Moderna Announces Positive Interim Phase 1 Data for First Combination Vaccine Against the Respiratory Viruses hMPV and PIV3
Interim data show vaccination with mRNA-1653 boosted serum neutralization titers against hMPV and PIV3 at all dose levels tested and was generally well tolerated
Company plans to advance mRNA-1653 into a Phase 1b study in seropositive pediatric subjects
Conference call to be held at
mRNA-1653 is designed to protect against human metapneumovirus (hMPV) and parainfluenza type 3 (PIV3), two viruses that cause respiratory infections.It is a combination vaccine that consists of two distinct mRNA sequences encoding the fusion (F) proteins of hMPV and PIV3 formulated in Moderna’s proprietary lipid nanoparticle (LNP) technology.
“There are no approved vaccines to prevent hMPV or PIV3 infections,
which are significant causes of severe respiratory diseases and
hospitalizations for infants and children,” said
These Phase 1 interim data show that a single vaccination with mRNA-1653 boosted serum neutralization titers against hMPV and PIV3, and that the magnitude of the boost was similar at all dose levels tested. Consistent with prior exposure to hMPV and PIV3, all study participants had neutralizing antibodies against both viruses at baseline. One month after a single mRNA-1653 vaccination, the hMPV neutralization titers were approximately six-fold baseline and PIV3 neutralization titers were approximately three-fold baseline (based on geometric mean ratios). A second mRNA-1653 vaccination one month after the first vaccination did not further boost antibody titers, suggesting a single vaccination was sufficient to achieve a plateau in neutralizing antibodies in this pre-exposed population.
mRNA-1653 was found to be generally well tolerated. No serious adverse events (SAEs), adverse events of special interest, or adverse events leading to withdrawal were reported. Injection site pain was the most commonly reported adverse event and the most common Grade 3 adverse event.
Much of Moderna’s commercial vaccine development efforts are focused on addressing major causes of respiratory infections, including hMPV+PIV3 and respiratory syncytial virus (RSV). These infections share many of the same features, often causing upper and lower respiratory tract illness, characterized by wheezing, bronchiolitis and pneumonia and are associated with a substantial burden of hospitalizations and outpatient visits among children throughout the first five years of life. There are currently no approved vaccines for hMPV, PIV3 or RSV.
Conference Call
About the Study
mRNA-1653-P101 is a Phase 1, first-in-human, randomized, observer-blind,
placebo-controlled, dose-ranging study in healthy adults. The trial’s
key objectives include evaluating the safety and tolerability,
reactogenicity and humoral immunogenicity of mRNA-1653, and selecting
the optimal dose and vaccination schedule for further clinical
development. This study is being conducted in
About Moderna’s Prophylactic Vaccines Modality
Moderna has 21 mRNA development candidates in its pipeline, with 12 programs now in clinical development. These investigational medicines are grouped together into six modalities based on similar mRNA technologies, delivery technologies and manufacturing processes. Typically, programs within a modality will also share similar pharmacology profiles, including the desired dose response, expected dosing regimen, target tissue for protein expression, safety and tolerability goals as well as their pharmaceutical properties.
Five development candidates in this modality are being explored for
potential global health uses including: influenza H10N8 vaccine
(mRNA-1440), influenza H7N9 vaccine (mRNA-1851), Zika vaccine (mRNA-1325
and mRNA-1893 with BARDA) and chikungunya vaccine (mRNA-1388 with
About hMPV and PIV3
hMPV was discovered in 2001 as the cause of acute respiratory infections in up to 15 percent of patients. The virus primarily affects young children but can also infect adults, the elderly and those who are immunocompromised. Symptoms range from a mild upper respiratory tract infection to life-threatening severe bronchiolitis and pneumonia. Despite the need, there is currently no approved vaccine for hMPV.
Infections from PIV account for up to seven percent of acute respiratory infections among children younger than five years of age. Of the four PIV types identified, PIV3 most frequently results in infections and leads to the more serious lower respiratory tract infections. Though PIV3-related infections were identified in the past, their burden to patients and hospitals has been elevated over the past few years. There is currently no approved vaccine for PIV3.
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Special Note Regarding 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, but not limited to, statements concerning: the
design, safety profile, tolerability and future expectations regarding
mRNA-1653; the Company’s plans to advance mRNA-1653 into a Phase 1b
study; and the final and expected outcomes of Moderna’s other clinical
trials. In some cases, forward-looking statements can be identified by
terminology such as “will,” “may,” “should,” “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 press
release 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 interim results for mRNA-1653 will be
predictive of the final results for the ongoing study or any future
clinical studies; whether mRNA-1653 will be unsafe or intolerable during
further clinical studies, particularly studies involving pediatric
subjects; 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 described in Moderna’s Prospectus filed with
the U.S. Securities and Exchange Commission (
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Source:
Moderna Contacts:
Investors:
Lorence Kim
Chief
Financial Officer
617-209-5849
Lorence.kim@modernatx.com
Media:
Jason Glashow
Head, Corporate Communications
617-674-5648
Jason.glashow@modernatx.com