Moderna is preparing for multiple product launches over the next several years, including RSV and flu vaccines and boosters for COVID-19. It is also aiming mRNA programs at rare diseases.
Moderna is preparing for multiple product launches over the next several years, including RSV and flu vaccines, boosters for COVID-19 and mRNA programs for rare diseases.
Between 2023 and 2026, Moderna anticipates multiple vaccine launches across the globe, beginning with boosters aimed at the various strains of COVID-19. In 2023, Moderna aims to pursue approval under the accelerated pathway for its flu vaccine mRNA-1010. As part of its launch plans, Moderna said it will continue investing in its manufacturing capabilities to support vaccine production.
On Thursday, the Cambridge, Mass.-based company hosted its annual R&D day for investors. Leadership showcased the company’s clinical programs across multiple indications, including 34 vaccine programs in development.
During its presentation, Chief Executive Officer Stéphane Bancel called that a remarkable number. He said Moderna has always been excited about the use of mRNA technology, nothing that the software-like nature of RNA has had the company excited about the mRNA modality.
“We are investing for other launches and we are investing for scale… because with the pipeline that is coming, it is important that we do that to maximize the potential for patients,” Bancel said.
Rare Diseases
Among its presentations were proof-of-concept studies on rare diseases. Because mRNA is like software for the body, Bancel stated the company would be delving into rare diseases more and more due to the potential of the technology.
These include potential therapeutics for multiple rare diseases, including propionic academia and methylmalonic acidemia, metabolic disorders that share disease pathology and glycogen storage diseases. For propionic academia (PA), the company is developing mRNA-3927, which encodes for two proteins that can help the body make the missing enzyme absent in PA patients. Moderna is enrolling patients in a Phase I/II study that will evaluate the safety and pharmacology of mRNA-3927.
In methylmalonic academia (MMA), the company has enrolled the first two groups of patients in a Phase I/II study assessing the safety and pharmacology of mRNA-3705. The mRNA-based therapy is designed to instruct the body to restore the missing or dysfunctional proteins that cause MMA.
For glycogen storage disease 1a, Moderna initiated the Phase I/II Ba1ance trial assessing a single intravenous dose of mRNA-3745. Enrollment in the trial is ongoing, and the company anticipates data in 2023. Moderna is also advancing a new development candidate, mRNA-3139, a potential drug for ornithine transcarbamylase deficiency. It uses the same lipid nanoparticle as the mRNA-3745 program for GSD1a.
Respiratory Vaccines
Moderna has already seen significant success with its COVID-19 vaccine. The company continues to develop booster doses that address new strains of the SARS-CoV-2 virus that run rampant across the globe.
Moderna has launched two vaccine boosters to meet different needs across the largest markets: mRNA-1273.214 and mRNA-1273.222. mRNA-1273.214 targets both the original strain of SARS-CoV-2 and the Omicron variant of concern (BA.1). Moderna’s mRNA-1273.222 targets the Omicron BA.4 and BA.5 variants, combined with mRNA-1273. A Phase II/III trial for this candidate is underway.
The company’s seasonal influenza vaccine candidate, mRNA-1010, is in Phase III development in the Southern hemisphere, with approximately 6,000 patients. Moderna aims to initiate a Phase III trial in the Northern Hemisphere designed to evaluate mRNA-1010 against a licensed seasonal influenza vaccine.
In RSV (respiratory syncytial virus), Moderna launched a Phase III trial that will evaluate mRNA-1345 in older adults aged 60 and above. The test has enrolled more than 24,000 patients so far. Full enrollment is expected at 34,000 patients. The study has been designed to provide an efficacy readout in the 2022-2023 winter season. In addition to older adults, RSV is also a virus of concern in young children. Moderna is also assessing mRNA-1345 in a Phase I trial in pediatric populations. There is currently no vaccine available for RSV.
In addition to single-agent vaccines, Moderna is advancing several combination respiratory vaccines, including a fully enrolled Phase I/II trial testing mRNA-1073 for both COVID-19 and influenza. The company is also conducting a study of mRNA-1230, a vaccine candidate for COVID-19, influenza and RSV. A clinical trial for this vaccine is expected to be initiated this year.
CMV and Cancer Vaccines
Moderna is developing a vaccine for cytomegalovirus (CMV), a type of latent herpes virus known to cause long-term health problems in newborns. The company is assessing mRNA-1647 in the Phase III CMVictory that is designed to prevent congenital CMV. Enrollment in this study is ongoing.
The company is also developing personalized cancer vaccines, including mRNA-4157, which is being assessed in combination with Merck’s Keytruda in patients with resected melanoma at high risk of recurrence. The combination is in Phase II, and primary data is expected by the end of the fourth quarter of this year.
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