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mRNA-1647 |
Moderna |
CMV |
V1GL |
Yes |
Yes |
Started: Nov '17 |
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Modality: Prophylactic Vaccines | Therapeutic Area: Infectious Diseases / Viral Vaccines | Disease: Cytomegalovirus
About the Disease
Cytomegalovirus, or CMV, is a member of the herpes virus family. Often a person will not have any symptoms of viral infection. CMV leads to severe disease in two populations: newborns and transplant patients.
CMV is the most common cause of newborn disability, leading to deafness, microcephaly (small, not fully developed heads), vision loss and neurologic disabilities, among other serious complications. It is also the most frequent viral disease in transplant recipients, often leading to transplant failure.
There are currently no approved vaccines for CMV.
Our CMV mRNA Vaccine (mRNA-1647)
Our investigational CMV vaccine in development, mRNA-1647, combines six mRNAs encoding for six viral proteins, including five proteins that comprise the CMV gH Pentamer complex (gH, gL, UL128, UL130 and UL131A), as well as another CMV antigen, the herpesvirus glycoprotein (gB) protein. The mRNAs direct cells in the body to produce and express all six proteins on the cell surface, including the expression of gB and a fully formed Pentamer complex, or five proteins expressed as a single antigen, much like a native infection would do but without the ability to cause disease or spread. As a result, the body’s immune system responds as if the actual virus in present. The immune system produces antibodies against the Pentamer and gB that have the potential to neutralize the virus and prevent infections in the event the vaccinated person is exposed to the actual CMV virus in the future.
mRNA-1647 has been nominated as a development candidate and is progressing to GLP toxicology studies.
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mRNA-1653 |
Moderna |
HMPV/PIV3 |
V1GL |
Yes |
Yes |
Started: Dec '17 |
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Modality: Prophylactic Vaccines | Therapeutic Area: Infectious Diseases / Viral Vaccines | Diseases: HMPV / PIV3
About the Diseases
Human Metapneumovirus (HMPV) and Parainfluenza Virus 3 (PIV3) are both part of the paramyxovirus family.
Most children have been infected at least once with both viruses by the age of 5. The viruses typically cause mild respiratory illness, but can become severe in young children, the elderly and other immunocompromised adults. HMPV and PIV3 can lead to bronchitis, bronchiolitis, croup and pneumonia.
HMPV and PIV3 are the second and third most common causes, respectively, of lower respiratory hospitalizations in children, behind RSV. HMPV and PIV3 each cause 10 – 25% of respiratory infections in babies, and approximately 75,000 babies are hospitalized annually due to one or both of these viruses.
There are no approved vaccines for either HMPV or PIV3.
Our HMPV/PIV3 mRNA Vaccine (mRNA-1653)
Our investigational HMPV/PIV3 vaccine, mRNA-1653, is a multivalent vaccine, meaning it is designed to immunize against multiple pathogens, in this case HMPV and PIV3. We combine mRNA encoding for a viral antigenic protein associated with HMPV and mRNA encoding for a viral antigenic protein associated with PIV3 into a single vaccine. The mRNAs are delivered to the body and direct cells to produce and express both antigenic proteins on the cell surface, much like a native infection would do but without the ability to cause disease or spread. As a result the body’s immune system responds as if the actual virus is present. The immune system produces antibodies that have the potential to neutralize the viruses and prevent infections in the event the vaccinated person is exposed to HMPV or PIV3 in the future.
mRNA-1653 has been nominated as a development candidate and is progressing to GLP toxicology studies
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mRNA MRK-1777 |
Merck |
Undisclosed |
In Licensed |
Yes |
Yes |
Started: Nov ‘16 |
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Modality: Prophylactic Vaccines | Therapeutic Area: Infectious Diseases / Viral Vaccines | Disease: Undisclosed
Partnered Program; Led by Merck
A Phase 1 clinical study is underway for mRNA MRK-1777, an mRNA-based vaccine for an undisclosed infectious disease.
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mRNA MRK-V213 |
Merck |
Undisclosed |
Undisclosed |
No |
No |
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Modality: Prophylactic Vaccines | Therapeutic Area: Infectious Diseases / Viral Vaccines | Disease: Undisclosed
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mRNA-1440 |
Moderna |
Influenza H10 |
In Licensed |
Yes |
Yes |
Fully enrolled |
n/a** |
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Modality: Prophylactic Vaccines | Therapeutic Area: Infectious Diseases / Viral Vaccines | Disease: Influenza A virus subtype H10N8
About the Disease
Influenza, also known as the flu, is a contagious respiratory illness caused by influenza viruses. Two influenza A virus subtypes, H1N1 and H3N2, are currently in general circulation among people. A pandemic, or global outbreak, occurs when there is a genetic shift that causes a new influenza A virus to emerge and spread rapidly because people have little or no immunity to the new strain.
Our influenza vaccine program is focused on two influenza A virus strains, both with pandemic potential: H10N8 (mRNA 1440) and H7N9 (mRNA 1851).
Influenza A viruses are classified by subtypes based on two proteins on the virus’s surface: hemagglutinin (HA) and neuraminidase (NA). The H10N8 virus has the viral antigenic proteins H10 and NA 8.
Of our two pandemic flu vaccine programs, H10N8 has currently only infected three people in China in 2013 although two of them died. If the H10N8 was to become a pandemic the world would not currently have a vaccine.
Source: Centers for Disease Control and Prevention
Our H10N8 mRNA Vaccine (mRNA-1440)
Our investigational H10N8 vaccine is being developed to deliver mRNA encoding for the membrane-bound hemagglutinin 10 (H10) protein. The mRNA directs the cells to produce and express H10 on the cell surface, exactly as a native infection would do but without the ability to cause disease or spread. As a result the body’s immune system responds as if the actual virus is present. The immune system produces antibodies that have the potential to neutralize the virus and prevent infections in the event the vaccinated person is exposed to the actual H10N8 virus in the future.
Moderna strategically selected the H10N8 vaccine as one of its first two clinical development programs (the other, an H7N9 vaccine – mRNA-1851) in order to rapidly assess both the safety and efficacy of its mRNA platform in humans.
Because this strain is not circulating in the general population in Germany, where the trial is taking place, Moderna is able to study the efficacy of its vaccine technology in a naïve patient population. Antibodies present in subjects’ blood after treatment with mRNA-1851 are likely attributed to Moderna’s vaccine and not to active immunity as a result of previous exposure to the virus.
Studying mRNA vaccines for Influenza strains allows Moderna to measure vaccine efficacy against a well-understood endpoint, the hemagglutination inhibition assay, or HAI. HAI is used by U.S. FDA and World Health Organization (WHO) to measure how well antibodies bind to and inactivate an Influenza virus. Vaccines demonstrating titers of 1:40 are considered effective in reducing the risk for Influenza infection and are, thus, approved as seasonal flu vaccines.
Clinical Development
- Phase 1 dose-escalating, placebo-controlled, immunogenicity and safety trial in healthy adult volunteers
- Completed enrollment, with a total of 201 subjects enrolled. The study remains active, with subjects continuing to be followed
- Moderna plans to publish topline study findings in 2017 and complete findings in 2018 upon completion of the study and full data analysis
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mRNA-1851 |
Moderna |
Influenza H7 |
In Licensed |
Yes |
Yes |
Fully enrolled |
n/a** |
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Modality: Prophylactic Vaccines | Therapeutic Area: Infectious Diseases / Viral Vaccines | Disease: Influenza A virus subtype H7N9
About the Disease
Influenza, also known as the flu, is a contagious respiratory illness caused by influenza viruses. Two influenza A virus subtypes, H1N1 and H3N2, are currently in general circulation among people. A pandemic, or global outbreak, occurs when there is a genetic shift that causes a new influenza A virus to emerge and spread rapidly because people have little or no immunity to the new strain.
Our influenza vaccine program is focused on two influenza A virus strains, both with pandemic potential: H10N8 (mRNA-1440) and H7N9 (mRNA-1851).
Influenza A viruses are classified by subtypes based on two proteins on the virus’s surface: hemagglutinin (HA) and neuraminidase (NA). The H7N9 virus has the viral antigenic proteins H7 and NA 9.
H7N9 has a high potential of becoming a pandemic. More than 600 cases have been reported, to date, in China, with a mortality rate of approximately one in three infected people.
Source: Centers for Disease Control and Prevention
Our H7N9 mRNA Vaccine (mRNA-1851)
Our investigational H7N9 vaccine is being developed to deliver mRNA encoding for the membrane-bound hemagglutinin 7 (H7) protein. The mRNA directs the cells to produce and express H7 on the cell surface, much like a native infection would do but without the ability to cause disease and spread. As a results, the body’s immune system responds as if the actual virus is present. The immune system produces antibodies that have the potential to neutralize the virus and prevent infections in the event the vaccinated person is exposed to the actual H7N9 virus in the future.
Moderna strategically selected the H7N9 vaccine as one of its first two clinical development programs (the other, an H10N8 vaccine – mRNA-1440) in order to rapidly assess both the safety and efficacy of its mRNA platform in humans.
Because this strain is not circulating in the general population in the U.S., where the trial is taking place, Moderna is able to study the efficacy of its vaccine technology in a naïve patient population. Antibodies present in subjects’ blood after treatment with mRNA-1851 are likely attributed to Moderna’s vaccine and not to active immunity as a result of previous exposure to the virus.
Studying mRNA vaccines for Influenza strains allows Moderna to measure vaccine efficacy against a well-understood endpoint, the hemagglutination inhibition assay, or HAI. HAI is used by U.S. FDA and World Health Organization (WHO) to measure how well antibodies bind to and inactivate an Influenza virus. Vaccines demonstrating titers of 1:40 are considered effective in reducing the risk for Influenza infection and are, thus, approved as seasonal flu vaccines.
Clinical Development
A Phase 1 study of healthy volunteers is underway in the U.S., with 104 healthy volunteers dosed to date.
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mRNA-1325 |
Moderna/ BARDA |
Zika |
In Licensed |
Yes |
Yes |
Started: Dec ‘16 |
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DARPA, BARDA |
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Modality: Prophylactic Vaccines | Therapeutic Area: Infectious Diseases / Viral Vaccines | Disease: Zika Virus
About the Disease
Zika is a member of the flavivirus family, which also includes viruses such as Dengue Fever and Yellow Fever. A rapidly emerging pandemic with the potential for long-term health implications. Zika is transmitted by the Aedes mosquito and mother to fetus transmission as well as sexual transmission have also been confirmed. There is a causal link between Zika infection and at least two serious diseases: microcephaly and Guillain-Barré Syndrome (GBS).
Children born to mothers infected with Zika can develop microcephaly, a severe disease characterized by abnormally small heads and severe neurologic disabilities. GBS is an autoimmune disease that attacks the peripheral nervous system, leading to rapidly progressive and potentially life-threatening muscle weakness. GBS can lead to death caused by respiratory arrest if a patient is not ventilated.
As of November 2016, 48 countries and territories in the Americas have confirmed autochthonous, vector-borne transmission of the Zika virus, and five countries in the Americas have reported sexually transmitted Zika cases. 184 locally transmitted cases have been reported in South Florida, and 34,000 locally transmitted cases throughout the U.S. and its territories, with most cases in Puerto Rico.
There are no treatment options or approved vaccines for the Zika virus.
Our Zika mRNA Vaccine (mRNA-1325)
Our investigational Zika vaccine, mRNA-1325, is being developed to deliver mRNA encoding for viral antigenic proteins associated with the Zika virus. The mRNA directs cells to produce and express the proteins on the cell surface, much like a native infection would do but without the ability to cause disease or spread. As a result the body’s immune system responds as if the actual virus is present. The immune system produces antibodies that have the potential to neutralize the virus and prevent infections in the event the vaccinated person is exposed to the actual Zika virus in the future.
Our mRNA platform, research engine and early development engine enabled us to advance our Zika vaccine from initial discovery concept to first-in-human dosing in 12 months.
mRNA-1325 is one of two Zika mRNA vaccines we are developing. mRNA-1325, the earlier of our two Zika mRNA programs, utilizes an in-licensed formulation, while our second investigational Zika mRNA vaccine, mRNA-1706, utilizes V1GL, one of our novel, proprietary formulations.
Clinical Development
A Phase 1/2 clinical study of mRNA-1325 began enrolling healthy volunteers in December 2016.
Funding
In 2016, Moderna received a funding award of up to $125 million from the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), to accelerate development of our Zika mRNA vaccine. Moderna’s preclinical work for mRNA-1325 was funded through a grant from the Defense Advanced Research Projects Agency (DARPA).
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mRNA-1893* |
Moderna |
Zika |
V1GL |
No |
No |
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Modality: Prophylactic Vaccines | Therapeutic Area: Infectious Diseases / Viral Vaccines | Disease: Zika virus
About the Disease
Zika is a member of the flavivirus family, which also includes viruses such as Dengue Fever and Yellow Fever. A rapidly emerging pandemic with the potential for long-term health implications. Zika is transmitted by the Aedes mosquito and mother to fetus transmission as well as sexual transmission have also been confirmed. There is a causal link between Zika infection and at least two serious diseases: microcephaly and Guillain-Barré Syndrome (GBS).
Children born to mothers infected with Zika can develop microcephaly, a severe disease characterized by abnormally small heads and severe neurologic disabilities. GBS is an autoimmune disease that attacks the peripheral nervous system, leading to rapidly progressive and potentially life-threatening muscle weakness. GBS can lead to death caused by respiratory arrest if a patient is not ventilated.
As of November 2016, 48 countries and territories in the Americas have confirmed autochthonous, vector-borne transmission of the Zika virus, and five countries in the Americas have reported sexually transmitted Zika cases. 184 locally transmitted cases have been reported in South Florida, and 34,000 locally transmitted cases throughout the U.S. and its territories, with most cases in Puerto Rico.
There are no treatment options or approved vaccines for the Zika virus.
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mRNA-1388 |
Moderna/ DARPA |
Chikungunya |
In Licensed |
Yes |
Yes |
Started: Aug '17 |
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DARPA |
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Modality: Prophylactic Vaccines | Therapeutic Area: Infectious Diseases / Viral Vaccines | Disease: Chikungunya Virus
About the Disease
Chikungunya virus, or CHIKV, is a type of alphavirus and is transmitted by mosquitos.
It typically causes mild fever and transient, or fleeting, joint pain. However, in approximately 15 percent of infected patients it can cause long-term, severe arthritis. CHIKV has historically has been limited to warmer climates in Asia and Africa, but recent cases have been identified in the Americas and Europe. This is likely due to an increase in global travel, as well as the onset of transmission by the Aedes albopictus mosquito. Previously, the Aedes aegypti mosquito typically transmitted the disease.
There are no treatment options or approved vaccines for CHIKV. Management of the infection from the virus has been limited to supportive care and avoidance of mosquito bites.
Our CHIKV mRNA Vaccine (mRNA-1388)
Our CHIKV vaccine delivers mRNA encoding for viral antigenic proteins associated with CHIKV. The mRNA directs cells to produce and express the proteins, closely mimicking a native viral infection and tricking the body into thinking the actual virus is present. The immune system produces antibodies against the viral antigenic proteins.
If the person is exposed to the actual Chikungunya virus in the future, the body recognizes it as foreign. Antibodies target the viral antigenic proteins, activating a robust immune response to target and destroy the Chikungunya virus, so it cannot cause an infection.
Clinical Development
GLP toxicology studies have been completed and an IND filed with the U.S. Food & Drug Administration.
A Phase 1 study is anticipated to begin enrolling healthy volunteers in 2017.
Funding
In 2015, Moderna extended an existing grant from the Defense Advanced Research Projects Agency (DARPA) to finance preclinical toxicology studies and the Phase I study of mRNA-1388. The extension builds on an original grant announced in 2013 to develop antibody-producing drugs to protect against a wide range of known and unknown emerging infectious diseases and engineered biological threats.
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