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Moderna Announces Significant Advances Across Industry-Leading mRNA Portfolio at 2021 R&D Day

Moderna announces significant advancements to be presented at its annual R&D Day, including a combination booster vaccine for COVID-19 and seasonal flu, a pediatric combination candidate for RSV and hMPV, promising interim Phase 1 data for an RSV vaccine candidate, an infectious disease therapeutic vaccine candidate, and full enrolment for a Phase 2 study of a personalized cancer vaccine. The company also has 37 programs in development, with 22 ongoing clinical studies.

Article Summary

Moderna announces major advancements across its portfolio of mRNA programs presented at its annual R&D Day.
“Today we are announcing the first step in our novel respiratory vaccine program with the development of a single-dose vaccine that combines a booster against COVID-19 and a booster against flu. We are making progress on enrolling patients in our rare disease programs, and we are fully enrolled in our personalized cancer vaccine trial. We believe this is just the beginning of a new age of information-based medicines.” said Stéphane Bancel, Chief Executive Officer of Moderna. The company now has 37 programs in development across 34 development candidates, including 22 in ongoing clinical studies.

Key updates and recent progress include:

  • Covid-19 Vaccine Development: submission of Biologics License Application (BLA) for its COVID-19 vaccine (mRNA-1273) in the U.S. and strong antibody responses observed in a Phase 2 study of the mRNA-1273 booster shot.
  • New Development Candidates: combination vaccine candidate (mRNA-1073) combining Moderna’s COVID-19 vaccine and flu vaccine candidate, paediatric combination vaccine candidate (mRNA-1365), EBC therapeutic vaccine candidate (mRNA-1195), and investigative mRNA therapy for the ultra-rare disease, Crigler-Najjar Syndrome Type 1 (mRNA CN-1).
  • Infectious Diseases: full enrolment in Phase 1 study of quadrivalent seasonal flu vaccine candidate (mRNA-1010) and positive interim date from Phase 1 study of RSV vaccine candidate (mRNA-1345). Preparation for a global Phase 2/3 study of mRNA-1345 to begin by end-2021.
  • Oncology: full enrolment of Phase 2 study of personalized cancer vaccine (PCV) (mRNA-4157) in combination with Merck’s pembrolizumab to treat high-risk resected melanoma.
  • Cardiovascular: completion of recruitment for Phase 2a study of AZD8601 VEGF-A for ischemic heart disease patients undergoing coronary artery bypass grafting surgery with moderately impaired systolic function, led by AstraZeneca.
  • Rare Diseases: full enrolment of Phase 1/2 Paramount study of Propionic Acidemia (mRNA-3927), and opening of Investigational New Drug application (IND) and granting of Orphan Drug Designation by U.S. FDA for GSD1a program (mRNA-3745).
  • Corporate Updates: Moderna Genomics (MGX) to leverage the current mRNA and lipid nanoparticle (LNP) platform and pursue novel technology within nucleic acids.

Select Program Highlights cover Core and Exploratory Modalities Core Modalities cover:

  • Prophylactic Vaccines: against viral diseases where there is unmet medical need –including vaccines against acute respiratory infections (including COVID-19 vaccine), vaccines against persistent infections (seasonal influenza, respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and parainfluenza type 3 (PIV3), and pediatric RSV and hMPV combination) as well as vaccines against threats to global public health.
  • Systemic Secreted & Cell Surface Therapeutics: mRNA is delivered systemically to create proteins either secreted or expressed on the cell surface, like the relaxin fusion protein.

Exploratory Modalities cover:

  • Cancer Vaccines: these focus on stimulating the immune system with antigens enabling it to elicit a more effective anti-tumor response (personalized cancer vaccine (PCV)).
  • Localized Regenerative Therapeutics: localized production of proteins could potentially be used as a regenerative therapy for damaged tissues (VEGF-A (AZD8601)).
  • Systemic Intracellular Therapeutics: these programs will deliver mRNA into cells of target organs to treat diseases caused by a missing or defective protein (propionic acidemia (PA), methylmalonic

About Novavax Moderna is a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines. It has a diverse clinical portfolio of vaccines and therapeutics, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant. Moderna collaborates with both domestic and overseas government and commercial partners and has most recently developed one of the earliest and most effective COVID-19 vaccines. For more information, visit

(Source: Moderna, 9th September 2021)


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