Preclinical and Clinical Data Publication in Molecular Therapy

April 27, 2017

Title: Preclinical and clinical demonstration of immunogenicity by mRNA vaccines against H10N8 and H7N9 influenza viruses
Authors: Bahl K, Senn J, Yuzhakov O, Bulychev A, Brito LA, Hassett KJ, Laska ME, Smith M, Almarsson Ö, Thompson J, Ribeiro A, Watson M, Zaks T, Ciaramella G

Overview

In April 2017, Moderna published positive interim data from a 100 µg intramuscular (IM) cohort from its ongoing Phase 1 study of mRNA-1440, an mRNA infectious disease vaccine against avian H10N8 influenza. The findings, published in the journal Molecular Therapy, demonstrated mRNA-1440 induced high levels of immunogenicity, and was safe and well-tolerated.

These are the first human proof-of-concept data from Moderna’s mRNA technology platform. In addition, they are the first-ever published data demonstrating an mRNA vaccine’s ability to elicit robust prophylactic immunity in humans.

The publication also included preclinical data demonstrating that mRNA-1440 and Moderna’s second mRNA vaccine program, mRNA-1851 against avian H7N9 influenza, both generated strong protective immunity in mice, ferrets and non-human primates, demonstrating that Moderna’s platform technology translated across species from small animals to large animals to humans.

Publication | Press Release

 

Video Overview

 

Giuseppe Ciaramella, Ph.D., Chief Scientific Officer of Valera, Moderna’s infectious disease-focused venture, gives a high level overview of the publication and significance of the findings.

 

 

Webcast

Dr. Ciaramella gives a five-part presentation on Moderna’s mRNA vaccine technology, an overview of the preclinical and clinical data, and discusses the advantages of mRNA vaccines versus other vaccine approaches.

Part 1 of 5 – Introduction to our mRNA vaccine technology

Part 2 of 5 – Overview of H10N8 and H7N9 influenza

 

Part 3 of 5 – Preclinical data

Part 4 of 5 – Phase 1 interim clinical data

Part 5 of 5 – Advantages of mRNA vaccines