Moderna is moving three vaccines into final-stage trials

Moderna It has more to offer than the Covid vaccine.

The biotechnology company on Wednesday announced positive clinical trial data for three experimental vaccines against other viruses. The company said it is moving those shots into final-stage studies.

The update brings Moderna a step closer to having multiple products on the market, which it desperately needs amid declining demand for Covid vaccines around the world. The company's Covid jab vaccine is its only commercially available product.

Moderna stock has long been associated with this vaccine, with shares falling nearly 45% in the past year. But the company's shares closed up 3% on Wednesday after the announcements.

Moderna will chart its post-Covid future on Wednesday during the fifth annual Vaccine Day, an investor event in Boston focused on the company's vaccine portfolio.

This business has a total addressable market of $52 billion for infectious disease vaccines, which includes $27 billion for respiratory vaccines and more than $25 billion for latent and other vaccines.

There is a class of viruses called latent viruses, which stay inside patients for long periods without causing any symptoms but can “reactivate” again and cause serious health complications later in their lives. These products represent a huge unmet need that Moderna can fill, Moderna CEO Stephane Bancel told CNBC in an interview on Wednesday.

“Once these viruses get into your body, they're in your body forever,” he said, adding that there are no approved shots for many latent viruses, including some that Moderna targets.

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

These vaccines include a shot against norovirus, a highly contagious disease that causes vomiting and diarrhea; Vaccine against Epstein-Barr virus, a common herpes virus that can cause infectious infections and is linked to some types of cancer; And a shot designed to target the virus that causes shingles and chickenpox.

Moderna will also discuss other updates across its vaccine business. The company has five more doses in the final stage of clinical trials, and said it expects to publish data on two of these vaccines this year. That includes its combination vaccine against Covid and influenza and a shot against another common herpes virus called cytomegalovirus, or CMV.

Other vaccines still in the late stages of development include a vaccine against respiratory syncytial virus, or RSV, which is expected to receive regulatory approval in the United States in May.

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

Another dose in Phase 3 trials is the company's influenza vaccine.

Also on Wednesday, Moderna said it recently entered into a development and commercialization financing agreement with Blackstone Life Sciences, the private equity division of Blackstone Group. Blackstone will fund up to $750 million to develop Moderna's flu vaccine program, with a “return based on commercial milestones” and low single-digit returns.

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

“Think [total addressable market] He said that Moderna is pursuing us, and we will become one of the most important vaccine companies in the world.

However, it will take some time before Moderna's pipeline comes to fruition.

The company said in its third-quarter earnings statement in November that it expects revenue to decline to $4 billion in 2024 before growing again in 2025. Executives said during an earnings call in November that the company expects to break even in 2026.

Moderna's latest shots of moving into late-stage trials represent big opportunities for the company.

There is currently no approved vaccine to prevent norovirus, the most common cause of stomach flu. The virus causes nearly 200,000 deaths annually and high health care costs, according to Moderna.

The company examined two different norovirus vaccine candidates in a Phase 1 trial in more than 600 patients ages 18 to 49 and 60 to 80 years in the United States.

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

Moderna said it would move that dose to the third phase of the trial. The norovirus vaccine market represents an annual market of $3 billion to $6 billion, according to the company.

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 HIV and mono are associated with an increased risk of certain cancers. The virus also increases a patient's risk of developing multiple sclerosis by 32-fold, according to Moderna. This disease is characterized by the fact that the immune system erodes the protective covering of the nerves.

“It's a big problem for teens. Sometimes kids have to repeat a year of high school or college, which is a huge waste of your life,” Bancel said. “But it's also linked to multiple sclerosis, which is a terrible disease that mostly affects women…so we think we can prevent that.”

Moderna is developing two doses designed to treat multiple conditions associated with the Epstein-Barr virus. This includes a shot designed to prevent mono called mRNA-1189, which will move into a phase 3 study after positive data from early-stage trials.

A phase 1 trial examined this vaccine in patients ages 12 to 30 in the United States. The study found that the shot produced an immune response against mono and was generally well tolerated at all dose sizes.

Moderna is developing another shot called mRNA-1195, which is designed to target multiple sclerosis and a subclass of lymphoma in solid organ transplant patients. The first phase trial on this vaccine has been fully registered, according to the company.

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

The varicella zoster virus causes both chickenpox and shingles. Older adults have lower immunity to this virus, making them more susceptible to developing a painful, itchy, pimple-like rash. About 1 in 3 adults in the United States will get shingles at some point in their lives, according to the Centers for Disease Control and Prevention.

Moderna studied its coronavirus vaccine, mRNA-1468, in an early to mid-stage trial in healthy adults ages 50 and older in the United States.

The injection caused a strong immune response 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