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Self-Amplifying mRNA COVID-19 Vaccine Demonstrates Superior Immune Response Compared with mRNA Vaccine at 12 Months Post-Vaccination

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CSL (CSLLY) and Arcturus Therapeutics announced results from a head-to-head study showing their self-amplifying mRNA (sa-mRNA) COVID-19 vaccine maintained superior immunogenicity compared to Comirnaty® for up to one year. The study, presented at the OPTIONS XII conference, demonstrated ARCT-154 elicited superior antibody persistence against multiple SARS-CoV-2 strains at one-sixth the dose of Comirnaty®.

Key findings include:

  • ARCT-154 showed superior neutralizing antibodies against Wuhan-Hu-1 strain at Day 361
  • Similar advantages were observed against Omicron BA.4-5 and other variants
  • A bivalent formula, ARCT-2301, also demonstrated superior immunogenicity over Comirnaty®

The sa-mRNA COVID-19 vaccine is approved in Japan under the name KOSTAIVE® for adults 18 and older.

CSL (CSLLY) e Arcturus Therapeutics hanno annunciato i risultati di uno studio comparativo che mostra come il loro vaccino COVID-19 a mRNA auto-amplificante (sa-mRNA) mantenga una superiorità in termini di immunogenicità rispetto a Comirnaty® per un anno. Lo studio, presentato alla conferenza OPTIONS XII, ha dimostrato che ARCT-154 ha provocato una persistenza degli anticorpi superiore contro diversi ceppi di SARS-CoV-2 a un sesto della dose di Comirnaty®.

Le principali scoperte includono:

  • ARCT-154 ha mostrato anticorpi neutralizzanti superiori contro il ceppo Wuhan-Hu-1 al Giorno 361
  • Vantaggi simili sono stati osservati contro le varianti Omicron BA.4-5 e altre
  • Una formula bivalente, ARCT-2301, ha dimostrato anche una superiorità in termini di immunogenicità rispetto a Comirnaty®

Il vaccino COVID-19 sa-mRNA è approvato in Giappone con il nome KOSTAIVE® per adulti di 18 anni e oltre.

CSL (CSLLY) y Arcturus Therapeutics anunciaron los resultados de un estudio comparativo que muestra que su vacuna COVID-19 de ARNm auto-amplificante (sa-mRNA) mantuvo una inmunogenicidad superior en comparación con Comirnaty® durante hasta un año. El estudio, presentado en la conferencia OPTIONS XII, demostró que ARCT-154 provocó una mayor persistencia de anticuerpos contra múltiples cepas de SARS-CoV-2 a una sexta parte de la dosis de Comirnaty®.

Los hallazgos clave incluyen:

  • ARCT-154 mostró anticuerpos neutralizantes superiores contra la cepa Wuhan-Hu-1 en el Día 361
  • Se observaron ventajas similares contra Omicron BA.4-5 y otras variantes
  • Una fórmula bivalente, ARCT-2301, también demostró una inmunogenicidad superior en comparación con Comirnaty®

La vacuna sa-mRNA COVID-19 está aprobada en Japón bajo el nombre KOSTAIVE® para adultos de 18 años o más.

CSL (CSLLY)과 Arcturus Therapeutics는 자가 증폭 mRNA (sa-mRNA) COVID-19 백신이 Comirnaty®에 비해 우수한 면역원성을 유지했다는 임상 연구 결과를 발표했습니다. 이 연구는 OPTIONS XII 회의에서 발표되었으며, ARCT-154가 Comirnaty®의 1/6 용량에서 여러 SARS-CoV-2 변종에 대해 우수한 항체 지속성을 유도했다는 것을 보여주었습니다.

주요 발견은 다음과 같습니다:

  • ARCT-154는 Day 361에서 Wuhan-Hu-1 변종에 대해 우수한 중화 항체를 보여주었습니다
  • Omicron BA.4-5 및 다른 변종에 대해서도 유사한 이점이 관찰되었습니다
  • 이분 백신인 ARCT-2301도 Comirnaty®에 비해 우수한 면역원성을 보여주었습니다

sa-mRNA COVID-19 백신은 일본에서 KOSTAIVE®라는 이름으로 18세 이상의 성인에게 승인되었습니다.

CSL (CSLLY) et Arcturus Therapeutics ont annoncé les résultats d'une étude comparative montrant que leur vaccin COVID-19 à ARN messager auto-amplifiant (sa-mRNA) maintenait une immunogénicité supérieure par rapport à Comirnaty® pendant jusqu'à un an. L'étude, présentée lors de la conférence OPTIONS XII, a démontré que ARCT-154 a provoqué une persistance d'anticorps supérieure contre plusieurs souches de SARS-CoV-2 à un sixième de la dose de Comirnaty®.

Les principales conclusions comprennent :

  • ARCT-154 a montré des anticorps neutralisants supérieurs contre la souche Wuhan-Hu-1 au Jour 361
  • Des avantages similaires ont été observés contre Omicron BA.4-5 et d'autres variantes
  • Une formule bivalente, ARCT-2301, a également montré une immunogénicité supérieure par rapport à Comirnaty®

Le vaccin sa-mRNA COVID-19 est approuvé au Japon sous le nom de KOSTAIVE® pour les adultes de 18 ans et plus.

CSL (CSLLY) und Arcturus Therapeutics haben die Ergebnisse einer Vergleichsstudie bekannt gegeben, die zeigt, dass ihr selbstverstärkendes mRNA (sa-mRNA) COVID-19-Impfstoff eine überlegene Immunogenität im Vergleich zu Comirnaty® bis zu einem Jahr aufrechterhielt. Die Studie, die auf der OPTIONS XII-Konferenz präsentiert wurde, zeigte, dass ARCT-154 eine überlegene Antikörperpersistenz gegen mehrere SARS-CoV-2-Stämme bei einem Sechstel der Dosis von Comirnaty® hervorrief.

Wichtige Ergebnisse sind:

  • ARCT-154 zeigte überlegene neutralisierende Antikörper gegen den Wuhan-Hu-1-Stamm am Tag 361
  • Ähnliche Vorteile wurden gegen Omicron BA.4-5 und andere Varianten beobachtet
  • Eine bivalente Formel, ARCT-2301, zeigte ebenfalls eine überlegene Immunogenität im Vergleich zu Comirnaty®

Der sa-mRNA COVID-19-Impfstoff ist in Japan unter dem Namen KOSTAIVE® für Erwachsene ab 18 Jahren zugelassen.

Positive
  • Sa-mRNA vaccine maintained superior immunogenicity compared to Comirnaty® for up to one year
  • ARCT-154 elicited superior antibody persistence against multiple SARS-CoV-2 strains
  • Sa-mRNA vaccine effective at one-sixth the dose of Comirnaty® (5 μg vs 30 μg)
  • Bivalent formula ARCT-2301 showed superior immunogenicity over Comirnaty® up to six months post-vaccination
  • Sa-mRNA COVID-19 vaccine (KOSTAIVE®) approved in Japan for adults 18 and older
Negative
  • None.

Head-to-head data, presented at OPTIONS XII for the Control of Influenza Conference, demonstrates advantage of sa-mRNA over conventional mRNA in duration of immune response; Results highlight CSL and Arcturus Therapeutics' commitment to advancing COVID-19 vaccine innovation to protect public health.

WALTHAM, Mass. and SAN DIEGO, Sept. 30, 2024 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and self-amplifying messenger RNA (sa-mRNA) pioneer Arcturus Therapeutics (Nasdaq: ARCT) today announced the results of a head-to-head study demonstrating that self-amplifying (sa-mRNA) COVID-19 vaccine maintained superior immunogenicity compared to the conventional mRNA vaccine Comirnaty® for up to one year against Wuhan-Hu-1, Omicron BA.4-5 and certain other variants, and at one-sixth the dose of the comparator (5 μg vs 30 μg, respectively).

The data, presented as a poster at the OPTIONS XII for the Control of Influenza conference, highlights 12-month follow-up analysis of the Phase 3 trial conducted in Japan by Meiji Seika Pharma, evaluating a booster dose of ARCT-154, showing that the vaccine elicited superior immunogenicity and antibody persistence over Comirnaty® for up to 12 months postvaccination, against multiple SARS-CoV-2 strains and in both younger and older adult age groups.

"The 12-month results from the ARCT-154 study continue to establish the durability of immune response from this self-amplifying mRNA vaccine and reinforce the ability of this vaccine to provide protection against COVID-19 at lower doses compared to conventional mRNA vaccines," said Jonathan Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL. "We are proud to showcase at the 2024 OPTIONS conference with these important data about the first sa-mRNA COVID-19 vaccine now approved in Japan."

Additional data presented by CSL and Arcturus finds that the bivalent formula, ARCT-2301, developed on the same platform as ARCT-154, induces superior immunogenicity over conventional bivalent mRNA vaccine Comirnaty® that persists against key variants up to six months postvaccination.

"The recent surge in COVID-19 infections and the emerging new variants illustrate the critical need for vaccines that provide a longer duration of protection compared to conventional mRNA vaccines," said Igor Smolenov, M.D., Ph.D. Chief Development Officer of Arcturus Therapeutics. "These compelling new studies reaffirm that these sa-mRNA vaccines have the potential to offer potent protection against COVID-19."

The COVID-19 vaccine from this sa-mRNA platform targeted against the JN.1 variant is approved in Japan for immunization against COVID-19 in adults 18 years and older and is being sold under the trade name KOSTAIVE®

ARCT-154 12-month Study Design and Results
The randomized, double-blind, active-controlled Phase 3 study was conducted at 11 clinical sites in Japan. The study enrolled 828 adults who had previously been fully immunized with three doses of mRNA vaccine(s). Participants were randomized equally to receive a booster dose of either ARCT-154 or Comirnaty®. Immune responses were measured as neutralizing antibodies against the Wuhan-Hu-1 and Omicron BA.4-5 strains in sera obtained at Day 1 before booster vaccination, and Days 29, 91, 181, and 361 after vaccination of participants who were seronegative for SARS-CoV-2 nucleocapsid protein (N-protein), considered to be an indicator of recent COVID-19 infection. At the same timepoints neutralizing antibodies against Delta, Omicron BA.2, Omicron BA.2.86, and Omicron XBB.1.5.6 variants were measured in subsets of participants (~30 per group). Responses are expressed as group geometric mean titers (GMT) with 95% confidence intervals, and geometric mean titer ratio (GMTR) between the two vaccine groups at each timepoint.

At Day 29, neutralizing antibodies (GMTs unadjusted) against the Wuhan-Hu-1 strain in ARCT-154 recipients (n = 378) were superior to those in the Comirnaty® group (n = 374): GMT = 5390 (95% CI: 4899–5931) vs. 3738 (3442–4060), a GMT ratio of 1.44 (1.27–1.64). This advantage persisted through all time points.  At Day 361 (unadjusted) GMTs were 3396 (3019–3821) and 1771 (1532–2047) in ARCT-154 (n = 272) and Comirnaty® (n = 266) groups, a GMT ratio of 1.92 (1.59–2.31). Differences were also observed in responses against Omicron BA.4-5, with GMT ratios of 1.31 (1.07–1.59) at Day 29 and 1.89 (1.42– 2.50) at Day 361. A subset of subjects who were seronegative for N-protein displayed similar differences in immune responses between ARCT-154 and Comirnaty® against the Delta, Omicron BA.2, BA.2.86, and XBB.1.5.6 variants at Day 361. The GMT ratios were 1.88 (0.79–4.49) against Delta, 2.34 (1.06–5.17) against Omicron BA.2, 2.51 (1.00–6.31) against Omicron BA.2.86 and 2.81 (1.09–7.28) against Omicron XBB.1.5.6.

Bivalent 6-month Study Design and Results
In this randomized, multicenter, Phase 3, observer-blind, active-controlled trial in Japan, fully-immunized (3‒5 doses of mRNA vaccine) adults were randomized 1:1 to receive a booster dose of ARCT-2301 or Comirnaty® Original/BA.4-5. The primary objective was to demonstrate non-inferiority of the immunogenicity of ARCT-2301 vs. Comirnaty® Original/BA.4-5 at Day 29 as neutralizing antibody GMT and seroresponse rates (SRR) against Omicron BA.4-5. Key secondary outcomes included titers of neutralizing antibodies against Wuhan-Hu-1 and Omicron XBB.1.5.

Between September and November 2023, 930 men and women (19‒80 years) with at least three prior mRNA COVID-19 vaccinations were enrolled at nine medical centers in Japan and administered ARCT-2301 (n = 465) or Comirnaty® Original/BA.4-5 (n = 465) boosters. At Day 29 ARCT-2301 (n = 398) induced superior neutralizing antibody responses vs. Comirnaty® (n = 405) against Omicron BA.4-5 (GMT ratio 1•49 [95% CI: 1.26–1.76], SRR difference 7.2% [95% CI: 0.6–13.7]), and against Wuhan-Hu-1 (GMT ratio 1.45 [1.28–1.63], SRR difference 12.5% [5.9–19.0]). The difference persisted through six months with GMT ratios of 2.17 (95% CI: 1.75-2.69) and 1.98 (95% CI: 1.69-2.31), respectively. Antibody responses against Omicron XBB.1.5 were also higher after ARCT-2301 vs. Comirnaty® (GMT ratio 1.63 [1.36–1.94], SRR difference 16.7% [10.1–23.2]).

About sa-mRNA
mRNA vaccines help protect against infectious diseases by providing a blueprint for cells in the body to make a protein to help our immune systems recognize and fight the disease. Unlike standard mRNA vaccines, self-amplifying mRNA vaccines instruct the body to make more mRNA and protein to boost the immune response.

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
Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR® mRNA Technology (sa-mRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus developed KOSTAIVE®, the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine in the world to be approved. Arcturus has an ongoing global collaboration for innovative mRNA vaccines with CSL Seqirus, and a joint venture in Japan, ARCALIS, focused on the manufacture of mRNA vaccines and therapeutics. Arcturus' pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase (OTC) deficiency and cystic fibrosis (CF), along with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza. Arcturus' versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics. Arcturus' technologies are covered by its extensive patent portfolio (over 400 patents and patent applications in the U.S., Europe, Japan, China, and other countries). For more information, visit www.ArcturusRx.com. In addition, please connect with us on Twitter and LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact included in this press release, are forward-looking statements, including those regarding strategy, future operations, the likelihood that KOSTAIVE will provide a longer duration of protection, the likelihood and timing of future approvals of KOSTAIVE anywhere in the world including Europe, the plans to submit additional regulatory filings and timing thereof, that preclinical or clinical data will be predictive of future clinical results, and the impact of general business and economic conditions. Arcturus may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in any forward-looking statements such as the foregoing and you should not place undue reliance on such forward-looking statements. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements, including those discussed under the heading "Risk Factors" in Arcturus' most recent Annual Report on Form 10-K, and in subsequent filings with, or submissions to, the SEC, which are available on the SEC's website at www.sec.gov. Except as otherwise required by law, Arcturus disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.

CSL Media Contacts:
Sue Thorn
Mobile: 617 799 3151
Email: sue.thorn@cslbehring.com

Australia:
Jimmy Baker
Mobile: +61 450 909 211
Email: Jimmy.Baker@csl.com.au

Asia Pacific:
Hamish Walsh
+61 422 424 338
Email: hamish.walsh@seqirus.com 

Arcturus Media Contact:
Neda Safarzadeh
VP, Head of IR/PR/Marketing
Email: IR@arcturusrx.com

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SOURCE CSL

FAQ

What are the key findings of the CSL (CSLLY) and Arcturus Therapeutics sa-mRNA COVID-19 vaccine study?

The study showed that the sa-mRNA COVID-19 vaccine maintained superior immunogenicity compared to Comirnaty® for up to one year against multiple SARS-CoV-2 strains, including Wuhan-Hu-1 and Omicron variants, at one-sixth the dose of Comirnaty®.

How does ARCT-154 compare to Comirnaty® in terms of neutralizing antibodies at Day 361?

At Day 361, ARCT-154 showed superior neutralizing antibodies against the Wuhan-Hu-1 strain compared to Comirnaty®, with GMTs of 3396 vs 1771, respectively, resulting in a GMT ratio of 1.92.

What is the current approval status of the sa-mRNA COVID-19 vaccine developed by CSL (CSLLY) and Arcturus Therapeutics?

The sa-mRNA COVID-19 vaccine is approved in Japan under the trade name KOSTAIVE® for immunization against COVID-19 in adults 18 years and older.

How does the bivalent formula ARCT-2301 perform compared to Comirnaty® Original/BA.4-5?

ARCT-2301 induced superior neutralizing antibody responses compared to Comirnaty® Original/BA.4-5 against Omicron BA.4-5 and Wuhan-Hu-1 strains, with the difference persisting through six months post-vaccination.

Arcturus Therapeutics Holdings Inc.

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