Biotech Company Secures $453 Million Award For Covid-19 Oral Pill Candidate
Vaxart Receives BARDA-Funded Project NextGen Award Valued Up to $453 Million to Conduct a Phase 2b Study Evaluating Its COVID-19 Oral Pill Vaccine Candidate.
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Vaxart, Inc. (Nasdaq: VXRT), a biotechnology company known for its innovative oral vaccines, has announced a significant milestone in the development of its COVID-19 oral pill vaccine candidate. The company received a project award valued at up to $453 million through the Rapid Response Partnership Vehicle (RRPV), a consortium funded by the Biomedical Advanced Research and Development Authority (BARDA). PART OF THE Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), this funding aims to support a Phase 2b comparative study evaluating Vaxart’s oral vaccine against an FDA-approved mRNA vaccine comparator.
The Award
This funding will be pivotal for Vaxart as it advances its innovative approach to vaccine delivery. The award will be disbursed in two parts: approximately $65.7 million will be made available immediately to kickstart the study activities, and the remaining $387.2 million will be provided as the study progresses, contingent on mutually agreed milestones between Vaxart and BARDA. This phased funding approach ensures that resources are allocated efficiently, supporting the study from its initiation through critical phases of data collection and analysis.
The primary objective of the Phase 2b study is to evaluate the efficacy of Vaxart’s next-generation oral pill COVID-19 vaccine in comparison to an FDA-approved mRNA vaccine. The trial is set to commence enrollment as early as summer 2024, with an interim analysis possibly occurring by the first quarter of 2025. This timeline reflects the urgency and importance of developing effective and accessible vaccines as COVID-19 continues to pose global health challenges. In preparation for this trial, Vaxart has created and manufactured its new oral COVID-19 vaccine tablet candidate under Good Manufacturing Practice (GMP) standards. Preclinical data suggests that this new vaccine candidate is more potent than Vaxart’s earlier constructs, which had already shown promising results in previous trials.
Dr. James F. Cummings, Vaxart’s Chief Medical Officer, expressed gratitude towards BARDA for the substantial funding. He emphasized that the Phase 2b trial would provide valuable data on how Vaxart’s oral vaccine compares to existing mRNA vaccines. Dr. Cummings highlighted previous research indicating that Vaxart’s earlier COVID-19 vaccine constructs had triggered long-lasting immune responses and induced a cross-reactive immunogenic response against multiple SARS-CoV-2 variants.
Steven Lo, Vaxart’s Chief Executive Officer, elaborated on the potential transformative impact of their oral pill vaccine platform. He noted that vaccine delivery has largely depended on injections for over 150 years, and the funding from BARDA represents a significant opportunity to explore new methods of vaccination. Lo believes that Vaxart’s oral vaccine could better meet societal needs, especially as COVID-19 becomes endemic and new infectious diseases emerge.
Vaxart’s Previous Achievements
Vaxart has established itself as a pioneer in oral vaccine technology. It was the first U.S. company to complete a Phase 2 clinical trial of an oral vaccine for COVID-19. Results from earlier trials indicated that Vaxart’s COVID-19 vaccine candidates generated robust mucosal IgA responses, enhanced immune responses to existing vaccines, increased neutralizing antibodies against the Omicron 4/5 variants, and exhibited a favorable tolerability profile.
The funding awarded to Vaxart falls under Project NextGen, a $5 billion initiative by HHS aimed at developing new, innovative vaccines and therapeutics. The goal of Project NextGen is to provide broader and more durable protection against COVID-19 compared to first-generation vaccines and medicines. By investing in cutting-edge vaccine technologies, such as Vaxart’s oral pill platform, Project NextGen seeks to address the evolving challenges posed by COVID-19 and enhance preparedness for future pandemics.
The Phase 2b study funded by BARDA represents a critical step towards potentially revolutionizing vaccine delivery methods. If successful, Vaxart’s oral COVID-19 vaccine could offer several advantages over traditional injectable vaccines, including ease of administration, improved accessibility, and enhanced patient compliance. These benefits are particularly relevant in low-resource settings where cold chain logistics for injectable vaccines present significant challenges. Vaxart’s oral vaccine platform holds promise beyond COVID-19. The company envisions applying its technology to other infectious diseases that pose endemic and pandemic threats. By leveraging the support from BARDA and the broader Project NextGen initiative, Vaxart aims to contribute to a more resilient and adaptive global healthcare system.
The collaboration between Vaxart and BARDA, facilitated through the Rapid Response Partnership Vehicle, underscores the commitment to advancing innovative vaccine technologies. The upcoming Phase 2b study will be instrumental in determining the efficacy of Vaxart’s oral COVID-19 vaccine compared to existing mRNA vaccines. As the world continues to navigate the complexities of COVID-19 and prepares for future public health challenges, the development of versatile and effective vaccines remains a top priority. Vaxart’s pioneering work in oral vaccine delivery could play a crucial role in shaping the future of global vaccination strategies.
Disclaimer: The information provided in this article is intended solely for informational purposes and does not constitute financial, medical, or professional advice. Readers should conduct their own research and consult with professionals before making any decisions based on the content of this article.
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