CAMBRIDGE, Mass.—A year after it attracted the largest private financing round ever for a biotechnology company, Moderna Therapuetics is receiving another major show of support for its messenger RNA (mRNA) technology. The Bill & Melinda Gates Foundation has announced a $20-million grant to Moderna to advance the development of an affordable mRNA-based cocktail of antibody therapeutics to help prevent human immunodeficiency virus (HIV) infection. The development efforts will be led by Valera, Moderna’s year-old infectious disease-focused subsidiary.
Stéphane Bancel, CEO of Moderna, tells DDNews that the Gates Foundation grant will provide support for GLP toxicology studies, preparations for clinical trials and a Phase 1 study. “We are honored that the Bill & Melinda Gates Foundation has selected Moderna as a partner, recognizing the tremendous potential of our mRNA drug platform to address some of the world’s most widespread and urgent health concerns,” he says.
The initial $20 million provided by the Gates Foundation grant could be just a fraction of a longer-term contribution. The Gates Foundation and Moderna have reached an agreement that could eventually lead to another $80 million in grants from the foundation. Bancel says that the additional funding could be used to advance the HIV antibody program if Phase 1 studies are successful, or it could also be used to launch new programs focused on developing mRNA-based antibody treatments for other infectious diseases.
“Moderna Therapeutics’ research has considerable potential for the development of an effective prevention intervention for HIV, and potentially other infectious diseases that disproportionately affect the world’s poorest people,” said Trevor Mundel, president of Global Health at the Bill & Melinda Gates Foundation, in a press statement. “We look forward to collaborating with Moderna on the advancement of new tools to fight HIV.”
Moderna was founded four years ago with the goal of developing a new class of drugs using mRNA. Its drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, including native proteins, antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. The company intends to use its platform to develop treatments for hundreds of diseases and already has dozens of preclinical programs in its pipeline.
Bancel tells DDNews that the ability of Moderna’s mRNA platform to combine several mRNAs in a single dose gives the company a significant advantage in developing treatments for infectious diseases, and particularly HIV. “Given how the human immune system works, when somebody gets infected, the immune system produces several antibodies to the pathogens,” he explains. “The idea here is to try to mimic the immune system, and to provide to patients in need several antibodies in a single dose to mimic what the immune system would do. It is of particular interest for HIV, as HIV is a very complex virus. The advantage of this approach is being able to provide a single dose at a low cost.”
Moderna has created several subsidiaries that are each tasked with using the mRNA platform to develop therapies in key disease areas with high unmet medical needs. Valera, the unit spearheading the HIV project, is focused on the advancement of vaccines and therapeutics for the prevention and treatment of viral and bacterial infectious diseases.
During the year since its launch, Valera has demonstrated preclinical efficacy of Moderna’s mRNA-based vaccines in multiple viral disease models. In January, Moderna announced that a Phase 1 study is currently underway in Europe for mRNA 1440, an infectious disease vaccine being developed by Valera for an undisclosed target and indication. The company also announced that an investigational new drug application has been filed with the U.S. Food and Drug Administration for a second, undisclosed infectious disease vaccine, mRNA 1850, with a Phase 1 study anticipated to commence early this year.
The announcement of the Gates Foundation grant comes just weeks after Moderna revealed two new partnerships focused on leveraging its mRNA platform. Merck will license a vaccine program from Moderna to be used against an undisclosed viral target, and AstraZeneca entered a collaboration with Moderna to discover, co-develop and co-commercialize mRNA therapeutic candidates for the treatment of a range of cancers. Both agreements build on ongoing collaborations with the two pharmaceutical companies.