ARCT-021 / Arcturus Therap, CSL Behring, Meiji Seika - LARVOL DELTA

Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021 (clinicaltrials.gov) - P2 | N=65 | Terminated | Sponsor: Arcturus Therapeutics, Inc. | Phase classification: P2a ➔ P2

Phase classification • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Trial Evaluating the Safety and Immunogenicity of 3 COVID-19 SARS-CoV-2 RNA Vaccines in Healthy Adults (clinicaltrials.gov) - P1/2 | N=72 | Completed | Sponsor: Arcturus Therapeutics, Inc. | Recruiting ➔ Completed | Trial completion date: Mar 2023 ➔ Dec 2023 | Trial primary completion date: Mar 2023 ➔ Dec 2023

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A phase I/II randomized, double-blinded, placebo-controlled trial of a self-amplifying Covid-19 mRNA vaccine. (PubMed, NPJ Vaccines) - "T-cell responses were also observed in response to stimulation with S-protein peptides. Taken collectively, ARCT-021 is immunogenic and has favorable safety profile for further development."

Clinical • Journal • P1/2 data • Fatigue • Infectious Disease • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Respiratory Diseases

Immune gene expression analysis indicates the potential of a self-amplifying Covid-19 mRNA vaccine. (PubMed, NPJ Vaccines) - "The transcriptomic signature for ARCT-021 vaccination strongly correlated with live viral vector vaccines, adjuvanted vaccines and BNT162b2 1 day post-vaccination. Moreover, the ARCT-021 signature correlated with day 7 YF17D live-attenuated vaccine transcriptomic responses. Altogether, our findings show that sa-mRNA vaccination induces innate immune responses that are associated with the development of adaptive immunity from other forms of vaccines, supporting further development of this vaccine platform for clinical application."

IO biomarker • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Trial Evaluating the Safety and Effects of an RNA Vaccine ARCT-021 in Healthy Adults (clinicaltrials.gov) - P2 | N=581 | Terminated | Sponsor: Arcturus Therapeutics, Inc. | Active, not recruiting ➔ Terminated; A decision was made to terminate the study for operational/business reasons. The study was not terminated for reasons of safety or immunogenicity.

Trial termination • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021 (clinicaltrials.gov) - P2a | N=65 | Terminated | Sponsor: Arcturus Therapeutics, Inc. | N=106 ➔ 65 | Trial completion date: Jun 2022 ➔ Dec 2021 | Recruiting ➔ Terminated | Trial primary completion date: Jun 2022 ➔ Dec 2021; A decision was made to terminate the study for operational/business reasons. This study was not terminated for reasons of safety or immunogenicity.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

[VIRTUAL] Preclinical Immunogenicity Characterization of ARCT-021 SARS-CoV-2 Vaccine (VACCINES SUMMIT 2021) - No abstract available

Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Trial Evaluating the Safety and Immunogenicity of 3 COVID-19 SARS-CoV-2 RNA Vaccines in Healthy Adults (clinicaltrials.gov) - P1/2; N=72; Recruiting; Sponsor: Arcturus Therapeutics, Inc.

Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Ascending Dose Study of Investigational SARS-CoV-2 Vaccine ARCT-021 in Healthy Adult Subjects (clinicaltrials.gov) - P1/2; N=106; Completed; Sponsor: Arcturus Therapeutics, Inc.; Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Single Dose of Self-Transcribing and Replicating RNA Based SARS-CoV-2 Vaccine Produces Protective Adaptive Immunity In Mice. (PubMed, Mol Ther) - "Finally, single LUNAR-COV19 vaccination at both 2 μg and 10 μg doses completely protected human ACE2 transgenic mice from both mortality and even measurable infection following wild-type SARS-CoV-2 challenge. Our findings collectively suggest the potential of LUNAR-COV19 as a single dose vaccine."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4 • CD8 • IFNG • IL4

A Trial Evaluating the Safety and Effects of an RNA Vaccine ARCT-021 in Healthy Adults (clinicaltrials.gov) - P2; N=600; Active, not recruiting; Sponsor: Arcturus Therapeutics, Inc.; Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021 (clinicaltrials.gov) - P2a; N=106; Recruiting; Sponsor: Arcturus Therapeutics, Inc.

Clinical • New P2a trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Trial Evaluating the Safety and Effects of an RNA Vaccine ARCT-021 in Healthy Adults (clinicaltrials.gov) - P2; N=600; Recruiting; Sponsor: Arcturus Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Arcturus Therapeutics Receives FDA Allowance to Proceed with Phase 2 Study of ARCT-021 (LUNAR-COV19) Vaccine Candidate in the United States (Businesswire) - "Phase 2 study to be conducted in the U.S. and Singapore....Targeting global Phase 3 study start in Q2 2021 which could allow application for emergency use authorization/conditional approval in H2 2021; Arcturus Therapeutics Holdings Inc....today announced that the Company has received allowance of the Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for the Phase 2 clinical study of its vaccine candidate ARCT-021 following review of data from the Phase 1/2 study."

FDA event • IND • Non-US regulatory • Infectious Disease • Novel Coronavirus Disease

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 (Businesswire) - P1/2, N=92; NCT04480957; Sponsor: Arcturus Therapeutics, Inc; "Phase 1/2 data demonstrates favorable tolerability; immunogenicity observed in 100% (44/44) of vaccinated subjects receiving 7.5 µg single dose & 5 µg single and prime-boost regimens; In primate challenge model, ARCT-021 demonstrates protection following both single dose and prime-boost regimens....Investor conference call at 4:30 p.m. ET today....Company has received approval from the Singapore Health Sciences Authority to proceed with a Phase 2 clinical study of its vaccine candidate ARCT-021....'The Phase 2 study will enable selection of the optimal ARCT-021 vaccination regimen for Phase 3 registrational studies. We look forward to obtaining interim Phase 2 data in early 2021 providing support for the anticipated initiation of a global Phase 3 study in Q2 2021.'"

New P2 trial • New P3 trial • P1/2 data • P2 data • Preclinical • Infectious Disease • Novel Coronavirus Disease

A Trial Evaluating the Safety and Effects of an RNA Vaccine ARCT-021 in Healthy Adults (clinicaltrials.gov) - P2; N=600; Not yet recruiting; Sponsor: Arcturus Therapeutics, Inc.

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

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 (Businesswire) - P1/2, N=92; NCT04480957; Sponsor: Arcturus Therapeutics, Inc; "Singapore Economic Development Board (EDB) financial commitment includes $45 million up front to fund manufacture of ARCT-021....Lyophilized drug product on track for Phase 3 implementation; The study is fully enrolled with 106 subjects, including older adult subjects....A robust anti-spike protein IgG immune response was observed at all doses evaluated. PRNT50 GMT levels for neutralizing antibodies were within the range of titers observed in COVID-19 patient convalescent plasma....The Company is in discussions with the Singapore Health Sciences Authority to advance ARCT-021 into later stage clinical studies....Arcturus and the EDB have agreed to terms providing the EDB with the right to purchase up to $175 million of ARCT-021 vaccine at pre-negotiated prices, with shipments expected to begin in the first quarter of 2021."

Commercial • Financing • P1/2 data • Infectious Disease • Novel Coronavirus Disease

Arcturus Therapeutics Executes Definitive Supply Agreement with the Israeli Ministry of Health (GlobeNewswire) - "Arcturus Therapeutics Holdings Inc....today announced that it has 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)....Arcturus is in the process of manufacturing millions of doses in 2020 and positioned to supply hundreds of millions of doses annually thereafter."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease

Ascending Dose Study of Investigational SARS-CoV-2 Vaccine ARCT-021 in Healthy Adult Subjects (clinicaltrials.gov) - P1/2; N=92; Recruiting; Sponsor: Arcturus Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease

Arcturus Therapeutics Announces that it has Initiated Dosing of its COVID-19 STARR mRNA Vaccine Candidate, LUNAR-COV19 (ARCT-021) in a Phase 1/2 study (GlobeNewswire) - "Arcturus Therapeutics Holdings Inc....today announced that all subjects in the first cohort have been dosed in the Phase 1/2 clinical study with its ARCT-021 investigational vaccine for COVID-19. The study is being conducted with CTI Clinical Trial and Consulting Services...in collaboration with Duke-NUS Medical School in Singapore....'We look forward to sharing initial clinical data from this Phase 1/2 study in Q4 which we expect to enable dose selection for late phase clinical trials.'"

P1/2 data • Trial status • Infectious Disease • Novel Coronavirus Disease

Phase 1/2 Ascending Dose Study of Investigational SARS-CoV-2 Vaccine ARCT-021 in Healthy Adult Subjects (clinicaltrials.gov) - P1/2; N=85; Not yet recruiting; Sponsor: Arcturus Therapeutics, Inc.

Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease

Arcturus Therapeutics & Duke-NUS Received Approval to Proceed with Phase 1/2 Clinical Trial for COVID-19 Vaccine Candidate, LUNAR-COV19 (GlobeNewswire) - "Arcturus Therapeutics Holdings Inc....today announced that the Clinical Trial Application (CTA) for COVID-19 vaccine candidate LUNAR-COV19 has been approved to proceed by the Singapore Health Sciences Authority (HSA)....Arcturus & Duke-NUS will initiate human dosing of LUNAR-COV19 as soon as possible. The healthy volunteer study will evaluate several dose levels of LUNAR-COV19 in up to 108 adults, including older adults."

New P1/2 trial • Infectious Disease • Novel Coronavirus Disease

Covid-19 vaccine update today: Human trials of Singapore’s Lunar-Cov19 vaccine to begin, says report (The Financial Express) - "Human trials for Lunar-Cov19 COVID-19 vaccine could begin in Singapore as early as this week....Volunteers involved in the Lunar-Cov19 trials will be injected with the COVID-19 vaccine developed by Duke-NUS Medical School....On the global front, more than 140 candidates are involved in the development of the vaccine at several stages of human and animal trials....A total of 142 vaccine candidates are at the pre-clinical-stage around the world....A total of 17 vaccines are at the first phase, 13 at the second and only 5 candidates are at the phase 3 trial across the world respectively."

Trial initiation date • Infectious Disease • Novel Coronavirus Disease

Arcturus Therapeutics Announces Agreement with Israeli Ministry of Health to Supply COVID-19 Vaccine Candidate, LUNAR-COV19 (GlobeNewswire) - "Arcturus Therapeutics Holdings Inc...today announced 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 finalize a comprehensive supply agreement within 30 days....Arcturus continues to scale up manufacturing to potentially produce hundreds of millions of doses across 2020 and 2021."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease

Arcturus Therapeutics Announces First Quarter 2020 Financial Results and Provides a Corporate Update (GlobeNewswire, Arcturus Therapeutics, Inc.) - "Arcturus today provided new preclinical immunogenicity data from its COVID-19 vaccine candidate, extending previously disclosed neutralizing antibody seroconversion results (demonstrating 100% seroconversion at single 2 µg dose, day 19)....The antibody data also showed that the Company’s proprietary self-replicating mRNA approach resulted in superior immunogenicity to conventional mRNA technology....The Company believes that the LUNAR-COV19 preclinical data provide additional compelling support for the upcoming clinical trial. Efforts are ongoing to obtain initial regulatory approval in Singapore to begin human dosing as rapidly as possible. In parallel, activities are underway to support global development of the COVID-19 vaccine."

New trial • Preclinical • Regulatory • Infectious Disease • Novel Coronavirus Disease