A Milestone Week at Moderna
April 28, 2017
Chief Executive Officer, Moderna
Welcome to the Moderna Blog.
We’ve considered launching this blog for a while – and this week seemed like the perfect time.
Why launch a blog? We wanted to have a channel to communicate directly and more personally to all those interested in Moderna.
We plan to share insights and our viewpoint on important topics related to our company, our science and pipeline, and our industry as a whole. The blog also will give various team members a platform to talk about what motivates, inspires and drives them in their work here.
Why launch a blog this week?
In the first 18 months of the company, we did not know if our mRNA drug products were going to be efficacious safely in non-human primates, so we decided not to have a website or communicate externally, and be patient until we had the scientific data in hand.
Yesterday we published the first human data for our mRNA medicines.
The publication, which is now online in the journal Molecular Therapy, included data from a 100 µg cohort from our ongoing Phase 1 study of mRNA-1440, our first mRNA vaccine candidate, which is for a strain of avian influenza with pandemic potential. We saw 100% efficacy in this cohort based on an approvable FDA endpoint and 0% efficacy as expected in the 25% placebo controlled arm.
While we plan to publish full data once we complete this study next year with the 12 month safety monitoring of the subjects, our first human data publication is a very big milestone for our company.
It gives us proof-of-concept not only for our vaccine technology but also for our overall approach and our core mRNA platform technology. We have demonstrated that we can direct the body’s cells, safely and effectively, to produce proteins.
We appreciate that these Phase 1 study data represent early results and don’t guarantee that Moderna will bring mRNA vaccines and therapeutics to market. Making medicines is hard. Making new medicines is even harder.
But these data, coincidentally published during World Immunization Week, certainly give us confidence that we’re on the right track.
Dr. Orin Levine, Director of Vaccine Delivery at the Bill & Melinda Gates Foundation recently wrote this about the potential of mRNA vaccine technology:
Their work represents a huge opportunity for resource-poor countries—and could be a game-changer in fighting global pandemics … It’s exactly the type of advancement that matters most in medicine, and from my view, an especially exciting example of how cutting-edge science can be harnessed for the global good.
You can read Dr. Levine’s full article, “The Immunization ‘Innovations of Tomorrow’ Are Here Today” here.
The potential impact of our mRNA medicines to advance global health and save lives is energizing – and humbling. From this vantage point, we consider bringing our mRNA vaccines and therapeutics to market a societal responsibility.
As we mark this milestone of our first human data publication, there are many people I want to thank who have made this clinical trial and our overall progress to date possible. Thank you to …
… our partners, whose commitment and collaboration is enabling us to explore the broad potential of mRNA technology across a spectrum of diseases, and advance multiple development and research programs simultaneously.
… our suppliers and vendors, whose expertise and attention is helping us accelerate the pace of mRNA drug research and development.
… our investors for their ongoing belief and trust in our company and our management team to execute on our ambitious strategy.
Above all, I want to thank our employees, whose dedication and persistence is enabling us to drive toward our mission to deliver on the promise of mRNA medicines to create a new generation of transformative medicines for patients.
In January, we highlighted our full development pipeline, which comprises 12 development candidates, five of which currently are in clinical study.
In February, we published preclinical data in Cell related to our Zika mRNA vaccine (mRNA-1325) currently in Phase 1/2 study.
And yesterday we published preclinical data on our first two vaccine programs, as well as our first human data.
In the months ahead, we look forward to sharing more data and milestones.
Nobody has ever made a medicine alone. And we are no different. We are so grateful for all of our employees, partners, collaborators and supporters on this incredible journey.
What if mRNA could be a drug? This question has led us since the inception of Moderna – and continues to excite and motivate us today.