VXA-CoV2-1 / Vaxart, Emergent Biosolutions - LARVOL DELTA

A Study to Evaluate VXA-CoV2-3.3 COVID-19 Vaccine Against Currently Approved/Authorized mRNA COVID-19 Injectable Booster Vaccine in Adults Previously Immunized Against COVID-19 Infection (clinicaltrials.gov) - P2 | N=10400 | Active, not recruiting | Sponsor: Vaxart | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate VXA-CoV2-3.3 COVID-19 Vaccine Against Currently Approved/Authorized mRNA COVID-19 Injectable Booster Vaccine in Adults Previously Immunized Against COVID-19 Infection (clinicaltrials.gov) - P2 | N=10400 | Recruiting | Sponsor: Vaxart | Active, not recruiting ➔ Recruiting | N=400 ➔ 10400 | Trial completion date: Jan 2026 ➔ Nov 2026 | Trial primary completion date: Jan 2026 ➔ Nov 2026

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate VXA-CoV2-3.1 COVID-19 Vaccine Against Currently Approved/Authorized mRNA COVID-19 Injectable Booster Vaccine in Adults Previously Immunized Against COVID-19 Infection (clinicaltrials.gov) - P2 | N=400 | Active, not recruiting | Sponsor: Vaxart | N=10000 ➔ 400 | Recruiting ➔ Active, not recruiting

Enrollment change • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Ph 2 Trial With an Oral Tableted COVID-19 Vaccine (clinicaltrials.gov) - P2 | N=66 | Terminated | Sponsor: Vaxart | Completed ➔ Terminated; The study drug was no longer available.

Trial termination • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate VXA-CoV2-3.1 COVID-19 Vaccine Against Currently Approved/Authorized mRNA COVID-19 Injectable Booster Vaccine in Adults Previously Immunized Against COVID-19 Infection (clinicaltrials.gov) - P2 | N=10000 | Recruiting | Sponsor: Vaxart

New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Ph 2 Trial With an Oral Tableted COVID-19 Vaccine (clinicaltrials.gov) - P2 | N=66 | Completed | Sponsor: Vaxart | Active, not recruiting ➔ Completed

Trial completion • Viral vector • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Ph 2 Trial With an Oral Tableted COVID-19 Vaccine (clinicaltrials.gov) - P2 | N=66 | Active, not recruiting | Sponsor: Vaxart | Trial completion date: Jun 2023 ➔ Oct 2023

Trial completion date • Viral vector • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Ph 2 Trial With an Oral Tableted COVID-19 Vaccine (clinicaltrials.gov) - P2 | N=66 | Active, not recruiting | Sponsor: Vaxart | N=896 ➔ 66

Enrollment change • Viral vector • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Ph 2 Trial With an Oral Tableted COVID-19 Vaccine (clinicaltrials.gov) - P2 | N=896 | Active, not recruiting | Sponsor: Vaxart | Recruiting ➔ Active, not recruiting | Trial primary completion date: Dec 2022 ➔ May 2022

Enrollment closed • Trial primary completion date • Viral vector • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Efficacy of COVID-HIGIV in animal models of SARS-CoV-2 infection. (PubMed, Sci Rep) - P3 | "It has caused millions of hospitalizations and deaths, despite the use of COVID-19 vaccines. In hamsters, COVID-HIGIV treatment reduced infection-associated lung pathology including lung inflammation, and pneumocyte hypertrophy in the lungs. These results support ongoing trials for outpatient treatment with COVID-HIGIV for safety and efficacy evaluation (NCT04910269, NCT04546581)."

Journal • Preclinical • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Safety and Immunogenicity Trial of an Oral SARS-CoV-2 Vaccine (VXA-CoV2-1) for Prevention of COVID-19 in Healthy Adults (clinicaltrials.gov) - P1 | N=35 | Completed | Sponsor: Vaxart | Active, not recruiting ➔ Completed | Trial primary completion date: May 2021 ➔ Oct 2021

Trial completion • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Ph 2 Trial With an Oral Tableted COVID-19 Vaccine (clinicaltrials.gov) - P2 | N=896 | Recruiting | Sponsor: Vaxart | Trial primary completion date: Mar 2022 ➔ Dec 2022

Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Oral vaccination protects against SARS-CoV-2 in a Syrian hamster challenge model. (PubMed, J Infect Dis) - "Oral immunization induced anti-spike IgG and neutralizing antibodies were induced upon oral immunization with the sera demonstrating neutralizing activity. Overall this data demonstrates the ability of oral vaccine candidate VXA-CoV2-1 to provide protection against SARS-CoV-2 disease."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

[VIRTUAL] Oral Tablet Vaccination Induces Heightened Cross-Reactive CD8 T Cell Responses to SARS-COV-2 in Humans (IDWeek 2021) - "Here we describe a room temperature stable tablet that induces SARS-CoV-2 S specific CD8 T cells of high magnitude after one dose in humans. Overall, the level of antiviral SARS-CoV-2 specific T cells, particularly IFNg-producing CD8s, induced following oral immunization with VXA-CoV2-1 are of higher magnitude than the mRNA vaccines currently in use against COVID-19. T cell responses against 4 endemic HCoV were also induced."

Infectious Disease • Novel Coronavirus Disease • CD4 • CD8 • IFNG • LAMP1 • TNFA

A Ph 2 Trial With an Oral Tableted COVID-19 Vaccine (clinicaltrials.gov) - P2; N=896; Recruiting; Sponsor: Vaxart

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity Trial of an Oral SARS-CoV-2 Vaccine (VXA-CoV2-1) for Prevention of COVID-19 in Healthy Adults (clinicaltrials.gov) - P1; N=35; Active, not recruiting; Sponsor: Vaxart; Trial primary completion date: Dec 2020 ➔ May 2021

Clinical • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Coronavirus Updates: The Latest Treatments and Vaccines - "'That trial did not find any difference in outcomes between the treatment and placebo,' said Yvonne Maldonado....Dr. Aruna Subramanian...lead investigator for the inpatient trial, said the 21 hospitalized patients in the study receive a high dose like Trump, a lower dose or a placebo. Subramanian plans to expand the inpatient trial to 45 patients. The outpatient study has enrolled a little more than 40 of the 60 patients researchers intend to sign up. 'There's enough promising evidence that it helps people early in the infection,' Subramanian said. 'What we don't know is whether it helps people who are pretty sick but not critically ill.'"

Clinical • Novel Coronavirus Disease

Vaxart Provides Business Update and Reports Fourth Quarter and Full Year 2020 Financial Results (GlobeNewswire) - "...it plans to initiate the first Phase 2 study of its oral COVID-19 vaccine candidate, VXA-CoV2-1, in 2Q 2021....Research and development expenses were $8.6 million for the fourth quarter of 2020 compared to $3.3 million for the fourth quarter of 2019. The increase was mainly due to manufacturing and clinical trial expenses related to the COVID-19 vaccine candidate....Research and development expenses were $19.9 million for 2020 compared to $14.5 million for 2019. The increase was mainly due to higher preclinical, manufacturing and clinical trial expenses related to our COVID-19 vaccine candidate."

Commercial • New P2 trial • Infectious Disease • Novel Coronavirus Disease

Vaxart Announces Positive Preliminary Data from Phase 1 Clinical Trial Evaluating Its Oral COVID-19 Tablet Vaccine Candidate (GlobeNewswire) - P1, N=35; NCT04563702; Sponsor: Vaxart; "Study reached primary and secondary endpoints of safety and immunogenicity, respectively; VXA-CoV2-1 induced potent CD8+ T-cell responses; VXA-CoV2-1 potentially protective against new and emerging COVID-19 strains; Data to be presented today at the New York Academy of Sciences Symposium...Oral COVID-19 tablet vaccine candidate was generally well-tolerated, and immunogenic as measured by multiple markers of immune response to SARS-CoV-2 antigens....Vaxart expects to broaden its COVID-19 vaccine development plans, with efforts that could include...Phase II studies to evaluate optimal dosing schedule, and to then assess efficacy against COVID-19....VXA-CoV2-1 in previously vaccinated or exposed subjects: investigating single dose boosting protocol to broaden and strengthen immune responses."

P1 data • Infectious Disease • Novel Coronavirus Disease

"VAXART COVID-19 VACCINE PILL" (@MarkReis70)

Infectious Disease • Novel Coronavirus Disease

Safety and Immunogenicity Trial of an Oral SARS-CoV-2 Vaccine (VXA-CoV2-1) for Prevention of COVID-19 in Healthy Adults (clinicaltrials.gov) - P1; N=35; Active, not recruiting; Sponsor: Vaxart; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Vaxart Hosting Key Opinion Leader Panel Call for Investors (GlobeNewswire) - "Vaxart, Inc....announced today that it will host a Key Opinion Leader (KOL) panel for investors...on Thursday, November 19, 2020 at 12pm Eastern Time. These KOLs will provide their perspectives on the COVID-19 and Norovirus disease landscapes....Vaxart's management team will also provide an update on its first-in-class oral tablet vaccine platform...and results from preclinical studies on Vaxart’s investigational COVID-19 vaccine."

Live event • Preclinical • Infectious Disease • Novel Coronavirus Disease

Vaxart Reports Third Quarter 2020 Financial Results and Provides Business Update (GlobeNewswire) - "Pre-Clinical and Clinical Developments: Completed enrollment in the Company’s Phase 1 study of VXA-CoV2-1....Reported COVID-19 Hamster Challenge Study data showing protection against COVID-19 in hamsters receiving two oral doses of Vaxart’s oral vaccine."

Enrollment closed • Preclinical • Infectious Disease • Novel Coronavirus Disease

Vaxart Announces Dosing First Subject in Phase 1 Clinical Trial of Its Oral Tablet COVID-19 Vaccine (GlobeNewswire) - "Vaxart, Inc....today announced that the first subject has been dosed in its Phase 1 study of VXA-CoV2-1, an oral tablet COVID-19 vaccine candidate. 'We are advancing VXA-CoV2-1 into clinical development based on the strength of pre-clinical data that showed that the vaccine is capable of inducing both a robust systemic immune response and a strong mucosal immune response, specifically in the lungs'....Enrollment is expected to be completed by early November 2020, with participants receiving the low or high dose of the VXA-CoV2-1 oral tablet at days 1 and 29....'We are looking forward to receiving the first clinical data in the next few weeks.'"

Enrollment status • Trial status • Infectious Disease • Novel Coronavirus Disease

Kindred Biosciences Announces Expansion of Manufacturing Agreement with Vaxart for COVID-19 and Other Vaccine Candidates (PRNewswire) - "Kindred Biosciences, Inc....today announced it has expanded an agreement with Vaxart, Inc....for the manufacture of Vaxart's oral vaccine for COVID-19 and other vaccine candidates. The manufacturing services will be performed via Centaur Biopharmaceutical Services...that provides full service contract development and manufacturing services."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease