The company plans to launch up to 15 new products and bring up to 50 new candidates to the clinic over the next five years as part of its growth plan, while scaling down COVID-19 manufacturing.
Pictured: Moderna headquarters/iStock, hapabapa
Determined to expand its product pipeline beyond COVID-19 vaccines, Moderna on Wednesday announced a strategic plan with expectations to launch up to 15 new products across cancer as well as rare and infectious diseases over the next five years.
Moderna provided Wednesday’s business and clinical updates as part of the company’s annual R&D Day in which it reinforced an mRNA-based approach “to create medicines addressing high unmet needs at unprecedented speed and efficiency.”
However, after explosive growth during the coronavirus pandemic, Moderna’s shares have been sliding all year as sales wane for COVID vaccines, the biotech’s only approved product. Stock prices are down over 40% year-to-date, a trend CEO Stéphane Bancel is determined to turn around.
An updated version of its COVID vaccine was approved by the FDA earlier this week, and sales for 2023 are expected to bring in $6 billion to $8 billion. At the same time, Moderna is downsizing its manufacturing footprint to help reach the company’s gross margin growth goal of 75% to 80%.
The company is promoting a slew of new mRNA-technology vaccines across respiratory, oncology and infectious disease. Its RSV vaccine is in the lead having already been submitted to authorities for approval. The mRNA-1345 vaccine is for the prevention of RSV-associated lower respiratory tract disease and acute respiratory disease in adults over 60, a particularly vulnerable population. Moderna used its Priority Review Voucher with the FDA to move up in line and are expecting a PDUFA date of April 2024.
After a rocky Phase III for its seasonal flu vaccine, Moderna updated its mRNA-1010 formulation and tried again. An interim analysis of the P303 study revealed better results with mRNA-1010 meeting all co-primary endpoints across all four A and B strains of influenza. Separate Phase I/II data showed a higher level of antibody titers than GSK’s vaccine Fluarix.
Moderna expects to meet with regulators soon, with hopes of a potential flu vaccine launch as soon as next year, Bancel told Fierce Biotech.
The goal going forward is to combine the shots with a flu and COVID vaccine launch as soon as 2025. The following year, the plan is for a potential triple shot combining Moderna’s COVID, flu and RSV vaccines.
Moderna’s latent and other virus vaccine pipeline includes candidates for cytomegalovirus, Epstein Barr, herpes simplex, varicella zoster virus, norovirus and HIV. According to the company, the market size for these diseases is between $10 billion and $25 billion. Its cytomegalovirus vaccine is in a pivotal Phase III study.
The biotech has partnered with Merck for its cancer vaccine pipeline. mRNA-4157/V940 is being co-developed and commercialized by Moderna and Merck under the terms of its existing collaboration and license agreement. Referred to as an individualized neoantigen therapy (INT), Moderna’s adjuvant shot is being coupled with Merck’s blockbuster Keytruda in clinical studies. Phase II and III trials are underway in patients with resected melanoma at different stages, while a Phase III trial in non-small cell lung cancer is coming soon. Development is planned to expand into additional tumor types.
Other oncology vaccines and a rare disease portfolio are also progressing, according to Moderna, whose goal is to launch 15 new products and bring up to 50 new candidates into clinical trials over the next five years.
Its oncology, rare and latent disease products are expected to increase annual sales by $10 billion to $15 billion in 2028, adding to the $8 billion to $15 billion expected from the respiratory franchise by 2027.
From 2024 to 2028, Moderna has allotted $25 billion for R&D as the company looks to “continue to invest in science to expand the field of mRNA medicine into new frontiers.”
Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.
