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mRNA 1273

Drug Profile

mRNA 1273

Alternative Names: mRNA-1273

Latest Information Update: 02 Jun 2020

At a glance

  • Originator Moderna Therapeutics; National Institute of Allergy and Infectious Diseases
  • Developer Moderna Therapeutics
  • Class RNA vaccines; Viral vaccines
  • Mechanism of Action Immunostimulants
  • Orphan Drug Status

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

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase II COVID 2019 infections

Most Recent Events

  • 27 May 2020 Barbuto & Johansson, P.A. initiates investigation against Moderna Therapeutics over reporting insufficient data from a clinical study regarding immunogenicity of mRNA 1273 in USA
  • 25 May 2020 Phase-II clinical trials in COVID-2019 infections (In the elderly, Prevention, In adults) in USA (IM) (NCT04405076)
  • 18 May 2020 Interim immunogenicity and adverse events data from a phase I trial and immunogenicity data from a preclinical study in COVID-2019 infections released by Moderna Therapeutics

Development Overview

Introduction

mRNA 1273 is a mRNA prophylactic vaccine encoding for a prefusion stabilised form of the spike (S) protein, being developed by Moderna Therapeutics and National Institute of Allergy and Infectious Diseases, for the prevention of COVID-2019 infections. Moderna Therapeutics will be utilising its proprietary in-house digital application suite, Drug Design Studio that contains a dequence designer module to create mRNAs for specific proteins, that are further optimised using bioinformatics algorithms. Clinical development is underway in the US.

Company Agreements

In April 2020, Moderna Therapeutics entered into an agreement with the Biomedical Advanced Research and Development Authority (BARDA), to support the development mRNA 1273 against COVID-2019 infections. Under the terms of agreement, Moderna received up to $US483 million contract to accelerate development of the vaccine and BARDA will fund the advancement of mRNA 1273 to FDA licensure. BARDA will also be responsible to support late-stage clinical development programs, as well as the scale-up of mRNA 1273 manufacture in 2020 to enable potential pandemic response. [1]

In January 2020, Moderna Therapeutics entered into a research and development agreement with Vaccine Research Center of the National Institute of Allergy and Infectious Diseases (NIAID), to design a vaccine against COVID-2019 infections. Under the terms of the agreement, Moderna will manufacture an mRNA vaccine against coronavirus, which will be funded by Coalition for Epidemic Preparedness Innovations (CEPI). Moderna Therapeutics has a multi-year relationship with the NIH. IND-enabling studies and a phase I clinical study in the US will be conducted by NIAID. [2]

In May 2020, Moderna Therapeutics entered into a 10-year strategic manufacturing agreement with Lonza to enable large scale manufacture of mRNA 1273 against COVID-2019 infections. Under the terms of the agreement, Moderna and Lonza intend to establish manufacturing sites in the US and Switzerland. Technology transfer will be initiated in June 2020, and the first batches of mRNA 1273 are expected to manufacture in the US in July 2020. A part of the funding for establishment of manufacturing operation in the US was covered under Moderna's contract with the BARDA. Further financial details were not disclosed.

Key Development Milestones

In May 2020, experts in vaccine field lodged criticism against mRNA 1273 on ground of lack of sufficient data of the candidate to support the development of the vaccine for the treatment of COVID-2019 infections. Barbuto & Johansson, P.A. (“BARJO”) and Of Counsel, Neil Rothstein, Esq. has initiated an investigation into Moderna Therapeutics on behalf of investors as to whether Moderna and certain of its officers and/or directors have engaged in fraud, negligence or other unlawful business practices. The "reason for caution" cited was lack of immune response data for 37 participants in a phase I trial which was evaluating the safety and immunogenicity of mRNA 1273, in healthy volunteers. On Monday, 18 May 2020, Moderna shared that 8 out of 45 participants in its COVID-19 vaccine study developed neutralizing antibodies [3] .

In May 2020, Moderna Therapeutics in collaboration with Biomedical Advanced Research and Development Authority initiated a phase II trial to evaluate the safety, reactogenicity, and immunogenicity of 2 doses of mRNA 1273 vaccine for prevention of COVID-2019 infections in adults 18 years of age or older (mRNA-1273-P201; 75A50120C00034; NCT04405076). The randomised, observer-blind, placebo controlled, dose-confirmation study will enrol approximately 600 volunteers in the US [4] . By the end of May 2020, first participants in each age cohort had been dosed in the trial [5] .

In May 2020, the US FDA granted a fast track designation to mRNA 1273 for prevention of COVID-2019 infections [6] .

As of May 2020, Moderna Therapeutics was finalising the protocol for a planned phase III trial [6] [7] .

As of May 2020, US FDA approved Investigational New Drug (IND) application of mRNA 1273 for initiating a phase II trial in prevention of COVID-2019 infections. In the same month, Moderna received initial feedback from the US FDA regarding design of the planned phase II study. Earlier, in April 2020, Moderna Therapeutics submitted an IND application for the same [6] [7] [8] .

In March 2020, National Institute of Allergy and Infectious Diseases dosed its first patient and initiated a phase I trial to evaluate the safety and immunogenicity of mRNA 1273, in healthy volunteers (1UM1AI148373-01; 20-0003; NCT04283461).The primary objective is to evaluate the safety and reactogenicity of a two-dose vaccination schedule of mRNA-1273. The secondary objective is to evaluate the immunogenicity to the SARS-CoV-2 S protein. As of April 2020, enrolment of 3 dose cohorts (25 µg, 100 µg and 250 µg) was completed with 45 adults (aged 18 to 55) in the US. However as per the latest amended protocol by NIH, enrolment was underway in additional six cohorts (60 participants) that included three cohorts of 30 older adults (aged 56-70) and three cohorts of 30 elderly adults (aged 71 and above). Favourable interim results from the 25 µg and 100 µg cohorts were released in May 2020. Based on these results, the trial is proposed to be amended to include two dose levels, 50 µg and 100 µg, to select a dose for pivotal studies. A 50 µg dose level cohort will be included across each of the three age groups [9] [10] [11] [2] [12] .

In May 2020, Moderna reported favourable preclinical data from a mouse challenge model of COVID-2019 infections [9] .

Financing information

In May 2020, Moderna Therapeutics announced an underwritten public offering of $US1.25 billion in shares of its common stock with a 30 day purchase option of an additional $US187.5 million. The net proceeds will be utilized for manufacturing of mRNA 1273 [13]

In January 2020, Moderna Therapeutics announced that Coalition for Epidemic Preparedness Innovations (CEPI) will be funding the manufacture of an mRNA vaccine against COVID-2019 infections [2] .

Patent Information

Moderna Therapeutics holds broad and deep patent estate that include foundational patents in modified mRNA technologies and delivery technologies for mRNA vaccines and therapeutics in the USA, Japan, Europe and other jurisdictions (Modern Therapeutics website, January 2020).

Moderna Therapeutics have in-licensed patents for modified mRNA technologies and delivery technologies from Harvard University and University of Pennsylvania (Modern Therapeutics website, January 2020).

Drug Properties & Chemical Synopsis

  • Route of administration IM
  • Formulation Injection
  • Class RNA vaccines, Viral vaccines
  • Mechanism of Action Immunostimulants
  • WHO ATC code

    J05 (Antivirals for Systemic Use)

    J07B-X (Other viral vaccines)

  • EPhMRA code

    J5B9 (Antivirals, others)

    J7E9 (All other viral vaccines)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - In adults, In the elderly, Prevention Phase II USA (fast track) IM / Injection Moderna Therapeutics 25 May 2020

Priority Development Status

Type Region Indication
Fast Track US COVID 2019 infections

Commercial Information

Involved Organisations

Organisation Involvement Countries
Moderna Therapeutics Originator USA
National Institute of Allergy and Infectious Diseases Originator USA
Moderna Therapeutics Owner USA
National Institute of Allergy and Infectious Diseases Owner USA
University of Pennsylvania Technology Provider USA
Harvard University Technology Provider USA
Biomedical Advanced Research and Development Authority Funder USA
Coalition for Epidemic Preparedness Innovations Funder Norway

Scientific Summary

Adverse Events

Favourable interim data from a phase I trial established a generally safe and well tolerated profile for mRNA 1273, which was consistent with the company's earlier infectious disease vaccine clinical studies. A solitary grade 3 adverse event of erythema at the injection site was seen in one volunteer, in the 100 µg dose cohort. The 250 µg dose level reflected the most notable adverse events in three volunteers with grade 3 systemic symptoms, only after the second dose. The adverse events were predominantly transient and self-resolving. Grade 4 adverse events or serious adverse events were not reported [9] [12] .

Immunogenicity

Summary

Favourable interim data from a phase I trial showcased dose-dependent increases in immunogenicity across 25 µg, 100 µg and 250 µg dosage levels, and between prime and boost within the 25 µg and 100 µg dose levels. All volunteers aged 18-55 (n=15 per cohort) across all three dose levels seroconverted by day 15, after administration of a single dose. At day 43, two weeks after the second dose, at the 25 µg dose level (n=15), the binding antibody levels matched the levels observed in convalescent sera (blood samples from people who have recovered from COVID-19), tested in the same assay. At day 43, at the 100 µg dose level (n=10), binding antibody levels significantly surpassed the levels in convalescent sera. Samples were unavailable for remaining volunteers. These results were reported for the 25 µg and 100 µg dose level (ages 18-55) after two doses (day 43) and at the 250 µg level (ages 18-55) after one dose (day 29). Neutralising antibody data from first four volunteers in each of the 25 µg and 100 µg dose level cohorts, also exhibited an evoking of neutralising antibodies in all eight volunteers, as determined by plaque reduction neutralization (PRNT) assays against live SARS-CoV-2, following administration of mRNA 1273. At day 43, neutralising antibody levels either matched or exceeded levels characteristically seen in the convalescent sera. Protective neutralising titres seen at the 25 µg and 100 µg dose levels in the trial displayed consistency with those seen in a preclinical mouse challenge model [9] [12] .

Preclinical results from a mice viral challenge study showed prevention of viral replication in the lungs of animals challenged with SARS-CoV-2, following vaccination with mRNA 1273. Protective neutralising titres seen in this model displayed consistency with those seen at the 25 µg and 100 µg dose levels in volunteers, in a phase I trial [9] .

Future Events

Expected Date Event Type Description Updated
31 Jul 2020 Trial Update Moderna Therapeutics plans a phase III trial for COVID-2019 infections (Prevention) in USA (IM) in July 2020 [9] 22 May 2020
30 Jun 2020 Trial Update Moderna Therapeutics plans a phase II trial for COVID-2019 infections (Prevention) in USA in the second quarter of 2020 [1] 01 Jun 2020
30 Jun 2020 Trial Update Moderna therapeutics plans to files an IND application with the US FDA for COVID-2019 infections in the second quarter of 2020 [1] 29 Apr 2020
19 Mar 2020 Trial Update National Institute of Allergy and Infectious Diseases (NIAID) plans a phase I trial for COVID-2019 infections (Prevention) in USA (IM, Injection) (NCT04283461) (700318512) [2] 12 Mar 2020

Development History

Event Date Update Type Comment
27 May 2020 Other Barbuto & Johansson, P.A. initiates investigation against Moderna Therapeutics over reporting insufficient data from a clinical study regarding immunogenicity of mRNA 1273 in USA [3] Updated 02 Jun 2020
25 May 2020 Phase Change - II Phase-II clinical trials in COVID-2019 infections (In the elderly, Prevention, In adults) in USA (IM) (NCT04405076) Updated 01 Jun 2020
18 May 2020 Scientific Update Interim immunogenicity and adverse events data from a phase I trial and immunogenicity data from a preclinical study in COVID-2019 infections released by Moderna Therapeutics [9] Updated 22 May 2020
18 May 2020 Trial Update Moderna Therapeutics plans a phase III trial for COVID-2019 infections (Prevention) in USA (IM) in July 2020 [9] Updated 22 May 2020
14 May 2020 Regulatory Status mRNA 1273 receives Fast Track designation for COVID-2019 infections [IM,Injection] (In the elderly, Prevention, In adults) in USA [6] Updated 14 May 2020
08 May 2020 Regulatory Status Moderna Therapeutics plans to file BLA for COVID-19 infections [7] Updated 19 May 2020
08 May 2020 Regulatory Status US FDA approves IND application for mRNA 1273 in COVID-19 infections [7] Updated 12 May 2020
27 Apr 2020 Regulatory Status Moderna Therapeutics files an IND application with the US FDA for a phase II trial for COVID-2019 infections [8] Updated 29 Apr 2020
16 Apr 2020 Trial Update Moderna Therapeutics plans a phase II trial for COVID-2019 infections (Prevention) in USA in the second quarter of 2020 [1] Updated 01 Jun 2020
16 Apr 2020 Trial Update Moderna therapeutics plans to files an IND application with the US FDA for COVID-2019 infections in the second quarter of 2020 [1] Updated 29 Apr 2020
16 Apr 2020 Licensing Status Moderna Therapeutics collaborates with the Biomedical Advanced Research and Development Authority (BARDA) for the development of mRNA 1273 against COVID-2019 infections [1] Updated 20 Apr 2020
03 Mar 2020 Phase Change - I Phase-I clinical trials in COVID-2019 infections (Prevention, In adults, In the elderly) in USA (IM) (NCT04283461) Updated 12 Mar 2020
21 Feb 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections (Prevention) in USA (IM, Injection) before February 2020 (Moderna Therapeutics pipeline, February 2020) Updated 06 Mar 2020
31 Jan 2020 Licensing Status Moderna Therapeutics in-licenses modified mRNA technologies and delivery technologies from Harvard University and University of Pennsylvania (Modern Therapeutics website, January 2020). Updated 31 Jan 2020
31 Jan 2020 Patent Information Moderna Therapeutics has patent protection for mRNA and its delivery technologies for mRNA vaccines in in the USA, Japan, Europe and other jurisdictions (Modern Therapeutics website, January 2020). Updated 31 Jan 2020
31 Jan 2020 Regulatory Status NIAID announces intention to submit IND to the US FDA for COVID-2019-infections [2] Updated 31 Jan 2020
27 Jan 2020 Licensing Status Moderna Therapeutics and National Institute of Allergy and Infectious Diseases agree to co-develop mRNA based coronavirus vaccine in USA for COVID-2019-infections [2] Updated 27 Jan 2020
23 Jan 2020 Trial Update National Institute of Allergy and Infectious Diseases (NIAID) plans a phase I trial for COVID-2019 infections (Prevention) in USA (IM, Injection) (NCT04283461) [2] Updated 12 Mar 2020
23 Jan 2020 Phase Change Early research in COVID-2019-infections (Prevention) in USA (Parenteral) [2] Updated 27 Jan 2020

References

  1. Moderna Announces Award from U.S. Government Agency BARDA for up to $483 Million to Accelerate Development of mRNA Vaccine (mRNA-1273) Against Novel Coronavirus.

    Media Release
  2. Moderna Announces Funding Award from CEPI to Accelerate Development of Messenger RNA (mRNA) Vaccine Against Novel Coronavirus.

    Media Release
  3. CORRECTION and REPLACING - Shareholder Investigation: The Law Firm of Barbuto & Johansson, P.A. Investigates Moderna, Inc. (NasdaqGS: MRNA) After Vaccine Experts Lodge Criticism.

    Media Release
  4. A Phase 2a, Randomized, Observer-Blind, Placebo Controlled, Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 SARS-COV-2 Vaccine in Adults Aged 18 Years and Older

    ctiprofile
  5. Moderna Announces First Participants in Each Age Cohort Dosed in Phase 2 Study of mRNA Vaccine (mRNA-1273) Against Novel Coronavirus.

    Media Release
  6. Moderna Receives FDA Fast Track Designation for mRNA Vaccine (mRNA-1273) Against Novel Coronavirus.

    Media Release
  7. Moderna Reports First Quarter 2020 Financial Results and Provides Business Updates.

    Media Release
  8. Moderna Announces IND Submitted to U.S. FDA for Phase 2 Study of mRNA Vaccine (mRNA-1273) Against Novel Coronavirus.

    Media Release
  9. Moderna Announces Positive Interim Phase 1 Data for its mRNA Vaccine (mRNA-1273) Against Novel Coronavirus.

    Media Release
  10. NIH Clinical Trial of a Vaccine for COVID-19 Now Enrolling Older Adults.

    Media Release
  11. Moderna Announces First Participant Dosed in NIH-led Phase 1 Study of mRNA Vaccine (mRNA-1273) Against Novel Coronavirus.

    Media Release
  12. Phase I, Open-Label, Dose-Ranging Study of the Safety and Immunogenicity of 2019-nCoV Vaccine (mRNA-1273) in Healthy Adults

    ctiprofile
  13. Moderna Announces Proposed Public Offering of Shares of Common Stock, May 18, 2020.

    Media Release
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