Vaxart Highlights Progress of COVID-19, Norovirus and Influenza Programs
Vaxart provided updates on its COVID-19, norovirus, and influenza programs. The COVID-19 Phase 2b study is set to begin a 10,000-participant trial pending FDA review of 30-day safety data. The Norovirus program is moving to a Phase 1 study, set to start in early 2025 with topline data expected mid-2025. A new avian influenza vaccine candidate is in preclinical testing.
CEO Steven Lo highlighted the progress, noting the 30-day safety data for the COVID-19 trial was favorably reviewed by an independent DSMB. The trial will continue upon FDA and BARDA approval. The norovirus Phase 1 trial will compare second-generation constructs against first-generation ones, aiming to identify the most effective candidate.
The company aims to sustain momentum through partnerships and non-dilutive funding. The COVID-19 project is funded under Project NextGen, with a potential award of up to $460.7 million. Vaxart's cash runway extends into 2026, supported by this award and existing funds.
Vaxart ha fornito aggiornamenti sui suoi programmi per COVID-19, norovirus e influenza. Lo studio di Fase 2b sul COVID-19 è pronto per iniziare uno studio con 10.000 partecipanti, in attesa della revisione da parte della FDA dei dati di sicurezza di 30 giorni. Il programma sul norovirus passerà a uno studio di Fase 1, che dovrebbe iniziare all'inizio del 2025, con i dati attesi a metà 2025. Un nuovo candidato vaccinale per l'influenza aviaria è attualmente in fase di test preclinici.
Il CEO Steven Lo ha messo in evidenza i progressi, notando che i dati di sicurezza di 30 giorni per lo studio sul COVID-19 sono stati esaminati favorevolmente da un DSMB indipendente. Lo studio continuerà previa approvazione della FDA e di BARDA. Lo studio di Fase 1 sul norovirus confronterà i costrutti di seconda generazione con quelli di prima generazione, con l'obiettivo di identificare il candidato più efficace.
L'azienda mira a mantenere slancio attraverso partnership e finanziamenti non diluitivi. Il progetto COVID-19 è finanziato nell'ambito del Progetto NextGen, con un premio potenziale fino a 460,7 milioni di dollari. La disponibilità di liquidità di Vaxart si estende fino al 2026, supportata da questo premio e da fondi esistenti.
Vaxart ha proporcionado actualizaciones sobre sus programas para COVID-19, norovirus e influenza. El estudio de Fase 2b del COVID-19 está listo para comenzar un ensayo con 10,000 participantes, pendiente de la revisión de la FDA de los datos de seguridad de 30 días. El programa para el norovirus avanzará a un estudio de Fase 1, que comenzará a principios de 2025, con datos preliminares que se esperan a mediados de 2025. Un nuevo candidato a vacuna contra la influenza aviar se encuentra en pruebas preclínicas.
El CEO Steven Lo destacó el progreso, mencionando que los datos de seguridad de 30 días del ensayo del COVID-19 fueron revisados favorablemente por un DSMB independiente. El ensayo continuará con la aprobación de la FDA y BARDA. El ensayo de Fase 1 del norovirus comparará los constructos de segunda generación con los de primera generación, con el objetivo de identificar el candidato más efectivo.
La empresa busca mantener el impulso a través de asociaciones y financiamiento no dilutivo. El proyecto de COVID-19 está financiado bajo el Proyecto NextGen, con una posible subvención de hasta 460.7 millones de dólares. La liquidez de Vaxart se extiende hasta 2026, respaldada por esta subvención y fondos existentes.
Vaxart는 COVID-19, 노로바이러스 및 인플루엔자 프로그램에 대한 업데이트를 제공했습니다. COVID-19 2b 단계 연구는 FDA의 30일 안전성 데이터 검토를 기다리며 10,000명 참가자에 대한 시험을 시작할 예정입니다. 노로바이러스 프로그램은 2025년 초에 시작될 1단계 연구로 진행되며, 이 때 최고의 데이터가 2025년 중반에 예상됩니다. 새로운 조류 인플루엔자 백신 후보는 전임상 시험에 있습니다.
CEO 스티븐 로는 COVID-19 시험의 30일 안전성 데이터가 독립적인 DSMB에 의해 유리하게 검토되었다고 강조했습니다. 이 시험은 FDA 및 BARDA의 승인을 받은 이후 계속 진행될 것입니다. 노로바이러스의 1단계 시험은 1세대와 2세대 구성을 비교하여 가장 효과적인 후보를 식별하는 데 초점을 맞출 것입니다.
회사는 파트너십과 희석성 없는 자금 조달을 통해 추진력을 유지하는 것을 목표로 하고 있습니다. COVID-19 프로젝트는 NextGen 프로젝트의 일환으로 자금 지원을 받아 최대 4억6070만 달러의 보조금을 받을 수 있습니다. Vaxart의 현금 흐름은 이 보조금과 기존 자금으로 2026년까지 연장됩니다.
Vaxart a fourni des mises à jour sur ses programmes COVID-19, norovirus et influenza. L'étude de phase 2b sur le COVID-19 devrait débuter un essai avec 10 000 participants, en attendant l'examen par la FDA des données de sécurité de 30 jours. Le programme sur le norovirus passe à une étude de phase 1, qui devrait commencer début 2025, avec des résultats préliminaires attendus à mi-2025. Un nouveau candidat vaccin contre l'influenza aviaire est en phase de tests précliniques.
Le PDG Steven Lo a souligné les progrès, notant que les données de sécurité de 30 jours pour l'essai COVID-19 ont été favorablement examinées par un DSMB indépendant. L'essai se poursuivra après approbation de la FDA et de la BARDA. L'essai de phase 1 sur le norovirus comparera des constructions de deuxième génération à celles de première génération, afin d'identifier le candidat le plus efficace.
L'entreprise cherche à maintenir son élan grâce à des partenariats et un financement non dilutif. Le projet COVID-19 est financé dans le cadre du projet NextGen, avec une subvention potentielle allant jusqu'à 460,7 millions de dollars. La trésorerie de Vaxart devrait durer jusqu'en 2026, soutenue par cette subvention et des fonds existants.
Vaxart hat Aktualisierungen zu seinen Programmen gegen COVID-19, Norovirus und Influenza bereitgestellt. Die COVID-19 Phase 2b Studie soll einen Test mit 10.000 Teilnehmern beginnen, während die FDA die Sicherheitsdaten der letzten 30 Tage überprüft. Das Norovirus-Programm geht in eine Phase-1-Studie über, die Anfang 2025 beginnen soll, mit ersten Ergebnissen, die für Mitte 2025 erwartet werden. Ein neuer Kandidatenimpfstoff gegen aviäre Influenza befindet sich in der präklinischen Testphase.
CEO Steven Lo hob die Fortschritte hervor und stellte fest, dass die Sicherheitsdaten der letzten 30 Tage für die COVID-19-Studie positiv von einem unabhängigen DSMB überprüft wurden. Die Studie wird nach Genehmigung durch die FDA und BARDA fortgesetzt. Die Phase-1-Studie zum Norovirus wird Konstrukte der zweiten Generation mit denen der ersten Generation vergleichen, um den effektivsten Kandidaten zu identifizieren.
Das Unternehmen beabsichtigt, den Schwung durch Partnerschaften und nicht verwässernde Finanzierung aufrechtzuerhalten. Das COVID-19-Projekt wird im Rahmen des Projekts NextGen finanziert, mit einer möglichen Förderung von bis zu 460,7 Millionen Dollar. Vaxarts finanzielle Mittel reichen bis ins Jahr 2026 und werden durch diese Förderung und bestehende Mittel unterstützt.
- FDA review of COVID-19 Phase 2b safety data pending; trial could soon enroll 10,000 participants.
- Norovirus Phase 1 trial to start in early 2025 with topline data expected mid-2025.
- New avian influenza vaccine candidate in preclinical testing.
- Project NextGen award could provide up to $460.7 million in funding.
- Cash runway extends into 2026, funding key clinical and regulatory milestones.
- Norovirus Phase 1 trial dependent on future funding or partnerships.
Insights
This comprehensive pipeline update reveals critical progress across Vaxart's key vaccine programs. The COVID-19 Phase 2b trial is advancing with a favorable DSMB safety review, positioning for the pivotal 10,000-participant study. The
The norovirus program's pivot to include second-generation constructs in a Phase 1 comparative study represents a strategic optimization, leveraging previous efficacy signals while pursuing potentially enhanced immunogenicity. The streamlined development timeline targeting Phase 3 initiation by 2026 demonstrates aggressive yet methodical progression.
The cash runway extension into 2026 provides operational flexibility across multiple value-creating milestones. The parallel advancement of three vaccine programs, supported by federal funding and potential partnership opportunities, creates multiple shots on goal with relatively lower financial risk.
The secured
The strategic approach to seek additional non-dilutive funding and partnerships for program advancement demonstrates prudent capital management. The parallel progression of three vaccine programs creates multiple potential value inflection points while maintaining financial efficiency. The norovirus program's accelerated timeline, if successful, could open significant commercial opportunities given the lack of approved vaccines in this space.
Vaxart's oral pill vaccine platform represents a potentially disruptive approach in the vaccine space. The COVID-19 program's progression to a 10,000-participant study, backed by substantial government funding, validates the platform's potential. The head-to-head comparison against an mRNA vaccine will be a important differentiator.
The norovirus program's strategic refinement, incorporating second-generation constructs while building on previous efficacy data, balances innovation with risk management. The avian influenza program's focus on the latest clade 2.3.4.4b demonstrates market awareness and platform versatility.
The company's multi-program approach, supported by significant government funding and potential partnerships, creates a robust risk-adjusted value proposition in the competitive vaccine landscape.
COVID-19 Phase 2b study poised to initiate 10,000 participant portion of trial pending U.S. Food and Drug Administration (FDA) review of sentinel cohort 30-day safety data
Norovirus program to proceed with Phase 1 study following scientific advisory board and FDA feedback; Trial to initiate the first half of 2025 with topline data expected as early as mid-2025
New avian influenza vaccine candidate being tested in preclinical studies
SOUTH SAN FRANCISCO, Calif., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today provided business updates as the Company continues to advance its oral pill vaccine platform.
“We continue to execute on our lead COVID-19 and norovirus programs as evidenced by the advancement of both programs toward key milestones,” said Steven Lo, Vaxart’s Chief Executive Officer. “Starting with our COVID-19 program, we believe that the favorable review of the 30-day sentinel cohort safety data of our Phase 2b trial by an independent DSMB has us well-positioned to initiate the 10,000-participant portion of the trial following a positive review from the FDA as well as approval from BARDA to proceed.”
“Regarding our norovirus program, after a thorough review of the constructive feedback from the FDA on our GI.1 norovirus candidate, discussions with advisors and infectious disease experts, and promising preclinical data on our second-generation constructs, we believe that performing a Phase 1 trial substantially improves our chance of success. The trial will compare the second-generation constructs to our first-generation constructs, providing us with supporting data to rapidly proceed with the best candidate,” added Mr. Lo.
“We proved efficacy against a robust controlled human infection using our first-generation norovirus construct and identified important immune markers that track with norovirus protection,” said James F. Cummings, MD, Vaxart’s Chief Medical Officer. “Our second-generation constructs induced stronger immune responses in preclinical models. As a result, our next clinical study will evaluate these next generation constructs head-to-head against our first-generation constructs to verify this robust response.”
“Through the tireless work of our dedicated team, we are now prepared to advance our two lead programs. At the same time, we will explore value creating partnerships and non-dilutive funding options to sustain our continued momentum and extend our cash runway,” concluded Mr. Lo.
COVID-19 Program Developments
An independent Data and Safety Monitoring Board (DSMB) recommended the continuation of the Phase 2b study. The DSMB reviewed 30-day safety data of the sentinel cohort of a Phase 2b clinical trial evaluating Vaxart’s oral pill COVID-19 vaccine candidate against an approved mRNA vaccine comparator.
The FDA is reviewing the 30-day safety data from the sentinel cohort, and, upon favorable review, the study will progress following the Biomedical Advanced Research and Development Authority’s (BARDA’s) approval to the second part of the trial by enrolling approximately 10,000 participants. The primary efficacy analysis will be performed when all participants have either discontinued or completed a study visit 12 months post-vaccination.
Funding for this award was received under Project NextGen, a
Norovirus Program Developments
Vaxart will proceed with a Phase 1, open label, dose ranging clinical trial evaluating its second-generation oral norovirus vaccine constructs head-to-head against its first-generation constructs. The study will measure safety and immune parameters that have correlated to protection in the completed norovirus challenge study. The Phase 1 trial is expected to initiate in the first half of 2025 with topline data expected as early as mid-2025.
If the Phase 1 trial is successful, the next step, pending a partnership or other funding, would be to conduct a Phase 2 safety and immunogenicity study that could potentially begin as early as the second half of 2025 followed by an End of Phase 2 meeting with the FDA. A Phase 3 trial could then begin as early as 2026.
Influenza Program Developments
Vaxart continues to advance its avian influenza program. The Company previously published data demonstrating protection in a preclinical model against avian influenza after oral immunization (Clin Vaccine Immunol 2013). Vaxart recently created a new avian influenza vaccine candidate to cover the latest clade 2.3.4.4b. The Company is in the process of conducting several preclinical studies to evaluate the new construct and preparing to manufacture it for clinical use. Vaxart will publish the results of the preclinical studies when complete.
Cash Runway Update
Vaxart expected fees and reimbursements under its Project NextGen award of up to
Vaxart will explore various strategies to extend its cash runway through business development partnerships and non-dilutive funding options with the goal of achieving its upcoming clinical and regulatory milestones and maximizing shareholder value.
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 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.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart's strategy, prospects, plans and objectives, receipt of funding from BARDA, future cash runway and funding milestones, the results of the FDA’s review of any trials, studies, or data, results from preclinical and clinical trials and the timing of such results and such trials, commercialization agreements and licenses, and beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as “should,” “believe,” “could,” “potential,” “will,” “expected,” “anticipate,” “plan,” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart’s receipt of funding from BARDA for the Phase 2b study (or for any other purpose); Vaxart's ability to develop and commercialize its product candidates, including its vaccine booster products; Vaxart's expectations regarding clinical results and trial data, including their design, and the timing of such trials and of receiving and reporting such clinical results and trial data; Vaxart’s expectations regarding timing of enrollment in studies; and Vaxart's expectations with respect to the effectiveness of its product candidates and the potential of its vaccine pill platform. Vaxart may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in the forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations, and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement, and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates, and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart's product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart's product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart's or its partners' control; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state, and foreign regulations; that Vaxart may not be able to obtain, maintain, and enforce necessary patent and other intellectual property protection; that Vaxart's capital resources may be inadequate; Vaxart's ability to resolve pending legal matters; Vaxart's ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the "Risk Factors" sections of Vaxart's Quarterly and Annual Reports filed with the U.S. Securities and Exchange Commission. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law.
Contact
Vaxart Media and Investor Relations
Matt Steinberg
FINN Partners
IR@vaxart.com
(646) 871-8481
FAQ
What is the status of Vaxart's COVID-19 Phase 2b study?
What are the next steps for Vaxart's norovirus program?
What funding has Vaxart received for its COVID-19 program?
When is Vaxart's norovirus Phase 1 trial expected to start?
What is the cash runway for Vaxart?
What are the developments in Vaxart's avian influenza vaccine program?
