FDA Clears Vaxart's IND Application for S-Only Oral Tablet COVID-19 Vaccine Candidate

Vaccine candidate expressing S-only protein produced higher serum antibodies than construct expressing both S and N in NHP study

Phase II clinical trial with S-only candidate to begin in 2H21

Development of this and other S-only constructs will proceed in parallel with that of S+N construct, as previously announced

SOUTH SAN FRANCISCO, CA, USA I August 2, 2021 I Vaxart, Inc., (NASDAQ: VXRT), a clinical-stage biotechnology company developing oral vaccines administered by tablet, announced today that the U.S. Food and Drug Administration has cleared Vaxart's Investigational New Drug application for an S-only oral tablet SARS-CoV-2 vaccine candidate.

"This is great news because it allows us to move forward with our first S-only vaccine construct," said Andrei Floroiu, Vaxart's Chief Executive Officer. "As we said at the end of the first quarter, we will explore multiple S-only constructs in clinical trials alongside the S+N construct that has already completed its Phase I trial.

"Together, the S-only and S+N constructs are part of our unique oral tablet COVID-19 vaccine candidate portfolio, which we believe could make a significant contribution to the fight against COVID-19 globally."

"Preliminary data from our current Non-Human Primate study indicates that the S-only vaccine produced much higher serum antibodies than the one expressing both S and N proteins," said Dr. Sean Tucker, Vaxart's Chief Scientific Officer. "Our Phase I results from the S+N vaccine candidate showed remarkable T-cell responses and a mucosal antibody response, but not as strong serum antibody responses.

"This new clinical trial will allow us to compare the S-only and S+N vaccine candidates and put us in a position to decide which approach offers the best way forward for our COVID-19 vaccine development program, particularly in the face of emerging variant strains."

Vaxart announced in February that it had completed a Phase 1 clinical trial for its oral S+N COVID-19 vaccine.  The results from that study found that the investigational oral vaccine triggered multiple immune responses against SARS-CoV-2 antigens, while reaching primary and secondary endpoints of safety and immunogenicity, respectively.

The Phase II clinical trial with the S-only construct is expected to start in 2H21.

About Vaxart

Vaxart (www.vaxart.com) 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 tablets that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary tablet 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. Its development programs currently include tablet vaccines designed to protect against coronavirus, Norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart's first immuno-oncology indication. Vaxart has filed broad domestic and international patents covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.

SOURCE: Vaxart

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