Moderna Inc. said Tuesday it’s working to develop its first bacterial vaccine to protect against Lyme disease, the tick-borne illness that causes a range of painful symptoms, including fever, headaches, fatigue, joint pain and rash.
whose first product to be approved by the U.S. Food and Drug Administration was its mRNA-based COVID vaccine, said it has two candidates in development to address Lyme disease, named mRNA-1982 and mRNA-1975.
It announced the news at its fourth Vaccine Day, where it offered a full update on its clinical pipeline, which includes vaccines to protect against flu and respiratory syncytial virus, or RSV, as well as HIV, Epstein-Barr virus and herpes simplex virus, among others.
There are about 120,000 cases of Lyme disease in the U.S. and Europe every year, creating a “significant quality of life burden,” the company said in a statement. Rising temperatures are helping the disease spread more easily, and it is difficult to diagnose, because the symptoms are similar to those of many other diseases. It most seriously affects children below the age of 15 and older adults.
“Older adults appear to have higher odds of unfavorable treatment response as compared with younger patients, and neurologic manifestations are more common at presentation for this older adult population,” said the statement.
The mRNA-1982 candidate is designed to create antibodies for Borrelia burgdorferi, the pathogen that causes almost all Lyme disease in the U.S., while mRNA-1975 is designed to elicit antibodies specific to the four major Borrelia species that cause the disease in the U.S. and Europe.
Other new candidates in Moderna’s pipeline include mRNA-1405 and mRNA-1403, which aim to address the enteric virus norovirus. Norovirus is highly contagious and is the leading cause of diarrheal disease globally, Moderna said. It’s associated with about 18% of all such illnesses worldwide and causes about 200,000 deaths every year.
Overall, Moderna is expecting to launch six major vaccine products in the next few years, all of them with large addressable markets.
The company expects the annual global endemic market for COVID boosters alone to be worth about $15 billion.
It has dosed the first participant in a late-stage trial of its next-generation, refrigerator-stable COVID-19 vaccine candidate, mRNA-1283. The vaccine “has demonstrated encouraging results in multiple clinical studies,” the company said.
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A separate trial of a flu vaccine called mRNA-1010 fared less well, however.
That trial “did not accrue sufficient cases at the interim efficacy analysis to declare early success in the Phase 3 Northern Hemisphere efficacy trial and the independent DSMB recommended continuation of efficacy follow-up,” the company said.
The company expects the market for respiratory-product sales to range from $8 billion to $15 billion by 2027 and for operating profit that year to range from $4 billion to $9 billion.
The stock was down 4% Tuesday and has fallen 15% in the year to date, while the S&P 500
has gained 7%.
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