Breaking News
October 22, 2018 - Merck presents MK-1454 Phase 1 data for treatment of advanced solid tumors or lymphomas
October 22, 2018 - Aspirin may be effective in preventing blood clots after knee replacement
October 22, 2018 - Gilead Sciences presents Phase 3 results of filgotinib in biologic-experienced rheumatoid arthritis at 2018 ACR/ARHP Annual Meeting
October 22, 2018 - Immunotherapy with pembrolizumab extends survival in metastatic or recurrent head and neck cancer
October 22, 2018 - Health Tip: Keep Ticks Away
October 22, 2018 - Obsessive-compulsive disorder – Genetics Home Reference
October 22, 2018 - Researchers find disrupted functional connectivity in cerebellum of adults with HF-ASD
October 22, 2018 - Deciphera presents Phase 1 clinical results of DCC-2618 in patients with gastrointestinal stromal tumors
October 22, 2018 - Combination of Opdivo and Yervoy shows four-year survival benefits in patients with advanced melanoma
October 22, 2018 - Overcoming bottlenecks in early drug discovery with the power of sound
October 22, 2018 - Scientists discover genes that contribute to ADHD development
October 22, 2018 - Incyte announces Phase 2 FIGHT-202 trial data in patients with cholangiocarcinoma
October 22, 2018 - FDA approves update to Rituxan label to include information on treatment of rare forms of vasculitis
October 22, 2018 - At-home biofeedback therapy effective in relieving difficult-to-treat constipation
October 22, 2018 - Merck presents KEYNOTE-057 trial results for patients with high-risk non-muscle invasive bladder cancer
October 22, 2018 - People with periodontal disease less likely to reach healthy blood pressure ranges
October 22, 2018 - Phase III LONSURF study shows progression-free survival in patients with refractory metastatic gastric cancer
October 22, 2018 - Primary care doctors ‘not doing enough’ to curb STDs
October 22, 2018 - Pfizer announces PALOMA-3 trial results in patients with HR+, HER2- metastatic breast cancer
October 22, 2018 - ImmunoGen announces study results of platinum-resistant ovarian cancer therapy at ESMO 2018 Congress
October 22, 2018 - Study findings could set new standard of care for advanced anal cancer
October 22, 2018 - Erlotinib improves progression-free survival in EGFR mutated NSCLC
October 22, 2018 - Pain, insomnia, and depression often drive osteoarthritis patients to seek medical care
October 22, 2018 - The International Society of Refractive Surgery honors Vivior Chairman with Casebeer Award
October 22, 2018 - Multi-strain probiotic helps reduce chemotherapy-induced diarrhea in cancer patients
October 22, 2018 - Study shows potential of avelumab plus axitinib as new treatment option for patients with advanced RCC
October 22, 2018 - Vertex gets European CHMP positive opinion for KALYDECO to treat patients with cystic fibrosis
October 22, 2018 - Phase III trial reports positive results with HDAC inhibitor in advanced breast cancer patients
October 22, 2018 - Prostate radiotherapy improves survival in men with low burden of metastatic disease
October 22, 2018 - Duration of respiratory disturbances may better predict mortality risk from OSA
October 22, 2018 - Free phone app helps low-income obese patients to lose weight
October 22, 2018 - Immunotherapy with nivolumab and ipilimumab may improve survival in patients with MSI-high metastatic colorectal cancers
October 22, 2018 - FOTIVDA expected to be included in new ESMO guidelines for advanced renal cell carcinoma
October 22, 2018 - Compression Collar May Protect Brain of Female Soccer Players
October 22, 2018 - Technique visualizes neuron communication
October 22, 2018 - Advancement in medical imaging methods for health care
October 22, 2018 - Takeda presents vedolizumab phase 3 VISIBLE 1 trial results for treatment of moderately to severely active ulcerative colitis
October 22, 2018 - Immunotherapy increases survival in some patients with metastatic triple negative breast cancer
October 22, 2018 - Exelixis presents CABOSUN and METEOR trial results in patients with advanced renal cell carcinoma
October 22, 2018 - LYNPARZA Phase III SOLO-1 results show improved outcome for patients with advanced BRCA-mutated ovarian cancer
October 22, 2018 - Brainlab unveils ExacTrac Dynamic at ASTRO meeting in San Antonio, Texas
October 22, 2018 - Not exercising is worse than smoking, diabetes or heart disease finds study
October 22, 2018 - Shorter course of trastuzumab could be an option for women with HER2+ early breast cancer
October 22, 2018 - Map of Mouse Hippocampus Could Be Weapon Against Alzheimer’s
October 22, 2018 - Psychotropic polypharmacy is common in Alzheimer’s disease
October 22, 2018 - Texas A&M and UTA establish Texas Genomics Core Alliance
October 22, 2018 - Analyzing mouse’s potential as animal model of decision-making
October 22, 2018 - Radiotherapy can prolong survival in prostate cancer
October 22, 2018 - A genetic mutation involved in relapse
October 21, 2018 - Report reveals growing impact of cannabis on young people
October 21, 2018 - NSF awards $5 million grant to help scientists magnify societal impact of research
October 21, 2018 - Fertility Rates Down for Each Urbanization Level 2007 to 2017
October 21, 2018 - Genetically engineered 3-D human muscle transplant in a murine model
October 21, 2018 - Moms’ tight work schedules may affect their children’s sleep
October 21, 2018 - AHA: No Direct Link Between Preeclampsia and Cognitive Impairment, Study Finds
October 21, 2018 - Weight loss success linked with active self-control regions of the brain
October 21, 2018 - Scripps researchers successfully test potential new smoking-cessation treatment in rodents
October 21, 2018 - More accurate and less stressful way to measure a baby’s heartbeat
October 21, 2018 - Researchers show better cardiorespiratory fitness leads to longer life
October 21, 2018 - Healthy candies for diabetic patients
October 21, 2018 - Environment impact of microplastics remains unclear
October 21, 2018 - Antibiotics for appendicitis? Surgery often not needed
October 21, 2018 - AHA and AMA recognize more than 800 medical practices, health systems for blood pressure control
October 21, 2018 - Scientists obtain clearest ever image of Ebola virus protein
October 21, 2018 - Study reveals connection between two proteins known to be hyperactive in cancer
October 21, 2018 - Gabapentin Beats Pregabalin for Chronic Sciatica
October 21, 2018 - Cosmetic surgeons offering incomplete information for breast augmentation customers
October 21, 2018 - Chronic sleep disruption in early adult life accelerates AD-related tau pathology
October 21, 2018 - Take 10 for Mindfulness – Drugs.com MedNews
October 21, 2018 - Length of breathing disruption in OSA may be better predictor of mortality risk
October 21, 2018 - ApoE4 gene linked with chronic inflammation increases risk for Alzheimer’s disease
October 21, 2018 - Mother-daughter conflict associated with suicide risk in abused adolescent girls
October 21, 2018 - Scientists molding bacteria into unnatural shapes
October 21, 2018 - High diet quality associated with lower risk of death in colorectal cancer patients
October 21, 2018 - Discharged mental health patients ‘at greater risk of dying’
October 21, 2018 - Research provides insight into neurobiology of aggression and bullying
October 21, 2018 - As billions in tax dollars flow to private Medicaid plans, Who’s minding the store?
October 21, 2018 - Neuroscientists identify brain region that appears to be related to food preference decisions
October 21, 2018 - Deaths related to air pollution in the U.S. decreased by 47% between 1990 and 2010
October 21, 2018 - Study shows correlation between spatial memory and the sense of smell
Firm advances human trials of revolutionary vaccine

Firm advances human trials of revolutionary vaccine

image_pdfDownload PDFimage_print
Yoshihiro Kawaoka, professor of pathobiological sciences in the School of Veterinary Medicine and a co-founder of FluGen, gives a slide presentation to a group of media representatives touring the Influenza Research Institute. Credit: Jeff Miller

Amid predictions that this year’s flu vaccine will offer limited protection, medical researchers are renewing their focus on a universal flu vaccine.

A universal flu vaccine would offer more broad protection than today’s vaccines, which must be targeted at viral strains deemed dangerous many months before flu season begins.

The problem is that the flu virus can change fast enough to evade those vaccines.

No versatile influenza vaccine is on the market, but one of the most promising is being developed by FluGen, a spinoff from the University of Wisconsin–Madison. The Madison startup has announced a plan to evaluate its innovative influenza vaccine in a trial of 100 people later this spring.

For almost a decade, the company has been exploring a genetically altered virus that can reproduce only once in the human body. “Our vaccine contains a live virus that infects you but cannot make you sick,” says CEO Paul Radspinner.

Viruses reproduce by hijacking cellular machinery. The essential technology for Flugen’s project deletes a gene the virus needs to reproduce more than once. The discovery was made in 2002 by company co-founders Yoshihiro Kawaoka, an internationally known influenza researcher at the School of Veterinary Medicine, and his colleague Gabrielle Neumann.

The principle that an infection can be powerful medicine, however, is much older, Radspinner says. “Our vaccine is based on the concept that if you get the flu this year, the odds that you will get it next year go down dramatically.”

Beyond creating a real but extremely limited infection, Flugen’s invention also uses a promising delivery route. Instead of being injected into the muscle, it will be squirted into the nose, which is far more faithful to a natural infection. “If you think how you get the flu. It’s usually through the nasal passages or the throat,” Radspinner says.

Intranasal delivery triggers immunity in the mucus been shown to “activates multiple immune systems in the body, while the traditional shot in the arm affects primarily the antibody-based immune system.”

Influenza is a global disease caused by a group of viruses that change rapidly and spread easily through coughs and sneezes. Worldwide, the disease kills between 250,000 and 500,000 per year. Due to the long lead time needed to produce vaccine in eggs, public-health authorities must choose vaccine for the northern hemisphere in February.

During the nine or more months before flu season begins, the virus undergoes “genetic drift” as it evolves and reasserts its genetics. Such drift is a major reason why, even in healthy adults, influenza vaccines are only 10 to 60 percent protective.

FluGen’s vaccine is made in mammalian cells, not eggs, so faster production should allow less time for genetic drift. Unlike the current vaccine, the virus is alive, and therefore more likely to trigger immunity. Already, FluGen has shown that the vaccine triggers a much broader immune response, affecting not just the mucus tissues but also B-cells, T-cells and antibodies.

FluGen’s technology is protected by multiple patents held by both the Wisconsin Alumni Research Foundation and FluGen.

A test in healthy adults, completed in 2016, showed no warning flags related to safety, “and it told us we are hitting many sections of the immune system,” Radspinner says.

Those results helped to justify a $14.4 million grant awarded by the Department of Defense to test whether a vaccine based on a 2009 strain of flu can protect against the strains that circulated in 2014-15. “We’re aiming to prove effectiveness after six years of genetic drift,” says Radspinner. “That’s a big mismatch.”

Half of the 100-odd volunteers in the upcoming study will get a saline squirt in the nose; the others will get FluGen’s vaccine. Later, everyone will get a nasal dose of live flu virus. “They’ll be in ‘flu camp’ for 11 days in an isolation facility in Belgium,” Radspinner says. “We will measure how well our vaccine protected against the flu challenge, based on infection and symptoms, and we’ll look at a broad range of safety indicators as well.”

The goal is to have initial results by the end of the year.

Despite the dual benefits from faster vaccine production and broader immunity, regulatory approval is expected to entail safety-efficacy trials involving several thousand people. “With any vaccine, safety is the paramount issue, so the FDA [Food and Drug Administration] wants to see as many subjects as possible,” Radspinner says.

Depending on the scientific results, and regulatory approval, 2025 is a reasonable time for gaining FDA approval and reaching the market, he says.

As FluGen’s dozen employees prepare for the larger trials, the company has begun to use more outside resources, including specialized manufacturers that are not found locally. “We are a semi-virtual company,” says Radspinner. “We have half of our employees doing basic research and development in the lab, and we coordinate external clinical research and manufacturing through outside organizations.”

Influenza can be extraordinarily dangerous, and flu researchers are haunted by the 1917-18 pandemic, which killed 50 to 100 million people worldwide. Public-health authorities continue to promote the benefits of flu vaccine, but the protection is better in some years than others, Radspinner says. “It may be too early to tell, but the early surveillance, an area where Wisconsin has long been a leader, clearly indicates that this is going to be strong year for flu.”

Even though getting the flu is your best protection against another bout, “Who wants to get sick for a couple of weeks?” he asks. “Our goal is to trick the body into thinking that it’s infected, so you get protected, without getting the symptoms that are the historic price of protection.”


Explore further:
Strategy introduces stable components of flu virus for long-lasting, DNA-enhanced protection

Provided by:
University of Wisconsin-Madison

Tagged with:

About author

Related Articles