a preparation of killed microorganisms, living attenuated organisms, or living fully virulent organisms that is administered to produce or artificially increase immunity to a particular disease
The mRNA molecule
makes us a drug factory
Roughly two years ago, an obscure news story that most of us understandably missed provided a first glimpse of the science involved in carefully designing molecules called messenger RNA (mRNA), which uniquely prompt the body to make its own medicine. A biotech event in Cambridge, Mass., hosted by Moderna Therapeutics, a company that most of us had never heard of but has since become famous, took the wraps off mRNA. As Moderna president Stephen Hoge explained to his enthralled audience: “…all life that we know flows through messenger RNA. . . . In our language, mRNA is the software of life.”
Hoge went on to explain that cells use mRNA to translate the genes of DNA into proteins. These proteins are involved in every bodily function. Normally, biotech companies produce many of these proteins as drugs and indeed stockpile them in large vats for eventual distribution. But what if mRNA could be therapeutically introduced into people’s bodies in ways that put the drug factory inside each one of them?
While the idea, of course, is conceptually very appealing, implementation is not. The key problem and challenge for biotechnology is that when mRNA is injected into the body, it triggers sensors that nature designed to guard the body against viruses. These virus-detecting sensors cause cells to shut down protein production. Thus, doing their genetic job, the sensors foil therapy. But what if an mRNA molecule somehow makes it into a cell? The mRNA might not make enough protein to actually fulfill its therapeutic mission.
Continued from the emailed newsletter
Two years ago, Moderna had already spent more than a half billion dollars and employed more than 600 scientists to implement a long-term vision to transform the drug industry. This was almost two years before COVID-19 arrived. Other companies and research centers also had started to develop similar protein therapies called biologics. Then, SARS-COV-2 engulfed the world in the COVID-19 pandemic, triggering vast new infusions of capital into mRNA research and development.
At the same time that Moderna held its mRNA unveiling in 2018, BioNTech (Biopharmaceutical New Technologies), a world leader in oncology R&D based in Germany, was developing therapeutic drug platforms for the rapid development of mRNA-based therapies. Probably no pharma company in the world had more expertise in mRNA vaccine development as well as in-house manufacturing capabilities. Probably most important was that from the outset, BioNTech has been committed to establishing collaborations with global pharma companies, including Sanofi, Bayer, Genentech, Roche, and Pfizer.
The relationship with Pfizer has developed into a world leader in mRNA-based vaccine development which has entered a Phase III clinical study to evaluate the efficacy of modRNA against SARS-CoV-2. Slated to enroll more than 30,000 participants, the Phase III study has already dosed more than 11,000 participants as of the beginning of September 2020. The results thus far are promising. As the Pfizer head of vaccine research and development Kathrin Jansen said in a statement. “We are especially pleased to offer early data showing our vaccine candidates’ promising safety and immunogenicity profile from the U.S. trial, and we look forward to sharing T-cell immune response data from the German trial in the near future.”
Based in Cambridge, Mass., not far from Moderna’s HQ, BioNTech US serves as BioNTech’s North American headquarters. Assuming clinical success for the vaccine, Pfizer and BioNTech will seek regulatory review and authorization in the next few months to produce up to 100 million doses of a COVID-19 RNA vaccine by the end of 2020 and more than a billion doses by the end of 2021. Of course it remains yet to be seen whether any COVID-19 vaccine candidate provides long-term protection such that annual vaccinations would be enough to guard against infection. St. James Faith Lab will be closely following the progress of modRNA and other vaccines in late-stage development and trials including Moderna’s mRNA-1273, also an mRNA vaccine which AstraZeneca licensed from the University of Oxford in the U.K. (This is not the same vaccine as AZD1222, whose clinical trial was temporarily halted on Sept. 8 when a participant in the U.K. experienced an adverse reaction.)
We will continue to follow developments relating to the vaccine and COVID-19 in general.
The Rev. Canon Cindy Evans Voorhees
St. James Faith Lab