Centered on revolutionary science, the story of mRNA technology as a new class of drug is packed with passion and brilliance.

The PMWC Sep 23-24, 2021 Pittsburgh conference will honor with the PMWC 2021 Luminary Award Dr. Ugur Sahin and Dr. Özlem Türeci, co-founders of BioNTech and co-developers of the Pfizer Vaccine who, more than almost anyone else in the world, have contributed to the global response to the 2019 novel coronavirus pandemic. See the other speakers and program here.

Over the past eighteen months, the lifes’ work of this husband and wife team has been catapulted into the global spotlight due to the pandemic; it is their powerful mRNA vaccines against COVID-19 that now protect much of the world’s population.

“For us it was about protecting people and saving lives. We understood how SARS-CoV-2 is spread, and we were able to adapt the mRNA technology to develop the COVID-19 vaccine so quickly and effectively because we had made so much progress in the previous 10 years.” – Dr. Ugur Sahin

This story begins over two decades ago when Ugur Sahin met Özlem Türeci while studying in Cologne, Germany. Both of Turkish descent, they were immediately inseparable.

Half a lifetime later, Dr. Sahin and Dr. Türeci sold their first company, Ganymed Pharmaceuticals, to Astellas in 2016 for $1.4B.

It is their second company, though, that stands to make an even greater impact on the world.

Like Ganymed, Dr. Sahin and Dr. Türeci launched BioNTech in 2008 with the goal of treating cancer, but they created BioNTech specifically to explore a wider range of technologies at the cutting edge of science.

After raising hundreds of millions of dollars in funding and growing to a staff of over 1,800, BioNTech partnered with Pfizer in 2018 with the goal of developing an improved vaccine for influenza, with offices in Germany and the United States.

That all changed, though, in March of 2020, when human world stopped on its axis. We the world confronted a global pandemic, the husband and wife duo shifted their efforts to developing a vaccine against the coronavirus.

In parallel, the 10-year-old biotech Moderna was employing the very same synthetic mRNA technology to create an effective vaccine against COVID-19, and in December 2020, within three weeks of one another, the Moderna (mRNA-1273) and Pfizer/BioNTech (BNT162b1) vaccines were both granted emergency-use-authorization by the FDA. Of the nearly three-dozen vaccine candidates created at the start of Operation Warpspeed, these were the first two to cross the finish line, with efficacies far higher than the rest of the field, and Pfizer’s manufacturing powers scaled-up production.

The BioNTech messenger RNA vaccine was by far the most rapid development and deployment of any response to a public health crisis in the history of the world, and history had been made.

The Potential of mRNA Technology Beyond SARS-CoV-2

In 2014 Sahin, Türeci, and Kariko summarized in Nature a review the potential of mRNA as a new drug class, writing that, “Synthetic mRNA can be engineered to transiently express proteins by structurally resembling natural mRNA,” and that “…advances in addressing the inherent challenges of this drug class, particularly related to controlling the translational efficacy and immunogenicity of the IVTmRNA, provide the basis for a broad range of potential applications.”

Since that review, mRNA-based cancer immunotherapies and infectious disease vaccines have entered clinical development.

As a result of the successful BioNTech vaccine, interest in mRNA-based therapeutics, specifically mRNA-based vaccines against cancer, has increased exponentially, and the subject has moved to the forefront of scientific discussion.

According to Dr. Türeci and Dr. Sahin, there are several big lessons learned from the success of the BioNTech COVID-19 vaccine, all of which can be extended to treating disease beyond COVID-19:
• an mRNA vaccine, delivered at a well-tolerated dose, is able to induce neutralizing antibody responses and strong CD8+ and CD4+ T cell responses;
• mRNA vaccines have the ability to extend protection against disease, reduce the severity of a disease, confer an improved outcome, thus reduce infection rates and hospitalization frequencies;
• an mRNA vaccine can induce a robust immune response not just against the virus, but also against its emerging variants with no significant reduction in efficacy;
• mRNA vaccines are well-positioned for booster administration, given not only the short amount of time required for development and production but also a favorable profile of tolerability, as demonstrated after repeat administration.

“With the coronavirus vaccine, we have gone through all the stages of development, but we have not reached these benchmarks with the cancer vaccines yet. We can now bring those lessons and expertise to bear in the cancer projects. Of course, we need further data for each additional drug, and you can’t just extrapolate things, but regulators around the world have seen very clearly how mRNA works, what the safety and tolerability profile is, and what quality testing of the production can look like. So we now have presented to them important information, although we are not yet as far along in the development of actual cancer vaccines.” – Dr. Özlem Türeci

The Superpower of Cancer Vaccines Might Best Help Patients with Early-Stage Disease

“Our vision is to be able to use the immune system to fight cancer. That’s what we are doing with BioNTech. We have developed a series of immune-therapy approaches, and mRNA is one of four. We are using it as part of a range of methods to attack tumors from different angles.” – Dr. Özlem Türeci

Interestingly, several of the newest cancer vaccines train the immune system to recognize ‘tumor-associated antigens’ that are shared between patients, while several others focus on ‘neoantigens’ that are unique to each patient and his or her specific cancer occurrence. While unique challenges remain – for example, shared, non-neoantigens are only weakly immunogenic and therefore do not represent viable molecular targets for therapy – one of Dr. Sahin’s recent trials in melanoma has demonstrated that, in patients who had already received significant treatment on checkpoint blockade therapy, the addition of a tumor-associated antigen vaccine resulted in a significant objective response in a large percentage of patients.

“BioNTech is currently testing mRNA-based treatments against specific cancer types in Phase II Trials. Depending on whether those studies are successful, we imagine that we could have a package for initial submission to the authorities in 2024.” – Dr. Ugur Sahin

The September 23-24 PMWC 2021 Pittsburgh program will include several talks by Dr. Sahin and Dr. Türeci: “On COVID Vaccine Lessons Learned,” and “mRNA Technology Beyond COVID.”

These are a large number of exciting developments like these in the new area of therapeutics, specifically the future of cancer treatments at the intersection of mRNA-mediated therapeutic delivery and cell-checkpoint control.

Lastly, and most importantly, we are incredibly fortunate that Dr. Ugur Sahin and Dr. Özlem Türeci will discuss their work, the challenges in mRNA technology, and the future of the field part in a more relaxed, fireside chat format at PMWC this September.

Please join us to learn about the potential mRNA-based therapeutics from two of the most important key pioneers in the field at the intersection of human health and synthetic biology.
Catch the current rates before they expire in a few days!

Sincerely,

Tal Behar
President, PMWC
650-961-8877