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Vaxart to Present Norovirus Data at IDWeek 2024 Underscoring Commitment to Address Significant Unmet Need

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Vaxart (Nasdaq: VXRT) will present research on its norovirus oral pill vaccine candidate at IDWeek 2024 in Los Angeles. With no approved vaccines for norovirus, Vaxart's candidate is the most advanced in clinical development for oral administration and gastrointestinal delivery. Norovirus affects 21 million Americans annually, including 15% of children under 5, forcing 3 million parents to miss work. Adults ≥65 are at high risk for severe symptoms.

Two presentations are scheduled:

  • A Phase 2 study on the oral tableted norovirus vaccine VXA-G1.1-NN, showing immunogenicity, efficacy, and reduced viral shedding.
  • A Phase I study on the safety, tolerability, and immunogenicity of an orally administered bivalent GI.1/GII.4 norovirus vaccine in lactating females and their infants.

The annual disease burden from norovirus in the US is estimated at $10.6 billion.

Vaxart (Nasdaq: VXRT) presenterà una ricerca sul suo candidato vaccino orale contro il norovirus a IDWeek 2024 a Los Angeles. Senza vaccini approvati per il norovirus, il candidato di Vaxart è il più avanzato nello sviluppo clinico per l'amministrazione orale e la somministrazione gastrointestinale. Il norovirus colpisce annualmente 21 milioni di americani, incluso il 15% dei bambini sotto i 5 anni, costringendo 3 milioni di genitori a saltare il lavoro. Gli adulti ≥65 anni sono a rischio elevato di sintomi severi.

Sono programmati due presentazioni:

  • Uno studio di Fase 2 sul vaccino norovirus compresso in compresse VXA-G1.1-NN, che mostra immunogenicità, efficacia e riduzione dell'emissione virale.
  • Uno studio di Fase I sulla sicurezza, tollerabilità e immunogenicità di un vaccino bivalente GI.1/GII.4 contro il norovirus somministrato per via orale a donne in allattamento e ai loro neonati.

Il carico annuale della malattia da norovirus negli Stati Uniti è stimato in 10,6 miliardi di dollari.

Vaxart (Nasdaq: VXRT) presentará una investigación sobre su candidato a vacuna oral contra el norovirus en IDWeek 2024 en Los Ángeles. Sin vacunas aprobadas para el norovirus, el candidato de Vaxart es el más avanzado en desarrollo clínico para administración oral y entrega gastrointestinal. El norovirus afecta anualmente a 21 millones de estadounidenses, incluyendo el 15% de los niños menores de 5 años, obligando a 3 millones de padres a faltar al trabajo. Los adultos ≥65 años están en alto riesgo de síntomas severos.

Se programaron dos presentaciones:

  • Un estudio de Fase 2 sobre la vacuna contra el norovirus en tabletas VXA-G1.1-NN, que muestra inmunogenicidad, eficacia y reducción de la excreción viral.
  • Un estudio de Fase I sobre la seguridad, tolerabilidad e inmunogenicidad de una vacuna bivalente GI.1/GII.4 contra el norovirus administrada por vía oral en mujeres lactantes y sus lactantes.

La carga anual de la enfermedad por norovirus en EE. UU. se estima en 10.6 mil millones de dólares.

Vaxart (Nasdaq: VXRT)는 로스앤젤레스에서 열리는 IDWeek 2024에서 노로바이러스 경구용 백신 후보에 대한 연구를 발표할 예정입니다. 노로바이러스에 대한 승인된 백신이 없는 상황에서, Vaxart의 후보는 경구 투여 및 위장관 전달을 위한 임상 개발에서 가장 앞서 있습니다. 노로바이러스는 매년 2천 1백만 명의 미국인에게 영향을 미칩니다, 이 중 5세 이하 어린이가 15%를 차지하며, 300만 명의 부모가 일을 빠져나가게 만듭니다. 65세 이상의 성인은 중증 증상의 높은 위험에 처해 있습니다.

두 가지 발표가 예정되어 있습니다:

  • 면역원성, 효능, 그리고 바이러스 배출 감소를 보여주는 경구용 제형 노로바이러스 백신 VXA-G1.1-NN에 대한 2상 연구.
  • 모유 수유 중인 여성과 그들의 유아를 대상으로 한 경구 투여된 이분형 GI.1/GII.4 노로바이러스 백신의 안전성, 내약성 및 면역원성에 대한 1상 연구.

미국에서의 노로바이러스에 의한 연간 질병 부담은 106억 달러로 추정됩니다.

Vaxart (Nasdaq: VXRT) présentera des recherches sur son candidat vaccin oral contre le norovirus lors de IDWeek 2024 à Los Angeles. N'ayant pas de vaccins approuvés pour le norovirus, le candidat de Vaxart est le plus avancé en développement clinique pour une administration orale et une distribution gastro-intestinale. Le norovirus affecte chaque année 21 millions d'Américains, dont 15 % d'enfants de moins de 5 ans, obligeant 3 millions de parents à manquer le travail. Les adultes de ≥65 ans sont à haut risque de symptômes sévères.

Deux présentations sont prévues :

  • Une étude de Phase 2 sur le vaccin norovirus sous forme de comprimés VXA-G1.1-NN, montrant l'immunogénicité, l'efficacité et la réduction de l'excrétion virale.
  • Une étude de Phase I sur la sécurité, la tolérabilité et l'immunogénicité d'un vaccin bivalent GI.1/GII.4 contre le norovirus administré par voie orale chez des femmes allaitantes et leurs nourrissons.

La charge annuelle de la maladie causée par le norovirus aux États-Unis est estimée à 10,6 milliards de dollars.

Vaxart (Nasdaq: VXRT) wird Forschung zu seinem norovirus-oralen Pillenimpfstoffkandidaten auf der IDWeek 2024 in Los Angeles präsentieren. Da es keine zugelassenen Impfstoffe gegen Norovirus gibt, ist der Kandidat von Vaxart der am weitesten fortgeschrittene in der klinischen Entwicklung zur oralen Verabreichung und gastrointestinalen Lieferung. Norovirus betrifft jährlich 21 Millionen Amerikaner, darunter 15 % der Kinder unter 5 Jahren, was dazu führt, dass 3 Millionen Eltern die Arbeit verpassen. Erwachsene ≥65 Jahre sind einem hohen Risiko für schwere Symptome ausgesetzt.

Zwei Präsentationen sind geplant:

  • Eine Phase-2-Studie zum norovirus-oral-tablettierten Impfstoff VXA-G1.1-NN, die Immunogenität, Wirksamkeit und reduzierte virale Ausscheidung zeigt.
  • Eine Phase-I-Studie zu Sicherheit, Verträglichkeit und Immunogenität eines oral verabreichten bivalenten GI.1/GII.4-Norovirus-Impfstoffs bei stillenden Frauen und ihren Säuglingen.

Die jährliche Krankheitslast durch Norovirus in den USA wird auf 10,6 Milliarden Dollar geschätzt.

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SOUTH SAN FRANCISCO, Calif., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced that it will present research demonstrating the potential of its norovirus oral pill vaccine candidate at IDWeek taking place October 16-19, 2024, at the Los Angeles Convention Center in Los Angeles.

With no currently approved vaccines against norovirus, Vaxart remains committed to progressing what it believes to be the most advanced norovirus vaccine candidate in clinical development that is both formulated for oral administration and designed for delivery to the gastrointestinal system. Norovirus sickens approximately 21 million people in the United States each year, including the 15% of children under age 5 who contract norovirus annually. Approximately 3 million sets of parents are forced by this virus to miss work – approximately 2.2 days on average – to care for their children. Adults ≥65 years old are at high-risk for severe symptoms and clinical outcomes including longer disease duration and death. The annual disease burden from norovirus in the United States is estimated to be $10.6 billion

Presentation Information:

Title: A Phase 2 Double-Blind, Placebo-Controlled Study Showing Oral Tableted Norovirus Vaccine VXA-G1.1-NN is Immunogenic, Efficacious, and Reduces Viral Shedding Following Norovirus Challenge
Speaker: Dr. Sean Tucker, Founder and Chief Scientific Officer of Vaxart
Date: Thursday, October 17
Time: 3:45 p.m. PT
Room: 404 AB

Title: A Phase I, Multicenter, Randomized, Double-blind, Placebo-controlled Single Dose, Dose-ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of Orally Administered Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females ≥ 18 years Old and Their Breast-feeding Infants
Speaker: Dr. Lam Nguyen, Medical Director & Head of Pharmacovigilance of Vaxart
Date: Saturday, October 19, 2024
Time: 2:15 p.m. PT
Room: 403 B

About Vaxart
Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using pills that can be stored and shipped without refrigeration and to eliminate the risk of needle-stick injury. Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxart’s development programs currently include pill vaccines designed to protect against coronavirus, norovirus and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.

Contact

Vaxart Media and Investor Relations
Matt Steinberg
FINN Partners
IR@vaxart.com
(646) 871-8481

This press release was published by a CLEAR® Verified individual.


FAQ

What is Vaxart presenting at IDWeek 2024 regarding their norovirus vaccine candidate?

Vaxart is presenting research on their norovirus oral pill vaccine candidate, including a Phase 2 study showing immunogenicity, efficacy, and reduced viral shedding, and a Phase I study on safety and immunogenicity in lactating females and their infants.

How many people in the United States are affected by norovirus annually according to Vaxart's press release?

According to Vaxart's press release, norovirus affects approximately 21 million people in the United States each year, including 15% of children under age 5.

What is the estimated annual disease burden from norovirus in the United States?

The annual disease burden from norovirus in the United States is estimated to be $10.6 billion, according to the information provided in Vaxart's press release.

When and where is IDWeek 2024 taking place, as mentioned in Vaxart's announcement?

IDWeek 2024 is taking place from October 16-19, 2024, at the Los Angeles Convention Center in Los Angeles, as stated in Vaxart's press release.

What makes Vaxart's norovirus vaccine candidate unique according to the press release?

Vaxart's norovirus vaccine candidate is described as the most advanced in clinical development that is both formulated for oral administration and designed for delivery to the gastrointestinal system.

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