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Modern has more to offer beyond its Covid vaccine.
The biotech company announced positive clinical trial data on three experimental vaccines against other viruses on Wednesday. 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. But the company’s shares closed 3% higher on Wednesday following the announcements.
Moderna will plan its post-Covid future on Wednesday during its fifth annual “Vaccines 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.
A category of viruses called latent viruses remain in the patient for an extended period of time without causing any symptoms, but can “reactivate” and cause serious health complications later in life. They represent a huge unmet need that Moderna can fill, Moderna CEO Stéphane Bancel said in an interview with CNBC on Wednesday.
“Once these viruses are in your body, they stay in your body forever,” he said, adding that there are no approved vaccines for several of the latent viruses, including some targeted by Moderna.
The company will present new clinical trial data on the three vaccines, including some against latent viruses, at Wednesday’s event.
These vaccines include vaccination against norovirus, a highly contagious gastrointestinal virus that causes vomiting and diarrhea; a vaccine against Epstein-Barr virus, a common herpes virus that can cause contagious infections and is linked to some types of cancer; and a shot aimed at a virus that causes shingles and chickenpox.
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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 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.
Bancel told CNBC that the company’s messenger RNA platform used in its Covid vaccine works “very well” against other diseases. This mRNA technology works by teaching the body to produce a harmless piece of a virus that triggers an immune response against certain diseases.
“Think about it [total addressable market] Moderna is looking for – we will be one of the most important vaccine companies in the world,” he said.
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 found 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 is responsible for more than 90% of cases of infectious mononucleosis, a contagious infection called mononucleosis 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. 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 attacking the protective covering of the nerves.
“This is a big problem for teenagers. There are sometimes children who have to repeat a year of high school or college, which is a huge waste of life,” Bancel said. “But it has also been linked to multiple sclerosis, a terrible disease that primarily affects women… so we think we could prevent that.”
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.
Moderna is developing another vaccine called mRNA-1195 that targets multiple sclerosis and a subcategory of lymphoma in organ transplant patients. According to the company, a phase 1 study of this vaccine has been fully completed.
Bancel said the company expects the Epstein-Barr virus to be “a multibillion-dollar market.”
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. According to the Centers for Disease Control and Prevention, about one in three adults in the U.S. will develop shingles at some point in their life.
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.
Moderna estimates the market for varicella-zoster virus could be $5 billion to $6 billion annually.
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2024-03-28 00:22:11
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