Subtitles section Play video Print subtitles 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.
B1 US mrna cancer pfizer clinical covid pandemic How BioNTech Used Cancer Research To Create Its Covid Vaccine 15 3 joey joey posted on 2021/10/28 More Share Save Report Video vocabulary