Moderna Announces Clinical Progress from its Industry-Leading mRNA Vaccine Franchise and Continues Investments to Accelerate Pipeline Development
Moderna (Nasdaq: MRNA) hosted its second annual Vaccines Day, showcasing its mRNA vaccine capabilities. The company revealed new positive interim Phase 1 data for its Respiratory Syncytial Virus (RSV) vaccine candidate (mRNA-1345) and interim Phase 2 data for its cytomegalovirus (CMV) candidate. Moderna aims to leverage its mRNA platform to accelerate vaccine development, addressing the significant gap in available vaccines for many human viruses. The Phase 1 analysis indicates mRNA-1345 is well-tolerated, with no severe adverse events reported, furthering Moderna's innovative vaccine pipeline.
- New positive interim data for RSV vaccine candidate mRNA-1345 shows it is well-tolerated and boosts antibody titers.
- Plans to expand mRNA vaccine pipeline utilizing COVID-19 development experience.
- The ability to rapidly develop mRNA vaccines against previously unaddressed viruses enhances market position.
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Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, is today hosting its second annual Vaccines Day, with presentations highlighting the advantages of mRNA vaccines. The Company is also announcing new positive interim Phase 1 data from its Respiratory Syncytial Virus (RSV) vaccine candidate (mRNA-1345) and new 7-month interim Phase 2 data from its cytomegalovirus (CMV) vaccine candidate. Building on its COVID-19 vaccine clinical development experience, the Company plans to invest resources and continue to leverage the power of its mRNA platform to accelerate the development of its mRNA vaccine pipeline.
“Moderna has one of the world’s largest and most innovative vaccine development pipelines. We believe we have a unique opportunity to develop new vaccines against viruses hurting people around the world, at a pace that is radically different from what the industry has previously done,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We are working to further increase our vaccine pipeline and accelerate these important programs. With our mRNA vaccines, we believe we have an opportunity to have a profound impact on human health.”
The vast majority of human viruses do not have a commercially available vaccine. This gap includes many long-known viruses causing a spectrum of long-term sequelae, such as cytomegalovirus (CMV) (discovered in 1956), Zika (1952) and Epstein-Barr virus (EBV, 1964), but also includes many emerging novel viruses. Since 1980, an average of two novel viruses that infect humans have been discovered each year. Examples of these novel viruses include HIV 1 (discovered in 1983), Hepatitis C (1989), H1N1 (2009), and SARS-CoV-2 (2019).
To date, Moderna has entered 14 different mRNA vaccine candidates into clinical trials. Clinical data demonstrate that Moderna’s proprietary vaccine technology has been generally well-tolerated and can elicit durable immune responses to viral antigens. The Company has demonstrated the ability to attain high biological flexibility with the ability to develop mRNA vaccines against complex antigens and combination vaccines while leveraging mRNA as a platform with a flexible manufacturing infrastructure to advance a large portfolio quickly and efficiently.
On Tuesday, April 13, the Company provided an update on its COVID-19 Vaccine program.
Interim Phase 1 data for Respiratory Syncytial Virus (RSV) vaccine candidate (mRNA-1345)
mRNA-1345 is a vaccine against RSV encoding for a prefusion F glycoprotein, which elicits a superior neutralizing antibody response compared to the postfusion state. RSV is the leading cause of respiratory illness in young children. Older adults (65+) are at high risk for severe RSV infections. mRNA-1345 uses the same lipid nanoparticle (LNP) as Moderna’s authorized Covid-19 vaccine and contains optimized protein and codon sequences. The Phase 1 study of mRNA-1345 to evaluate the tolerability and reactogenicity of mRNA-1345 in younger adults, older adults and children is ongoing. All four cohorts of younger adults (ages 18-49 years) are fully enrolled. Dosing in the older adult cohort (ages 65-79 years) is ongoing. The age range of toddlers in this de-escalation Phase 1 study is 12-59 months.
Today, the Company is sharing the first interim analysis of the Phase 1 study of mRNA-1345, through 1-month post-vaccination, of the younger adult cohorts. A single mRNA-1345 vaccination of 50 μg (N=19) or 100 μg (N=20) was generally well-tolerated in younger adults (ages 18-49 years). Ten participants received placebo. The most common local solicited adverse reaction was injection site pain, and the most common systemic solicited adverse reactions were headache, fatigue and myalgia. The majority of solicited adverse reactions occurred within 1-3 days after vaccination and resolved after 1-4 days. There were no deaths, no severe adverse events, no study discontinuations due to adverse events, and no adverse events that led to a study pause.
mRNA-1345 was shown to increase RSV neutralizing antibodies in seropositive younger adults. Neutralizing antibodies were confirmed to be present at baseline in all participants, as expected. A single vaccination of mRNA-1345 at the 50 or 100 μg dose level boosted neutralizing antibody titers against both serotypes of RSV-A and RSV-B with no apparent dose r
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