Moderna moves three vaccines into final stage trials

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Moderna has more to supply beyond its Covid vaccine.

The biotech company made that clear on Wednesday, announcing positive clinical trial data on three experimental vaccines for other diseases. The corporate is moving those shots to final stage studies, it said.

The update brings Moderna a step closer to having multiple products available on the market, which it badly needs amid plunging demand for Covid shots worldwide. The corporate’s Covid jab is its only commercially available product. Moderna’s stock has long been tied to that vaccine, with shares falling nearly 45% last yr. 

Moderna will chart its post-Covid future on Wednesday during its fifth annual “Vaccines Day,” an investor event in Boston, Massachusetts, specifically focused on Moderna’s vaccine portfolio. That business has an estimated total addressable market of $52 billion for infectious disease shots, which incorporates $27 billion for respiratory vaccines and greater than $25 billion for other shots.

In the course of the event, the corporate will provide additional details on the brand new clinical trial data on the three vaccines.

Those vaccines include a shot against norovirus, a highly contagious stomach bug that causes vomiting and diarrhea; a vaccine against Epstein-Barr virus, a standard herpes virus that may cause contagious infections and is related to some cancers; and a shot designed to focus on a virus that causes shingles and chickenpox.

Moderna can even discuss other updates across its vaccine business. The corporate has five other shots in late-stage clinical trials and said it expects to release data on two of those jabs this yr, including its combination vaccine against Covid and the flu and a shot against one other herpes virus called CMV. 

Among the many other vaccines in late-stage development is a jab against respiratory syncytial virus, which is predicted to win regulatory approval within the U.S. in May. 

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

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

Also on Wednesday, Moderna said it recently entered right into a development and commercialization funding agreement with Blackstone Life Sciences, a personal equity segment of The Blackstone Group. Blackstone will fund as much as $750 million to advance Moderna’s flu shot program, with “a return based on business milestones” and low single-digit royalties. 

“With five vaccines in Phase 3, and three more moving toward Phase 3, we have now built a really large and diverse portfolio addressing significant unmet medical needs,” Moderna CEO Stéphane Bancel said in a release on Wednesday. “We’re focused on execution to further construct momentum across our pipeline and business, and to deliver for patients who’re impacted by these infectious diseases.”

Still, it can take time before Moderna’s pipeline can pay off. Moderna in its third-quarter earnings release in November said it expects revenue to fall to $4 billion in 2024 before it grows again in 2025. The corporate expects to interrupt even in 2026. 

Latest clinical trial data on three vaccines

The corporate examined two different norovirus shot candidates in a phase one trial on greater than 600 patients ages 18 to 80.

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

Moderna said it’s moving that shot to a phase three trial. The marketplace for norovirus vaccines represents a $3 billion to $6 billion annual market, based on Moderna. 

There are also no shots currently approved to stop Epstein-Barr virus. It accounts for greater than 90% of cases of a contagious infection generally known as mono, which may cause fever, sore throat, and chronic fatigue. Each the virus and mono are related to a better risk of certain cancers.

Moderna has been developing two shots designed to tackle multiple conditions related to Epstein-Barr virus. That features a shot designed to stop mono, called mRNA-1189, which can move to a phase three study after positive early-stage trial data.

A phase one trial examined that vaccine in patients 12 to 30 years of age within the U.S. The study found that the shot caused an immune response against mono and was well tolerated across all dose sizes.

Varicella-Zoster virus causes each chickenpox and shingles, that are itchy and blister-like rashes. Older adults have declining immunity against that virus, making them more vulnerable to those conditions. About one in three adults within the U.S. will develop shingles sooner or later of their lives, based on the Centers for Disease Control and Prevention. 

Moderna studied its vaccine against the virus, mRNA-146, in an early- to mid-stage trial on healthy adults ages 50 and older within the U.S.

The shot caused a robust immune response at one month after the second dose and was generally well tolerated by patients, based on the corporate. Additional data from that ongoing trial shall be available later this yr.