Moderna

Doctors are trialling the world's first mRNA vaccine against norovirus, aiming to reduce health and economic burdens. The phase 3 trial, called Nova 301, will enroll 25,000 adults, focusing on those over 60, across several countries. The vaccine, based on mRNA technology, is expected to generate a strong immune response. If successful, a marketing application could be submitted in 2026, with further trials planned for teenagers and younger children.

Vertex Pharmaceuticals developed a therapy for cystic fibrosis, challenging low drug development odds. Their R&D strategy focuses on causal human biology, using human genomics and modality agnosticism to improve success rates, exemplified by FDA approvals for CF, sickle cell disease, and beta thalassemia treatments.

Moderna presented interim results for mRNA-1403, a norovirus vaccine candidate, at IDWeek 2024. The Phase I/II trial showed promising safety, reactogenicity, and immunogenicity, with robust antibody responses. Older adults were well-represented, addressing their high risk for NoV. A Phase III trial is underway, and mRNA-1403 is one of six NoV vaccine candidates in late-stage development.

Innovative cancer therapies like mRNA-based treatments and CAR T-cell therapy are transforming research, leveraging the immune system to fight cancer effectively. Nonclinical studies are crucial for evaluating efficacy and safety before clinical trials, focusing on potential toxicities and immune responses. CAR T-cell therapy, approved for certain hematologic cancers, is being explored for solid tumors and next-generation enhancements. mRNA-based therapies, including cancer vaccines and immune modulators, show promise in early trials, with ongoing research addressing delivery challenges and immune response management. Future directions include personalized cancer vaccines and expanded CAR T-cell applications for solid tumors.

Novavax's combined COVID-19 and flu vaccine program faces a clinical hold by the FDA due to a serious adverse event, causing a 20% share drop. The hold delays a potential major product for the biotech, adding uncertainty to its revenue prospects. Despite this, Novavax's latest COVID-19 vaccine is available in more locations, and the company plans to unveil an expanded clinical pipeline by year-end.

UK biopharma sues US rival Moderna for infringing mRNA tech patents in Spikevax development, alleging Moderna used protected inventions despite touting speed. Moderna reported over $6bn from Spikevax in 2023.

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GSK sues Moderna for patent infringement on mRNA vaccine technology, claiming Moderna's COVID-19 vaccines rely on GSK's foundational patents from a team led by Christian Mandl at Novartis. GSK seeks damages and licensing fees.