Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced progress across its portfolio of pipeline assets being presented at the Company’s annual R&D Day today.
“The Moderna team has made significant progress since our last R&D Day 12 months ago. The pipeline has matured with our COVID-19 vaccine in a Phase 3 study and four candidates in Phase 2 studies. We are actively preparing for a potential commercial launch of mRNA-1273, our COVID-19 vaccine, and we continue to expand the breadth of Moderna’s platform,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We are announcing that we are increasing our investment in vaccines and we will develop a seasonal flu vaccine given the unmet need for highly effective vaccines. In our systemic secreted & cell surface therapeutics core modality, we are sharing positive interim data for repeat dosing of our systemic mRNA therapeutic against chikungunya, which is important progress for our therapeutics modalities, particularly in rare diseases. With our second collaboration with Vertex, we are entering the field of gene editing using Moderna’s technology. As we continue to scale for commercialization, we are more committed than ever to our mission to deliver on the promise of mRNA medicines to treat or prevent serious diseases.”
Presentation highlights from Moderna’s R&D Day include:
- COVID vaccine candidate (mRNA-1273) Phase 3 COVE study of 30,000 volunteers in the U.S. being conducted with NIH and BARDA has enrolled 25,296 participants as of September 16, 2020; 10,025 participants have received their second vaccination to date; to provide additional transparency in context of pandemic, Phase 3 protocol now available online
- Positive interim analysis from Phase 2 study of CMV vaccine candidate (mRNA-1647); Phase 3 study of mRNA-1647 to begin in 2021 at 100 μg dose
- The U.S. Food and Drug Administration (FDA) has completed its review of the Investigational New Drug (IND) application for the Company’s pediatric RSV vaccine (mRNA-1345) and allowed it to proceed to the clinic
- First 10 pediatric patients dosed in Phase 1 study of hMPV/PIV3 vaccine (mRNA-1653)
- Moderna plans to enter the seasonal flu business
- Data from Phase 1 study of OX40L(mRNA-2416) as a monotherapy were presented at the American Association for Cancer Research Annual Meeting; first patients dosed in Phase 2 dose expansion study of mRNA-2416 in combination with durvalumab for ovarian cancer
- Positive data from additional cohorts of Phase 1 study evaluating escalating doses of antibody against the chikungunya virus (mRNA-1944) administered via intravenous infusion in healthy adults
- New next generation MMA candidate (mRNA-3705) protocol revision to enhance operational performance and improve outreach to the patient community
- New protocol amendment for Phase 1/2 study of propionic acidemia (PA) candidate (mRNA-3927)
Moderna currently has 23 mRNA development candidates in its portfolio with 14 in clinical studies. Across Moderna’s pipeline, more than 27,000 healthy volunteers and patients have been enrolled in clinical studies including the Phase 3 study of mRNA-1273.
Moderna should have enough data from its late-stage trial to know whether its coronavirus vaccine works in November, CEO Stephane Bancel told CNBC’s “Squawk Box” on Thursday.