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
Moderna will host a conference call and webcast today at 5:00 p.m. ET to discuss these interim data and the Company’s broader efforts to develop respiratory vaccines. Participants are invited to listen by dialing (866)922-5184 (domestic) or (409) 937-8950 (international) and providing conference ID 3580988 or join the live webcast by going to the “Events and Presentations” area on the Investors page of the Company’s website, www.modernatx.com. An archived webcast of the conference call can also be accessed through the Company’s website and a replay of the call will be available there for four weeks after the 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 the United States, and enrolled 124 subjects across four dose levels of mRNA-1653 (25, 75, 150, and 300 µg) and placebo. Subjects were randomized to aone-dose ortwo-dose vaccination schedule, with the second vaccination of mRNA-1653 administered one month after the first vaccination.
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.
Moderna scientists designed the Company’s prophylactic vaccines modality to prevent or control infectious diseases. This modality now includes nine programs, all of which are vaccines against viruses. Some of these programs are designed for commercial use and others for public health. The goal of any vaccine is to safelypre-expose the immune system to a small quantity of a protein from a pathogen, called an antigen, so that the immune system is prepared to fight the pathogen if exposed in the future, and prevent infection or disease.
Moderna currently has four development candidates for potential commercial uses in this modality including: RSV (mRNA-1777 with Merck), cytomegalovirus (CMV) vaccine (mRNA-1647), hMPV+PIV3 vaccine (mRNA-1653) and varicella zoster virus (VZV) vaccine (mRNA-1278 with Merck).
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 DARPA).
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