Moderna Therapeutics, Through Valera, its Infectious Disease Venture, Announces Initial Grant of up to $20 Million to Advance mRNA-Based Antibody Combination to Help Prevent HIV Infection

January 12, 2016 07:30 AM Eastern Standard Time
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Moderna Therapeutics, a pioneer in the development of messenger RNA (mRNA) Therapeutics™, today announced a partnership with the Bill & Melinda Gates Foundation to advance the development of a novel, affordable combination of mRNA-based antibody therapeutics to help prevent human immunodeficiency virus (HIV) infection. The development efforts will be led by Valera, Moderna's infectious disease-focused venture.

The Gates Foundation has committed up to $20 million in grant funding to support Moderna's evaluation of the antibody combination in a preclinical setting as well as the conduct of a first-in-human Phase 1 clinical study. Through an agreement between the two organizations, there may be potential for follow-on projects of up to $100 million total (including the HIV antibody project) to support the development of additional mRNA-based projects for various 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. "We look forward to collaborating with Moderna on the advancement of new tools to fight HIV."

"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," said Stéphane Bancel, CEO of Moderna. "The foundation's mission to help all people lead healthy and productive lives is well aligned with Moderna's mission to deliver on the promise of transformative mRNA science to bring new medicines to patients. We are excited to initiate the first project with the foundation to develop an antibody-combination prevention modality to prevent HIV infection. Working together, I believe we will have a profound impact on millions of lives."

Since Valera's launch in January 2015, the venture has focused exclusively on utilizing Moderna's platform to advance vaccines and therapeutics for the prevention and treatment of viral, bacterial and parasitic infectious diseases. Efforts at the venture already have yielded substantial results, including the demonstration of preclinical efficacy of Moderna's mRNA-based vaccines in multiple viral disease models.

On January 11, 2016, Moderna announced that a Phase I 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 (IND) application has been filed with the U.S. Food and Drug Administration (FDA) for a second, undisclosed infectious disease vaccine, mRNA 1850, with a Phase I study anticipated to commence in Q1 2016.

Valera will apply its mRNA vaccine platform and Moderna's drug platform to its programs of focus for the Bill & Melinda Gates Foundation partnership.

About Valera, A Moderna Venture
Valera, a Moderna venture, is focused exclusively on the advancement of vaccines and therapeutics for the prevention and treatment of infectious diseases. Valera is leveraging Moderna's messenger RNA Therapeutics™ platform, an entirely new in vivo drug technology that produces human proteins, antibodies and entirely novel protein constructs inside patient cells, which are in turn secreted or active intracellularly. For more information please visit www.modernatx.com/ventures.

About Moderna Therapeutics
Moderna is a clinical stage pioneer of messenger RNA Therapeutics™, an entirely new in vivo drug technology that produces human proteins, antibodies and entirely novel protein constructs inside patient cells, which are in turn secreted or active intracellularly. This breakthrough platform addresses currently undruggable targets and offers a superior alternative to existing drug modalities for a wide range of disease conditions. Moderna is developing and plans to commercialize its innovative mRNA drugs through its own ventures and its strategic relationships with established pharmaceutical and biotech companies. Its current ventures are: Onkaido, focused on oncology, Valera, focused on infectious diseases, Elpidera, focused on rare diseases, and Caperna, focused on personalized cancer vaccines. Cambridge-based Moderna is privately held and currently has strategic agreements with AstraZeneca, Alexion Pharmaceuticals and Merck. www.modernatx.com.

Contacts
Feinstein Kean Healthcare
Liz Melone, 617-256-6622

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