Jill Sederstrom is a Contributing Editor
Biotech companies join forces to develop oral flu vaccines.
Researchers are exploring new oral flu vaccine and treatment options, as possible alternatives to more traditional means of prevention and treatment.
This month, Vaxart-a biotechnical company focused on developing oral recombinant vaccines-announced it had reached an agreement with Janssen Vaccines & Prevention B.V. to evaluate an oral vaccine platform.
Through the agreement, Vaxart will work on developing an oral vaccine using certain propriety antigens from Janssen, according to a release announcing the new agreement.
The vaccine developed will then be tested in a preclinical challenge model to evaluate its effectiveness. After the study is completed, Janssen will then be given the exclusive option to negotiate for the license to the Vaxart technology that uses the antigens.
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“Development of a universal flu vaccine is a high priority public health objective and we are delighted to be working with Janssen in this important field,” said Wouter Latour, MD, CEO of Vaxart.
Latour went on to say that Vaxart’s oral H1 seasonal influenza vaccine appears to work primarily through mucosal immunity and could be a key component of a universal vaccine.
“In addition, we have the benefit of a convenient room temperature-stable tablet which may improve vaccination rates,” he said.
While interest in an oral flu vaccine continues to grow, researchers are also making progress in developing more oral treatment options for influenza.
Earlier this month, Genentech announced that a phase III study of new oral suspension drug baloxavir marboxil (Xofluza) in children. It found the one-dose medication was well tolerated as a treatment option for children with the flu under the age of 12 years old.
Results of MINISTONE-2 showed baloxavir marboxil was as effective as current treatment with oseltamivir (Tamiflu) in reducing the duration of flu symptoms, including fever, and could be a promising option for children in the coming years.
“This is the fourth positive phase III study for baloxavir marboxil and these results add to robust clinical evidence already demonstrating the benefit of baloxavir marboxil in various adult and adolescent populations,” Barry Clinch, PhD, group clinical science director and global head of influenza and infectious disease in product development at Genentech/Roche told Drug Topics.
The drug is unique in that it’s the first single-dose oral medicine approved to treat the flu and uses a novel proposed mechanism of action, Clinch said.
“With Xofluza, patients now have a convenient treatment option that reduces flu symptoms by more than a day with a single oral dose,” he said.
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According to Clinch, the drug prevents the formation of new viral particles by blocking virus republication early in the flu cycle, potentially reducing the length of time that children suffer from the disease. It has also been shown to have “greater antiviral potency compared to Tamiflu.”
The FDA accepted Genentech’s supplemental new drug application for baloxavir marboxil as a single-dose oral treatment for patients who are at a high risk of complications. It is expected to make a decision of whether to approve the application later this fall.