Moderna Announces First Participants Dosed in Phase 1/2 Study with mRNA-1020 and mRNA-1030 Seasonal Influenza Vaccine Candidates

Moderna, Inc. (NASDAQ:MRNA), has announced the first participants have been dosed in the Phase 1/2 study of the company’s seasonal influenza vaccine candidates, mRNA-1020 and mRNA-1030.

Moderna explained that this Phase 1/2 randomized, observer-blind, dose-ranging study will evaluate the safety, reactogenicity and immunogenicity of a single dose of mRNA-1020 or mRNA-1030 in healthy adults 18 years and older in the U.S. The mRNA-1020 and mRNA-1030 candidates each include eight mRNAs, targeting both hemagglutinin and neuraminidase at different doses and ratios. Similar to Moderna’s influenza vaccine candidate mRNA-1010, mRNA-1020 and mRNA-1030 will target the strains recommended by the World Health Organization (WHO) for the prevention of influenza, including seasonal influenza A/H1N1, A/H3N2 and influenza B/Yamagata and B/Victoria. The Company intends to enroll approximately 560 participants in the study.

“We are pleased to apply Moderna’s mRNA platform to address the longstanding design and manufacturing challenges associated with developing seasonal influenza vaccines. We believe that by targeting both hemagglutinin and neuraminidase, we can achieve broader immunity and higher vaccine efficacy against circulating influenza strains than traditional influenza vaccines. Moreover, we expect that our platform’s flexibility in targeting multiple strains coupled with our ability to manufacture quickly will facilitate production of a vaccine that matches the predominant circulating influenza strain,” said Stéphane Bancel, Chief Executive Officer of Moderna.

Worldwide, influenza leads to 3-5 million severe cases of flu and 290,000-650,000 flu-related respiratory deaths annually, despite the availability of influenza vaccines. Three main types of influenza viruses (A, B, and C) infect humans, with influenza A and B viruses causing significant morbidity and mortality. Although influenza A and B viruses cause seasonal flu epidemics, it is the influenza A viruses that lead to >95% of flu-related hospitalization in adults. Influenza A and B viruses carry two major surface glycoproteins that are essential across the viral life cycle: hemagglutinin (HA) and neuraminidase (NA). While the importance of targeting the viral HA with vaccines is well known, data suggests NA will also be an important vaccine target given that it has a slower rate of mutation and anti-neuraminidase antibodies have been shown to inhibit multiple stages of the virus life cycle and thereby contribute to protection against infection. Targeting both viral proteins may limit the virus’ ability to escape the host immune responses through mutations and can potentially lead to better protection, the company said.

Moderna said that it is pursuing an iterative approach to influenza vaccine development, with increasing levels of enhancements aimed at improving immune responses and increasing immunologic breadth. Though currently licensed influenza vaccines target predominantly the viral HA, in the mRNA-1020/1030 trial, Moderna adds neuraminidase antigens in order to target both major glycoproteins with the aim of promoting a broad and robust antibody response.