ARCT-021 (LUNAR-COV19)

cas 2541451-24-3

A lipid-enabled and UnlockedNucleomonomer Agent modified RNA (LUNAR) of self-replicating RNA for vaccination against spike protein of SARS-CoV-2 (Arcturus)

Self-replicating RNA vaccine

Arcturus Therapeutics and Duke-NUS Medical School, Singapore

• OriginatorArcturus Therapeutics
• ClassCOVID-19 vaccines; RNA vaccines; Viral vaccines
• Mechanism of ActionImmunostimulants

• Orphan Drug StatusNo
• New Molecular EntityNo
• Available For LicensingYes – COVID 2019 infections
• Phase IICOVID 2019 infections

• 01 Mar 2021Arcturus Therapeutics has patent pending for STARR platform in USA
• 01 Mar 2021Immunogenicity data from a preclinical studies in COVID-2019 infections released by Arcturus Therapeutics
• 01 Mar 2021Arcturus Therapeutics completes a phase I/II trial in COVID-2019 infection in the Singapore

ref International Journal of Biological Sciences (2021), 17(6), 1446-1460. https://www.ijbs.com/v17p1446.htm

LUNAR-COV19	T7	m7GpppNmN	Yes	VEEV-FL-S	N1-methyl pseudouridine	Silicon column
protein	[54]

ARCT-021: Currently undergoing phase 1/2 clinical trials, it combines two technologies, i.e., saRNA STARR™ and LUNAR® lipid-mediated delivery method. It was designed to enhance and extend antigen expression, enabling vaccination at lower doses [87]. In addition, LUNAR® lipids are pH-sensitive and biodegradable, causing minimal lipid accumulation in cells after multiple dosing [87]The Arcturus COVID-19 vaccine, commonly known as ARCT-021 and LUNAR-COV19, is a COVID-19 vaccine candidate developed by Arcturus Therapeutics.

LUNAR- COV19

1

Day 0

0.2 μg and 10 μg (Preclinical)

IM

Arcturus Therapeutics

N/A

Phase 2

NCT04668339 NCT04480957

[54]

54. de Alwis R, Gan ES, Chen S, Leong YS, Tan HC, Zhang SL. et al. A Single Dose of Self-Transcribing and Replicating RNA Based SARS-CoV-2 Vaccine Produces Protective Adaptive Immunity In Mice. bioRxiv. 2020. 2020 09.03.280446
Development

Arcturus Therapeutics partnered with Singapore’s Duke–NUS Medical School to develop a COVID-19 vaccine.^[1] The company also partnered with Catalent, a contract development and manufacturing organization, to manufacture multiple batches of Arcturus’ COVID-19 mRNA vaccine candidate.^[2]

Clinical research

Phase I-II

LUNAR-COV19 clinical trials in humans began in July 2020.^[3] On 4 January 2021, Arcturus Therapeutics started phase-2 clinical trials.^[4]

Deployment

Arcturus has entered into development and supply agreements with the Economic Development Board of Singapore and supply agreements with the Israel Ministry of Health for LUNAR-COV19.^[5][6]

Arcturus Therapeutics Receives FDA Allowance to Proceed with Phase 2 Study of ARCT-021 (LUNAR-COV19) Vaccine Candidate in the United States

https://www.businesswire.com/news/home/20210104005377/en/Arcturus-Therapeutics-Receives-FDA-Allowance-to-Proceed-with-Phase-2-Study-of-ARCT-021-LUNAR-COV19-Vaccine-Candidate-in-the-United-States

Phase 2 study to be conducted in the U.S. and Singapore, and will evaluate both single dose and two dose priming regimens of ARCT-021 in up to 600 participants

Anticipate interim Phase 2 data in early 2021; targeting global Phase 3 study start in Q2 2021 which could allow application for emergency use authorization/conditional approval in H2 2021January 04, 2021 07:01 AM Eastern Standard Time

SAN DIEGO–(BUSINESS WIRE)–Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a leading clinical-stage messenger RNA medicines company focused on the development of infectious disease vaccines and significant opportunities within liver and respiratory rare diseases, 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.

Arcturus Therapeutics Receives FDA Allowance to Proceed with Phase 2 Study of ARCT-021 (LUNAR-COV19) Vaccine Candidate in the United States

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Arcturus previously announced that the ARCT-021 Phase 2 study had been approved to proceed by the Singapore Health Sciences Authority (HSA), who reviewed the same data as reviewed by the FDA. These Phase 1/2 study results demonstrated favorable tolerability and both humoral and cellular immunogenicity following administration of ARCT-021.

The Phase 2 study will enroll 600 participants, with 450 receiving ARCT-021 and 150 receiving placebo. Both older and younger adult participants will be included. Early interim analyses of safety and immunogenicity will be performed to inform dose selection for a Phase 3 study, which is targeted to start in Q2 2021, if the Phase 2 study is successful.

“Allowance of the IND for our ARCT-021 Phase 2 clinical study represents an important milestone for the program and we look forward to starting to screen study participants at U.S. and Singapore clinical sites very soon,” said Steve Hughes, M.D., Chief Medical Officer of Arcturus. “We have advanced ARCT-021 to Phase 2 based on promising interim results from our Phase 1/2 study and extensive preclinical data. Our prior clinical results show that ARCT-021 administration results in humoral and cellular immunogenicity, and we are encouraged by an increasing body of evidence highlighting the potential importance of T cells in providing protection against SARS-CoV-2 infection and COVID-19. We believe that ARCT-021 holds promise to be a highly effective vaccine with a differentiated clinical profile, including the potential to only require a single dose for protection.”

About Arcturus Therapeutics

Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a clinical-stage mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR™ mRNA Technology and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus’ diverse pipeline of RNA therapeutic and vaccine candidates includes self-replicating mRNA vaccine programs for SARS-CoV-2 (COVID-19) and Influenza, and other programs to potentially treat Ornithine Transcarbamylase (OTC) Deficiency, Cystic Fibrosis, and Cardiovascular Disease along with partnered programs including Glycogen Storage Disease Type 3, Hepatitis B Virus, and non-alcoholic steatohepatitis (NASH). Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, replicon RNA, antisense RNA, microRNA, DNA, and gene editing therapeutics. Arcturus’ technologies are covered by its extensive patent portfolio (205 patents and patent applications, issued in the U.S., Europe, Japan, China and other countries). Arcturus’ commitment to the development of novel RNA therapeutics has led to collaborations with Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Ultragenyx Pharmaceutical, Inc., Takeda Pharmaceutical Company Limited, CureVac AG, Synthetic Genomics Inc., Duke-NUS Medical School, and the Cystic Fibrosis Foundation. For more information visit www.ArcturusRx.com. In addition, please connect with us on Twitter and LinkedIn.

References

1. ^ Teo J (15 April 2020). “Coronavirus: Clinical trials for Singapore’s vaccine project could start in August”. The Straits Times. Retrieved 27 April 2020.
2. ^ Stanton D (6 May 2020). “With Arcturus, Catalent bags another COVID project”. Bioprocess Insider. Retrieved 8 May 2020.
3. ^ Clinical trial number NCT04480957 for “Phase 1/2 Ascending Dose Study of Investigational SARS-CoV-2 Vaccine ARCT-021 in Healthy Adult Subjects” at ClinicalTrials.gov
4. ^ “Arcturus Therapeutics Receives FDA Allowance to Proceed with Phase 2 Study of ARCT-021 (LUNAR-COV19) Vaccine Candidate in the”. Bloomberg. 4 January 2021. Retrieved 17 January 2021.
5. ^ Anwar N (26 November 2020). “Singapore’s co-developed vaccine candidate is in ‘good shape’ for delivery in 2021”. CNBC. Retrieved 18 March 2021.
6. ^ Cheok M, Mookerjee I (5 August 2020). “Singapore Will Get First Claim to Any Successful Arcturus Vaccine”. Bloomberg. Retrieved 18 March 2021.

External links

Scholia has a profile for Lunar-COV19 (Q98713328).

Vaccine description
Target	SARS-CoV-2
Vaccine type	mRNA
Clinical data
Other names	ARCT-021, LUNAR-COV19
Routes of administration	Intramuscular

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