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


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

CAMBRIDGE, MA / ACCESSWIRE / July 12, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapies and vaccines, today announced that the first participant has been dosed in a Phase 1 trial of its vaccine candidate against the Nipah virus (NiV), mRNA-1215, which was developed in collaboration with the Vaccine Research Center (VRC), a division of the National Institute of Allergy and Infectious Diseases (NIAID) of 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. As a deadly pathogen for which there is currently no vaccine or treatment, Moderna is eager to bring our mRNA expertise to this partnership in hopes 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 the NIAID. The IND sponsor is the NIAID’s Division of Microbiology and Infectious Diseases (DMID) and the trial will be conducted by the NIAID’s Vaccine Research Center. The ClinicalTrials.gov ID is NCT05398796.

NiV is a zoonotic virus, meaning it can spread between animals and humans. The virus can be transmitted to humans through infected animals, through consumption of contaminated food or directly from other infected persons. NiV is a deadly pathogen that can cause rapidly progressive disease, including acute respiratory infection and encephalitis that can lead to 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 passed from animals to humans, with outbreaks being recorded almost annually in some parts of Asia. Although the dynamics of NiV are unpredictable, the virus has a high degree of mutation and is considered a significant pandemic threat and a pathogen with bioterrorism potential. Due to its high pandemic potential, NiV is listed as a high priority pathogen by the World Health Organization (WHO), the 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) into Phase 2 clinical trials. Like NiV, Zika is an emerging disease and is considered an imminent threat to global health. With its NiV vaccine development program and portfolio of clinical trials on COVID-19, Zika and HIV, Moderna has advanced 4 of the 15 priority vaccine programs it plans to develop by 2025, targeting emerging or neglected infectious diseases that threaten global health .

About Moderna

In more than 10 years since its inception, Moderna has transformed from a research-stage company promoting messenger RNA (mRNA) programs to a company with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas such as mRNA and lipid nanoparticle formulation, and an integrated plant enabling rapid, large-scale clinical and commercial production. Moderna maintains alliances with a wide range of domestic and foreign government and commercial employees, which has led to the pursuit of both groundbreaking science and rapid production scaling. Recently, Moderna’s capabilities have come together to enable 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 continued advances in basic and applied mRNA science, delivery technology and manufacturing, and has enabled the development of therapies and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular and autoimmune diseases. Moderna Named Top Employer for Biopharmaceuticals by Science for the past seven years. For more information, 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: the conduct of Moderna’s Phase 1 trial of mRNA-1215; Moderna’s plans to develop a portfolio of 15 global public health vaccines, and the timing for advancing those vaccine programs; and the dynamics and threat of the NiV. The forward-looking statements in this press release are not promises or 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 be material. may differ from the results expressed or implied in 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 U.S. Securities and Exchange Commission (SEC) 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 intent or responsibility to update or revise any forward-looking statements contained in this press release as a result 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:
by Mary Beth Wood
Senior Director, R&D Communication
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: modern, inc.

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https://www.accesswire.com/708173/Moderna-Announces-First-Participant-Dosed-in-a-Phase-1-Trial-of-its-Nipah-Virus-mRNA-Vaccine-mRNA-1215

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