Moderna, Inc., a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced progress on late-stage development of mRNA-1273, the Company’s mRNA vaccine candidate against COVID-19.
Moderna, in collaboration with the NIH and NIAID, has finalized the Phase 3 study protocol based on feedback from FDA. The randomized, 1:1 placebo-controlled trial is enrolling 30,000 participants in the U.S. with a primary endpoint of preventing symptomatic COVID-19 disease (see also Moderna’s mRNA-1273 Vaccine Put to Biggest Test).
Prophylactic Vaccines Modality
The potential advantages of an mRNA approach to prophylactic vaccines include the ability to combine 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. The company currently has nine development candidates in its prophylactic vaccines modality, including:
Vaccines against respiratory infections
- Respiratory syncytial virus (RSV) vaccine for older adults (mRNA-1777 and mRNA-1172 or V172 with Merck)
- RSV vaccine for young children (mRNA-1345)
- Human metapneumovirus (hMPV) and parainfluenza virus type 3 (PIV3) vaccine (mRNA-1653)
- COVID-19 vaccine (mRNA-1273)
- Influenza H7N9 (mRNA-1851)
Vaccines against infections transmitted from mother to baby
- Cytomegalovirus (CMV) vaccine (mRNA-1647)
- Zika vaccine (mRNA-1893 with BARDA)
Vaccines against highly prevalent viral infections
- Epstein-Barr virus (EBV) vaccine (mRNA-1189)
To date, Moderna has demonstrated positive Phase 1 data readouts for seven prophylactic vaccines (H10N8, H7N9, RSV, chikungunya virus, hMPV/PIV3, CMV and Zika). Their CMV vaccine is currently in a Phase 2 dose-confirmation study. The investigational Zika vaccine (mRNA-1893), currently in a Phase 1 study, was granted FDA Fast Track designation in August 2019.
Other drugs in Moderna’s pipeline and their phase can be seen below.
Systemic Intracellular Therapeutics
Localized Regenerative Therapeutics
Systemic Secreted & Cell Surface Therapeutics
Source: Moderna Therapeutics