Moderna moves three vaccines into final stage trials

The update brings Moderna one step closer to bringing several products to market, which it urgently needs amid a sharp drop in global demand for COVID-19 vaccines. The company’s COVID-19 vaccine is its only commercial product. Moderna’s stock has long been tied to the vaccine, falling nearly 45% in the last year.

Moderna will plan for its post-COVID future on Wednesday during its fifth annual “Vaccine Day,” an investor event in Boston, Massachusetts, with a special focus on Moderna’s vaccine portfolio. The business’s total addressable market for infectious disease vaccines is estimated at $52 billion, including $27 billion for respiratory vaccines and more than $25 billion for other vaccines.

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

The vaccines include one against norovirus, a highly contagious stomach bug that causes vomiting and diarrhea; and one against Epstein-Barr virus, a common herpes virus that causes contagious infections , and has been linked to some cancers; and vaccines designed against the viruses that cause shingles and chickenpox.

Moderna will also discuss other updates on its vaccine business. The company has five other vaccines in late-stage clinical trials and said it expects to release data on two of them this year, including a combination vaccine against COVID-19 and influenza, and another called cytomegalovirus (CMV). Herpes virus vaccine.

Other vaccines in late stages of development include one against respiratory syncytial virus, 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 lens. The company said on Tuesday that its “next-generation” Covid vaccine elicited a stronger immune response against the virus in late-stage clinical trials than vaccines currently on the market.

The final shot in the Phase 3 trial is the company’s flu vaccine.

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

Moderna CEO Stéphane Bancel said in a press release on Wednesday: “With five vaccines entering Phase 3 and three additional vaccines entering Phase 3, we have built a very large and diverse portfolio to meet the needs of Significant unmet medical needs.” “We are focused on execution to further strengthen the momentum of our pipeline and business and serve patients affected by these infectious diseases.”

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

The latest shot of Moderna entering late-stage trials means a major opportunity for the company.

There is currently no approved vaccine to prevent norovirus, the most common cause of stomach flu. According to Moderna, the virus kills about 200,000 people every year and causes huge medical costs.

The company examined two different norovirus vaccine candidates in a Phase 1 trial of more than 600 patients ages 18 to 80.

An interim analysis showed that a single-dose trivalent vaccine against three norovirus strains, called mRNA-1403, elicited strong immune responses at all doses. The vaccine also has a “clinically acceptable” safety profile.

Moderna said it is moving the measure into a Phase 3 trial. According to Moderna, the norovirus vaccine market is worth $3 billion to $6 billion annually.

There is currently no approved vaccine to prevent Epstein-Barr virus. It causes more than 90% of cases of a contagious infection called mononucleosis, which can cause fever, sore throat and chronic fatigue. Both the virus and mononucleosis are associated with a higher risk of certain cancers.

Moderna has been developing two vaccines designed to address a variety of illnesses associated with the Epstein-Barr virus. These include a vaccine designed to prevent mononucleosis, called mRNA-1189, which will enter a Phase 3 study after positive early trial data.

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

The varicella-zoster virus causes chickenpox and shingles, and shingles causes itching and blistering rashes. Older adults have reduced immunity to viruses, making them more susceptible to these illnesses. About one-third of adults in the United States will develop shingles at some point in their lives, according to the Centers for Disease Control and Prevention.

Moderna is conducting an early-to-mid-stage trial studying its vaccine against the virus, mRNA-146, in healthy adults aged 50 and older in the United States.

The company said the vaccine elicited a strong immune response one month after the second dose and was generally well tolerated by patients. More data from this ongoing trial will be available later this year.