Therapy Areas: Cardiovascular
Moderna Publishes Phase 1 Data for mRNA Vaccines Against Two Potential Pandemic Influenza Strains
16 May 2019 - - Results from two Phase 1 clinical studies have been published showing that mRNA vaccines against H10N8 and H7N9 influenza viruses were well-tolerated and elicited robust immune responses, US-based biotechnology company Moderna, Inc. (NASDAQ: MRNA) said.

The results support the potential of mRNA-based vaccines to quickly and effectively address pandemic influenza strains.

Published in the scientific journal Vaccine, the findings include results from two randomised, placebo-controlled, double-blind Phase 1 studies. Both studies met their primary safety and secondary immunogenicity endpoints, and there were no vaccine-related serious adverse events reported.

In both studies, injection site pain was the most common solicited local AE.

Both H10N8 and H7N9 influenza infections have demonstrated high fatality rates, however neither have an approved vaccine.

In the H10N8 study, 201 healthy volunteers aged 18 to 64 years received two doses of vaccine or placebo three weeks apart, intramuscularly at dose levels from 25 μg to 400 μg, or intradermally at dose levels of 25 μg or 50 μg.

The 100 μg IM dose induced seroprotective immunity of hemagglutination inhibition ≥ 1: 40 in 100% of participants and microneutralization titers ≥ 1:20 in 87% of participants.

The 25 μg ID dose induced HAI titers ≥ 1: 40 in 64.7% of participants compared to 34.5% of participants receiving the IM dose.

HAI titers of 1: 40 and MN titers of 1:20 are expected to be protective in seasonal flu vaccines.

In the H7N9 study, 156 healthy volunteers aged 18 to 49 years received two doses of vaccine or placebo three weeks apart at dose levels of 10 μg, 25 μg and 50 μg.

A small subgroup also received two doses of 25 μg or 50 μg IM six months apart. IM doses of 10 μg, 25 μg and 50 μg achieved HAI titers ≥ 1: 40 in 36%, 96.3% and 89.7% of participants, respectively.

MN titers ≥ 1:20 were achieved by 100% in the 10 μg and 25 μg groups and by 96.6% in the 50 μg group.

Future development of Moderna's pandemic influenza program is contingent on government or other grant funding.

This is the third peer-reviewed publication of human data using Moderna mRNA technology. In the past three years, Moderna and collaborators have published more than 25 peer-reviewed papers, with 12 in the last year alone.

Moderna has 21 mRNA development candidates in its pipeline, with 11 programs now in the clinic. These investigational medicines are grouped together into six modalities based on similar mRNA technologies, delivery technologies and manufacturing processes.

Typically, programs within a modality will also share similar pharmacology profiles, including the desired dose response, expected dosing regimen, target tissue for protein expression, safety and tolerability goals, as well as their pharmaceutical properties.

Moderna scientists designed the company's prophylactic vaccines modality to prevent or control infectious diseases.

This modality now includes eight development candidates, all of which are vaccines against viruses.

Some of these programs are designed for commercial use and others for global public health. The goal of any vaccine is to safely pre-expose the immune system to a small quantity of a protein from a pathogen, called an antigen, so that the immune system is prepared to fight the pathogen if exposed in the future and prevent infection or disease.

Moderna currently has four development candidates for potential commercial uses in this modality, including: respiratory syncytial virus vaccine (mRNA-1777 and mRNA-1172 with Merck), cytomegalovirus vaccine (mRNA-1647) and human metapneumovirus and parainfluenza virus type 3 (hMPV+PIV3) vaccine (mRNA-1653).

Four development candidates in this modality are being explored for potential global health uses including: influenza H10N8 vaccine (mRNA-1440), influenza H7N9 vaccine (mRNA-1851), Zika vaccine (mRNA-1893) with the Biomedical Advanced Research and Development Authority (BARDA) and chikungunya vaccine (mRNA-1388) with the Defense Advanced Research Projects Agency (DARPA).

Moderna is advancing messenger RNA science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases.

The company's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the company the capability to pursue in parallel a robust pipeline of new development candidates.

Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the US Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant secretary for Preparedness and Response within the US Department of Health and Human Services. Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past four years.

Vaccine is the pre-eminent journal for those interested in vaccines and vaccination. It is the official journal of The Edward Jenner Society and The Japanese Society for Vaccinology and is published by Elsevier.
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