Health

Moderna is entering the final testing phase with three vaccines to recover from the Covid crisis

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Moderna has more to offer beyond its Covid vaccine.

The biotech company announced positive clinical trial data on three experimental vaccines on Wednesday other viruses. The company is postponing these shots to the final stages of studies, it said.

The update brings Moderna one step closer to having several products on the market that it desperately needs amid falling global demand for Covid vaccinations. The company’s Covid vaccination is the only commercially available product. Moderna shares have long been tied to this vaccine, with shares falling nearly 45% over the past year.

Moderna will plan its post-Covid future during its fifth year on Wednesday “Vaccination Day” An investor event in Boston focused on the company’s vaccine portfolio.

This company has an estimated total addressable market of $52 billion for infectious disease vaccinations, including $27 billion for respiratory vaccines and more than $25 billion for latent and other vaccinations. Latent viruses remain in the patient for a long time without causing symptoms.

During the event, the company will present the new clinical trial data for the three vaccines.

These vaccines involve vaccination Norovirus, a highly contagious gastrointestinal virus that causes vomiting and diarrhea; a vaccine against it Epstein Barr virus, a common herpes virus that can cause contagious infections and has been linked to some types of cancer; and a shot aimed at aiming at a virus this causes shingles and chickenpox.

Moderna will also discuss other updates to its vaccine business. The company has five additional shots in late-stage clinical trials and expects to release data on two of those shots this year. These include the combination vaccine against Covid and the flu, as well as a vaccination against another common herpes virus called cytomegalovirus CMV.

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

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

Another opportunity in Phase III trials is the company’s flu vaccine.

Also on Wednesday, Moderna announced that it had recently entered into a development and commercialization financing agreement with Blackstone Life Sciences, a private equity arm of Blackstone Group. Blackstone will fund up to $750 million to advance Moderna’s flu protection program, with “a return based on commercial milestones” and royalties in the low single digits.

“With five vaccines in Phase 3 and three more approaching Phase 3, we have built a very large and diverse portfolio that addresses significant unmet medical needs,” Moderna CEO Stéphane Bancel said in a press release on Wednesday. “We are focused on execution to continue building the momentum of our pipeline and business to care for patients affected by these infectious diseases.”

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

The company said in its third-quarter earnings release in November that it expects revenue to decline to $4 billion in 2024 before rebounding in 2025. It expects to break even in 2026, executives said during an earnings call in November.

New data from clinical trials for three vaccines

Moderna’s recent attempts to move into late-stage testing represent significant opportunities for the company.

There is currently no approved vaccination to prevent norovirus, the most common cause of stomach flu. According to Moderna, the virus results in about 200,000 deaths per year and significant health care costs.

The company tested two different norovirus shot candidates in a Phase 1 study in more than 600 patients ages 18 to 49 and 60 to 80 in the United States

An interim analysis showed that a single dose of a trivalent vaccine called mRNA-1403, which targets 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 will move this shot into a Phase 3 trial. According to the company, the norovirus vaccine market represents an annual market of $3 billion to $6 billion.

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There are currently no approved vaccinations to prevent Epstein-Barr virus. It accounts for more than 90% of cases infectious mononucleosis, a contagious infection called mono that can cause fever, sore throat, and chronic fatigue. Both the virus and mono are linked to a higher risk of certain types of cancer.

Moderna has developed two vaccinations that are intended to combat several diseases associated with the Epstein-Barr virus. This includes a vaccination called mRNA-1189 to prevent mono, which will move into a phase III trial after positive early-stage trial data.

A Phase 1 study evaluated this vaccine in patients ages 12 to 30 in the United States. The study found that the vaccination induced an immune response against Mono and was well tolerated overall at all dose sizes.

The varicella-zoster virus causes both chickenpox and shingles. In older adults, immunity to this virus wanes, making them more susceptible to developing painful, itchy, and blistering rashes. About one in three adults in the U.S. will do this Develop shingles will die 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 study in healthy adults aged 50 and older in the United States

According to the company, the vaccination produced a strong immune response a month after the second dose and was generally well tolerated by patients. Additional data from this ongoing study will be available later this year.

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