Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

Research programme: anti-infective mRNA therapeutics - Moderna Therapeutics/Valera

Drug Profile

Research programme: anti-infective mRNA therapeutics - Moderna Therapeutics/Valera

Alternative Names: mRNA 1850; mRNA Therapeutics - Valera; mRNA Vaccines - Valera

Latest Information Update: 09 Jun 2020

At a glance

  • Originator Moderna Therapeutics
  • Developer Valera LLC
  • Class Bacterial vaccines; Parasitic vaccines; RNA vaccines; Viral vaccines
  • Mechanism of Action Immunostimulants; Protein synthesis stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Research HIV infections
  • No development reported Bacterial infections; Infections; Parasitic infections; Viral infections

Most Recent Events

  • 02 Jun 2020 Early research is ongoing for HIV-infections in USA (parenteral)
  • 28 Feb 2020 No recent reports of development identified for preclinical development in Infections(Prevention) in USA (Parenteral)
  • 28 Feb 2020 No recent reports of development identified for research development in HIV-infections(Prevention) in USA (Parenteral)

Development Overview

Introduction

Messenger RNA therapeutics are being developed by Valera, a venture formed by Moderna Therapeutics using Moderna's proprietary messenger RNA therapeutics™ platform for the prevention and treatment of bacterial, viral and parasitic infectious diseases. The programme includes mRNA-based antibody therapeutics to prevent HIV infections. An IND application has been filed with the US FDA for mRNA 1850, a vaccine candidate for an undisclosed disease. Early research for HIV infections is underway in the US. No recent reports of development had been identified for preclinical development in bacterial infections, parasitic infections and viral infection in the US.

mRNA therapeutics™ technology is an alternative to gene therapy, which is based on delivering functional analogues of endogenous mRNA. Depending on the therapy needed, the mRNA can be designed to be translated naturally into either an intracellular, transmembrane, or secreted protein. This will allow the therapeutic protein to potentially restore function at a desired location, without eliciting an innate immune response. Valera builds on a team at Moderna's laboratory for preclinical research of the vaccines, which has shown the in vivo ability of modified mRNA to express viral antigens and to induce robust immune responses.

mRNA 1388, mRNA 1440, mRNA 1647, mRNA 1851 and mRNA 1893 are in clinical development [see Adis Insight drug profile 800050387, 800044365 800050994 800046879 800055566] [1] [2] .

In January 2015, Valera was launched as a new venture by Moderna Therapeutics, to focus on the development of mRNA therapeutics for the treatment of infectious diseases [3] .

As at February 2020, no recent reports of development had been identified for preclinical development in Infections (Prevention) in USA (Parenteral), research development in HIV-infections (Prevention) in USA (Parenteral).

Company Agreements

Valera and Institut Pasteur, in February 2015, entered into a long-term research agreement for the discovery and development of drugs and vaccines using its mRNA therapeutics™ platform. Under the terms of the agreement, Valera will sponsor preclinical and clinical research programmes at the Institut Pasteur to identify and develop new approaches to combat known and emerging viral and bacterial diseases. [4]

Key Development Milestones

In January 2016, Moderna announced that an IND application was filed with the US FDA for Valera's infectious disease vaccine mRNA 1850 for an undisclosed indication [5] [6] .

Valera is developing vaccines and therapeutics for prevention and treatment of viral, bacterial and parasitic infectious diseases. Moderna's mRNA-based vaccines have demonstrated preclinical efficacy in various viral disease models [5] .

Additionally, Valera is developing mRNA-based antibody therapeutics for prevention of HIV infections [5] .

Financing information

In January 2016, the Bill & Melinda Gates Foundation committed a grant funding up to $US20 million to support develpment of Moderna's combination of mRNA-based antibody therapeutics to prevent HIV infections. The funding will support preclinical studies and a first-in-human phase I study. There is potential for follow-on projects of up to $US100 million to support development of additional mRNA-based projects for infectious diseases, including the HIV antibody project [5] .

Moderna Therapeutics announced in January 2015 that it has closed a $US450 million financing to support drug discovery and development activities utilising its mRNA Therapeutics™ platform, including its infectious disease programme [7] .

Moderna Therapeutics received a $US24.6 million grant from the Defense Advanced Research Projects Agency in October 2013. The grant will be used to develop antibody messenger RNA therapeutics, using Moderna's RNA therapeutics™ platform, to protect against a range of infectious diseases. Moderna intends on using the funds to advance candidates into preclinical testing and human clinical trials [8] .

Patent Information

Moderna has filed 144 patent applications covering its messenger RNA therapeutics™ technology and programs for drug discovery and development.

Drug Properties & Chemical Synopsis

  • Route of administration Parenteral
  • Formulation unspecified
  • Class Bacterial vaccines, Parasitic vaccines, RNA vaccines, Viral vaccines
  • Target Protein synthesis
  • Mechanism of Action Immunostimulants; Protein synthesis stimulants
  • WHO ATC code

    J (Anti-infectives For Systemic Use)

    J05 (Antivirals for Systemic Use)

    J07A (Bacterial Vaccines)

    J07B (Viral Vaccines)

    J07X (Other vaccines)

  • EPhMRA code

    J (General Anti-Infectives Systemic)

    J5 (Antivirals for Systemic Use)

    J7 (Vaccines)

    J7E (Viral Vaccines)

    J8X (All Other Anti-Infectives)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Bacterial infections - Prevention No development reported (Preclinical) USA Parenteral / unspecified Valera LLC 28 Feb 2019
Bacterial infections - - No development reported (Preclinical) USA Parenteral / unspecified Valera LLC 28 Feb 2019
HIV infections - Prevention Research USA Parenteral / unspecified Valera LLC 12 Jan 2016
Infections - Prevention No development reported (Preclinical) USA Parenteral / unspecified Valera LLC 28 Feb 2020
Parasitic infections - Prevention No development reported (Preclinical) USA Parenteral / unspecified Valera LLC 28 Feb 2019
Parasitic infections - - No development reported (Preclinical) USA Parenteral / unspecified Valera LLC 28 Feb 2019
Viral infections - - No development reported (Preclinical) USA Parenteral / unspecified Valera LLC 28 Feb 2019
Viral infections - Prevention No development reported (Preclinical) USA Parenteral / unspecified Valera LLC 28 Feb 2019

Commercial Information

Involved Organisations

Organisation Involvement Countries
Moderna Therapeutics Originator USA
Moderna Therapeutics Owner USA
Bill & Melinda Gates Foundation Funder USA
Biomedical Advanced Research and Development Authority Funder USA
International AIDS Vaccine Initiative Collaborator USA
Institut Pasteur Collaborator France
National Institute of Allergy and Infectious Diseases Collaborator USA
Valera LLC Collaborator USA

Development History

Event Date Update Type Comment
02 Jun 2020 Active Status Review Early research is ongoing for HIV-infections in USA (parenteral) Updated 09 Jun 2020
28 Feb 2020 Phase Change - No development reported No recent reports of development identified for preclinical development in Infections(Prevention) in USA (Parenteral) Updated 28 Feb 2020
28 Feb 2020 Phase Change - No development reported No recent reports of development identified for research development in HIV-infections(Prevention) in USA (Parenteral) Updated 28 Feb 2020
06 Mar 2019 Regulatory Status Moderna announces intention to submit IND to the US FDA for mRNA 1893 Updated 12 Mar 2019
28 Feb 2019 Phase Change - No development reported No recent reports of development identified for preclinical development in Bacterial-infections in USA (Parenteral) Updated 28 Feb 2019
28 Feb 2019 Phase Change - No development reported No recent reports of development identified for preclinical development in Bacterial-infections(Prevention) in USA (Parenteral) Updated 28 Feb 2019
28 Feb 2019 Phase Change - No development reported No recent reports of development identified for preclinical development in Parasitic-infections in USA (Parenteral) Updated 28 Feb 2019
28 Feb 2019 Phase Change - No development reported No recent reports of development identified for preclinical development in Parasitic-infections(Prevention) in USA (Parenteral) Updated 28 Feb 2019
28 Feb 2019 Phase Change - No development reported No recent reports of development identified for preclinical development in Viral-infections in USA (Parenteral) Updated 28 Feb 2019
28 Feb 2019 Phase Change - No development reported No recent reports of development identified for preclinical development in Viral-infections(Prevention) in USA (Parenteral) Updated 28 Feb 2019
07 Sep 2016 Regulatory Status Moderna Therapeutics announces intention to submit IND to the US FDA in 2016 Updated 16 Sep 2016
12 Jan 2016 Phase Change Early research in HIV infections (Prevention) in USA (Parenteral) [5] Updated 16 Jan 2016
11 Jan 2016 Phase Change - Preclinical Preclinical trials in Infections (Prevention) in USA (Parenteral) [5] Updated 16 Jan 2016
11 Jan 2016 Regulatory Status Valera files an IND application with the FDA in USA [5] Updated 16 Jan 2016
11 Jan 2016 Trial Update Valera plans a phase I trial in USA [5] Updated 16 Jan 2016
08 Jan 2015 Patent Information Valera has patent protection for messenger RNA therapeutics™ technology Updated 22 Jan 2015
08 Jan 2015 Phase Change - Preclinical Preclinical trials in Bacterial infections (Prevention) in USA (Parenteral) Updated 22 Jan 2015
08 Jan 2015 Phase Change - Preclinical Preclinical trials in Parasitic infections (Prevention) in USA (Parenteral) Updated 22 Jan 2015
08 Jan 2015 Phase Change - Preclinical Preclinical trials in Viral infections (Prevention) in USA (Parenteral) Updated 22 Jan 2015
08 Jan 2015 Phase Change - Preclinical Preclinical trials in Bacterial infections in USA (Parenteral) Updated 13 Jan 2015
08 Jan 2015 Phase Change - Preclinical Preclinical trials in Parasitic infections in USA (Parenteral) Updated 13 Jan 2015
08 Jan 2015 Phase Change - Preclinical Preclinical trials in Viral infections in USA (Parenteral) Updated 13 Jan 2015
02 Oct 2013 Phase Change Early research in Infections (Prevention) in USA (Parenteral) Updated 22 Jan 2015

References

  1. Moderna Provides Business Updates and Reports Second Quarter 2019 Financial Results.

    Media Release
  2. Moderna Announces Pipeline and Corporate Update.

    Media Release
  3. Moderna Launches New Venture Valera LLC for Infectious Diseases.

    Media Release
  4. Moderna and Institut Pasteur Sign Strategic Research Collaboration.

    Media Release
  5. Moderna Therapeutics, Through Valera, its Infectious Disease Venture, Announces Initial Grant of up to $20 Million to Advance mRNA-Based Antibody Combination to Help Prevent HIV Infection.

    Media Release
  6. Phase I study of mRNA 1850

    ctiprofile
  7. Moderna Closes $450 Million Financing to Support Growth of Messenger RNA Therapeutics(TM) Platform across Diverse Therapeutic Areas.

    Media Release
  8. DARPA Awards Moderna Therapeutics A Grant For Up To $25 Million To Develop Messenger RNA Therapeutics(Tm).

    Media Release
Back to top