Moderna strikes three vaccines into ultimate stage trials

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Moderna has more to offer beyond its Covid vaccine.

The biotech company Wednesday announced positive clinical trial data on three experimental vaccines against other viruses. 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. But shares of the company rose more than 3% in premarket trading Wednesday after the announcements.

Moderna will chart its post-Covid future Wednesday during its fifth annual “Vaccines Day,” an investor event in Boston focused on the company’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 latent shots and other jabs.

A category of viruses called latent viruses linger inside patients for prolonged periods without causing any symptoms but can “reactivate” and cause serious health complications later in their lives. They represent a huge unmet need that Moderna can address, Moderna CEO Stéphane Bancel told CNBC in an interview on Wednesday.

“Once those viruses are in your body, it’s in your body forever,” he said, adding that there are no approved shots for several of the latent viruses, including several that Moderna is targeting.

The company will present new clinical trial data on the three vaccines, including some against latent viruses, at the event Wednesday.

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.

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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. That includes its combination vaccine against Covid and the flu and a shot against another common herpes virus called cytomegalovirus, or CMV. 

Among the other vaccines in late-stage development is a jab against respiratory syncytial virus, or RSV, 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 its current vaccine on the market in a late-stage clinical trial.

Another 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. 

Bancel told CNBC the company’s messenger RNA platform, used in its Covid vaccine, “is working so well” against other diseases. That mRNA technology works by teaching the body to produce a harmless piece of a virus, which triggers an immune response against certain diseases.

“Think about the [total addressable market] Moderna is going after – we’re going to be one of the most important vaccine companies in the world,” he said.

Still, it will take time before Moderna’s pipeline will pay off.

The company 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. It expects to break even in 2026, executives said during a November earnings call.

New clinical trial data on three vaccines

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 49 and 60 to 80 in the U.S.

An interim analysis showed that a single dose of a trivalent vaccine called mRNA-1403 targeting three norovirus strains 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 the company. 

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There are also no shots currently approved to prevent Epstein-Barr virus. It accounts for more than 90% of cases of infectious mononucleosis, 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. The virus also increases a patient’s risk of developing multiple sclerosis by 32-fold, according to Moderna. That disease is characterized by the the immune system eating away at the protective covering of nerves.

“It’s a big issue for teenagers. There are sometimes kids who have to redo a year of high school or college, which is a big waste of your life,” Bancel said. “But it has also been associated with multiple sclerosis, which is a terrible disease affecting mostly women … so we think we could prevent that.”

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 old in the U.S. The study found that the shot produced an immune response against mono and was overall well tolerated across all dose sizes.

Moderna is developing another shot called mRNA-1195, which is designed to target multiple sclerosis and a subcategory of lymphoma in solid organ transplant patients. A phase one trial on that vaccine is fully enrolled, according to the company.

Bancel said the company believes the Epstein-Barr virus will be “a several billion dollar market.”

Varicella-Zoster virus causes both chickenpox and shingles. Older adults have declining immunity against that virus, making them more vulnerable to developing painful, itchy and blister-like rashes. About 1 in 3 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-1468, 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.

Moderna estimates that the market for Varicella-Zoster virus could be $5 billion to $6 billion annually. 

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