News | Heart Failure | November 13, 2017

Moderna and AstraZeneca to Co-Develop, Commercialize Relaxin mRNA Therapeutic for Heart Failure

Pharmaceutical would instruct cells to produce and express Relaxin hormone to impact underlying conditions that exacerbate heart failure

November 10, 2017 — Moderna Therapeutics announced a new license and collaboration with AstraZeneca to co-develop and co-commercialize a messenger RNA (mRNA) therapeutic encoding for Relaxin. The companies will advance the new Relaxin development candidate, AZD7970, toward the clinic as an investigational treatment for heart failure.

Heart failure occurs when the heart is weakened and cannot pump enough blood to meet the body’s needs. AZD7970 is being developed to instruct cells in the body to produce and express Relaxin, a secreted protein with systemic effect. Biologic functions for Relaxin suggest that expression of the hormone may directly impact underlying conditions that exacerbate heart failure, leading to the regrowth of heart tissue, controlling inflammation, reordering the extracellular matrix, improving renal function and relieving hepatic portal pressure. AZD7970 utilizes one of Moderna’s proprietary formulations, N2GL, which enables systemic, repeat dosing of mRNA therapeutics.

Approximately 5.7 million adults in the U.S. alone have heart failure. About half of those who develop heart failure die within five years of being diagnosed. A global health burden, heart failure impacts approximately 26 million people around the world.

Under the terms of the new agreement between the companies, Moderna will fund and be responsible for preclinical development of AZD7970, including the conduct of Good Laboratory Practice (GLP) toxicology studies. AstraZeneca will be responsible for early clinical development of AZD7970, and Moderna and AstraZeneca will share the costs of late-stage clinical development. Moderna and AstraZeneca will co-commercialize AZD7970 in the U.S. under a 50:50 profit sharing arrangement. AstraZeneca will lead ex-U.S. commercialization efforts, with Moderna receiving tiered royalties up to substantial double digits on ex-U.S. sales.

This marks the second strategic agreement between Moderna and AstraZeneca to advance mRNA therapeutics in the cardiometabolic space. The lead program from the first strategic agreement, which was announced in 2013, is AZD8601, a localized mRNA therapeutic that encodes for vascular endothelial growth factor (VEGF-A). AZD8601 has successfully completed a Phase 1 study, and AstraZeneca has submitted a Clinical Trial Application (CTA) in Europe to initiate a Phase 2a study of AZD8601 in heart failure patients undergoing cardiac bypass grafting (CABG) surgery.

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