Collaboration to target bacterial and viral pathogens including HIV, SARS-CoV-2, antimicrobial-resistant pathogens, and tuberculosis

NEW YORK, NY and CAMBRIDGE, MA / ACCESSWIRE / April 7, 2022 / Moderna, Inc., (NASDAQ:MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and the nonprofit scientific research organization IAVI today announced a new collaboration to employ mRNA technology to meet the challenge of a range of global health threats. These diseases - HIV/AIDS, tuberculosis (TB), antimicrobial-resistant enteric infections, and COVID-19 - are estimated to have caused at least 95 million new infections and more than 4 million deaths in 2020 alone. The collaboration combines the power of Moderna's mRNA platform and IAVI's expertise in discovery and product development to advance vaccines and antibodies designed to be globally accessible, especially in low-income countries where the targeted diseases have high incidence and prevalence.

"We are excited to partner with IAVI to leverage the power of mRNA and extend our commitment to global health across multiple diseases. Moderna's mRNA platform, with its speed, scale, and flexibility, is uniquely suited to tackle current and emerging pathogens," said Stéphane Bancel, Chief Executive Officer of Moderna. "With our mRNA technology and IAVI's discovery and development expertise, together we have an opportunity to address persistent global health threats."

"Since our founding 25 years ago, we at IAVI have been focused on translating scientific discovery into broadly accessible solutions for global health problems. Moderna's proven, innovative platform has the potential to be a key that unlocks rapid production of vaccine and antibody candidates that could significantly accelerate our ability to solve the most difficult public health problems. IAVI's partnership with Moderna is a unique example of two organizations with complementary expertise and shared goals combining the best of our science to address urgent global public health needs," said Mark Feinberg, M.D., Ph.D., president and CEO of IAVI.

mRNA technology enables more rapid production of material for clinical testing than can be achieved by conventional recombinant protein synthesis or cell systems. The partners hope to harness this speed of production to accelerate research and development. If the products are shown to be efficacious and safe, they could be rapidly manufactured at a large scale.

HIV vaccine antigens in clinical development

Within the partnership, the program furthest along in development is a Phase I clinical trial, IAVI G002, of HIV vaccine antigens being delivered by mRNA. The trial was initiated in January 2022 and is testing vaccine antigens that were originally developed as proteins by a team led by William Schief, Ph.D., professor at Scripps Research and executive director of vaccine design at IAVI's Neutralizing Antibody Center (NAC). In early 2021, Dr. Schief announced results from the IAVI G001 clinical trial, showing that an adjuvanted protein-based version of the immunogen eOD-GT8 60mer induced the desired B cell response in 97% of recipients. IAVI G002 takes this concept further: it will determine whether mRNA-encoded eOD-GT8 60mer followed by an additional mRNA-encoded immunogen induces further maturation of B cells. This trial, funded by the Bill & Melinda Gates Foundation, represents the first time mRNA for HIV vaccines is evaluated in humans. Another Phase I trial is expected to begin this year in South Africa and Rwanda. This trial, IAVI G003, is sponsored by IAVI and is made possible by the support of the American people through the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) through the United States Agency for International Development (USAID). Additional support is provided by the Bill & Melinda Gates Foundation through grants to Moderna and to the Collaboration for AIDS Vaccine Discovery Vaccine Immunology Statistical Center. The trial will assess whether receipt of the priming vaccine antigen being evaluated in IAVI G002 in U.S. populations induces similar responses in African populations. Eventually, through these and future trials, the partners hope to demonstrate proof-of-principle for the elicitation of HIV broadly neutralizing antibodies in humans via the vaccine approach pioneered by Dr. Schief's lab.

Preclinical research on vaccines and antibodies

The other joint IAVI-Moderna programs for TB vaccine candidates and antibodies for SARS-CoV-2, HIV, and enteric pathogens are in preclinical stages. The TB collaboration will advance research on a set of promising antigens that the partners hope will bring much-needed diversity to the global preclinical TB vaccine pipeline. For the antibody programs, scientists at the NAC are collaborating with Moderna researchers with the aim to improve the antibody-mRNA platform and establish proof-of-concept for testing in humans.

About IAVI

IAVI is a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV, tuberculosis, and emerging infectious diseases. Its mission is to translate scientific discoveries into affordable, globally accessible public health solutions. Read more at iavi.org.

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.

Moderna 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 of mRNA technology to address a range of global health threats; Moderna's collaborations with IAVI; the speed at which vaccines can be developed using an mRNA platform; the potential of Moderna's platform to allow rapid production at scale of vaccine and antibody candidates in order to accelerate research and development; expected commencement of the IAVI G003 trial; and the potential for vaccines to elicit HIV broadly neutralizing antibodies in humans. 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.

IAVI Media Contact
Karie Youngdahl
Head, Global Communications
+1 212-857-1051
KYoungdahl@iavi.org

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.