier process and
developing the Covid vaccine. That's because of the time it
takes to recruit cancer patients for clinical trials and monitor
their condition over a number of years. Still, though they say
there's much to be learned from the rapid response to the
coronavirus pandemic.
Namely that it's important also on the regulator side to have
sufficient resources in order to enable very efficient work on
receivers for clinical trials approvals of drug approvals
processes, which could be much leaner and much faster.
The question is can be can we use that model also for other
severe diseases, and I believe we have to consider how to use
it. Because if you take for example cancer in the in the
time between 2020 beginning 2020 and now more patients die with
this cancer patients died by by COVID-19. So it is not a
pandemic, but it's an endemic.
Sahin and Tureci are modest about their success. They ride
their bikes to work and don't own a car or TV. And while their
company has grown from about 1300 employees at the beginning
of 2020 to around 2500 today, it's still minuscule compared to
the likes of Pfizer, which employs about 78,000 people
worldwide. But what the influx of money and attention will
change is the level to which BioNTech can invest in and
accelerate its other endeavors.
We have now the chance to invest to accelerate our cancer
immunotherapies. We have the chance to make it bolder. We
have the chance to go in other fields.
It's also very valuable to acquire technologies or assets
which we otherwise would need to develop ourselves, which means
saving time and being faster to bring medicines to patients.
In July, BioNTech acquired Kite Pharma cell therapy platform as
well as its Maryland based manufacturing facility. Kite is
also focused on developing cancer immunotherapy products.
And Sahin said in a statement that the acquisition will
accelerate BioNTech's development of novel cell
therapies in the US. And the company is expanding beyond the
oncology space too.
In the next years, we will certainly see that we will enter
into clinical development for infectious disease vaccines like
malaria, tuberculosis, HIV continue to work in the cancer
field, start projects in the autoimmune fear stat projects
for treatment of inflammatory diseases, and have also projects
in the field of regenerative medicine.
Since the pandemic began, companies developing mRNA
technologies have raised billions of dollars combined.
And according to roots analysis, and India base biopharma
research firm, there are over 150 mRNA based vaccines and
therapies in development.
The Covid-19 pandemic provided this incredible proof of concept
for messenger RNA. It showed it really works as a vaccine
against this Coronavirus. Now the question is, will this
really work as a vaccine against flu? Will this really work as a
drug for cancer? Those questions are not yet answered.
For their part, Sahin and Tureci say the Covid vaccine is just
the beginning.
I believe that mRNA as a technology will be
transformative for the biopharma space mRNA can be used not only
for vaccines for all sorts of pharmaceuticals, and yet,
biotech, we are actually already doing it.
I expect that in about 15 years, about 30% of new products
develop they'll be based on mRNA therapies and that will not only
include products which are copying existing products or
replacing them, but very completely new type of medicines
which are made possible only because this technology is now
available. And this is of course exciting, to become part of this
future and to drive the development of new medicines
this this this type of technology.