Clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform, Vaxart (NASDAQ:VXRT) saw its shares surge by almost 10% after it announced FDA clearing investigational new Drug application for an S-only oral tablet SARS-CoV-2 vaccine candidate. Andrei Floroiu, Vaxart’s CEO, said that along with S-only and S+N constructs comprise of its COVID-19 vaccine candidate portfolio.
The clinical trial will enable the firm to compare the S+N and S-only vaccine candidates for deciding the approaching offering best way forward for COVID-19 vaccine development program. The company had completed Phase 1 trial for its oral S+N COVID-19 vaccine in February 2021 that suggested multiple immune responses against SARS-CoV-2 antigens. Phase II trials with the S-only construct is expected to start in H2 2021.
Andrei Floroiu, Vaxart’s Chief Executive Officer, said that FDA approval is good for the firm to move forward with its first S-only vaccine construct. Floroiu added that the company will explore multiple S-only constructs in clinical trials with S+N construct.
Dr.Sean Tucker, Vaxart’s Chief Scientific Officer, said that the preliminary data from current Non-Human Primate study shows that S-only vaccine produced much higher serum antibodies. Tucker added that the results will be important to decide on way forward, especially in the face of emerging variant strains.
