Breaking News
March 22, 2019 - Karyopharm Announces FDA Extension of Review Period for Selinexor New Drug Application
March 22, 2019 - Eruptive xanthomatosis
March 22, 2019 - Cause of vascular disease in kidney failure reversed in animal model
March 22, 2019 - Researchers discover possible new therapeutic strategy for pancreatic cancer
March 22, 2019 - Ebola spreads to second largest city in DRC
March 22, 2019 - Perivascular spaces contribute to worse cognitive health in older adults
March 22, 2019 - Adolescent daily users more likely to obtain electronic cigarettes from commercial sources
March 22, 2019 - FDA Approves Genentech’s Tecentriq in Combination With Chemotherapy for the Initial Treatment of Adults With Extensive-Stage Small Cell Lung Cancer
March 22, 2019 - Diabetes myths and facts: MedlinePlus Medical Encyclopedia
March 22, 2019 - TGen and ABL pursue global rollout of advanced TB test
March 22, 2019 - Traffic light labels influence people to choose healthier and more sustainable meals
March 22, 2019 - Alzheimer’s patients using antiepileptic drugs have twice the risk of pneumonia, study shows
March 22, 2019 - Skin diseases may be more prevalent than previously thought
March 22, 2019 - Overall rates of death from breast cancer are falling across the EU
March 22, 2019 - Novel plasmid could hold key to control of mosquito-borne illness
March 22, 2019 - Female Emergency Physicians Paid Less Than Males
March 22, 2019 - Estimated average glucose (eAG): MedlinePlus Medical Encyclopedia
March 22, 2019 - Experimental drug could be new option for type 2 diabetes
March 22, 2019 - Five Things To Know About The Electronic Health Records Mess
March 22, 2019 - TMJ disorders could be treated with tissue-engineered implants after successful animal study
March 22, 2019 - Team-based approach is key to successful care of pregnant women with heart failure
March 22, 2019 - Study identifies gene variant associated with accelerated cellular aging
March 21, 2019 - Salk scientists show how background noise from neurons can interrupt focused attention
March 21, 2019 - New class of drugs could help treat patients diagnosed with ovarian cancer
March 21, 2019 - Tecentriq Approved for Small Cell Lung Cancer
March 21, 2019 - Adipocyte glucocorticoid receptors play a role in developing steroid diabetes
March 21, 2019 - Climate change can affect nutrient content of crops, harming human health
March 21, 2019 - Podcast: KHN’s ‘What The Health’ Surprise! Fixing Surprise Medical Bills Is Harder Than it Looks
March 21, 2019 - Chemistry researchers patent new method for making anti-leukemia compounds
March 21, 2019 - UIC scientists identify hidden proteins in bacteria
March 21, 2019 - New Australian drug trial achieves remarkable results in patients with acute myeloid leukemia
March 21, 2019 - Females live longer when they have help raising offspring
March 21, 2019 - How did orthodontists sell orthodontics?
March 21, 2019 - In the Spotlight: From dietitian to physician assistant student
March 21, 2019 - The CRISPR Revolution: What You Need to Know
March 21, 2019 - FDA Chief Calls For Stricter Scrutiny Of Electronic Health Records
March 21, 2019 - Combined glucocorticoid and antioxidant therapy could benefit premature babies
March 21, 2019 - Low levels of certain eye proteins could serve as predictor for Alzheimer’s
March 21, 2019 - Post-traumatic holocaust survivors transmit negative views on aging to offspring
March 21, 2019 - City of Hope receives $7.5 million in grant awards to study cutaneous T cell lymphoma
March 21, 2019 - New video game-led training device helps stroke survivors regain arm mobility
March 21, 2019 - Compounds in coffee could slow prostate cancer growth
March 21, 2019 - New mobile DNA element in Wolbachia may contribute to improved disease control strategies
March 21, 2019 - Phase 2 Clinical Trial of Bermekimab Shows Potential New Standard of Care for Treatment of Hidradenitis Suppurativa, Including Significant Pain Reduction without Antibiotics
March 21, 2019 - More than one-third of patients risk major bleeding by doubling up on blood thinners
March 21, 2019 - A skeptical look at popular diets: Thumbs up for Mediterranean
March 21, 2019 - PTSD After Cardiac Arrest Predicts More Heart Trouble
March 21, 2019 - Role of immunological imprinting in elicitation of new antibodies
March 21, 2019 - Breast cancer relapse predictor tool may soon be a reality
March 21, 2019 - New computer program developed by TGen lights up cancer-causing genetic mutations
March 21, 2019 - FDA warns two breast implant makers for failure to comply with post-approval study requirements
March 21, 2019 - Butler Hospital receives COBRE grant to enhance research on neuropsychiatric illnesses
March 21, 2019 - Majority of osteoporosis clinical practice guidelines ignore patients’ voices
March 21, 2019 - Generic messages don’t help patients to lose weight
March 21, 2019 - Eisai and Imbrium Therapeutics Announce U.S. FDA Filing Acceptance of New Drug Application for Lemborexant for the Treatment of Insomnia
March 21, 2019 - Two-drug combos using popular calcium channel blocker show superiority in lowering BP
March 21, 2019 - Q BioMed and Mannin Research collaborate with McMaster University to develop GDF15 biomarker glaucoma diagnostic kit
March 21, 2019 - First-in-human pilot study shows positive results for ‘bacteria-phobic’ catheter
March 21, 2019 - Itamar Medical launches next-generation WatchPAT system for home sleep apnea testing
March 21, 2019 - Study estimates health and economic impacts of healthy food prescriptions
March 21, 2019 - Detecting fungal disease in crops with multispectral imaging system
March 21, 2019 - MIT announces creation of the Alana Down Syndrome Center
March 21, 2019 - Next-generation LVAD device clinically superior, safer for heart failure patients
March 21, 2019 - Allergan Announces FDA Approval of Avycaz (ceftazidime and avibactam) for Pediatric Patients
March 21, 2019 - Mutations in noncoding genes could play big role in regulating cancer, study finds
March 21, 2019 - A medical student’s thoughts on Match Day
March 21, 2019 - Are eggs good or bad for you?
March 21, 2019 - New analysis reveals precision oncology insights for colorectal cancer
March 21, 2019 - Pollutants appear to weaken immune system and increase pathogen virulence
March 21, 2019 - Researchers develop and validate scale for rating severity of mononucleosis
March 21, 2019 - Scientists identify generation of key immune response in mice on introducing solid food
March 21, 2019 - New nanomaterial could restore internal structure of damaged bones
March 21, 2019 - Selective destruction of prostate tumor as effective as complete prostate removal
March 21, 2019 - 2011 to 2015 Saw Increase in Psychiatric ED Visits for Youth
March 21, 2019 - Tapeworm drug targets common vulnerability in tumor cells
March 21, 2019 - WVU researcher discovers higher suicide rate among Medicaid-insured youth
March 21, 2019 - Off the beaten path for global health residency
March 21, 2019 - European Parliament’s report calls on EU to develop policies to regulate endocrine-disrupting chemicals
March 21, 2019 - Women with undiagnosed diabetes in pregnancy more likely to experience stillbirths
March 21, 2019 - Fish consumption can help prevent asthma, study reveals
Vaxart Announces Publication of the Phase 1 Results of its Oral Norovirus Tablet Vaccine in Journal of Clinical Investigation Insight

Vaxart Announces Publication of the Phase 1 Results of its Oral Norovirus Tablet Vaccine in Journal of Clinical Investigation Insight

image_pdfDownload PDFimage_print

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE) July 12, 2018 –Vaxart, Inc. (Nasdaq:VXRT), a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, today announced publication of the comprehensive results of the previously disclosed Phase 1 clinical trial with its norovirus oral tablet vaccine in the Journal of Clinical Investigation Insight.

The paper by Leesun, Kim, et al., “Safety and immunogenicity of an oral tablet norovirus vaccine, a phase 1 randomized, placebo-controlled trial”, highlights the benign safety profile of the Vaxart vaccine and describes the generation of robust systemic and mucosal immune responses, including mucosal IgA, memory B cells, and serum blocking antibody titers (BT50), all potential correlates of protection.

“Our oral tablet vaccine elicited a substantial serum antibody response as well as a strong local intestinal immune response as measured by mucosal homing B-cells and a greater than tenfold increase in fecal IgA antibodies,” said Sean Tucker, Ph.D., founder and chief scientific officer of Vaxart. “Local immunity in the gut is likely to be a key factor in protection against norovirus infection, and this data confirms our vaccine is uniquely positioned to generate this type of response.”

The primary immunological endpoint of the study, an increase in BT50 titers, was met in the high dose group with 78% of subjects showing a greater than or equal to twofold rise after a single immunization (P=0.0003). In addition, more than 80% of recipients of the high dose vaccine developed mucosally-primed norovirus specific circulating antibody secreting cells, IgA positive memory B cells expressing the α4β7 gut homing receptor, and fecal IgA.

“Norovirus causes substantial morbidity and mortality all across the globe, impacting populations of all ages in all walks of life. We believe our tablet vaccine could provide an optimal solution to help reduce the burden of disease in vulnerable populations such as the elderly and the very young, as well as people at-risk in the healthcare, travel and food industry,” said David Taylor, M.D., chief medical officer of Vaxart. “We look forward to initiating our Norovirus vaccine Phase 1 safety and immunogenicity bivalent study and Phase 2 monovalent challenge study in the coming months.”

About Norovirus

Norovirus is recognized as a leading cause of acute gastroenteritis. It is a common intestinal infection that typically lasts three to five days and is marked by watery diarrhea, vomiting, abdominal cramps, nausea and sometimes fever. Symptoms can be more severe in older adults and young children and may lead to serious complications including death. Norovirus causes frequent and widespread outbreaks in the military, food industry, travel industry, child care facilities, elderly homes and healthcare facilities.

The U.S. Centers for Disease Control and Prevention (CDC) estimates that norovirus causes 19 to 21 million illnesses in the United States each year, resulting in 56,000 to 71,000 hospitalizations and 570 to 800 deaths. In a recent John Hopkins University study, researchers estimated healthcare costs of norovirus at $4.2 billion and lost productivity costs at $56.2 billion globally. Currently there are no norovirus vaccines approved by the U.S. Food and Drug Administration.

About Vaxart

Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant protein vaccines based on its proprietary oral vaccine platform. Vaxart’s vaccines are designed to generate broad and durable immune responses that protect against a wide range of infectious diseases and may also be useful for the treatment of chronic viral infections and cancer. Vaxart’s vaccines are administered using a convenient room temperature-stable tablet, rather than by injection. Vaxart believes that tablet vaccines are easier to distribute and administer than injectable vaccines, and have the potential to significantly increase vaccination rates. Vaxart’s development programs include oral tablet vaccines that are designed to protect against norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV). For more information, please visit www.vaxart.com.

Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our strategy, prospects, plans and objectives, results from preclinical and clinical trials, commercialization agreements and licenses, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as “believe,” “could,” “potential”, “will” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to the Vaxart’s ability to develop and commercialize its product candidates and clinical results and trial data,. Vaxart may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Vaxart makes, that Vaxart’s product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart’s product candidates may not achieve broad market acceptance; and the risks described in the “Risk Factors” sections of Vaxart’s Quarterly Report filed on Form 10-Q for the quarter ended March 31, 2018 and of Vaxart’s other periodic reports filed with the SEC. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law.

Source: Vaxart, Inc.

Posted: July 2018

Tagged with:

About author

Related Articles