Moderna is moving three vaccines into final-stage trials

Modern has more to supply beyond the Covid vaccine.

The biotechnology company announced this on Wednesday positive data from clinical trials on three experimental vaccines against other viruses. The company says it is moving these photos into final stage research.

The update brings Moderna one step closer to having available on the market most of the products it badly needs amid falling demand for Covid shots all over the world. The company’s Covid vaccination is its only product available available in the market.

Moderna’s stock has long been tied to the vaccine, and has fallen nearly 45% previously yr. However, following the announcements on Wednesday, the corporate’s shares closed 3% higher.

On Wednesday, in its fifth yr, Moderna will chart its post-Covid future “Vaccine Day”, an investor event in Boston dedicated to the corporate’s vaccine portfolio.

The company’s total marketplace for infectious disease vaccines is estimated to be $52 billion, which incorporates $27 billion for respiratory disease vaccines and greater than $25 billion for latent and other vaccines.

A category of viruses called latent viruses remain in a patient’s body for a very long time without causing any symptoms, but can “reactivate” and cause serious health complications later in life. They represent an enormous unmet need that Moderna can fill, Moderna CEO Stéphane Bancel told CNBC in an interview on Wednesday.

“Once viruses get into the body, they stay there forever,” he said, adding that there are not any approved vaccines for several hidden viruses, including some targeted by Moderna.

At Wednesday’s event, the corporate will present latest data from clinical trials of three vaccines, including some against hidden viruses.

These vaccines include a shot against norovirus, a highly contagious stomach disease that causes vomiting and diarrhea; vaccine against Epstein-Barr virus, a typical herpes virus that may cause infectious infections and is related to some cancers; and a shot intended for the goal virus causing shingles and chickenpox.

Moderna will even discuss other updates in its vaccine business. The company has five other shots in late-stage clinical trials and said it expects to release data on two of them this yr. This includes a mix vaccine against Covid and flu, and a shot against one other common herpes virus called cytomegalovirus or CMV.

Other vaccines in late-stage development include a vaccine against respiratory syncytial virus (RSV), which is expected to receive U.S. regulatory approval in May.

It also features a latest, improved version of Moderna’s Covid shot. On Tuesday, the corporate said its “next-generation” Covid vaccine induced a stronger immune response against the virus than the present vaccine available on the market in a late-stage clinical trial.

The next shot in phase three trials is the corporate’s flu vaccine.

Also on Wednesday, Moderna said it recently entered into a development and commercialization financing agreement with the corporate Blackstone Life Sciences, the private equity segment of The Blackstone Group. Blackstone will commit as much as $750 million to expand Moderna’s flu vaccination program, with “reimbursement based on commercial achievements” and low-single-digit licensing fees.

Bancel told CNBC that the corporate’s messenger RNA platform, utilized in the Covid vaccine, “works so well” against other diseases. This mRNA technology works by teaching the body to provide a harmless fragment of the virus that triggers an immune response against certain diseases.

“Think about [total addressable market] Moderna is following suit – we will be one of the most important vaccine companies in the world,” he said.

However, it will take some time for Moderna’s pipeline to start paying off.

In its November third-quarter earnings release, the company said it expected revenue to decline to $4 billion in 2024 before rising again in 2025. It is expected to break even in 2026, executives said on a November earnings call.

Moderna’s latest plans to advance to late-stage testing present significant opportunities for the company.

There is currently no approved vaccine to prevent norovirus, the most common cause of stomach flu. According to Moderna, the virus causes approximately 200,000 deaths annually and incurs significant health care costs.

The company studied two different norovirus vaccine candidates in a phase 1 trial involving more than 600 patients aged 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 directed against three strains of norovirus induced a strong immune response regardless of dose size. The shot also had a “clinically acceptable” safety profile.

Moderna said it is moving the shot into a phase three trial. According to the company, the norovirus vaccine market is worth between $3 billion and $6 billion annually.

There are also no shots currently approved to prevent Epstein-Barr virus. It accounts for over 90% of cases infectious mononucleosisa contagious infection known as mono, which can cause fever, sore throat and chronic fatigue.

Both the virus and mono have been linked to a higher risk of certain cancers. According to Moderna, the virus also increases a patient’s risk of developing multiple sclerosis by 32 times. This disease is characterized by the immune system destroying the protective covering of the nerves.

“It’s a big problem for teenagers. Sometimes children have to repeat a year in high school or college, which is a great waste of life,” Bancel said. “But it has also been linked to multiple sclerosis, which is a terrible disease that mainly affects women… so we think we could have prevented it.”

Moderna is developing two vaccines to treat multiple conditions related to the Epstein-Barr virus. This features a shot to stop mononucleosis called mRNA-1189, which can advance to a phase 3 trial after positive data from early-stage trials.

A phase 1 study examined the vaccine in patients aged 12 to 30 within the US. The study showed that the shot induced an immune response against mono and was generally well tolerated in any respect dose sizes.

Moderna is developing one other shot called mRNA-1195, which is intended to treat multiple sclerosis and a subset of lymphomas in solid organ transplant patients. According to the corporate, full registration in the primary stage of trials for this vaccine has already been accomplished.

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

The Varicella-Zoster virus causes both chickenpox and shingles. In older people, immunity to this virus decreases, making them more susceptible to painful, itchy and blistering rashes. This will affect approximately 1 in 3 U.S. adults develop shingles According to the Centers for Disease Control and Prevention, in some unspecified time in the future of their lives.

Moderna studied its mRNA-1468 virus vaccine in an early- and mid-stage trial in healthy adults 50 years of age and older within the U.S.

According to the corporate, the vaccine induced a powerful immune response only one month after the second dose and was generally well tolerated by patients. Additional data from the continuing study will probably be available later this yr.

Moderna estimates that the varicella-zoster virus market might be price $5 billion to $6 billion annually.