Moderna Announces First Participants Dosed in Phase 1/2 Study with mRNA-1020 and mRNA-1030 Seasonal Influenza Vaccine Candidates

Both mRNA-1020 and mRNA-1030 target hemagglutinin and neuraminidase antigens, two major influenza surface glycoproteins that are essential across the viral life cycle

CAMBRIDGE, MA / ACCESSWIRE / April 11, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced the first participants have been dosed in the Phase 1/2 study of the Company's seasonal influenza vaccine candidates, mRNA-1020 and mRNA-1030. This Phase 1/2 randomized, observer-blind, dose-ranging study will evaluate the safety, reactogenicity and immunogenicity of a single dose of mRNA-1020 or mRNA-1030 in healthy adults 18 years and older in the U.S. The mRNA-1020 and mRNA-1030 candidates each include eight mRNAs, targeting both hemagglutinin and neuraminidase at different doses and ratios. Similar to Moderna's influenza vaccine candidate mRNA-1010, mRNA-1020 and mRNA-1030 will target the strains recommended by the World Health Organization (WHO) for the prevention of influenza, including seasonal influenza A/H1N1, A/H3N2 and influenza B/Yamagata and B/Victoria. The Company intends to enroll approximately 560 participants in the study.

"We are pleased to apply Moderna's mRNA platform to address the longstanding design and manufacturing challenges associated with developing seasonal influenza vaccines. We believe that by targeting both hemagglutinin and neuraminidase, we can achieve broader immunity and higher vaccine efficacy against circulating influenza strains than traditional influenza vaccines. Moreover, we expect that our platform's flexibility in targeting multiple strains coupled with our ability to manufacture quickly will facilitate production of a vaccine that matches the predominant circulating influenza strain," said St├ęphane Bancel, Chief Executive Officer of Moderna.

Worldwide, influenza leads to 3-5 million severe cases of flu and 290,000-650,000 flu-related respiratory deaths annually, despite the availability of influenza vaccines. Three main types of influenza viruses (A, B, and C) infect humans, with influenza A and B viruses causing significant morbidity and mortality. Although influenza A and B viruses cause seasonal flu epidemics, it is the influenza A viruses that lead to >95% of flu-related hospitalization in adults. Influenza A and B viruses carry two major surface glycoproteins that are essential across the viral life cycle: hemagglutinin (HA) and neuraminidase (NA). While the importance of targeting the viral HA with vaccines is well known, data suggests NA will also be an important vaccine target given that it has a slower rate of mutation and anti-neuraminidase antibodies have been shown to inhibit multiple stages of the virus life cycle and thereby contribute to protection against infection. Targeting both viral proteins may limit the virus' ability to escape the host immune responses through mutations and can potentially lead to better protection.

Moderna is pursuing an iterative approach to influenza vaccine development, with increasing levels of enhancements aimed at improving immune responses and increasing immunologic breadth. Though currently licensed influenza vaccines target predominantly the viral HA, in the mRNA-1020/1030 trial, Moderna adds neuraminidase antigens in order to target both major glycoproteins with the aim of promoting a broad and robust antibody response.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval 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, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven 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 conduct of clinical trials for its seasonal influenza vaccine candidates (mRNA-1020 and mRNA-1030); the enrollment targets for the clinical trials; the potential to combine multiple antigens in a single vaccine to obtain broader immunity against different influenza strains; the potential to obtain better matching between influenza strains and vaccines through the Company's mRNA platform; the disease burden of seasonal influenza; and the benefits of targeting certain influenza strains. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other 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 those other risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made 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 for updating or revising 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.

Moderna Contacts

Media:

Mary Beth Woodin
Senior Director, Communications
617-899-3991
Mary.BethWoodin@modernatx.com

Investors:

Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.



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