It took longer than FluGen planned, but a human clinical trial is now underway for the experimental universal influenza vaccine that the Madison, WI-based biotech startup is developing.
The primary goals of the trial announced Wednesday are to evaluate the safety of the vaccine, which is known as RedeeFlu, and evaluate antibody and T-cell responses in study participants, the company said.
Ninety-six subjects, all between the ages of 18 and 49, will be dosed with the vaccine, FluGen said. They are broken into three groups of 32, and the dosage will increase with each group, said Paul Radspinner, FluGen’s co-founder, president, and CEO.
“We’ve already started dosing subjects in the first cohort,” Radspinner said in an interview. “Once we clear the first week of this group, then we’ll start recruiting for the second group.”
Radspinner said that researchers will be taking measurements on subjects throughout the study, but investigators must wait 28 days after a cohort has been dosed before they can collect the most vital data on subjects’ immune responses.
FluGen leaders hope to have safety and immune response data on all three cohorts in the trial by December, Radspinner said.
One benefit of a universal flu vaccine is that it could protect against strains of the virus that vary from the ones groups like the CDC and World Health Organization predict will be the predominant strain (or strains) for a given flu season.
RedeeFlu is made up of a live flu virus from which a key gene, known as M2, has been deleted. The vaccine virus is able to live in the body just long enough to provoke a strong immune response, but thanks to the deleted gene it’s not able to cause disease or spread to other people, according to FluGen. Radspinner said that other companies, such as Fort Collins, CO-based Vivaldi Biosciences, are developing vaccines that have similarities to RedeeFlu, but that he does not know of any that remove the M2 gene.
Radspinner said that after the current clinical trial concludes, FluGen is likely to initiate a Phase 1b trial. The goal is for that to happen sometime in 2017, he said. The company also plans to conduct a challenge study in which subjects would receive a vaccine designed to primarily protect against a particular flu strain, then be “challenged” by being dosed with a different strain of the virus. The idea is to test a vaccine’s ability to protect against “drifted or mismatched flu strains,” as FluGen termed them in a press release.
“It would mimic what happened in 2014 and 2015 when there was a mismatch between the vaccine and the prevailing strain,” Radspinner said.
FluGen has raised a total of about $20 million from investors, Radspinner said, and the company is in the process of securing additional capital commitments. He co-founded FluGen in 2007, along with Yoshihiro Kawaoka and Gabriele Neumann.
At the time FluGen closed a $3.4 million bridge financing round in June 2014, the plan was to get a vaccine into human trials in early 2015. FluGen was still working toward that goal when it raised another $9.4 million in August 2015.
Radspinner said there are a few reasons for the delay between then and now. Among them were completing preclinical studies and a FDA Good Laboratory Practice study, as well as making sure the vaccine material was manufactured in a way that meets standard FDA specifications, he said.
“And then finally, probably the most important thing was to put together the [investigational new drug] document that had to be given to the FDA,” Radspinner said. “Obviously, we had to succeed with that in order to initiate this study.”
