Biotech Unicorn Moderna’s Vaccine Performs Well in First Human Trial
April 28, 2017
By Alex Keown, BioSpace.com Breaking News Staff
CAMBRIDGE, Mass. – There’s excitement running through the halls of Moderna Therapeutics following the publishing of interim data from a Phase I study of its messenger RNA (mRNA) therapy for avian H10N8 influenza.
Interim data showed the vaccine mRNA-1440 induced high levels of immunogenicity in the 31 patient trial. The vaccine was administered to 23 patients, with eight receiving a placebo. While the early data showed promise in patients who were dosed, Moderna said none of the patients who received a placebo responded. H10N8 is a subtype of the influenza A virus, for which there are no approved vaccines.
Privately-held Moderna said interim results show that the mRNA-1440 vaccine demonstrated strong efficacy based on Hemagglutination Inhibition Assay (HAI) and Microneutralization Assay (MN) titers, two measures of immunogenicity in response to vaccination. The majority of adverse events were mild to moderate, however three patients who received mRNA-1440 experienced severe adverse events, which included injection-site reactions and common cold-like symptoms, Moderna said. The interim reports are the first human proof-of-concept data from Moderna’s mRNA technology platform. In addition, they are the first-ever published data demonstrating a prophylactic mRNA vaccine’s ability to elicit robust immunity in humans, Moderna said in a statement this morning.
Tal Zaks, Moderna’s chief medical officer, said the data was encouraging and provides early evidence the company’s mRNA vaccine technology can direct “the body’s cells to produce and express viral antigenic proteins and elicit high levels of immunity that are expected to protect against viral infection.” He said the interim data also provides important validation of Moderna’s core mRNA platform.
Moderna published a report on the interim data in the journal Molecular Therapy. In addition to the information about the vaccine, the publication also provided information on a second mRNA vaccine program, mRNA-1851 against avian H7N9 influenza.
“These human proof-of-concept data mark a crucial milestone for Moderna as we work to advance the potential of mRNA vaccines and therapeutics to translate into clinical benefit across a breadth of diseases and unmet needs. Importantly, these published data also represent continued progress for the emerging field of mRNA science as a whole, as we explore the viability and expansive promise of this entirely new class of medicines,” Stéphane Bancel, chief executive officer of Moderna, said in a statement. “We look forward to completing this study and sharing the full data results in 2018, and to reporting other preclinical and clinical milestones related to our development pipeline this year.”
Currently there are four Phase I mRNA vaccine studies and one Phase 1 mRNA therapeutic study underway utilizing Moderna’s mRNA platform technology.