Moderna, Inc. MRNA, a biotech that rose to prominence with its successful coronavirus vaccine program, is holding its fifth annual R&D day Thursday.
What Happened: At the event, Cambridge, Massachusetts-based Moderna detailed recent progress in its clinical programs and issued updates on new development candidates.
The company also provided highlights on select key clinical programs.
Moderna's COVID-19 Vaccine Program: Moderna said it has completed rolling submission of the biologic license application for its mRNA coronavirus vaccine, mRNA-1273.
The vaccine was authorized for emergency use by the Food and Drug Administration in December.
The company said the Phase 2 study of a booster dose of the vaccine showed robust antibody responses.
New Developmental Candidates In The Pipeline: Moderna said it is developing a combination vaccine candidate, codenamed mRNA-1073, that combines its COVID-19 vaccine and flu vaccine candidate.
Incidentally, Novavax, Inc. NVAX, which has yet to receive approval for its COVID-19 vaccine candidate, said Wednesday it has initiated a Phase 1/2 study to test its combined flu and COVID-19 vaccine.
Moderna also said it is developing a pediatric combo vaccine, named mRNA-1365, that combines its RSV vaccine candidate with its mMPV vaccine candidate. The company has in the works a Epstein-Barr virus therapeutic vaccine candidate named MRNA-1195.
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Moderna's Pipeline Updates: With several candidates in development for infectious diseases, oncology, cardiovascular diseases and rare diseases, the company boasts a pipeline with 37 programs in development across 34 development candidates.
Moderna said it is prepping for a global Phase 2/3 study with approximately 34,000 participants of its RSV vaccine candidate, mRNA-1345. The study is expected to begin by the end of 2021.
A Phase 2 study of Moderna's personalized vaccine candidate mRNA-4157, in combination with Merck & Co, Inc. MRK's immunotherapy Keytruda in adjuvant setting of advanced skin cancer is complete.
Additionally, a Phase 2a study of AZD8601 VEGF-A, being developed for patients with ischemic heart disease undergoing coronary artery bypass grafting surgery with moderately impaired systolic function, led by AstraZeneca plc AZN, has completed recruitment after enrollment of the low dose cohort.
On rare diseases, Moderna said enrollment in the first cohort in the Phase 1/2 study of mRNA-3927 in propionic acidemia is complete. An investigational new drug application for the GSD1a program is now open, Moderna said. GSD1a is a genetically inherited glycogen storage disease.
MRNA Price Action: Moderna shares were trading 6.19% higher at $449.09 midmorning Thursday.
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