Moderna Announces First Participant Dosed in Phase 1 Study of its HIV Trimer mRNA Vaccine

CAMBRIDGE, MA / ACCESSWIRE / March 14, 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 clinical trial of an experimental human immunodeficiency virus (HIV) trimer mRNA vaccine (mRNA-1574).

"Developing a vaccine regimen that induces sustained protective levels of HIV neutralizing antibodies in humans has been difficult to achieve. At Moderna, we believe that mRNA offers an opportunity to take a fresh approach to this challenge. With the launch of our second HIV vaccine trial, we are advancing our strategy to utilize multiple mRNA encoded native-like HIV trimers and leverage the power of our mRNA platform to accelerate the discovery of a protective HIV vaccine," said Stephen Hoge, M.D., President of Moderna. "This study is another step in our fight against HIV, as well as other latent viruses such as our recently launched studies in CMV and EBV."

The open-label, multicenter, randomized Phase 1 trial (HVTN 302) is designed to evaluate the safety and immunogenicity of experimental HIV trimer mRNA vaccines. The primary hypothesis is that the soluble and membrane-bound HIV envelope trimer mRNA vaccines will be safe and well-tolerated by HIV-uninfected individuals and will elicit autologous neutralizing antibodies. The trial is expected to enroll approximately 100 HIV-negative adults, aged 18 to 55 years.

"It is gratifying to see that the experience with mRNA as a critical COVID-19 vaccine platform is now entering the HIV vaccine field," said Dr. Larry Corey, Principal Investigator, HIV Vaccine Trials Network (HVTN) Leadership Operations Center, which is based at the Fred Hutchinson Cancer Research Center. "We are optimistic that this study will pave the way for continued approaches for using mRNA in HIV."

The trial is sponsored and funded by the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID) within the National Institutes of Health (NIH). The ClinicalTrials.gov identifier is NCT05217641. The envelope trimers being evaluated in this study were developed by William Schief, Ph.D., and colleagues. Dr. Schief is a professor at Scripps Research and executive director of vaccine design at IAVI's Neutralizing Antibody Center. Development of the native-like HIV trimers and manufacture of the HIV trimer mRNA vaccine (mRNA-1574) was funded by an NIAID (DAIDS) Consortium for HIV/AIDS Vaccine Development (CHAVD) grant to Scripps Research.

HIV is the virus responsible for acquired immunodeficiency syndrome (AIDS), a lifelong, progressive illness with no effective cure. Worldwide, approximately 38 million are currently living with HIV, including approximately 1.2 million in the U.S.

Moderna is currently advancing two HIV preventative vaccine strategies based on germline targeting and immune-focusing approaches. In addition to this HIV trimer mRNA vaccine trial of mRNA-1574, Moderna is partnering in testing of HIV vaccine antigens mRNA-1644 and mRNA-1644v2-Core, being evaluated in a Phase I trial sponsored by IAVI and supported by the Bill & Melinda Gates Foundation.

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 potential for mRNA vaccines to induce sustained protective levels of HIV neutralizing antibodies in humans, and to be safe and well-tolerated by HIV-uninfected individuals; the potential to leverage Moderna's mRNA platform to accelerate the discovery of an HIV vaccine; and expected enrollment in the Phase 1 trial of mRNA-1574. 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
+1 617-899-3991
Mary.BethWoodin@modernatx.com

Investors:

Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.