Moderna announces first participant dosed in phase 1/2 study of quadrivalent seasonal influenza mRNA vaccine

CAMBRIDGE, Mass .– (COMMERCIAL THREAD) – Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapies and vaccines, today announced that the first participants have been assayed in the study phase 1/2 of mRNA-1010, mRNA influenza vaccine candidate.

This phase 1/2, randomized, stratified, blind to the observer study will evaluate the safety, reactogenicity and immunogenicity of mRNA-1010, Moderna’s seasonal influenza vaccine candidate in healthy adults 18 years of age and older in the United States. about 180 study participants. MRNA-1010 is Moderna’s first seasonal influenza vaccine candidate to enter clinical practice and targets World Health Organization (WHO) recommended lines for the prevention of influenza, including seasonal influenza A H1N1 , H3N2 and influenza B Yamagata and Victoria.

“We are delighted to have started this Phase 1/2 study of mRNA-1010, our first candidate vaccine against seasonal mRNA influenza to enter the clinic. We anticipate that our seasonal influenza vaccine candidates will be an important component of our future combined respiratory vaccines, ”said Stéphane Bancel, CEO of Moderna. “Combination respiratory vaccines are an important pillar of our overall mRNA vaccine strategy. We believe the benefits of mRNA vaccines include the ability to combine different antigens to protect against multiple viruses and the ability to respond quickly to evolving respiratory viruses, such as influenza, SARS-CoV-2, and RSV. . Our vision is to develop a combined mRNA vaccine so that people can be injected each fall for highly effective protection against the most problematic respiratory viruses. We look forward to advancing our core modality of prophylactic mRNA vaccines so that we can continue to make an impact on global public health. ”

Seasonal influenza epidemics (type A and type B) occur seasonally and vary in severity each year, causing respiratory illness and placing a heavy strain on health systems. WHO estimates that around 3 to 5 million severe cases of influenza each year worldwide¹, and 290,000 to 650,000 respiratory deaths from influenza. About 8% of the U.S. population experiences flu symptoms each year². In the United States, the estimated average economic burden of influenza is around $ 11 billion per year³.

Current influenza vaccines are only about 40 to 60% effective and their formulation is decided 6 to 9 months before the intended use of the vaccines. Egg-based vaccine production, the process used for the majority of currently licensed influenza vaccines, also has the potential to cause unintended antigenic modification of the vaccine virus. Moderna plans to explore potential combination vaccines against influenza, SARS-CoV-2, respiratory syncytial virus (RSV) and human metapneumovirus (hMPV). The company’s overall seasonal influenza program will aim to evaluate multiple candidates exploring different combinations of antigens against seasonal influenza viruses in the clinic.

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 large portfolio of intellectual property in areas such as the formulation of mRNA and lipid nanoparticles, and an integrated manufacturing facility that enables both clinical and commercial production on a large scale and at low speed. previous. Moderna maintains alliances with a wide range of domestic and foreign government and business collaborators, which has enabled 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 advances in basic and applied mRNA science, delivery technology and manufacturing, and has enabled the development of treatments 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, of which 15 programs have entered the clinic. Moderna has been named one of Science’s Top Biopharmaceutical Employers for the past 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, including regarding: the Company’s efforts to develop a multivalent seasonal influenza vaccine; conducting clinical trials for the vaccine; the potential benefits of developing mRNA-based vaccines; and the Company’s current and future plans for further vaccine development. 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.

¹ https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal)

² https://www.cdc.gov/flu/about/keyfacts.htm

³ https://pubmed.ncbi.nlm.nih.gov/29801998/