Moderna Receives FDA Fast Track Designation for Respiratory Syndrome Virus (RSV) Vaccine (mRNA-1345) | Work

Cambridge, Massachusetts-(BUSINESSWIRE)-August 3, 2021-

Moderna, Inc., a biotechnology company that is a pioneer in messenger RNA (mRNA) therapeutics and vaccines. (Nasdaq: mRNA) today announced that the US Food and Drug Administration (FDA) has approved the fast track designation of mRNA-1345, a single dose under investigation. An mRNA vaccine against respiratory syncytial virus (RSV) in adults over the age of 60.

Stephane Bancel, CEO of Modana, said: “We are studying mRNA-1345 in these populations in ongoing clinical trials and look forward to sharing the data when available. Fasttrack designation for the elderly is for RSV. Emphasizing the urgent need for vaccines. Our investment in science and manufacturing has brought 11 infectious disease vaccines into human clinical trials. We are accelerating research and development in the field of infectious disease treatment. We will continue to evolve the mRNA vaccine into a new field with high unmet needs. “

Respiratory syncytial virus is a common respiratory virus that commonly causes cold-like symptoms. In the United States and regions with similar climates, RSV infection occurs primarily in autumn, winter, and spring. Most people recover in a week or two, but RSV can be especially severe for babies and the elderly. RSV is the most common cause of bronchiolitis and pneumonia in children under the age of 1 in the United States and can cause pneumonia and dyspnea in the elderly. In the United States, RSV leads to an average of about 58,000 hospitalizations for children under the age of 5, 177,000 hospitalizations for adults 65 and older, and 14,000 deaths for adults over 65 years, according to the US Centers for Disease Control and Prevention. .. Currently, there are no approved vaccines available for RSV.

Fast track Is designed to facilitate the development of treatments and vaccines for serious conditions, facilitate reviews and meet unmet medical needs. Programs with Fast Track designations may benefit from early and frequent communication with the FDA, in addition to rolling submissions of marketing applications. We have previously designated Fast Track for the COVID-19 Vaccine Candidate, Dica Vaccine Candidate (mRNA-1893), Methylmalonic Acidemia (MMA) (mRNA-3704), and Propionic Acidemia (PA) (mRNA-3927) programs. Was receiving.

Phase 1 trials of mRNA-1345 to evaluate the tolerability and responsiveness of mRNA-1345 in young adults, the elderly, and children are underway. All four cohorts of young adults (ages 18-49) are fully enrolled. Dosing to the elderly cohort (65-79 years) is ongoing. The infant age range in this deescalation phase 1 study is 12-59 months. We shared the first interim analysis of a phase I trial of the annual young adult cohort of mRNA-1345 for the first month after vaccination. Vaccine day The results showed that the vaccine candidates produced a geometric mean increase in neutralizing antibodies compared to at least 11-fold baseline.

We will also evaluate the potential combination of mRNA-1345 with its vaccine individually for other respiratory pathogens in children and the elderly. Moderna owns the worldwide commercial rights to mRNA-1345.

About mRNA-1345

mRNA-1345 is a vaccine against RSV that encodes pre-fusion F glycoprotein and elicits a superior neutralizing antibody response compared to the post-fusion state. RSV is a major cause of respiratory illness in young children. Older people (65 years and older) are at increased risk of severe RSV infection. mRNA-1345 uses the same lipid nanoparticles (LNP) as Moderna’s certified COVID-19 vaccine and contains optimized proteins and codon sequences.

About Moderna

Ten years after its founding, Moderna has a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio, from scientific research-stage companies promoting programs in the field of messenger RNA (mRNA). It has transformed into. In areas that include mRNA and lipid nanoparticle formulations, and integrated manufacturing plants that enable both large-scale and unprecedented rates of clinical and commercial production. Moderna maintains partnerships with various government and commercial collaborators at home and abroad, enabling the pursuit of both innovative science and the rapid expansion of manufacturing. Most recently, Moderna’s capabilities have been integrated to allow the authorized use of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology, and manufacturing, with treatments for infectious diseases, immuno-oncology, rare diseases, cardiovascular, and autoimmune diseases. It enables the development of vaccines. Currently, 24 development programs are underway across these therapeutic areas, with 16 programs in the clinic. Moderna has been named the Top Biopharmacy Employer by. Chemistry The last 6 years. For more information, please visit: www.modernatx.com..

Description of future prospects

Within the meaning of the Private Securities Litigation Reform Act of 1995, this press release contains forward-looking statements, including: Conducting clinical trials of a vaccine against RSV (mRNA-1345). And the effect of FDA Fast Track designation on mRNA-1345. The forward-looking statements in this press release are neither promises nor guarantees. These forward-looking statements involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and should not be overly relied upon. This may result in actual results that differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include the “Risk Factors” heading in Moderna’s latest Form 10-K Annual Report filed with the US Securities and Exchange Commission (SEC) and subsequent submissions. Includes other risks and uncertainties mentioned in the documentation. Moderna with SEC available on the SEC website www.sec.gov.. Except as required by law, Moderna has no intention or liability to update or revise any forward-looking statements contained in this press release in the event of new information, future development, or otherwise. These forward-looking statements are based on Moderna’s current expectations and are stated only as of the date of this document.

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Contact: Modern:

media:

Colleen Hassy

Corporate Communication Director

617-335-1374

[email protected]

Investor:

Lavina Talukdar

Senior Vice President and General Manager of Public Relations for Investors

617-209-5834

[email protected]

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Source: Moderna, Inc.

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PUB: 08/03/2021 09:10 AM / DISC: 08/03/2021 09:12 AM

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