Moderna, Inc. and the nonprofit scientific research organization IAVI, on April 7th, 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 the 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.

Stéphane Bancel, Chief Executive Officer of Moderna, said:

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. With our mRNA technology and IAVI’s discovery and development expertise, together we have an opportunity to address persistent global health threats.

Mark Feinberg, M.D., Ph.D., president and CEO of IAVI, said:

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.

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.

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.

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.