ARCT 021
Alternative Names: ARCT 021; Coronavirus Vaccine - Arcturus TherapeuticsLatest Information Update: 24 Jan 2023
At a glance
- Originator Arcturus Therapeutics
- Class COVID-19 vaccines; RNA vaccines; Viral vaccines
- Mechanism of Action Immunostimulants
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
- Available For Licensing Yes - COVID 2019 infections
Highest Development Phases
- Discontinued COVID 2019 infections
Most Recent Events
- 24 Jan 2023 Discontinued - Phase-II for COVID-2019 infections (In the elderly, Prevention, In adults) in Singapore (IM)
- 24 Jan 2023 Discontinued - Phase-II for COVID-2019 infections (In the elderly, Prevention, In adults) in USA (IM)
- 08 Jul 2022 Arcturus Therapeutics terminates its phase IIa trial in COVID-2019 infections (Prevention, In adults, In the elderly) in Singapore and USA due to business reasons (IM) (NCT04728347)
Development Overview
Introduction
ARCT 021 is a mRNA-based prophylactic vaccine, is being developed by Arcturus Therapeutics, to prevent COVID-2019 coronavirus infections, 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 vaccine targets myocytes and dendritic cells. 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. Clinical development was underway in Singapore and in the US. However, as of January 2023, the drug candidate was no longer listed on the company pipeline, therefore, it appears that development has been discontinued for COVID-2019 infections in Singapore and the US.
ARCT 021, ARCT 154 [see Adis profile 800064814], ARCT 165 [see Adis profile 800064815] are part of LUNAR-COV19 Vaccines programme.
As of March 2020, ARCT 021 is available for licensing by Arcturus Therapeutics (Arcturus Therapeutics website, March 2020).
Company Agreements
In August 2021, Arcturus Therapeutics and Vinbiocare Biotechnology entered into manufacturing and collaboration agreement to establish a manufacturing facility in Vietnam for ARCT 021 in the prevention of COVID-2019 infections. Under the terms of the arrangement, Vinbiocare Biotechnology will, with consultation from Arcturus Therapeutics, build out a manufacturing facility in Vietnam, and Arcturus Therapeutics will provide to Vinbiocare Biotechnology access to proprietary technologies and processes for the manufacture ARCT 021 COVID-19 vaccines. Arcturus Therapeutics will provide Vinbiocare Biotechnology with an exclusive license to manufacture the vaccines in Vietnam at the facility solely for distribution in Vietnam. The license and technology transfer applies toward drug product manufacturing but not toward mRNA drug substance manufacturing. Technology transfer is underway. Vinbiocare Biotechnology will make an upfront payment of $US 40 million and be responsible for costs associated with the technology transfer. Vinbiocare Biotechnology will also pay for mRNA drug substance supplied by Arcturus Therapeutics and royalties on vaccines produced at the Facility. [1]
In October 2020, Arcturus Therapeutics entered into a manufacturing agreement with Recipharm for manufacture of ARCT 021 COVID-19 vaccine for 2021 and the future. Other financial details of the agreement were not disclosed. [2]
In August 2020, Arcturus Therapeutics executed the definitive supply agreement provided for in the previously announced binding term sheet agreement with the Israeli Ministry of Health, to supply COVID-19 STARR™ mRNA vaccine candidate (ARCT 021). Earlier, in July 2020, Arcturus Therapeutics had entered into a binding term sheet with the Israeli Ministry of Health to supply the Company’s COVID-19 vaccine candidate, LUNAR-COV19. The parties intend to finalise a comprehensive supply agreement within 30 days. Delivery to Israel of doses of Arcturus’ COVID-19 vaccine candidate is contingent upon achievement of near term clinical and regulatory milestones and other conditions to be set forth in the definitive supply agreement. The government of Israel is responsible for distributing the vaccine to its citizens subject to approval by their Ministry of Health. [3] [4]
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.
[5]
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. [6]
Key Development Milestones
In August 2021, Arcturus Therapeutics initiated a phase I/II trial to evaluate the safety, reactogenicity, and immunogenicity of 3 SARS-CoV-2 RNA vaccines including ARCT 021 and ARCT 154 [See Adisinsight drug profile800064814], ARCT 165 [See Adisinsight drug profile800064815] in previously vaccinated and not previously vaccinated adults against SARS-CoV-2 (ARCT-165-01; NCT05037097). The randomised, double-blind study intends to enroll 72 patients in the Singapore and the trial may expand to the US.
In July 2022, Arcturus Therapeutics terminated a phase IIa trial due to operational or business reasons. The trial was not terminated for reasons of safety or immunogenicity. Earlier in January 2021, Arcturus Therapeutics initiated a phase IIa open label extension trial for ARCT-021-01 trial (see below) to evaluate the safety and long term immunogenicity of ARCT 021 in healthy volunteers for prevention COVID-2019 infections (NCT04728347; ARCT-021-02). The open label trial was intends to enrol 65 healthy volunteers who have completed ARCT-021-01 trial in Singapore [7] .
In July 2022, Arcturus Therapeutics terminated a phase IIa trial due to operational or business reasons. The trial was not terminated for reasons of safety or immunogenicity. Earlier in January 2021, Arcturus Therapeutics initiated a phase II trial to evaluate the safety, reactogenicity, and immunogenicity of the study vaccine in younger and older adult participants. Enrolled participants will be randomly assigned to receive either study vaccine ARCT-021 or placebo (sterile saline) (NCT04668339; ARCT-021-04). The randomised trial was intends to enrol approximately 581 participants in the US and Singapore [8] .
In December 2020, Arcturus Therapeutics received FDA allowance to proceed with phase II trial of ARCT 021 (LUNAR-COV19) vaccine candidate in the United States following review of data from the phase I/II study. The phase II study will enroll 600 participants, with 450 receiving ARCT 021 and 150 receiving placebo. Both older and younger adult participants will be included in the trial. Early interim analysis of safety and immunogenicity will be performed to inform dose selection for a phase III study [9] .
In December 2020, Arcturus Therapeutics received approval from Singapore Health Sciences Authority to commence a phase II trial of ARCT 021. The trial will enable selection of optimal vaccination regimen for phase III registrational trial [10] . 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 [11] [12] .
In January 2021, Arcturus Therapeutics in collaboration with Duke-NUS Medical School completed phase I/II trial of COVID-19 vaccine for the prevention of COVID-2019 infection in healthy volunteers (ARCT-021-01; NCT04480957). The trial was conducted in two parts. The randomised, double-blind, placebo controlled trial initiated in August 2020 and enrolled 106 adults, elderly volunteers in Singapore. In July 2020, the Singapore Health Sciences Authority approved the clinical trial application for COVID-19 vaccine candidate [13] [14] [12] . In November 2020 enrolment for the trial was completed. As of November 2020, 78 subjects have received at least one injection of COVID-19 vaccine, 36 patients have received two injections (i.e., prime-boost), and 28 patients have received placebo. Arcturus Therapeutics released adverse events and immunogenicity data from a trial and based on results, a single 7.5 µg dose of COVID-19 vaccine, along with prime-boost regimens are selected to advance into later stage global clinical trials [15] . In December 2020, updated results from the trial were released by the Arcturus Therapeutics [10] .
In March 2021, immunogenicity data from a preclinical studies in COVID-2019 infections released by Arcturus Therapeutics [16] .
In July 2020, Arcturus Therapeutics released pharmacodynamics data from a preclinical study in COVID-2019 infections [14] .
In May 2020, Arcturus Therapeutics reported additional immunogenicity data from its preclinical study for COVID-19 vaccine that demonstrated robust and balanced immune response [17] .
In April 2020, Arcturus Therapeutics reported positive immunogenicity data from its preclinical study for COVID-19 vaccine [18] .
Preclinical in vitro studies for COVID-19 vaccine demonstrated generation of effective expression of the COVID-19 virus spike protein antigen developing protective antibodies [11] .
Financing information
In December 2020, Arcturus Therapeutics announced the pricing of an underwritten public offering of shares of its common stock, with the gross proceeds of approximately $US150 million. The company intends to use the net proceeds of the offering to conduct clinical trials and to commence manufacturing its COVID-19 (LUNAR-COV19) vaccine for stockpiling purposes [19] .
In October 2020, Arcturus Therapeutics awarded a grant from the Economic Development Board of the Republic of Singapor (EDB) to support the further development of our LUNAR-COV19 vaccine candidate. The Grant provides for up to S$9.3 million (approximately $US 6.7 million) to support the development of the vaccine candidate [20] .
As of August 2020, Arcturus Therapeutics raised approximately $US280 million in gross proceeds through public equity offerings in 2020. In July 2020, Arcturus Therapeutics raised approximately $US200 million in a public offering of its common stock. The company intends to use the net proceeds to develop, test and manufacture the COVID-19 vaccine, to continue clinical development of LUNAR-OTC [see Adis Insight Drug Profile 800058156], to advance its LUNAR-CF [see Adis Insight Drug Profile 800052590], LUNAR-CV [see Adis Insight Drug Profile 800054584] and LUNAR-FLU [see Adis Insight Drug Profile 800052590] preclinical programs into clinical development, to fund early research and development of novel and proprietary RNA medicines and for general corporate and working capital purposes [21] [22] [23] .
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 [24] [25] .
In March 2020, Arcturus Therapeutics awarded with a grant from the Singapore EDB to support the co-development of a potential COVID-19 vaccine with the Duke-NUS Medical School. The Grant provides for up to S$14.0 million (approximately US$10.0 million using the exchange rate at the time the grant contract was entered into) in grants to support the development of the vaccine [20]
Patent Information
As of March 2021, the Arcturus Therapeutics has one pending US patent application directed to specially designed RNA constructs, specific nucleotide and amino acid sequences, and lipid formulations comprising the same under the STARR technology. We anticipate that patents covering these developments in our STARR platform will last until 2041, not including any patent term extensions [20]
Prior to July 2020, the Arcturus Therapeutics has paptent protection for STARR™ mRNA technology and the lipid-mediated nucleic acid delivery system (LUNAR™) in the U.S., Europe, Japan, China and other countries [23] .
Drug Properties & Chemical Synopsis
- Route of administration IM
- Formulation unspecified
- Class COVID-19 vaccines, RNA vaccines, Viral vaccines
- Mechanism of Action Immunostimulants
-
WHO ATC code
J07B (Viral Vaccines)
-
EPhMRA code
J7E (Viral Vaccines)
Biomarker
| Drug Name | Biomarker Name | Biomarker Function |
|---|---|---|
| ARCT 021 | ACE2 | Outcome Measure |
| AMH | Detailed Description, Outcome Measure | |
| Apolipoprotein H antibodies | Eligibility Criteria | |
| B-cell lymphoma 2 (Bcl-2) | Arm Group Description | |
| B-lymphocyte antigen CD19 | Arm Group Label | |
| B-lymphocyte antigen CD20 | Arm Group Description, Brief Title, Official Title | |
| Bilirubin | Eligibility Criteria | |
| C-reactive protein (CRP) | Brief Summary, Detailed Description, Eligibility Criteria, Outcome Measure | |
| C1QL1 | Outcome Measure | |
| Calprotectin | Detailed Description | |
| Cardiac Troponin I | Eligibility Criteria, Outcome Measure | |
| CGA | Eligibility Criteria | |
| chorionic gonadotropin beta subunit 5 | Eligibility Criteria | |
| corticotropin releasing hormone | Outcome Measure | |
| Cytokeratin 20 | Arm Group Description | |
| D-dimer | Eligibility Criteria | |
| D-Urobilinogen | Eligibility Criteria | |
| Estradiol-17beta 3-sulfate | Outcome Measure | |
| Ferritin | Eligibility Criteria, Outcome Measure | |
| Ferrocytochrome | Eligibility Criteria | |
| Fibrinogen | Eligibility Criteria | |
| FSH | Eligibility Criteria | |
| fuzzy planar cell polarity protein | Outcome Measure | |
| GNPTAB | Eligibility Criteria | |
| Gut Microbiome | Brief Title, Official Title | |
| heat shock 27kDa protein 3 | Outcome Measure | |
| hypertrichosis 2 (generalized, congenital) | Eligibility Criteria | |
| immunoglobulin heavy constant epsilon | Outcome Measure | |
| Insulin | Brief Summary, Outcome Measure | |
| Interferon alpha (IFN-alpha) | Outcome Measure | |
| Interferon Gamma (IFNg) | Brief Summary, Detailed Description, Outcome Measure | |
| Interleukin-2 (IL-2) | Outcome Measure | |
| Interleukin-4 (IL-4) | Outcome Measure | |
| Interleukin-5 (IL-5) | Outcome Measure | |
| Interleukin-6 (IL-6) | Eligibility Criteria, Outcome Measure | |
| KRT88P | Eligibility Criteria | |
| L-Lactic acid | Eligibility Criteria | |
| mutated in colorectal cancers | Brief Summary | |
| PCNA | Arm Group Label | |
| PD-1/CD279 | Eligibility Criteria, Outcome Measure | |
| PD-L1/CD274 | Brief Title, Eligibility Criteria, Official Title, Outcome Measure | |
| Phosphonoacetate | Outcome Measure | |
| Progesterone | Brief Summary, Detailed Description, Outcome Measure | |
| Protein S | Outcome Measure | |
| protein tyrosine phosphatase, non-receptor type 6 | Eligibility Criteria | |
| Protoporphyrin IX | Eligibility Criteria | |
| pyrroline-5-carboxylate reductase 1 | Outcome Measure | |
| RBP4 | Outcome Measure | |
| serine peptidase inhibitor, Kunitz type 1 | Outcome Measure | |
| serine racemase | Outcome Measure | |
| seryl-tRNA synthetase | Brief Summary, Detailed Description, Eligibility Criteria, Outcome Measure | |
| Soluble transferrin receptor | Outcome Measure | |
| suppression of tumorigenicity 14 (colon carcinoma) | Outcome Measure | |
| T-box 1 | Eligibility Criteria | |
| T-Cell differentiation antigen CD8 | Detailed Description, Outcome Measure | |
| T-cell surface antigen CD4 | Detailed Description, Eligibility Criteria, Outcome Measure | |
| TF | Outcome Measure | |
| Thromboxane | Outcome Measure | |
| Toll-Like Receptor 4 (TLR4) | Outcome Measure | |
| Tumor necrosis factor alpha (TNF-alpha) | Outcome Measure | |
| Vitamin A | Outcome Measure | |
| vitronectin | Arm Group Description, Arm Group Label, Detailed Description, Official Title, Outcome Measure | |
| Y Chromosome | Eligibility Criteria | |
| zinc finger protein 415 | Arm Group Description |
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| COVID 2019 infections | - | In adults, In the elderly, Prevention | Discontinued (II) | Singapore, USA | IM / unspecified | Arcturus Therapeutics | 24 Jan 2023 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Arcturus Therapeutics | Originator | USA |
| Arcturus Therapeutics | Owner | USA |
| The Economic Development Board | Funder | Singapore |
| Israeli Ministry of Health | Collaborator | Israel |
| 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
Pharmacokinetics
Results from phase I/II trial demonstrated that peak antibody titer was observed at day 43 for 5 µg and 7.5 µg single administration groups, and day 57 for 5 µg prime-boost groups. Peak geometric mean binding antibody titers observed were 4,959 (5 µg single shot); 6,749 (7.5 µg single shot); 16,642 (5 µg prime-boost) compared to placebo which was less than 400. Responder peak geometric mean neutralizing antibody titers of 32, 33 and 46 were observed following 5 µg single dose, 7.5 µg single dose and 5 µg prime-boost participants, respectively. Neutralizing antibody titers in convalescent sera were ranged from 12 to 1818 [10] [12] .
Adverse Events
Updated results from phase I/II trial demonstrated no safety concerns, all the participant completed all the doses. All adverse events except 2 were mild or moderate at doses selected for phase II. One participant reported transient, asymptomatic grade 3 lymphopenia. Transient grade 3 fatigue and myalgia observed following second injection in one older adult. Serious adverse events were reported in placebo arm [10] . Earlier results from the trial showed favorable safety and tolerability profile in both younger (ages 21-55) and older (ages 56-80) patients with no moderate or severe fevers. COVID-19 vaccine was well tolerated and had a favorable local and systemic adverse event (AE) profile. The majority of AEs were mild; there were no moderate (Grade 2) or severe (Grade 3) fevers at any dose and no severe (Grade 3) injection site reactions at doses being contemplated for advancement. No patients had withdrawn from the trial and there had been no serious adverse events deemed to be treatment related [15] [12] .
Pharmacodynamics
Summary
In preclinical study, administration of LUNAR-COV19 (0.2, 2.0, 10.0 µg), demonstrated neutralising antibody levels in response which was continued to increase for 60 days. Also LUNAR-COV19 vaccine demonstrated robust humoral and cellular immunity at doses as low as 0.2 µg. Further the vaccine reported 100% seroconversion with a very low single dose (2.0 µg) [13] [14] .
Immunogenicity
Summary
Updated results from phase I/II trial demonstrated humoral immune response in all the subjects receiving 5µg or 7.5 µg dose. Vaccination with ARCT 021 showed cellular immune responses to SARS-COV-2 peptide pools at day 15 for 5 µg and 7.5 µg doses. PBMC ELISpot responses detected at day 15. At day 29, CD8+ and CD4+ T cell responses shown on cytokine staining (IFN-?), following single dose at 5 µg and 7.5 µg and sustained at 2 weeks following boost at 5 µg. Th1 dominant CD4+ response was observed following single dose and prime boost regimens [10] . Earlier results from the trial showed robust anti-spike protein IgG immune response at all doses evaluated. PRNT50 GMT levels for neutralizing antibodies were within the range of titers observed in COVID-19 volunteers convalescent plasma. Anti-spike IgG antibody titers was dose-dependent, and increased through approximately day 43 and confirmed the effect seen in preclinical studies for STARR™ mRNA which exhibited increasing antibody titers over extended periods of time. Cytokine staining and ELISpot tests showed T cell responses to multiple peptide pools derived from the SARS-CoV-2 spike protein. The CD4+ response was Th1 dominant and the CD8+ response includes reactivity to the receptor binding domain. T cell reactivity to spike protein peptides, including receptor binding domain (RBD) was also observed [15] [12] .
ARCT 021 demonstrated robust protection with single dose in a primate challenge model and in a human ACE2 receptor transgenic mouse challenge model. It also showed robust protection with a single dose in mice depleted of B cells, whereas depletion of T lymphocytes yielded no protection following virus challenge [16] .
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 [17] [18] .
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 [17] .
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 31 Dec 2021 | Regulatory Status | Arcturus Therapeutics announces intention to submit emergency use authorization/conditional approval to for COVID-2019 infections in the second half of a 2021 [9] | 06 Jan 2021 |
| 31 Dec 2020 | Regulatory Status | Arcturus Therapeutics announces intention to submit regulatory filing for COVID-2019 infections in or after 2020 [27] | 13 Mar 2020 |
| 27 Dec 2020 | Trial Update | Arcturus Therapeutics plans a phase II trial for COVID-2019 infections (Prevention, In adults, In the elderly) in December 2020 in the US and Singapore (IM)(NCT04668339) (700331487) [9] | 21 Jan 2021 |
| 30 Sep 2020 | Trial Update | Arcturus Therapeutics plans a clinical trial for COVID-2019 infections (Prevention) by Summer of 2020 [26] | 14 Aug 2020 |
| 30 Jun 2020 | Trial Update | Arcturus Therapeutics plans a global phase III ARCT-021-05 trial for COVID-2019 infections (Prevention) in second quarter of 2021 [10] | 10 Jun 2021 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 24 Jan 2023 | Phase Change - Discontinued(II) | Discontinued - Phase-II for COVID-2019 infections (In the elderly, Prevention, In adults) in Singapore (IM) Updated 24 Jan 2023 |
| 24 Jan 2023 | Phase Change - Discontinued(II) | Discontinued - Phase-II for COVID-2019 infections (In the elderly, Prevention, In adults) in USA (IM) Updated 24 Jan 2023 |
| 08 Jul 2022 | Trial Update | Arcturus Therapeutics terminates its phase IIa trial in COVID-2019 infections (Prevention, In adults, In the elderly) in Singapore and USA due to business reasons (IM) (NCT04728347) Updated 19 Jul 2022 |
| 08 Jul 2022 | Trial Update | Arcturus Therapeutics terminates its phase IIa trial in COVID-2019 infections (Prevention, In adults, In the elderly) in USA and Singapore due to business reasons (NCT04668339) Updated 19 Jul 2022 |
| 17 Jan 2022 | Biomarker Update | Biomarkers information updated Updated 20 Jan 2022 |
| 31 Dec 2021 | Trial Update | Arcturus Therapeutics plans a phase III trial for COVID-2019 infections (Prevention) Updated 20 Apr 2022 |
| 30 Aug 2021 | Trial Update | Arcturus Therapeutics initiates a phase I/II trial in COVID-2019 infections in Singapore and USA (Prevention, In adults, In the elderly) (IM) (NCT05037097) Updated 16 Sep 2021 |
| 01 Mar 2021 | Patent Information | Arcturus Therapeutics has patent pending for STARR platform in USA [20] Updated 10 Jun 2021 |
| 01 Mar 2021 | Scientific Update | Immunogenicity data from a preclinical studies in COVID-2019 infections released by Arcturus Therapeutics [16] Updated 03 Mar 2021 |
| 29 Jan 2021 | Trial Update | Arcturus Therapeutics completes a phase I/II trial in COVID-2019 infections (In adults, In elderly, Prevention) in Singapore (IM) (NCT04480957) [16] Updated 03 Mar 2021 |
| 07 Jan 2021 | Phase Change - II | Phase-II clinical trials in COVID-2019 infections (Prevention, In adults, In the elderly) in USA, Singapore (IM) (NCT04668339) Updated 21 Jan 2021 |
| 06 Jan 2021 | Regulatory Status | Arcturus Therapeutics receives allowance of the Investigational New Drug (IND) application from the US FDA for ARCT 021 in COVID-2019 infections [9] Updated 06 Jan 2021 |
| 04 Jan 2021 | Phase Change - II | Phase-II clinical trials in COVID-2019 infections (Prevention, In adults, In the elderly) in Singapore (IM) (NCT04728347) Updated 02 Feb 2021 |
| 04 Jan 2021 | Trial Update | Arcturus Therapeutics plans a phase II trial for COVID-2019 infections (Prevention, In adults, In the elderly) in December 2020 in the US and Singapore (IM)(NCT04668339) [9] Updated 21 Jan 2021 |
| 04 Jan 2021 | Regulatory Status | Arcturus Therapeutics announces intention to submit emergency use authorization/conditional approval to for COVID-2019 infections in the second half of a 2021 [9] Updated 06 Jan 2021 |
| 28 Dec 2020 | Trial Update | Arcturus Therapeutics plans a global phase III ARCT-021-05 trial for COVID-2019 infections (Prevention) in second quarter of 2021 [10] Updated 10 Jun 2021 |
| 28 Dec 2020 | Regulatory Status | Arcturus Therapeutics received approval from Singapore Health Sciences Authority to commence phase II trial of ARCT 021 for COVID-2019 infections [10] Updated 30 Dec 2020 |
| 28 Dec 2020 | Scientific Update | Interim pharmacokinetics, Immunogenicity and adverse event data from a phase I/II trial in CVID-2019 infections released by Arcturus Therapeutics [10] Updated 30 Dec 2020 |
| 13 Nov 2020 | Scientific Update | Adverse events and immunogenicity data from a phase I/II trial in COVID-19 infections released by Arcturus Therapeutics [15] Updated 13 Nov 2020 |
| 18 Aug 2020 | Licensing Status | Arcturus Therapeutics executes the definitive supply agreement with the Israeli Ministry of Health, to supply ARCT 021 [4] Updated 21 Aug 2020 |
| 11 Aug 2020 | Phase Change - I/II | Phase-I/II clinical trials in COVID-2019 infections (In adults, In elderly, Prevention) in Singapore (IM) [13] before August 2020 (NCT04480957) Updated 14 Aug 2020 |
| 29 Jul 2020 | Patent Information | Arcturus Therapeutics has patent protection for STARR™ mRNA technology and the LUNAR® lipid-mediated delivery technology in USA, Europe, Japan, China and other countries before July 2020 [23] Updated 03 Aug 2020 |
| 27 Jul 2020 | Trial Update | Arcturus Therapeutics plans a phase I/II trial for COVID-2019 infection (Prevention, In adults, In the elderly) in Singapore, In July 2020 (NCT04480957) Updated 27 Jul 2020 |
| 21 Jul 2020 | Regulatory Status | Singapore Health Sciences Authority approves the clinical trial application for COVID-2019 infections [14] Updated 23 Jul 2020 |
| 21 Jul 2020 | Scientific Update | Pharmacodynamics data from a preclinical study in COVID-2019 infections released by Arcturus Therapeutics [14] Updated 23 Jul 2020 |
| 01 Jul 2020 | Trial Update | Arcturus Therapeutics plans a clinical trial for COVID-2019 infections (Prevention) by Summer of 2020 [26] Updated 14 Aug 2020 |
| 08 May 2020 | Scientific Update | Immunogenicity data from a preclinical trial in COVID-2019 infections released by Arcturus Therapeutics [17] Updated 13 May 2020 |
| 27 Apr 2020 | Scientific Update | Positive immunogenicity data from a preclinical trial in COVID-2019 infections released by Arcturus Therapeutics [18] Updated 30 Apr 2020 |
| 09 Apr 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections (Prevention) in USA (IM), Singapore (IM) [11] Updated 15 Apr 2020 |
| 13 Mar 2020 | Licensing Status | ARCT 021 is available for licensing as of 04 Mar 2020. https://arcturusrx.com/ [6] Updated 13 Mar 2020 |
| 13 Mar 2020 | Regulatory Status | Arcturus Therapeutics announces intention to submit regulatory filing for COVID-2019 infections in or after 2020 [27] Updated 13 Mar 2020 |
| 04 Mar 2020 | Trial Update | Arcturus Therapeutics plans preclinical studies for COVID-2019 infections [6] Updated 13 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 [6] Updated 11 Mar 2020 |
| 04 Mar 2020 | Phase Change | Early research in COVID-2019 infections (Prevention) in Singapore (IM) [6] Updated 11 Mar 2020 |
| 04 Mar 2020 | Phase Change | Early research in COVID-2019 infections (Prevention) in USA (IM) [6] Updated 11 Mar 2020 |
References
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Arcturus Therapeutics Collaborates with Vingroup to Establish Manufacturing Facility in Vietnam for Arcturus Investigational mRNA Vaccines for COVID-19.
Media Release -
Recipharm signs agreement with Arcturus Therapeutics to support the manufacture of LUNAR(Rm)-COV19 (ARCT-021) vaccine candidate.
Media Release -
Arcturus Therapeutics Announces Agreement with Israeli Ministry of Health to Supply COVID-19 Vaccine Candidate, LUNAR-COV19.
Media Release -
Arcturus Therapeutics Executes Definitive Supply Agreement with the Israeli Ministry of Health.
Media Release -
Arcturus Therapeutics and Catalent Announce Partnership to Manufacture mRNA-Based COVID-19 Vaccine.
Media Release -
Arcturus Therapeutics and Duke-NUS Medical School Partner to Develop a Coronavirus (COVID-19) Vaccine using STARR Technology(TM) .
Media Release -
A Phase 2a, Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021
ctiprofile -
A Phase 2 Randomized, Observer-Blind, Placebo-Controlled Study to Assess the Safety, Reactogenicity, and Immunogenicity of the SARS CoV-2 Vaccine ARCT-021 in Healthy Adult Participants
ctiprofile -
Arcturus Therapeutics Receives FDA Allowance to Proceed with Phase 2 Study of ARCT-021 (LUNAR-COV19) Vaccine Candidate in the United States.
Media Release -
Arcturus Therapeutics Received Approval from Singapore Health Sciences Authority to Proceed with Phase 2 Study of ARCT-021 (LUNAR-COV19) Vaccine Candidate and Provides New and Updated Clinical and Preclinical Data.
Media Release -
Arcturus Therapeutics Announces Clinical Trial Timeline for its COVID-19 Vaccine.
Media Release -
A Phase 1/2 Randomised, Double Blinded, Placebo Controlled, Ascending Dose Study to Assess the Safety, Tolerability, and Immunogenicity of ARCT-021 in Healthy Adult Subjects
ctiprofile -
Arcturus Therapeutics Announces that it has Initiated Dosing of its COVID-19 STARR(Tm) mRNA Vaccine Candidate, LUNAR-COV19 (ARCT-021) in a Phase 1/2 study.
Media Release -
Arcturus Therapeutics & Duke-NUS Received Approval to Proceed with Phase 1/2 Clinical Trial for COVID-19 Vaccine Candidate, LUNAR-COV19.
Media Release -
Arcturus Therapeutics Announces Positive Interim ARCT-021 (LUNAR-COV19) Phase 1/2 Study Results for Both Single Shot and Prime-boost Regimens, and Up to $220 Million in Additional Financial Commitments from Singapore.
Media Release -
Arcturus Therapeutics Announces Fourth Quarter and Full Year 2020 Financial Results and Positive Clinical Updates.
Media Release -
Arcturus Reports Additional Supportive Preclinical Data for its COVID-19 Vaccine Candidate (LUNAR-COV19).
Media Release -
Arcturus Reports Positive Preclinical Data for its COVID-19 Vaccine Candidate.
Media Release -
Arcturus Therapeutics Announces Pricing of $150 Million Public Offering of Common Stock.
Media Release -
Arcturus Therapeutics -Sec-2020. Internet-Doc 2021;.
Available from: URL: https://www.sec.gov/ix?doc=/Archives/edgar/data/1768224/000156459021009872/arct-10k_20201231.htm -
Arcturus Therapeutics Announces Second Quarter 2020 Financial Results and Provides a Corporate Update.
Media Release -
Arcturus Therapeutics Announces Closing of Public Offering and Full Exercise of Underwriters Option to Purchase Additional Shares- 31 Jul 2020 .
Media Release -
Arcturus Therapeutics Announces Pricing of $173.0 Million Public Offering of Common Stock.
Media Release -
Arcturus Therapeutics Announces Pricing of $70.0 Million Public Offering of Common Stock.
Media Release -
Arcturus Therapeutics Announces Proposed Public Offering of Common Stock.
Media Release -
Arcturus Therapeutics Announces the Formation of its Vaccine Platform Scientific Advisory Board.
Media Release -
Arcturus Static files. Internet-Doc 2020;.
Available from: URL: https://ir.arcturusrx.com/static-files/ac1e7ab2-7b98-499d-8ef4-a16390802591
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