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
- ARCT-154 vaccine showed higher immune response than Comirnaty® against Wuhan-Hu-1 and Omicron BA.4/5 strains
- Results achieved with one-sixth the dose of Comirnaty®
- Study findings support approval of ARCT-154 for primary immunization and as a booster dose in Japan
- ARCT-154 was well-tolerated with no severe or serious adverse events reported
- None.
Insights
The recent publication detailing the Phase 3 study of ARCT-154, a novel sa-mRNA COVID-19 vaccine, is significant in the field of medical research and biotechnology. The study's findings suggest that ARCT-154, developed by CSL and Arcturus Therapeutics, exhibits a higher immune response compared to the conventional mRNA vaccine Comirnaty, with the added benefit of a lower dosage requirement. This could potentially lead to reduced manufacturing costs and easier logistics in vaccine distribution.
An important aspect to evaluate is the long-term efficacy and safety of ARCT-154, as well as its production scalability. The favorable immune response and tolerability profile position ARCT-154 as a potential market disruptor in the vaccine industry. However, the regulatory pathway and market acceptance will be critical factors in determining its commercial success.
From an investment perspective, this development could have implications for CSL and Arcturus Therapeutics' stock performance, as successful commercialization of ARCT-154 may lead to increased revenue streams and market share in the competitive vaccine market.
The approval of ARCT-154 in Japan marks a pivotal moment for the mRNA vaccine landscape. The data indicating a superior immune response to the Omicron variant with a lower dose could drive a shift in vaccine preference, particularly as governments and health organizations look to manage ongoing COVID-19 vaccination campaigns more efficiently.
It's essential to consider the competitive dynamics of the vaccine market. As ARCT-154 enters the market, it could challenge the dominance of established players like Pfizer-BioNTech and Moderna. The pricing strategy, manufacturing capacity and global distribution partnerships will be crucial elements that determine the new vaccine's market penetration.
Investors should monitor subsequent data releases from ongoing studies, including the durability of the immune response, which will further inform the vaccine's value proposition. Additionally, the ability of ARCT-154 to adapt to new variants will be a key determinant of its long-term market viability.
The financial implications of the successful development and approval of ARCT-154 are multifaceted. For CSL and Arcturus Therapeutics, the vaccine represents a potential significant revenue driver, especially if it gains traction in other markets beyond Japan. The lower dosage could translate into cost advantages in production and distribution, potentially improving profit margins.
Investors should assess the cost structures and capital expenditures associated with scaling up production, as these will impact the overall financial health of the companies involved. The stock valuation could see adjustments based on projected sales and market expansion, making it a point of interest for those invested in the biotech sector.
Given the ongoing nature of the COVID-19 pandemic and the possibility of future variants, the demand for effective vaccines remains high. The financial performance of CSL and Arcturus Therapeutics will be closely tied to the operational execution of ARCT-154's rollout and the strategic management of supply chain and regulatory hurdles.
Study conducted by Meiji Seika Pharma in
- Data follow approval of the world's first self-amplifying messenger RNA (sa-mRNA) COVID-19 vaccine for adults by Japan Ministry of Health, Labor and Welfare
- The randomized, double-blind, active-controlled study, conducted at 11 sites in
Japan , was designed to compare the immunogenicity and tolerability of the sa-mRNA vaccine ARCT-154 with Comirnaty® - Phase 3 Study published in The Lancet Infectious Diseases
The study included healthy adults initially immunized with two doses of an mRNA vaccine (Comirnaty® or Spikevax™); and then a third dose of Comirnaty® at least three months prior to the booster dose of either ARCT-154 or Comirnaty® in the study. 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
"The initial head-to-head results of the ARCT-154 study are exciting as they show that our sa-mRNA vaccine platform has the potential to produce immunogenicity against COVID-19 in previously vaccinated patients that is as good or better—and at a much lower dose—than first generation mRNA vaccines," said Jonathan Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL. "These results move CSL one step closer to delivering on our promise to develop and provide differentiated innovations that help protect the public against the ongoing burden of COVID-19. We look forward to sharing additional data from CSL's sa-mRNA programs as we continue to advance this exciting technology."
"These important study findings mark another major achievement in the development of our innovative sa-mRNA vaccine platform and a significant moment for Arcturus and CSL," said Pad Chivukula, Ph.D., Chief Scientific Officer of Arcturus Therapeutics. "This study represents the first phase of CSL and Arcturus' plans to launch this innovative vaccine platform globally."
The phase 3 study results with ARCT-154 were used to support the approval of ARCT-154 for primary immunization and as a booster dose in
The ARCT-154 study is ongoing and will continue to collect safety data and assess durability of the immune response in participants at 3-, 6- and 12-months post-vaccination.
Study design and results
The randomized, double-blind, active-controlled study, conducted at 11 sites in
Between December 13, 2022, and February 25, 2023, 828 participants were enrolled and randomized 1:1 to receive ARCT-154 (n = 420) or Comirnaty® (n = 408) booster doses. Four weeks after boosting, ARCT-154 induced higher Wuhan-Hu-1 neutralizing antibodies GMTs than Comirnaty® (5641 [(
The booster doses of ARCT-154 and Comirnaty® were equally well-tolerated in this adult population, with no causally associated severe or serious adverse events;
About sa-mRNA
In contrast to standard messenger RNA vaccine technology, self-amplifying messenger RNA (sa-mRNA) vaccine technology helps protect against infectious diseases by not only instructing cells in the body to make a specific protein, but also to make copies of these instructions in the cell. The produced protein antigen stimulates the immune response and leaves a blueprint to recognize and fight future infection. Because of the self-amplifying element of the vaccine, more protein is produced compared to an equivalent amount of standard mRNA, allowing for lower doses of sa-mRNA to be used. sa-mRNA also has the potential to prompt a potent and durable cellular immune response in addition to producing effective antibodies against the targeted virus.
About CSL
CSL (ASX:CSL; USOTC:CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSL. For more information about CSL, visit www.CSL.com.
About Arcturus Therapeutics
Founded in 2013 and based in
About Meiji Seika Pharma Co., Ltd.
Meiji Seika Pharma, since it launched penicillin in 1946, has been providing efficacious and high-quality pharmaceutical products such as therapeutics and vaccines for infectious diseases, therapeutics for central nervous system diseases as well as generic drugs in response to various medical needs. As a leading company in the field of infectious diseases, we are strengthening our platform for infection control and prevention with vaccines and antimicrobial agents.
Media Contacts:
CSL Media Contacts:
Sue Thorn
Mobile: 617 799 3151
Email: sue.thorn@cslbehring.com
Kim O'Donohue
Mobile: 0449 884 603
Email: kim.odonohue@csl.com.au
Jimmy Baker
Mobile: +61 450 909 211
Email: Jimmy.Baker@csl.com.au
Arcturus Media Contact:
Neda Safarzadeh
VP, Head of IR/PR/Marketing
Email: IR@arcturusrx.com
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