Vaxart Announces Favorable DSMB Review of Sentinel Cohort from COVID-19 Phase 2b Clinical Trial
Vaxart (VXRT) announced favorable results from an independent Data Safety Monitoring Board (DSMB) review of its COVID-19 Phase 2b clinical trial. The DSMB recommended the study continue without modifications after reviewing 30-day safety data from a sentinel cohort of 400 participants.
The company plans to expand the trial to 10,000 participants upon FDA review approval and BARDA authorization. This double-blind, multi-center study compares Vaxart's oral pill COVID-19 vaccine to an approved mRNA injectable vaccine in previously immunized adults, with at least 25% of participants over age 65.
The project is funded through BARDA's Project NextGen initiative, with Vaxart's award valued at up to $460.7 million. As a pioneer in oral vaccines, Vaxart was the first U.S. company to complete a Phase 2 trial of an oral COVID-19 vaccine.
Vaxart (VXRT) ha annunciato risultati favorevoli da una revisione indipendente del Data Safety Monitoring Board (DSMB) del suo studio clinico di fase 2b per il COVID-19. Il DSMB ha raccomandato di continuare lo studio senza modifiche dopo aver esaminato i dati di sicurezza a 30 giorni da un coorte sentinella di 400 partecipanti.
L'azienda prevede di espandere la sperimentazione a 10.000 partecipanti previa approvazione della revisione da parte della FDA e autorizzazione del BARDA. Questo studio multicentrico in doppio cieco confronta il vaccino orale contro il COVID-19 di Vaxart con un vaccino iniettabile mRNA approvato in adulti precedentemente immunizzati, con almeno il 25% dei partecipanti di età superiore ai 65 anni.
Il progetto è finanziato attraverso l'iniziativa Project NextGen del BARDA, con un premio a Vaxart del valore di $460,7 milioni. Come pioniere nei vaccini orali, Vaxart è stata la prima azienda statunitense a completare uno studio di fase 2 di un vaccino orale contro il COVID-19.
Vaxart (VXRT) anunció resultados favorables de una revisión independiente de la Junta de Monitoreo de Seguridad de Datos (DSMB) de su ensayo clínico de fase 2b para COVID-19. El DSMB recomendó continuar con el estudio sin modificaciones tras revisar los datos de seguridad a 30 días de una cohorte centinela de 400 participantes.
La compañía planea expandir el ensayo a 10,000 participantes tras la aprobación de la revisión por parte de la FDA y la autorización de BARDA. Este estudio multicéntrico a doble ciego compara la vacuna oral contra COVID-19 de Vaxart con una vacuna inyectable de mRNA aprobada en adultos previamente inmunizados, con al menos el 25% de los participantes mayores de 65 años.
El proyecto está financiado a través de la iniciativa Project NextGen de BARDA, con un premio a Vaxart valorado en $460.7 millones. Como pionero en vacunas orales, Vaxart fue la primera empresa de EE. UU. en completar un ensayo de fase 2 de una vacuna oral contra COVID-19.
Vaxart (VXRT)는 COVID-19 2b 단계 임상 시험에 대한 독립적인 데이터 안전성 모니터링 위원회(DSMB) 검토에서 긍정적인 결과를 발표했습니다. DSMB는 400명의 참가자로 구성된 중심 집단의 30일 안전성 데이터를 검토한 후 연구를 수정 없이 계속할 것을 권장했습니다.
회사는 FDA 검토 승인과 BARDA의 승인이 떨어지면 시험 참가자를 10,000명으로 확대할 계획입니다. 이 이중 맹검 다기관 연구는 사전 면역을 받은 성인에서 Vaxart의 경구 COVID-19 백신과 승인된 mRNA 주사 백신을 비교하며, 참가자의 최소 25%가 65세 이상입니다.
이 프로젝트는 BARDA의 Project NextGen 이니셔티브를 통해 자금을 지원받고 있으며, Vaxart의 수상 금액은 $460.7백만에 달합니다. 경구 백신 분야의 선구자로서 Vaxart는 미국에서 경구 COVID-19 백신의 2단계 시험을 완료한 최초의 회사였습니다.
Vaxart (VXRT) a annoncé des résultats favorables d'une révision indépendante du Data Safety Monitoring Board (DSMB) de son essai clinique de phase 2b sur le COVID-19. Le DSMB a recommandé de poursuivre l'étude sans modifications après avoir examiné les données de sécurité à 30 jours d'une cohorte sentinelle de 400 participants.
L'entreprise envisage d'élargir l'essai à 10 000 participants après approbation de la révision par la FDA et autorisation du BARDA. Cette étude multicentrique en double aveugle compare le vaccin oral contre le COVID-19 de Vaxart à un vaccin injectable à ARNm approuvé chez des adultes préalablement immunisés, avec au moins 25 % des participants âgés de plus de 65 ans.
Le projet est financé par l'initiative Project NextGen du BARDA, la récompense de Vaxart étant évaluée à $460,7 millions. En tant que pionnier des vaccins oraux, Vaxart a été la première entreprise américaine à terminer un essai de phase 2 d'un vaccin oral contre le COVID-19.
Vaxart (VXRT) gab positive Ergebnisse aus einer unabhängigen Prüfung des Data Safety Monitoring Boards (DSMB) seiner COVID-19-Phase-2b-Studie bekannt. Das DSMB empfahl, die Studie unverändert fortzusetzen, nachdem es die Sicherheitsdaten von 30 Tagen einer sentinel Kohorte von 400 Teilnehmern überprüft hatte.
Das Unternehmen plant, die Studie nach Genehmigung der FDA-Prüfung und der BARDA-Autorisierung auf 10.000 Teilnehmer auszuweiten. Diese doppelblinde, multi-zentrische Studie vergleicht Vaxarts orale COVID-19-Impfung mit einem zugelassenen mRNA-Injektionsimpfstoff bei zuvor geimpften Erwachsenen, von denen mindestens 25% über 65 Jahre alt sind.
Das Projekt wird durch die Initiative Project NextGen von BARDA finanziert, wobei Vaxarts Auszeichnung auf bis zu $460,7 Millionen geschätzt wird. Als Pionier im Bereich oraler Impfstoffe war Vaxart das erste US-Unternehmen, das eine Phase-2-Studie eines oralen COVID-19-Impfstoffs abschloss.
- Received favorable DSMB safety review recommendation for Phase 2b trial
- Secured potential funding of up to $460.7 million through BARDA's Project NextGen
- Plans to expand trial to 10,000 participants following approvals
- Still requires FDA and BARDA approval to proceed with expanded trial
- Current data to initial safety assessment of 400 participants
Insights
The favorable DSMB safety review represents a important milestone for Vaxart's oral COVID-19 vaccine program. The clean safety profile in the 400-participant sentinel cohort paves the way for the pivotal 10,000-participant Phase 2b trial, pending FDA and BARDA approvals. This head-to-head study against an mRNA vaccine could potentially demonstrate competitive efficacy with the significant advantage of oral administration.
The $460.7 million BARDA funding through Project NextGen substantially de-risks the development program financially. The trial's demographic targeting, including
The DSMB recommendation significantly reduces clinical development risk for Vaxart, potentially catalyzing the stock. The $460.7 million BARDA funding covers development costs while validating the technology's potential. With a market cap of just
The comparison against established mRNA vaccines is strategically sound - a non-inferior efficacy coupled with superior convenience could capture significant market share in the evolving COVID-19 vaccine landscape. The oral platform could represent a paradigm shift in vaccine administration, expanding beyond COVID-19 to other indications and creating multiple value-generating opportunities.
The oral vaccine platform addresses key market barriers in global vaccination programs. Patient preference for oral administration over injections could drive higher vaccination rates. The elimination of cold-chain requirements and medical personnel for administration could significantly reduce distribution costs and expand access in resource- settings.
The large-scale Phase 2b trial design with 10,000 participants will provide robust efficacy data for regulatory submissions and market positioning. The focus on previously vaccinated individuals aligns with the current market need for convenient boosters. Success could position Vaxart as a leader in next-generation vaccine delivery systems.
Independent Data Safety Monitoring Board (DSMB) recommends study to proceed without modifications based on initial safety assessment of 400 participant 30-day data
The company plans to progress the trial to enrollment of 10,000 participants, upon favorable review from the U.S. Food and Drug Administration (FDA) and upon Biomedical Advanced Research and Development Authority (BARDA) approval
SOUTH SAN FRANCISCO, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced that an independent DSMB, which conducted a planned review of the 30-day safety data from a sentinel cohort of 400 participants in its COVID-19 Phase 2b trial, has recommended that the study continue without any modifications.
“We are pleased with the DSMB recommendation, an important step forward in conducting our head-to-head study versus an mRNA comparator,” said Dr. James F. Cummings, Vaxart’s Chief Medical Officer. “We look forward to the next steps of review of the safety data by the FDA and approval from BARDA before advancing the Phase 2b trial to the second part that will measure both safety and efficacy.”
The FDA is reviewing the 30-day safety data from the sentinel cohort, and, upon favorable review as well as BARDA’s approval, the study will progress by enrolling approximately 10,000 participants. The trial will strive to enroll participants in line with U.S. demographics, as well as including at least
The Phase 2b trial is a double-blind, multi-center, randomized, comparator-controlled study to determine the relative efficacy, safety, and immunogenicity of Vaxart’s oral pill COVID-19 vaccine candidate compared to an approved mRNA COVID-19 injectable vaccine, in adults previously immunized against COVID-19 infection.
Funding for this award was received under Project NextGen, a
As a pioneer of oral vaccines, Vaxart was the first U.S. company to complete a Phase 2 clinical trial of an oral vaccine for COVID-19.
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, results from preclinical and clinical trials and the timing of such results as well as the outcome of the review of such results by regulatory authorities, 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 ability to develop and commercialize its product candidates, including its vaccine booster products; Vaxart's expectations regarding clinical results and trial data, and the timing of receiving and reporting such clinical results and trial data; and Vaxart's expectations with respect to the effectiveness of its product candidates. 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 SEC. 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
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