Moderna moves three vaccines into final stage trials

Moderna has more to offer beyond its Covid vaccine.

The biotech company made that clear on Wednesday, announcing positive clinical trial data on three experimental vaccines for other diseases. The company is moving those shots to final stage studies, it said.

The update brings Moderna a step closer to having multiple products on the market, which it badly needs amid plunging demand for Covid shots worldwide. The company’s Covid jab is its only commercially available product. Moderna’s stock has long been tied to that vaccine, with shares falling nearly 45% last year. 

Moderna will chart its post-Covid future on Wednesday during its fifth annual “Vaccines Day,” an investor event in Boston, Massachusetts, specifically focused on Moderna’s vaccine portfolio. That business has an estimated total addressable market of $52 billion for infectious disease shots, which includes $27 billion for respiratory vaccines and more than $25 billion for other shots.

During the event, the company will provide additional details on the new clinical trial data on the three vaccines.

Those vaccines include a shot against norovirus, a highly contagious stomach bug that causes vomiting and diarrhea; a vaccine against Epstein-Barr virus, a common herpes virus that can cause contagious infections and is associated with some cancers; and a shot designed to target a virus that causes shingles and chickenpox.

Moderna will also discuss other updates across its vaccine business. The company has five other shots in late-stage clinical trials and said it expects to release data on two of those jabs this year, including its combination vaccine against Covid and the flu and a shot against another herpes virus called CMV. 

Among the other vaccines in late-stage development is a jab against respiratory syncytial virus, which is expected to win regulatory approval in the U.S. in May. 

It also includes a new and improved version of Moderna’s Covid shot. The company on Tuesday said its “next-generation” Covid shot triggered a stronger immune response against the virus than the current vaccine on the market in a late-stage clinical trial.

The last shot in phase three trials is the company’s flu vaccine.

Also on Wednesday, Moderna said it recently entered into a development and commercialization funding agreement with Blackstone Life Sciences, a private equity segment of The Blackstone Group. Blackstone will fund up to $750 million to advance Moderna’s flu shot program, with “a return based on commercial milestones” and low single-digit royalties. 

“With five vaccines in Phase 3, and three more moving toward Phase 3, we have built a very large and diverse portfolio addressing significant unmet medical needs,” Moderna CEO Stéphane Bancel said in a release on Wednesday. “We are focused on execution to further build momentum across our pipeline and business, and to deliver for patients who are impacted by these infectious diseases.”

Still, it will take time before Moderna’s pipeline will pay off. Moderna in its third-quarter earnings release in November said it expects revenue to fall to $4 billion in 2024 before it grows again in 2025. The company expects to break even in 2026. 

Moderna’s latest shots to move into late-stage trials represent significant opportunities for the company.

There is currently no approved shot to prevent norovirus, the most common cause of the stomach flu. The virus results in approximately 200,000 deaths per year and substantial health-care costs, according to Moderna. 

The company examined two different norovirus shot candidates in a phase one trial on more than 600 patients ages 18 to 80.

An interim analysis showed that a single dose of a trivalent vaccine, called mRNA-1403, targeting three strains of norovirus triggered a strong immune response across all dose sizes. The shot also had a “clinically acceptable” safety profile. 

Moderna said it is moving that shot to a phase three trial. The market for norovirus vaccines represents a $3 billion to $6 billion annual market, according to Moderna. 

There are also no shots currently approved to prevent Epstein-Barr virus. It accounts for more than 90% of cases of a contagious infection known as mono, which can cause fever, sore throat, and chronic fatigue. Both the virus and mono are associated with a higher risk of certain cancers.

Moderna has been developing two shots designed to tackle multiple conditions associated with Epstein-Barr virus. That includes a shot designed to prevent mono, called mRNA-1189, which will move to a phase three study after positive early-stage trial data.

A phase one trial examined that vaccine in patients 12 to 30 years of age in the U.S. The study found that the shot caused an immune response against mono and was well tolerated across all dose sizes.

Varicella-Zoster virus causes both chickenpox and shingles, which are itchy and blister-like rashes. Older adults have declining immunity against that virus, making them more vulnerable to those conditions. About one in three adults in the U.S. will develop shingles at some point in their lives, according to the Centers for Disease Control and Prevention. 

Moderna studied its vaccine against the virus, mRNA-146, in an early- to mid-stage trial on healthy adults ages 50 and older in the U.S.

The shot caused a strong immune response at one month after the second dose and was generally well tolerated by patients, according to the company. Additional data from that ongoing trial will be available later this year.