– Topline data expected as early as mid-2025 –
SOUTH SAN FRANCISCO, CA, USA I March 11, 2025 I Vaxart, Inc. (Nasdaq: VXRT) today announced the initiation of 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.
“We are pleased to initiate a Phase 1 trial for our oral bivalent norovirus vaccine, delivered in a pill formulation, which will seek to demonstrate improved immune responses of our second-generation constructs,” said Steven Lo, Chief Executive Officer of Vaxart. “As norovirus continues to spread across the United States and globally, it has never been more important to address this urgent public health need. With no currently approved vaccines against norovirus, we are committed to advancing what we believe is the most promising norovirus vaccine candidate in clinical development and look forward to reviewing the topline data that is expected as early as mid-2025.”
The Phase 1 trial is an open label, dose ranging clinical study designed to evaluate Vaxart’s 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.
If the Phase 1 trial is successful, and assuming a partnership or other funding, Vaxart expects 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 U.S. Food and Drug Administration (FDA). A Phase 3 trial could then begin as early as 2026.
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.
SOURCE: Vaxart
Post Views: 155
– Topline data expected as early as mid-2025 –
SOUTH SAN FRANCISCO, CA, USA I March 11, 2025 I Vaxart, Inc. (Nasdaq: VXRT) today announced the initiation of 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.
“We are pleased to initiate a Phase 1 trial for our oral bivalent norovirus vaccine, delivered in a pill formulation, which will seek to demonstrate improved immune responses of our second-generation constructs,” said Steven Lo, Chief Executive Officer of Vaxart. “As norovirus continues to spread across the United States and globally, it has never been more important to address this urgent public health need. With no currently approved vaccines against norovirus, we are committed to advancing what we believe is the most promising norovirus vaccine candidate in clinical development and look forward to reviewing the topline data that is expected as early as mid-2025.”
The Phase 1 trial is an open label, dose ranging clinical study designed to evaluate Vaxart’s 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.
If the Phase 1 trial is successful, and assuming a partnership or other funding, Vaxart expects 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 U.S. Food and Drug Administration (FDA). A Phase 3 trial could then begin as early as 2026.
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.
SOURCE: Vaxart
Post Views: 155
