Arcturus

New COVID-19 sa-mRNA Results from CSL and Arcturus Therapeutics Demonstrate Longer Duration of Immunity Compared to Conventional COVID-19 mRNA Vaccine Booster

Retrieved on: 
Monday, February 5, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, COVID-19, Infectious Diseases, Clinical Trials, Pfizer–BioNTech COVID-19 vaccine, SARS-CoV-2, Senior, RNA, Arcturus, ARCT, GMT, Messenger, CSL, Therapy, ASX, Arcturus Therapeutics, Vaccine

Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics (Nasdaq: ARCT) today announced the results of a follow-up analysis of a Phase 3 study evaluating a booster dose of ARCT-154, the world's first approved self-amplifying messenger RNA (sa-mRNA) COVID-19 vaccine, compared to a conventional mRNA COVID-19 vaccine.

Key Points: 
  • Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics (Nasdaq: ARCT) today announced the results of a follow-up analysis of a Phase 3 study evaluating a booster dose of ARCT-154, the world's first approved self-amplifying messenger RNA (sa-mRNA) COVID-19 vaccine, compared to a conventional mRNA COVID-19 vaccine.
  • ARCT-154 was administered at one-sixth the dose of Comirnaty® (5 μg vs 30 μg, respectively).
  • “These results further support sa-mRNA’s differentiating attribute to provide prolonged protection against COVID-19 at lower doses,” said Jonathan Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL.
  • GMTs against Wuhan-Hu-1 remained numerically higher 180 days after ARCT-154 than those observed 28 days after the Comirnaty® booster.

New COVID-19 sa-mRNA Results from CSL and Arcturus Therapeutics Demonstrate Longer Duration of Immunity Compared to Conventional COVID-19 mRNA Vaccine Booster

Retrieved on: 
Monday, February 5, 2024
Pfizer–BioNTech COVID-19 vaccine, COVID-19, SARS-CoV-2, SAN, Senior, RNA, Arcturus, ARCT, GMT, Messenger, CSL, Therapy, ASX, Arcturus Therapeutics, Vaccine

KING OF PRUSSIA, Pa. and SAN DIEGO, Feb. 5, 2024 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics (Nasdaq: ARCT) today announced the results of a follow-up analysis of a Phase 3 study evaluating a booster dose of ARCT-154 , the world's first approved self-amplifying messenger RNA (sa-mRNA) COVID-19 vaccine, compared to a conventional mRNA COVID-19 vaccine. ARCT-154 was administered at one-sixth the dose of Comirnaty® (5 μg vs 30 μg, respectively).

Key Points: 
  • ARCT-154 was administered at one-sixth the dose of Comirnaty® (5 μg vs 30 μg, respectively).
  • The new analysis at 6 months post-vaccination shows that ARCT-154 induces a longer immune response as compared to Comirnaty for both the original Wuhan strain and Omicron BA.4/5 variant and an advantage in antibody persistence.
  • "These results further support sa-mRNA's differentiating attribute to provide prolonged protection against COVID-19 at lower doses," said Jonathan Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL.
  • GMTs against Wuhan-Hu-1 remained numerically higher 180 days after ARCT-154 than those observed 28 days after the Comirnaty® booster.

CSL and Arcturus Therapeutics’ ARCT-154 Demonstrates Non-Inferiority to Original Strain and Superior Immunogenicity to Omicron BA.4/5 Variant Compared to First-Generation mRNA Vaccine Booster

Retrieved on: 
Thursday, December 21, 2023
Science, Biotechnology, Research, Pharmaceutical, Health, COVID-19, Infectious Diseases, Clinical Trials, SRR, RNA, ASX, Partnership, Multimedia, Messenger, Vaccine, Arcturus Therapeutics, Therapy, Vaccination, GMT, Omicron, CSL, ARCT, Patient, Arcturus, Safety, Senior

ARCT-154 results were achieved with one sixth the dose of Comirnaty® (5 μg vs 30 μg).

Key Points: 
  • ARCT-154 results were achieved with one sixth the dose of Comirnaty® (5 μg vs 30 μg).
  • The study was conducted in partnership with Meiji Seika Pharma, a global health company based in Japan.
  • The primary objective was to demonstrate immunological non-inferiority of ARCT-154 to Comirnaty®, as measured by neutralizing antibodies against Wuhan-Hu-1 SARS-CoV-2.
  • Key secondary objectives included the assessment of immunological non-inferiority and superiority against the Omicron BA.4/5 subvariant and vaccine tolerability assessed using participant-completed electronic diaries.

CSL and Arcturus Therapeutics' ARCT-154 Demonstrates Non-Inferiority to Original Strain and Superior Immunogenicity to Omicron BA.4/5 Variant Compared to First-Generation mRNA Vaccine Booster

Retrieved on: 
Thursday, December 21, 2023
SRR, RNA, Senior, ASX, Partnership, Messenger, Vaccine, Arcturus Therapeutics, SAN, Therapy, Vaccination, GMT, Omicron, CSL, COVID-19, Doctor of Philosophy, Upendra J. Chivukula, Patient, Arcturus, Safety

KING OF PRUSSIA, Pa. and SAN DIEGO, Dec. 21, 2023 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics (Nasdaq: ARCT) today announced the publication in Lancet Infectious Diseases of a Phase 3 study showing that a booster dose of ARCT-154, a novel, self-amplifying messenger RNA (sa-mRNA) vaccine, elicited a numerically higher immune response (meeting the non-inferiority criteria) against the original Wuhan-Hu-1 virus strain,  and a superior immune response against Omicron BA.4/5 subvariant of SARS-CoV-2 virus compared to a booster dose of the conventional mRNA vaccine Comirnaty®. ARCT-154 results were achieved with one-sixth the dose of Comirnaty® (5 μg vs 30 μg).

Key Points: 
  • Both vaccines were well-tolerated, with no causally associated severe or serious adverse events.
  • The study was conducted in partnership with Meiji Seika Pharma, a global health company based in Japan.
  • "This study represents the first phase of CSL and Arcturus' plans to launch this innovative vaccine platform globally."
  • Key secondary objectives included the assessment of immunological non-inferiority and superiority against the Omicron BA.4/5 subvariant and vaccine tolerability assessed using participant-completed electronic diaries.

Japan's Ministry of Health, Labour and Welfare Approves CSL and Arcturus Therapeutics’ ARCT-154, the First Self-Amplifying mRNA Vaccine Approved for COVID in Adults

Retrieved on: 
Tuesday, November 28, 2023
Biotechnology, Infectious Diseases, COVID-19, Health, Pharmaceutical, Ministry, CSL, MHLW, Senior, Nobel, Therapy, MedRxiv, Risk, Vaccination, Multimedia, Ministry of Health, ASX, ARCT, Messenger, Arcturus Therapeutics, Public, COVID, Vaccine, Arcturus

Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics today announced that Japan's Ministry of Health, Labor and Welfare (MHLW) granted approval for ARCT-154, a self-amplifying mRNA (sa-mRNA) COVID-19 vaccine for initial vaccination and booster for adults 18 years and older.

Key Points: 
  • Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics today announced that Japan's Ministry of Health, Labor and Welfare (MHLW) granted approval for ARCT-154, a self-amplifying mRNA (sa-mRNA) COVID-19 vaccine for initial vaccination and booster for adults 18 years and older.
  • Initial study results have been published in MedRxiv and are expected to be published in a peer-reviewed journal by the end of the year.
  • "This approval for the sa-mRNA COVID-19 vaccine is a major achievement, and we are excited to embark on future endeavors that utilize our innovative sa-mRNA vaccine platform alongside our global exclusive partner, CSL."
  • CSL's vaccine business, CSL Seqirus, one of the largest influenza vaccine providers in the world, partnered exclusively with Meiji Seika Pharma for distribution of the sa-mRNA COVID vaccine, ARCT 154, in Japan.

Arcturus Therapeutics Receives Orphan Drug Designation from the U.S. FDA for ARCT-032, for the Treatment of Cystic Fibrosis

Retrieved on: 
Monday, November 27, 2023
FDA, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, Food, Therapy, Liver, Disease, Information Holdings Inc., Vaccine, ARCT, Arcturus Therapeutics, RNA, Drug, Infection, Cystic fibrosis, Pharmaceutical industry, Arcturus

Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for the Company’s product candidate ARCT-032 to treat cystic fibrosis (CF).

Key Points: 
  • Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for the Company’s product candidate ARCT-032 to treat cystic fibrosis (CF).
  • The FDA’s Office of Orphan Products Development grants orphan status to drugs being developed to treat, prevent, or diagnose a rare disease or condition affecting fewer than 200,000 people in the United States.
  • “Orphan Drug Designation is a very important regulatory milestone in our development plan for ARCT-032,” said Joseph Payne, President, and Chief Executive Officer of Arcturus Therapeutics.
  • "We are executing diligently to accelerate ARCT-032 as a potential new treatment option for people with cystic fibrosis.”
    The first CF patient in our Phase 1b study successfully completed two administrations of ARCT-032.

Arcturus Therapeutics Announces Third Quarter 2023 Financial Update and Pipeline Progress

Retrieved on: 
Tuesday, November 14, 2023
Biotechnology, Health, Genetics, Pharmaceutical, Clinical Trials, CSL, Safety, Research, DNA, Ornithine transcarbamylase deficiency, Therapy, Cystic fibrosis, Technology transfer, Liver, Clinical trial, Database, COVID-19, Patient, FDA, PMDA, Vaccine, ARCT, Messenger, Valencia CF Foundation, Arcturus Therapeutics, Conference, RNA, Ferret, Infection, Ivacaftor, CFTR, OTC, Government, HIV disease progression rates, Transfection, Travel, COVID, Pharmaceutical industry, Cryptocurrency, Arcturus

“We had considerable progress this quarter expanding our next generation STARR® vaccine platform,” said Joseph Payne, President & CEO of Arcturus Therapeutics.

Key Points: 
  • “We had considerable progress this quarter expanding our next generation STARR® vaccine platform,” said Joseph Payne, President & CEO of Arcturus Therapeutics.
  • ARCALIS Inc., the Company’s manufacturing joint venture in Japan to support the production of mRNA vaccines and therapeutics, continues to make operational progress while also obtaining financial support from the Japanese government.
  • Arcturus achieved a milestone for $35 million and anticipates receipt from CSL in November 2023.
  • Arcturus expects the final database lock to occur in the fourth quarter of 2023.

Japan's Ministry of Health, Labour and Welfare Approves CSL and Arcturus Therapeutics' ARCT-154, the first Self-Amplifying mRNA vaccine approved for COVID in adults

Retrieved on: 
Tuesday, November 28, 2023
Ministry, CSL, MHLW, SAN, Senior, Nobel, Therapy, MedRxiv, Risk, Vaccination, Ministry of Health, ASX, ARCT, Infection, Messenger, COVID-19, Arcturus Therapeutics, Public, COVID, Vaccine, Arcturus, Health

KING OF PRUSSIA, Pa. and SAN DIEGO, Nov. 27, 2023 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics today announced that Japan's Ministry of Health, Labor and Welfare (MHLW) granted approval for ARCT-154, a self-amplifying mRNA (sa-mRNA) COVID-19 vaccine for initial vaccination and booster for adults 18 years and older. 

Key Points: 
  • With the approval of ARCT-154, CSL now offers an even more comprehensive portfolio of innovative vaccines that combat respiratory viral diseases.
  • "We are committed to working with health authorities around the world to ensure this important vaccine technology will be available to people at risk for COVID-19."
  • "This approval for the sa-mRNA COVID-19 vaccine is a major achievement, and we are excited to embark on future endeavors that utilize our innovative sa-mRNA vaccine platform alongside our global exclusive partner, CSL."
  • CSL's vaccine business, CSL Seqirus, one of the largest influenza vaccine providers in the world, partnered exclusively with Meiji Seika Pharma for distribution of the sa-mRNA COVID vaccine, ARCT 154, in Japan.

Global COVID-19 Competitive Landscape Report 2023: Comprehensive Insights on 400+ Companies and 500+ Drugs - ResearchAndMarkets.com

Retrieved on: 
Monday, October 16, 2023
Infectious Diseases, Health, COVID-19, Shenzhen Stock Exchange, Respiratory failure, Acquisition, Report, Arcturus, Therapy, Coalition for Epidemic Preparedness Innovations, University, Safety, CEPI, Medication, AstraZeneca, Ageing, Siemens Healthineers, Vingroup, Developing country, Competitive landscape, Nanocovax, SARS-CoV-2, Epidemic, Coalition, Patient, Pharmaceutical industry, Vaccine

This "COVID-19 Competitive landscape 2023" report provides comprehensive insights about 400+ companies and 500+ drugs in COVID-19 Competitive landscape.

Key Points: 
  • This "COVID-19 Competitive landscape 2023" report provides comprehensive insights about 400+ companies and 500+ drugs in COVID-19 Competitive landscape.
  • The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition - deals values trends.
  • The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form.
  • Furthermore, the report delves into the development stages of emerging drugs, highlighting those in mid-stage and late-stage development, which are promising candidates for COVID-19 treatment.

Arcturus Therapeutics Joint Venture mRNA Manufacturing Partner, ARCALIS, Awarded Additional Financial Grants from Japanese Government

Retrieved on: 
Wednesday, October 4, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Vaccine, DNA, Diversified Specialty Institute Holdings, Inc., Therapy, Arcturus Therapeutics, Infection, ARCT, RNA, Messenger, MRNA vaccine, Liver, Arcturus

In total to date, $165 million has been awarded to ARCALIS by the Japanese government to build mRNA Drug Substance, mRNA Drug Product manufacturing capabilities and to construct a DNA template manufacturing facility.

Key Points: 
  • In total to date, $165 million has been awarded to ARCALIS by the Japanese government to build mRNA Drug Substance, mRNA Drug Product manufacturing capabilities and to construct a DNA template manufacturing facility.
  • The mRNA Drug Substance manufacturing facility was completed in July 2023.
  • ARCALIS will provide cGMP-integrated vaccine manufacturing, from mRNA drug substance to bulk nanoparticle-formulated drug product.
  • “This support has already enabled the completion of a state-of-the-art mRNA Drug Substance manufacturing facility, and we are excited to now extend this collaboration with the construction of an associated DNA manufacturing facility.