Moderna Announces First Participant Dosed in a Phase 1 Trial of its Nipah Virus mRNA Vaccine, mRNA-1215

Moderna advances global health commitment with mRNA vaccine candidate against the Nipah virus, a lethal pathogen with pandemic potential

CAMBRIDGE, MA / ACCESSWIRE / July 12, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the first participant has been dosed in a Phase 1 trial of its Nipah virus (NiV) vaccine candidate, mRNA-1215, that was developed in collaboration with the Vaccine Research Center (VRC), a division of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). This Phase 1 dose-escalation, open-label clinical trial is the first study of mRNA-1215 in healthy adults to evaluate the safety, tolerability, and immunogenicity of a NiV mRNA vaccine.

"Our partnership with NIAID to advance mRNA-1215 for Nipah virus reflects our commitment to advance a portfolio of 15 vaccine programs by 2025, targeting emerging or neglected infectious diseases that threaten global health. Since Nipah virus is a deadly pathogen for which there is currently no vaccine or treatment, Moderna is eager to bring our mRNA expertise to this partnership with the hope of halting the virus' pandemic potential to protect the health of our global citizens," said Stéphane Bancel, Chief Executive Officer of Moderna.

The trial is sponsored and funded by NIAID. The IND sponsor is NIAID's Division of Microbiology and Infectious Disease (DMID) and the trial will be conducted by the NIAID's Vaccine Research Center. The ClinicalTrials.gov identifier is NCT05398796.

NiV is a zoonotic virus, meaning that it can spread between animals and people. The virus can be transmitted to humans from infected animals, through consumption of contaminated food, or directly from other infected persons. NiV is a deadly pathogen that can cause rapidly progressive illness, including acute respiratory infection and encephalitis that can lead to a coma or death. While it is possible to recover, an estimated 40% to 75% of people infected with NiV die as a result of infection.

Since the first identification of NiV in Malaysia in 1999, it has regularly spilled over from animals to humans, with outbreaks recorded almost annually in some parts of Asia. Although the dynamics of NiV are unpredictable, the virus has a high rate of mutation and is considered a significant pandemic threat and a pathogen with bioterrorism potential. Because of its high pandemic potential, NiV is listed as a high-priority pathogen by the World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), and the Coalition of Epidemic Preparedness Innovations (CEPI).

In addition to the NiV program, Moderna has advanced its Zika vaccine candidate (mRNA-1893) to Phase 2 clinical trials. Like NiV, Zika is an emerging disease and is considered to be a looming threat to global health. With the NiV vaccine development program and the Company's portfolio of COVID-19, Zika, and HIV clinical trials, Moderna has advanced 4 of the 15 priority vaccine programs they committed to developing by 2025, targeting emerging or neglected infectious diseases that threaten global health.

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 conduct of Moderna's Phase 1 trial of mRNA-1215; Moderna's plans to advance a portfolio of 15 global public health vaccines, and the timing for advancing those vaccine programs; and the dynamics of and threat posed by NiV. 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, R&D 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.