Working relentlessly to deliver the greatest possible impact to people through Moderna’s mRNA platform
Moderna is harnessing the power of mRNA to create a new category of medicines to impact human health.
By WP Creative Group
March 27, 2023
Nearly 13 years ago, Moderna set out to study whether it is possible to instruct a patient’s own cells to produce proteins that may have the potential to treat a wide range of conditions with mRNA. We set out in 2010 with a mission: Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
Since our founding, we have built a diverse clinical portfolio of mRNA vaccines and therapeutics across seven modalities. We have pioneered the development of our mRNA platform and have expanded our mRNA pipeline to 48 programs in development including 38 in clinical studies.1
We now possess the necessary data, experience and expertise needed to develop innovative medicines and continue to advance the promise of mRNA science. With this, we are harnessing the power of mRNA to create a new category of medicines. We recently announced our new, evolved mission: Deliver the greatest possible impact to people through mRNA medicines.
We believe our mRNA platform could potentially solve some of the world’s greatest health challenges—from diseases impacting millions to medicines personalized down to the individual level—and we are working relentlessly to maximize our impact on human health.
What is mRNA?
mRNA is a naturally occurring part of the human body, and it exists in our cells. It functions as an information molecule, teaching the body how to make its own medicines in the form of protein. Each mRNA carries instructions like a blueprint to make a specific protein. Cells interpret this blueprint and put the protein together. Once mRNA does its job, it is broken down by the body. Moderna’s mRNA technology allows its scientists to create instructions to make different proteins that could help the body fight infections or prevent diseases.
Personalized cancer vaccine
A personalized cancer vaccine (PCV) targets an individual patient’s unique tumor mutations to selectively treat their cancer.2 Moderna’s PCV program is being developed in collaboration with Merck and is designed to stimulate an immune response by boosting T cells, which are believed to be necessary for recurrence-free survival.
We recently announced interim data from the Phase 2 study3 of our investigational personalized cancer vaccine in combination with KEYTRUDA® (pembrolizumab) in patients with resected melanoma at high risk of recurrence, compared to KEYTRUDA alone. We expect to begin additional studies in melanoma and other forms of cancer with the goal of bringing truly individualized cancer treatments to patients.
mRNA therapeutic candidates for rare diseases
In rare diseases, our programs aim to deliver mRNA into target organ cells as a therapeutic approach for diseases caused by a missing or defective protein. We are excited about a number of clinical trials in this therapeutic area.
The Phase 1/2 study4 of our Propionic Acidemia (PA) candidate is ongoing. The Phase 1/2 study5 of our Methylmalonic Acidemia (MMA) program is ongoing and the first two groups of patients are fully enrolled. We are recruiting participants in the United Kingdom, Canada and the United States.
We are also evaluating6 the safety, tolerability and pharmacology of a single IV dose of our therapeutic candidate for Glycogen Storage Disease Type 1a (GSD1a) in adult participants in a Phase 1 study. Enrollment is ongoing.
Based on proof-of-concept data and leveraging our learnings from our rare disease programs, we recently announced a new development candidate for ornithine transcarbamylase (OTC) deficiency, which uses the same lipid nanoparticle (LNP) as our GSD1a program. This is our sixth rare disease candidate.
Late-stage respiratory vaccine candidates
In January 2023, we announced interim data from the Phase 3 study7 of our respiratory syncytial virus (RSV) vaccine candidate in adults 60 years of age and older. From the first older adult participant in the Phase 1 study of our RSV vaccine candidate dosed in January 2021 to announcing Phase 3 data, we have accelerated this program, spending approximately two years in development.
Since RSV also causes a significant disease burden in children,8 we are studying our RSV vaccine candidate in an ongoing Phase 1 trial9 in pediatric populations.
Our late-stage respiratory vaccine pipeline continues to progress. We recently announced interim data from the Phase 3 study10 of one of our seasonal influenza vaccine candidates. This is one of five that we are evaluating.
Combination vaccine candidates
We are also researching several combination respiratory vaccine candidates. By pursuing combination vaccines to protect against a range of diseases, we can potentially help decrease morbidity and mortality from respiratory disease, lower systemic costs and increase health security globally. The Phase 1/2 study11 of our combination vaccine candidate targeting SARS-CoV-2 and influenza is fully enrolled. We have begun clinical trials for a combination vaccine candidate targeting SARS-CoV-2, influenza and RSV and a combination vaccine candidate targeting influenza and RSV.
Late-stage latent virus vaccine candidate
Once a human is infected by a latent virus, virus remains in the body and can lead to lifelong medical complications. We are committed to developing a portfolio of vaccine and therapeutic candidates against these latent viruses. To date, we have enrolled more than 40 percent of anticipated participants12 in the Phase 3 study13 of our cytomegalovirus (CMV) vaccine candidate. Enrollment is ongoing in the United States and internationally.
Our global public health strategy
Since our founding, we have focused on developing a global health vaccine program and in 2022, we announced our global public health strategy, renewing that focus by expanding our work to develop investigational vaccines against priority pathogens that threaten global health and by launching our new mRNA Access program.
As part of this global public health strategy, we plan to advance a portfolio of 15 mRNA vaccine programs targeting emerging or neglected infectious diseases into clinical studies by 2025, advancing vaccines that address current diseases of significant impact to low- and middle-income countries and those that prepare for Disease X.
We believe the world needs novel, innovative approaches to address both known and emerging infectious diseases and we know that we can’t go it alone. We are committed to bringing the full force of our mRNA vaccine platform to develop vaccines against priority pathogens that threaten global health including HIV, tuberculosis, malaria and neglected tropical diseases.
As part of our global public health strategy, we launched our mRNA Access program to create a community of global scientists who can access our mRNA vaccine technology from anywhere in the world. We look forward to working with global partners and to being part of the solution to potentially prevent future pandemics.
We will continue to transparently report on our progress in our ESG Report, the first of which published in June 2021.
The future potential of mRNA
Because mRNA is an information molecule, our hypothesis has always been this: If we invest in science over time, we may be able to create many applications of this technology, potentially bringing mRNA to different cell types. More than a decade later, we believe Moderna will become one of the most impactful healthcare companies in the world.
1https://investors.modernatx.com/news/news-details/2023/Moderna-Reports-Fourth-Quarter-and-Fiscal-Year-2022-Financial-Results-and-Provides-Business-Updates/default.aspx
2https://www.nature.com/articles/s43018-022-00418-6
3https://clinicaltrials.gov/ct2/show/NCT03897881
4https://clinicaltrials.gov/ct2/show/NCT04159103
5https://clinicaltrials.gov/ct2/show/NCT04899310
6https://clinicaltrials.gov/ct2/show/NCT05095727
7https://clinicaltrials.gov/ct2/show/NCT05127434
8https://www.cdc.gov/rsv/index.html
9https://clinicaltrials.gov/ct2/show/NCT04528719?intr=mRNA-1345&age=0&draw=2&rank=1
10https://clinicaltrials.gov/ct2/show/NCT05415462
11https://clinicaltrials.gov/ct2/show/NCT05375838
12https://investors.modernatx.com/news/news-details/2023/Moderna-Reports-Fourth-Quarter-and-Fiscal-Year-2022-Financial-Results-and-Provides-Business-Updates/default.aspx
13https://clinicaltrials.gov/ct2/show/NCT05085366
Forward-Looking Statement Disclaimer
This piece contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the potential of mRNA medicines; Moderna’s plans regarding additional studies of its PCV program in melanoma and other forms of cancer; the potential benefits of combination vaccines; Moderna’s global public health strategy, including its plans to develop vaccines against priority pathogens; the potential launch and approval of additional products by Moderna; the safety and tolerability of Moderna’s products in clinical development; and the advancement of clinical trials. The forward-looking statements in this piece are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (“SEC”) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this piece in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.
Programs outlined in this article are in clinical development and have not been approved by FDA or any other regulatory agency for any indication.
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