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Moderna (MRNA) Initiates Early-Stage Flu Vaccine Study

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Moderna (MRNA - Free Report) announced that it has initiated a phase I/II study to evaluate its seasonal influenza vaccine candidates, mRNA-1020 and mRNA-1030. Both candidates have been designed to include mRNAs to target both hemagglutinin and neuraminidase, two major surface glycoproteins that help the influenza virus to infect.

The company’s vaccine candidates 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 in the phase I/II study.

Moderna believes that by targeting both hemagglutinin and neuraminidase, the candidates have the potential to achieve broader immunity and higher vaccine efficacy against circulating influenza strains than traditional influenza vaccines. The majority of approved influenza vaccines target the hemagglutinin protein to inhibit the spread of the virus within the human body. Vaccines targeting the hemagglutinin protein have demonstrated favorable efficacy. However, Moderna believes neuraminidase will also be an important vaccine target, given that it has a slower rate of mutation. The company stated that antibodies targeting the neuraminidase protein have shown inhibition of multiple stages of the virus life cycle, resulting in protection against infection.

The flu vaccine candidates, mRNA-1020 and mRNA-1030, have the potential to provide broad and robust antibody response, and improved protection against the flu virus as targeting the two major surface glycoproteins of flu viruses may limit the virus' ability to escape the host immune responses through mutations.

Shares of Moderna have declined 37% in the year so far compared with the industry’s 12.1% decrease.

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Moderna has three other flu vaccine candidates in its pipeline. The most advanced candidate in the company’s flu program is mRNA-1010, which is currently being evaluated in a phase II study. A phase III study is expected to start soon to evaluate mRNA-1010. The hemagglutinin-targeting quadrivalent seasonal flu vaccine candidate is being developed to provide protection against influenza A/H1N1, A/H3N2 and influenza B/Yamagata and B/Victoria.

The company’s other two flu vaccine candidates — mRNA-1011 and mRNA-1012— are in pre-clinical studies. These two candidates will include the four WHO-recommended strains and aim to add additional hemagglutinin antigens.

Moderna has built a strong commercial presence across the globe, following the success of its mRNA-based COVID-19 vaccine, Spikevax. The vaccine led the company from a loss-making, clinical-stage company to inclusion in the S&P 500 Index.

Apart from flu and COVID-19 vaccines, Moderna has a strong portfolio of mRNA-based vaccine candidates to provide protection against a range of diseases including respiratory syncytial virus, HIV and cancer. Its pipeline candidates hold strong potential as they target lucrative indications. The company is also developing a pan-respiratory annual booster vaccine candidate, mRNA-1073, which will provide protection against COVID-19 and seasonal flu. It also has several early-stage mRNA-based therapeutics in its pipeline.

Zacks Rank & Stocks to Consider

Moderna currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Axcella Health , Trevi Therapeutics (TRVI - Free Report) and Voyager Therapeutics (VYGR - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

The Zacks Consensus Estimate for Axcella Health’s 2022 and 2023 loss has narrowed 12.9% and 16.4%, respectively, over the past 60 days. Shares of AXLA have declined 5.1% so far this year.

Earnings of Axcella Health surpassed estimates in three of the trailing four quarters and missed once, the average beat being 1.67%.

The consensus estimate for Trevi’s 2022 bottom line has narrowed 19.4% for 2022 and 14.1% for 2023 over the past 60 days. TRVI stock has surged 247.7% so far this year.

Earnings of Trevi surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions, the average beat being 5.09%.

Estimates for Voyager’s 2022 and 2023 loss have narrowed 38.6% and 29%, respectively, over the past 60 days. VYGR has rallied 203.7% so far this year.

Earnings of Voyager surpassed estimates in three of the trailing four quarters and missed once, the average beat being 41.00%.


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