Moderna Receives Fast Track Designation from the FDA for Respiratory Syncytial Virus (RSV) Vaccine (mRNA-1345)



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CAMBRIDGE, Mass., August 3, 2021– (BUSINESS WIRE) – Moderna, Inc., (Nasdaq: MRNA), a pioneering biotechnology company in messenger RNA (mRNA) therapies and vaccines, today announced that Food The United States and Drug Administration (FDA) has granted Fast Track designation for mRNA -1345, its investigational single-dose mRNA vaccine against respiratory syncytial virus (RSV) in adults over 60 years of age.

“We are researching an mRNA RSV vaccine to protect the most vulnerable populations – young children and the elderly,” said Stéphane Bancel, CEO of Moderna. “We are studying mRNA-1345 in these populations in an ongoing clinical trial and look forward to sharing the data when it becomes available. The Fast Track designation for the elderly underscores the urgent need for an RSV vaccine. With our investments in science and manufacturing, we have conducted eleven infectious disease vaccines in human clinical trials. We have accelerated the research and development of our therapeutic area against infectious diseases and we will continue to advance our mRNA vaccines into new areas where the needs are great and unmet. “

Respiratory syncytial virus is a common respiratory virus that usually causes cold-like symptoms. In the United States and areas with similar climates, RSV infections occur primarily in the fall, winter, and spring. Most people recover within a week or two, but RSV can be serious, especially in infants and the elderly. RSV is the most common cause of bronchiolitis and pneumonia in children under one year of age in the United States and can lead to pneumonia and respiratory distress in the elderly. According to the United States Centers for Disease Control and Prevention, in the United States, RSV causes, on average, about 58,000 hospitalizations each year in children under the age of five, 177,000 hospitalizations in adults aged 65 and over. more and 14,000 deaths among adults aged 65. years and older. There is no approved vaccine available today for RSV.

Fast Track is designed to facilitate the development and expedite review of therapies and vaccines for serious conditions and that address an unmet medical need. Programs with the Fast Track designation may benefit from early and frequent communication with the FDA, in addition to ongoing submission of marketing application. The Company has previously received Fast Track designation for its COVID-19 vaccine candidate, its Zika vaccine candidate (mRNA-1893), its methylmalonic acidemia (MMA) (mRNA-3704) and propionic acidemia (PA) programs ( MRNA-3927).

The phase 1 study of mRNA-1345 to assess the tolerability and reactogenicity of mRNA-1345 in young adults, the elderly and children is ongoing. All four cohorts of young adults (aged 18 to 49) are fully enrolled. Assaying in the elderly cohort (aged 65 to 79) is ongoing. The toddler age range in this Phase 1 de-escalation study is 12 to 59 months. The Company shared the first interim analysis of the Phase 1 mRNA-1345 study, up to one month after vaccination, of younger adult cohorts on its annual Immunization Day on April 14, 2021 The results showed that the vaccine candidate generated a geometric mean increase in neutralizing antibodies from baseline of at least 11-fold.

The Company also intends to evaluate the potential of combinations of mRNA-1345 with its vaccines against other respiratory pathogens in children and separately in the elderly. Moderna owns the worldwide commercial rights to mRNA-1345.

About mRNA-1345

MRNA-1345 is a vaccine against RSV encoding a pre-fusion F-glycoprotein, which elicits a superior neutralizing antibody response compared to the post-fusion state. RSV is the leading cause of respiratory illness in young children. Older people (65 years and older) are at high risk of serious RSV infections. MRNA-1345 uses the same lipid nanoparticle (LNP) as Moderna’s licensed COVID-19 vaccine and contains optimized protein and codon sequences.

About Moderna

In the 10 years since its inception, Moderna has grown from a company in the scientific research stage advancing programs in the field of messenger RNA (mRNA), to a company with a diverse clinical portfolio of vaccines and therapeutic products. through six modalities, a broad portfolio of intellectual property in areas such as the formulation of mRNA and lipid nanoparticles, and an integrated manufacturing facility that enables large-scale clinical and commercial production at unprecedented speed. Moderna maintains alliances with a wide range of domestic and foreign government and business collaborators, which has allowed the pursuit of both groundbreaking science and rapid scale up of manufacturing. More recently, Moderna’s capabilities have come together to enable the licensed use of one of the oldest and most effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advancements in basic and applied mRNA science, delivery technology and manufacturing, and has enabled the development of therapies and vaccines for them. infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Today, 24 development programs are underway in these therapeutic areas, with 16 programs entering the clinic. Moderna was named one of the top biopharmaceutical employers by Science for six years. To learn more, visit www.modernatx.com.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, in particular concerning: the conduct by the Company of clinical trials for its vaccine against RSV (mRNA-1345); and the impact of the FDA’s Fast Track designation for mRNA-1345. The forward-looking statements contained in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements as they involve risks, uncertainties and other known and unknown 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 the other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent annual report on Form 10-K filed with the State Securities and Exchange Commission (SEC). United and in subsequent filings by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility to update or revise any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.

View the source version on businesswire.com: https://www.businesswire.com/news/home/20210803005702/en/

Contacts

Modern:
Media:
Colleen Hussey
Director, Corporate Communications
617-335-1374
[email protected]

Investors:
Lavina Talukdar
Senior Vice President and Head of Investor Relations
617-209-5834
[email protected]

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