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COVID-19 vaccine - Arcturus Therapeutics

Drug Profile

COVID-19 vaccine - Arcturus Therapeutics

Alternative Names: Coronavirus Vaccine - Arcturus Therapeutics; LUNAR-COV19; LUNAR-COVID19

Latest Information Update: 13 May 2020

At a glance

  • Originator Arcturus Therapeutics
  • Developer Arcturus Therapeutics; Duke-NUS Graduate Medical School Singapore
  • 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
  • Available For Licensing Yes - COVID 2019 infections

Highest Development Phases

  • Preclinical COVID 2019 infections

Most Recent Events

  • 08 May 2020 Immunogenicity data from a preclinical trial in COVID-2019 infections released by Arcturus Therapeutics
  • 27 Apr 2020 Positive immunogenicity data from a preclinical trial in COVID-2019 infections released by Arcturus Therapeutics
  • 09 Apr 2020 Preclinical trials in COVID-2019 infections (Prevention) in USA (IM), Singapore (IM)

Development Overview

Introduction

An mRNA based prophylactic vaccine to prevent COVID-2019 coronavirus infections is being developed by Arcturus Therapeutics under LUNAR-COV19 program. Arcturus is combining the self-replicating RNA STARR™ technology with their nanoparticle-based LUNAR® RNA medicine delivery technology. The combination of these two technologies helps in rapid production, reduction in the RNA dose required for protective immune response and increase in the duration of antigen expression. The single dose vaccine will take the advantage of a platform developed at Duke-NUS Medical School of Singapore for rapid screening of vaccines for effectiveness and safety in severe acute respiratory syndrome (SARS-CoV) in SARS-CoV-19 infections. Preclinical development is underway in the US and Singapore.

As of March 2020, the COVID-19 vaccine is available for licensing by Arcturus Therapeutics (Arcturus Therapeutics website, March 2020).

Company Agreements

In May 2020, Arcturus Therapeutics entered into manufacturing agreement with Catalent to support the expected manufacture of LUNAR-COV19 program. The agreement will combine Arcturus’ low-dose STARR™ mRNA vaccine technology with Catalent’s scalable cGMP manufacturing capabilities to produce millions of doses of LUNAR-COV19 mRNA in 2020 and potentially 100s of millions of doses annually for worldwide use. Technology transfer will be completed in May and manufacture of the first cGMP batches of LUNAR-COV19 mRNA are expected to be completed by June 2020.
[1]

In March 2020, Arcturus Therapeutics and Duke-NUS Medical School announced a research and development agreement to develop a Coronavirus (COVID-19) vaccine for Singapore. The COVID-19 vaccine development will be based on Arcturus' STARR technology™ and will take advantage of a platform developed at Duke-NUS for rapid screening of vaccines for effectiveness and safety. [2]

Key Development Milestones

In April 2020, Arcturus Therapeutics announced that it plans to initiate human clinical trial for COVID-19 vaccine under the guidance of the Singapore Health Sciences Authority (HSA). The trial plans to enroll up to 76 healthy volunteer adults including elderly individuals, with follow-up over several months to evaluate extent and duration of immune response [3] [4] .

In May 2020, Arcturus Therapeutics reported additional immunogenicity data from its preclinical study for COVID-19 vaccine that demonstrated robust and balanced immune response [5] .

In April 2020, Arcturus Therapeutics reported positive immunogenicity data from its preclinical study for COVID-19 vaccine [6] .

Preclinical in vitro studies for COVID-19 vaccine demonstrated generation of effective expression of the COVID-19 virus spike protein antigen developing protective antibodies [3] .

Financing information

In April 2020, Arcturus Therapeutics announced proposed underwritten public offering of its shares of its common stock of approximately gross proceeding of $US7 million. In addition, Arcturus Therapeutics intends to grant the underwriters a thirty-day option to purchase up to an additional 15 percent of shares of its common stock offered in the public offering. The company intends to use the net proceeds of the offering for development expenditures related to the advancement of LUNAR-COV19, LUNAR-OTC, [see Adis Insight drug profile 800058156] and working capital and general corporate purposes [7] [8] .

Drug Properties & Chemical Synopsis

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

    J07B (Viral Vaccines)

  • EPhMRA code

    J7E (Viral Vaccines)

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections - Prevention Preclinical USA IM / unspecified Arcturus Therapeutics 09 Apr 2020
COVID 2019 infections - Prevention Preclinical Singapore IM / unspecified Arcturus Therapeutics, Duke-NUS Graduate Medical School Singapore 09 Apr 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Arcturus Therapeutics Originator USA
Arcturus Therapeutics Owner USA
Duke-NUS Graduate Medical School Singapore Collaborator Singapore

Licensing Availability

Licensing Organisation Available Indication Available Phase Region Date
Arcturus Therapeutics COVID 2019 infections Research - 04 Mar 2020

Scientific Summary

Immunogenicity

In preclinical studies, COVID-19 vaccine demonstrated positive immunogenic profile. All of the animals (100%) were seroconverted by day 19 at a single dose of 2µg. Moreover, it also showed that the self-transcribing and replicating (STARR™) mRNA induced higher seroconversion relative to conventional mRNA at equivalent doses. In contrast, anti-SARS-CoV-2 IgG and IgM antibody titers were also higher. At day 30 post vaccination, 80% of mice vaccinated with 0.2 µg COVID-19 vaccine elicited antibodies that neutralised 50% of SARS-CoV-2 virus at titers 20 and above. The geometric mean titer of the 4 animals with titers >20 was 57.72 (SD = 2.032). At the same time point, 100% of animals vaccinated with 2µg of COVID-19 vaccine developed antibody titers >20, with geometric mean titer of 217.9 (SD = 1.365). However, 80% of animals vaccinated with 10µg of COVID-19 vaccine developed antibody titers of 320 or greater, which was the upper limit of dilution of this test [5] [6] .

In preclinical studies, COVID-19 vaccine showed a robust and balanced immune response. The dose dependent CD8+ T-cell response, with a clear response observed at all doses, as well as a balanced Th1/Th2 CD4+ T-cell immune response. The percent of CD8+ T-cells increased from the 4% baseline to 8% with increasing doses of STARR™ mRNA. The Th1/Th2 ratio for T-helper cells (CD4+) showed a strong TH1 response which does not change with increasing dose, indicated that the immune response remains balanced across all dose levels [5] .

Future Events

Expected Date Event Type Description Updated
31 Dec 2020 Regulatory Status Arcturus Therapeutics announces intention to submit regulatory filing for COVID-2019 infections in or after 2020 [9] 13 Mar 2020

Development History

Event Date Update Type Comment
08 May 2020 Scientific Update Immunogenicity data from a preclinical trial in COVID-2019 infections released by Arcturus Therapeutics [5] Updated 13 May 2020
27 Apr 2020 Scientific Update Positive immunogenicity data from a preclinical trial in COVID-2019 infections released by Arcturus Therapeutics [6] Updated 30 Apr 2020
09 Apr 2020 Phase Change - Preclinical Preclinical trials in COVID-2019 infections (Prevention) in USA (IM), Singapore (IM) [3] Updated 15 Apr 2020
13 Mar 2020 Licensing Status COVID-19 vaccine - Arcturus Therapeutics is available for licensing as of 04 Mar 2020. https://arcturusrx.com/ [2] Updated 18 Mar 2020
13 Mar 2020 Regulatory Status Arcturus Therapeutics announces intention to submit regulatory filing for COVID-2019 infections in or after 2020 [9] Updated 18 Mar 2020
04 Mar 2020 Licensing Status Arcturus Therapeutics Duke-NUS Graduate Medical School Singapore agree to co-develop COVID-19 vaccine in Singapore for COVID-2019 infections [2] Updated 18 Mar 2020
04 Mar 2020 Phase Change Early research in COVID-2019 infections (Prevention) in Singapore (IM) [2] Updated 18 Mar 2020
04 Mar 2020 Phase Change Early research in COVID-2019 infections (Prevention) in USA (IM) [2] Updated 18 Mar 2020
04 Mar 2020 Trial Update Arcturus Therapeutics plans preclinical studies for COVID-2019 infections [2] Updated 18 Mar 2020
04 Mar 2020 Trial Update Arcturus Therapeutics plans clinical trials for COVID-2019 infections [2] Updated 18 Mar 2020

References

  1. Arcturus Therapeutics and Catalent Announce Partnership to Manufacture mRNA-Based COVID-19 Vaccine.

    Media Release
  2. Arcturus Therapeutics and Duke-NUS Medical School Partner to Develop a Coronavirus (COVID-19) Vaccine using STARR Technology(TM) .

    Media Release
  3. Arcturus Therapeutics Announces Clinical Trial Timeline for its COVID-19 Vaccine.

    Media Release
  4. Clinical trial for COVID-19 vaccine, LUNAR-COV19

    ctiprofile
  5. Arcturus Reports Additional Supportive Preclinical Data for its COVID-19 Vaccine Candidate (LUNAR-COV19).

    Media Release
  6. Arcturus Reports Positive Preclinical Data for its COVID-19 Vaccine Candidate.

    Media Release
  7. Arcturus Therapeutics Announces Pricing of $70.0 Million Public Offering of Common Stock.

    Media Release
  8. Arcturus Therapeutics Announces Proposed Public Offering of Common Stock.

    Media Release
  9. Arcturus Static files. Internet-Doc 2020;.

    Available from: URL: https://ir.arcturusrx.com/static-files/ac1e7ab2-7b98-499d-8ef4-a16390802591
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