Moderna, an mRNA specialist known for its COVID-19 vaccine Spikevax, is winding down development of three clinical mRNA programs, including two investigational vaccines for infectious diseases.
The company is ending development of a therapeutic vaccine candidate coded mRNA-1608 for herpes simplex virus (HSV). Moderna has decided not to advance the program into phase 3 testing, according to a Nov. 20 release.
Moderna had launched a phase 1/2 study for the vaccine back in 2023, with the trial wrapping earlier this spring, according to ClinicalTrials.gov.
The discontinuation follows GSK’s discarded efforts to develop the first vaccine for HSV after a phase 1/2 trial ended in failure. GSK’s recombinant protein vaccine, dubbed GSK3943104, failed to hit the primary efficacy endpoint of reducing episodes of recurrent genital herpes in the phase 2 portion of the study, the pharma announced this September.
GSK’s exit from the HSV race left Moderna and BioNTech in the running. Now that Moderna has bowed out, BioNTech’s mRNA vaccine remains the only active HSV injection in big biopharma development, with a phase 1 trial ongoing.
Next up on Moderna’s discard pile is another vaccine candidate, this one dubbed mRNA-1468 and designed to prevent shingles—also called herpes zoster virus—in healthy adults age 50 and older. The investigational shot is currently being tested in a phase 1/2 trial slated to read out in mid-2026, but the Massachusetts-based company has decided not to advance the asset into late-stage testing.
Moderna’s also pulling the plug on mRNA-3745, an intravenous solution that was designed to treat a genetic disorder called glycogen storage disease type 1a. A phase 1/2 open-label study assessing the therapy began in 2022, but Moderna has said it won’t be moving the program forward into phase 2 development.
The cuts come after the biopharma discontinued a vaccine known as mRNA-1647 in congenital cytomegalovirus in October. The candidate failed to protect women from the virus in a large phase 3 trial, though Moderna has said it will continue to evaluate the vaccine in an active phase 2 trial in patients who've had bone marrow transplants.
Moderna has “prioritized our pipeline and R&D investments as part of our broader cost efficiency efforts,” a spokesperson told Fierce Biotech about the cuts. The company did not provide further reasoning behind the specific discontinuations.
With much of Moderna’s recent rise tied to its COVID-19 vaccine, the company has struggled to match the sales highs it experienced amid the pandemic. In the same release laying out the discontinuations, the mRNA specialist outlined a three-year business strategy and set a goal to boost revenue by up to 10% in 2026.
The company also said it has closed a five-year loan from Ares Management worth $1.5 billion.
Lately, the biopharma has turned its focus toward its oncology programs, Kyle Holen, M.D., Moderna’s head of development, therapeutics and oncology, told Fierce in October.
Moderna has “many new oncology programs [and] not as many” new infectious disease programs, Holen said, adding that most of the company's upcoming investigational new drug applications will be in the oncology space.
The Moderna moves come amid the federal government's pullback from both mRNA and vaccines, a pivot that has included the government axing funding for Moderna’s bird flu vaccine candidate earlier this year.