Moderna has touted the potential of its ever-expanding mRNA platform, which includes an in vivo candidate, during its annual Science Day.
Held on 25 June, Moderna told participants that it will continue to broaden its mRNA platform to include infectious disease vaccines, cancer vaccines and rare disease therapeutics, while advancing a broad mRNA pipeline and continuing to invest in research and development.
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Stéphane Bancel, CEO of Moderna, said: “Working across three strategic horizons, we are applying our mRNA platform expertise to validate, scale and expand our modalities, with new modalities in the clinic, including T-cell engagers, and new modalities soon to be in the clinic, like in vivo CAR-T. At the same time, we are driving innovation by using data, AI and machine learning, and robotics to accelerate discovery and continuously improve how we execute for near-term growth while fuelling the next generation of mRNA medicines for patients around the world. We are fortunate to have the privilege to make medicine at this moment in time.”
Moderna is executing a strategy that balances near-term growth with long-term innovation. Building on the momentum of its four approved products – Spikevax, mRESVIA, mNEXSPIKE and mCOMBRIAX, Moderna is driving growth through infectious disease launches, geographic expansion, and the advancement of late-stage pipeline opportunities, including its investigational intismeran autogene therapy and propionic acidemia therapeutic.
In parallel, Moderna Research and Early Development (mRED) is focused on emerging and future modalities to advance high-potential programmes toward clinical proof-of-concept and first-in-human (FIH) milestones.
Early and late-stage candidates form platform strategy
Moderna has three Horizon programmes, which categorise the stage of development of its mRNA therapies.
Horizon 1 comprises Moderna’s late-stage and approved products, while continuing to enable innovation in these established modalities, and drives an end-to-end path from discovery through commercialisation.
Horizon 2 emerging modalities and Horizon 3 future modalities are led by mRED to scale and expand the Company’s mRNA platform. Horizon 2 modalities are in the clinic and awaiting human proof-of-concept. The majority are in Phase I/II trials in oncology, with a multiple sclerosis (MS) therapeutic in Phase II. Horizon 3 modalities have the potential to advance to FIH clinical trials by the end of 2027.
The Horizon 2 programme includes mRNA-4106, which is in a Phase I study in solid tumours, and mRNA-4200, which is set to advance into a Phase I study in combination with Keytruda (pembrolizumab), also in advanced solid tumours. It also includes mRNA-4194, which is in the second portion of an ongoing Phase I/II trial in first-line metastatic melanoma and first-line metastatic non-small cell lung cancer (NSCLC).
Three other candidates fall under the Horizon 2 programme: mRNA-2808 in multiple myeloma, mRNA-2151 in ovarian cancer and mRNA-1195 in MS. They are in varying stages of development.
The Horizon 3 programme contains just one asset, mRNA-6007, an in vivo CAR-T designed to enable deep B-cell depletion for autoimmune conditions using a multiplexed mRNA approach with targeted lipid nanoparticles (LNPs). The programme aims to deliver mRNA into immune cells in vivo, enabling transient CAR expression and potential immune reset. The initial clinical focus is systemic lupus erythematosus (SLE) and other B-cell-mediated autoimmune diseases.
mRNA therapeutics in regulatory spotlight
The annual event came shortly after Moderna gained recommendation for approval from a US Food and Drug Administration (FDA) Advisory Committee (AdCom) meeting for its mRNA influenza vaccine, mRNA-1010.
The positive vote marked a turnaround for Moderna’s prospects in the US vaccine sector, after mRNA-1010 was embroiled in regulatory controversy earlier in the year. In February, the FDA refused to accept Moderna’s application for review – in a letter, the agency highlighted the lack of a properly conducted study.
In August, RFK Jr cut $500m worth of mRNA vaccine research funding, impacting around 22 projects being run at the Biomedical Advanced Research and Development Authority (BARDA). Knock-on effects were also felt in the cancer mRNA vaccine space, as per experts interviewed by Pharmaceutical Technology, sister publication of Clinical Trials Arena.
mRNA vaccine coverage on Pharmaceutical Technology (Or Clinical Trials Arena) is supported by Trilink. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.
