Moderna Shifts Gears: Pioneering mRNA Medicines as COVID Vaccine Production Takes a New Direction

Moderna’s Ambitious Leap Beyond COVID: Unveils Plan for 15 New Medicines in the Next 5 Years

In a bold move to diversify beyond its COVID-19 vaccine success, Moderna revealed a strategic roadmap at its annual R&D Day, aiming to launch up to 15 innovative products spanning cancer, rare diseases, and infectious ailments over the next half-decade.

Despite its meteoric rise during the pandemic, Moderna has faced a turbulent year, with its stock prices plummeting by over 40% due to waning demand for COVID vaccines. CEO St├ęphane Bancel is now on a mission to reverse this trend.

While an updated version of its COVID vaccine gained FDA approval this week, bringing anticipated 2023 sales of $6 billion to $8 billion, Moderna is simultaneously streamlining its manufacturing footprint to achieve a lofty gross margin growth goal of 75% to 80%.

The biotech powerhouse is spearheading a new era in mRNA-based technology, focusing on vaccines for respiratory diseases, oncology, and infectious conditions. Leading the pack is their RSV vaccine, already in submission for regulatory approval. This vaccine targets RSV-associated respiratory diseases in vulnerable adults over 60, and Moderna’s priority is evident with a PDUFA date set for April 2024, thanks to a Priority Review Voucher.

Following a rocky Phase III for its seasonal flu vaccine, Moderna revamped its mRNA-1010 formulation, achieving stellar results with an interim analysis in the P303 study, surpassing co-primary endpoints for all influenza strains. Phase I/II data also indicated higher antibody titers than GSK’s Fluarix.

Moderna is gearing up to meet with regulators soon, aiming for a potential flu vaccine launch as early as next year, with the vision of combining flu and COVID shots by 2025 and potentially introducing a triple vaccine in 2026, featuring COVID, flu, and RSV protection.

Beyond this, Moderna is harnessing its mRNA technology to tackle latent and other viral diseases like cytomegalovirus, Epstein Barr, herpes simplex, varicella-zoster virus, norovirus, and HIV. These markets are valued between $10 billion and $25 billion. The company’s cytomegalovirus vaccine is currently undergoing pivotal Phase III trials.

In the realm of cancer, Moderna has joined forces with Merck for its vaccine pipeline. mRNA-4157/V940, referred to as an individualized neoantigen therapy (INT), is being developed alongside Merck’s Keytruda in clinical trials for resected melanoma and non-small cell lung cancer, with plans for expansion.

Moderna’s ambitious vision extends to other oncology vaccines and a rare disease portfolio. They aim to launch 15 new products and introduce up to 50 new candidates into clinical trials over the next five years.

The anticipated revenue boost from oncology, rare, and latent disease products is projected to reach $10 billion to $15 billion by 2028, complementing the $8 billion to $15 billion expected from the respiratory franchise by 2027.

With a whopping $25 billion allocated for R&D from 2024 to 2028, Moderna is poised to advance the field of mRNA medicine into uncharted territories.

Leave a Comment