ModernaTX Amplifies RSV Combat: mRNA-1345 Vaccine Commences Phase 2 Trials

AI generated by AppliedXL
November 7, 2023
STAT Trials Pulse
STAT Trials Pulse

ModernaTX Dives into Phase 2 Trials for mRNA-1345 Vaccine

  • ModernaTX, Inc. has registered an initial trial to examine the efficacy and side effects of its investigational compound, mRNA-1345. This research drug targets Respiratory Syncytial Virus in high-risk children aged 2 to <18 years. mRNA-1345 consists of a single mRNA sequence that encodes a stabilized prefusion F glycoprotein. That means it carries the blueprint for human cells to produce a specific protein from the RSV, preparing the person's immune system to recognize and fight the actual virus.
  • The company is undergoing testing for the safety, reactogenicity, and immunogenicity of this research drug specifically in children aged 2 to <5 years and in those at higher risk from ages 5 to <18.
  • The trial, which is still setting its recruitment goals, is eyeing an enrollment of 340 patients across 21 facilities. The expected finish for this study is due by January 12, 2024.

A Closer Look at ModernaTX’s mRNA-1345 Evaluations

  • They are sponsoring two trials putting mRNA-1345 under the lens for its safety, reactogenicity, and immunogenicity across various age groups and risk categories.
  • While the mid-stage trial is not yet recruiting and focuses on high-risk children aged 2 to <18 years, the initial trials, although active, are no longer recruiting and aim to evaluate the vaccine's impact on healthy adults and RSV-seropositive children.
  • Combined, these trials, conducted in a multi-center international scale involving 52 facilities, are set for their anticipated end dates due by January 12, 2024, and June 29, 2024.

What ModernaTX is Bringing to the Table

  • They are scrutinizing several investigational compounds in their trial programs. This includes the mRNA-1647 Cytomegalovirus (CMV) Vaccine, the mRNA-1010 seasonal influenza vaccine, and, as previously mentioned, the mRNA-1345 Respiratory Syncytial Virus (RSV) vaccine.
  • The timelines for these research drugs vary, with the CMV vaccine program expected to finish between January 2023 and April 2026, the influenza vaccine trials set for September 2022 to January 2024, and the RSV vaccine due between March 2024 and December 2025.

On the Respiratory Syncytial Virus Frontline: Who's Playing?

  • In the battle against RSV, ModernaTX faces competition from emerging players like Enanta Pharmaceuticals, and AlloVir.
  • Enanta Pharmaceuticals is currently in the Phase 2 trials for EDP-938, a nonfusion replication inhibitor of RSV that acts by modulating the viral nucleoprotein, with the study expected to finish by April 2024.
  • AlloVir is testing ALVR106, a T cell therapy that seeks to assess its impact on four respiratory viruses, including RSV. Their Phase 2trial is set for completion by June 30, 2023.

Sources:, PubMed, Press Releases, and AppliedXL. This report is generated algorithmically and may not cover all ongoing industry-sponsored trials. AppliedXL implements rigorous AI vetting processes but cannot guarantee the completeness of all insights.

What does this mean for you?

If you are a Pharma company:

  • Clinical Development Insights: Evaluate the design and progress of Moderna's mRNA-1345 trials to inform their own vaccine development strategies.
  • Market Opportunity Analysis: Assess the potential market impact of mRNA-1345 to understand the emerging competitive landscape in pediatric RSV vaccines.

If you are a Biotech firm:

  • Technology Positioning: Gauge the advancement of mRNA vaccine technology to position their own platforms competitively.
  • Strategic Alliances: Consider opportunities for strategic partnerships or acquisitions based on the progress and potential of mRNA-1345.

If you are CROs:

  • Trial Management Services: Prepare to offer specialized services for pediatric and vaccine trials, a growing market segment.
  • Recruitment Strategies: Develop targeted recruitment strategies for pediatric populations, which could be a key service differentiator.

If you are a biotech Investor:

  • Market Interest Indicators: Use Moderna's advancement into Phase 2 trials as an indicator of strong market interest in RSV vaccines, signaling a robust investment opportunity in biotechs working on similar platforms.
  • Emerging Competitor Analysis: Monitor the progress of other biotechs like Enanta Pharmaceuticals and AlloVir to identify potential early-stage investment opportunities in the RSV therapeutic area.

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