October 7, 2019
By Wellington Sun, M.D.
Head of Vaccine Strategy and Regulatory Affairs
One of the most rewarding parts of research is the opportunity to share and discuss findings with others. Last week, we were excited to present data from two of our prophylactic infectious disease vaccines at our very first IDWeek and engage with the infectious disease community from around the world.
This annual meeting, which drew around 11,000 attendees from more than 90 countries, highlights the incredible work being done in the field of infectious diseases that has an enormous impact on global public health. Today many infectious diseases still await a preventative vaccine.
We believe mRNA has the potential to become a new class of vaccines, with the ability to overcome many of the hurdles that face traditional vaccine development. First, our mRNA-based vaccines in development mimic natural infection and may even stimulate a more potent immune response. Second, because it is a platform, it allows for encoding of multiple antigens by combining multiple mRNAs into a single vaccine. Finally, synthetic mRNA production allows for rapid manufacture to quickly respond to emerging pandemic threats through a streamlined manufacturing process. We will push the boundaries of this platform so that the technology can reach its full potential. We are optimistic that a mRNA approach could work for many infectious diseases.
We’ve seen encouraging clinical results from this approach. To date, we’ve announced six positive Phase 1 readouts from our prophylactic vaccines modality. Most recently, we announced positive Phase 1 data showing the ability of our cytomegalovirus (CMV) vaccine (mRNA-1647) to induce high levels of durable immune responses similar to or exceeding the levels seen with natural infection. CMV is the most common infectious cause of birth defects in the U.S., so this was a particularly exciting milestone. Traditional CMV vaccine development has been thwarted by many challenges along the way, and there is currently no approved vaccine to prevent CMV. These new results represent a step closer to a safe and effective CMV vaccine.
Moderna Data at IDWeek 2019
At IDWeek 2019, we also presented Phase 1 data from mRNA-1653, our combination vaccine against human metapneumovirus (hMPV) and parainfluenza virus type 3 (PIV3), as well as preclinical data from mRNA-1893, our Zika vaccine.
hMPV and PIV3 are two viruses that can cause severe respiratory diseases in infants and children, and there are currently no approved vaccines for either. mRNA-1653 is designed to protect against both by encoding for specific antigens from each of these viruses.
Our data show that mRNA-1653 boosted hMPV and PIV3 neutralizing antibody titers above baseline, and the titers persisted through seven months in participants previously exposed to the viruses (seropositives). An interim safety analysis at one month after the second vaccination showed the vaccine was generally well-tolerated at all dose levels. Of note, mRNA-1653 tended to induce a greater boost in neutralizing antibody in participants with lower baseline titers, particularly for PIV3, regardless of dose. The most common solicited systemic adverse events were headache, fatigue and myalgia, and appeared to increase with dose level. You can learn more about the data from our poster presentation (Abstract 2754). As a next step, we plan to initiate a Phase 1b study in seropositive toddlers.
We were also excited to see our collaborator, Dr. Brett Jagger of Washington University, present preclinical data from mRNA-1893, our Zika vaccine. Zika virus continues to be a global public health concern, particularly in women during pregnancy who may pass the virus on to their developing child, leading to potential birth defects.
The data show mRNA-1893 induced a robust antibody response and provided complete protection against transmission of Zika during pregnancy in mice. You can learn more about these findings in The Journal of Infectious Diseases. Currently, mRNA-1893 is in a Phase 1 study evaluating safety and immunogenicity in healthy volunteers and was recently granted FDA Fast Track Designation. mRNA-1893 is being developed with funding from the U.S. Department of Health and Human Services HHS); the Office of the Assistant Secretary for Preparedness and Response; and the Biomedical Advanced Research and Development Authority (BARDA).
Our Commitment to Infectious Diseases
We recognize the significant burden of infectious diseases around the world. And that is why we are so encouraged by the potential of mRNA as an approach to vaccines based on these data.
We designed our mRNA prophylactic vaccines to prevent or control infectious diseases. This modality now includes seven programs. Respiratory viruses are a special focus for Moderna, with four of the programs in this modality aimed at preventing respiratory illnesses, including respiratory syncytial virus (RSV), hMPV+PIV3 and influenza. We look forward to advancing these candidates and sharing future data from our ongoing clinical trials.
As vaccines continue to be the best hope to control infectious diseases, it’s critically important that the field presses forward with research and innovation, and perseveres in making safe and effective vaccines a reality. It was a privilege to participate in this year’s IDWeek and share with the infectious disease community our optimism for the future.
Special Note Regarding Forward-Looking Statements
This blog contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended including, but not limited to, statements concerning:
the potential of mRNA to become a new class of vaccines, with the ability to overcome many of the hurdles that face traditional vaccine development; mRNA’s ability to mimic natural infection and stimulate a more potent immune response; Moderna’s ability to rapidly manufacture mRNA to quickly respond to emerging pandemic threats through a streamlined manufacturing process; the potential for mRNA vaccines to prevent many infectious diseases; and the initiation of a Phase 1b study in seropositive toddlers for mRNA-1653. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this blog 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, among others: whether the results for mRNA-1647 and mRNA-1653 will be predictive of any future clinical studies; whether mRNA-1647 and mRNA-1653 will be unsafe or intolerable during further clinical studies; the fact that clinical development is lengthy and uncertain, especially for a new class of medicines such as mRNA, and therefore our clinical programs or development candidates may be delayed, terminated, or may never advance; no mRNA drug has been approved in this new potential class of medicines, and may never be approved; mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new class of medicines; and those 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 www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements in this blog 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.