Moderna Announces Progress in Prophylactic Vaccines Modality with CMV Vaccine Phase 2 Study Data Now Expected in Third Quarter 2020 and Expands Investment in This Core Modality with Three New Development Candidates
Phase 2 CMV vaccine dose-confirmation study more than sixty percent enrolled
mRNA-1189 to prevent infectious mononucleosis and Epstein-Barr virus (EBV) infection
mRNA-1345 to prevent respiratory syncytial virus (RSV) disease in young children, with the intent to combine with mRNA-1653 to create a pediatric respiratory vaccine against RSV, hMPV and PIV3
mRNA-1273 to prevent novel coronavirus (2019-nCoV) disease, in collaboration with the
Moderna’s CMV vaccine (mRNA-1647), the first mRNA vaccine for an infectious disease to enter a Phase 2 study, is enrolling ahead of plan with the second cohort nearly completed. This Phase 2 study will investigate the safety and immunogenicity of mRNA-1647 in approximately 252 healthy adults in the U.S. at three dose levels (50, 100 and 150 μg) in both CMV-seronegative and CMV-seropositive participants administered in a three-dose vaccination schedule (0, 2 and 6 months). The first interim analysis, expected in the third quarter of 2020, will evaluate safety and immunogenicity at three months (one month after the second vaccination) and is intended to inform Phase 3 dose selection. The Company is actively preparing for a Phase 3 pivotal study, which will evaluate prevention of primary CMV infection in a population that includes women of childbearing age.
The development candidates announced today are mRNA vaccine candidates against Epstein-Barr virus (mRNA-1189), respiratory syncytial virus (mRNA-1345) in young children, and the novel coronavirus (mRNA-1273). mRNA-1345 will be evaluated in early clinical trials with the intention of combining the vaccine with mRNA-1653, Moderna’s hMPV/PIV3 vaccine, to address RSV, hMPV and PIV3, viruses that cause significant respiratory diseases in young children, in one vaccine. Each of these new development candidates utilizes the Company’s proprietary lipid nanoparticle (LNP) technology.
Today’s announcement reflects the Company’s belief that positive Phase 1 safety and immunogenicity data across nine studies with more than 1,000 participants have validated the Company’s prophylactic vaccine modality. Clinical data demonstrate that Moderna’s proprietary vaccine technology has been generally well-tolerated1 and can elicit durable immune responses to viral antigens. The Company also believes that it has demonstrated the ability to leverage shared technology, digital systems and its flexible manufacturing infrastructure to advance a large portfolio quickly and efficiently.
“Our investments in science and manufacturing have resulted in six positive Phase 1 infectious disease vaccine readouts. These data validate the technology used in our prophylactic vaccines modality, which has allowed us to accelerate research and development timelines, and advance our mRNA vaccines into new areas of high unmet need. I am pleased with the continued progress of our late-stage CMV vaccine program as we prepare for a pivotal Phase 3 study and commercial readiness. The three new development candidates reflect the continued productivity of our platform and the potential of our mRNA technology.
About Moderna’s New Development Candidates
- mRNA-1189 is an mRNA vaccine against Epstein-Barr virus (EBV) containing five mRNAs that encode viral proteins in EBV, gp350, gB, gp42, gH and gL. Similar to Moderna’s CMV vaccine (mRNA-1647), the viral proteins in mRNA-1189 are expressed in their native membrane-bound form for recognition by the immune system. There is no approved vaccine for EBV.
- mRNA-1345 is an mRNA vaccine against respiratory syncytial virus (RSV) in young children encoding for a prefusion F glycoprotein, which elicits a superior neutralizing antibody response compared to the postfusion state. The Company intends to combine mRNA-1345 with mRNA-1653, its vaccine against hMPV and PIV3, to create a combination vaccine against RSV, hMPV and PIV3. There is no approved vaccine for RSV.
mRNA-1273 is an mRNA vaccine against the novel coronavirus encoding for the viral Spike (S) protein, which was selected by
Modernain collaboration with the National Institutes of Health, the manufacture of which was funded by the Center for Epidemic Preparedness and Innovations(CEPI). The S protein complex is necessary for membrane fusion and host cell infection and has been the target of vaccines against the coronaviruses responsible for Middle Eastern Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). On January 13, the NIH and Moderna’s infectious disease research team finalized the sequence for the 2019-nCoV vaccine and Modernamobilized toward clinical manufacture. The first clinical batch, including fill and finishing of vials, was completed on February 7. This mRNA vaccine was designed and manufactured in 25 days and is undergoing analytical testing prior to release to the NIH for use in their planned Phase 1 clinical trial in the U.S. Currently, there are no approved vaccines specific to 2019-nCoV.
About Epstein-Barr Virus (EBV)
EBV is a common herpesvirus that is spread through bodily fluids, most commonly saliva, and contracted primarily by young children and adolescents (approximately 50% and approximately 89% seropositivity, respectively). It is a major cause of infectious mononucleosis (IM) in the U.S., accounting for over 90% of the approximately 1-2 million cases annually. IM can debilitate patients for weeks to months and, in some cases, can lead to hospitalization and splenic rupture. EBV infection is associated with the development and progression of certain lymphoproliferative disorders, cancers, and an increased risk of autoimmune diseases including multiple sclerosis (MS), an autoimmune disease of the central nervous system. There is no approved vaccine for EBV.
About Respiratory Syncytial Virus (RSV)
RSV is the leading cause of unaddressed severe lower respiratory tract disease and hospitalization in infants and young children worldwide, with most children infected at least once by two years of age. The virus is transmitted primarily via contamination of environmental surfaces with infectious secretions, and symptoms typically begin within several days of exposure. The illness may manifest as wheezing, bronchiolitis, pneumonia, hospitalization or even death.
About Coronavirus (2019-nCoV)
Coronaviruses are a family of viruses that can lead to respiratory illness, including Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). Coronaviruses are transmitted between animals and people and can evolve into strains not previously identified in humans. On
About Moderna’s Prophylactic Vaccines Modality
The potential advantages of an mRNA approach to prophylactic vaccines include the ability to mimic natural infection to stimulate a more potent immune response, combining multiple mRNAs into a single vaccine, rapid discovery to respond to emerging pandemic threats and manufacturing agility derived from the platform nature of mRNA vaccine design and production.
Vaccines against serious respiratory infections
Respiratory syncytial virus (RSV) vaccine for older adults (mRNA-1777 and mRNA-1172 or V172 with
- RSV vaccine for young children (mRNA-1345)
- Human metapneumovirus and parainfluenza virus type 3 (hMPV/PIV3) vaccine (mRNA-1653)
- Novel coronavirus (2019-nCoV) vaccine (mRNA-1273)
- Influenza H7N9 (mRNA-1851)
Vaccines against serious infections transmitted from mother to baby
- Cytomegalovirus (CMV) vaccine (mRNA-1647)
Zika vaccine (mRNA-1893) with the
Biomedical Advanced Research and Development Authority(BARDA)
Vaccines against common viral infections with high unmet need
- Epstein-Barr virus (EBV) vaccine (mRNA-1189)
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding plans for Moderna’s development candidates, plans to create a pediatric respiratory vaccine against RSV, hMPV and PIV3, plans regarding regulatory submission and clinical testing for mRNA-1273, expected timing of data from the Phase 2 study of mRNA-1647, and Moderna’s strategy, business plans and focus. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the
1 The most common adverse reactions in Moderna’s Phase 1 clinical trials in prophylactic vaccines include injection site pain, headache, myalgia, and fatigue.
Senior Manager, Corporate Communications
Head of Investor Relations