BiondVax may be operating in a flu vaccine field occupied by global giants, but that isn't stopping the Israeli biotech from pressing ahead with what it says is the world's most advanced universal flu vaccine candidate. The company recently signed a phase 3 trial agreement with a contract research organization with eyes on reaching the market quickly after the study wraps up, CEO Ron Babecoff told FiercePharma.
The two-year trial in eastern European countries will test the vaccine, M-001, in two doses against placebo in adults 50 and older. It'll enroll a first cohort this fall and another group of participants next fall. Babecoff said if the vaccine demonstrates efficacy: "We will have for the first time a vaccine that is protective for at least two seasons."
If the vaccine succeeds, the company will seek EMA approval for the following flu season, Babecoff said, citing an urgency and annual "drama" created by limitations with current flu vaccines. In the U.S., for instance, flu shots were estimated to be just 36% effective this year.
Traditional egg-based flu vaccines take months to manufacture, forcing health officials to predict strains far ahead of the actual flu season. Because of strain mismatch and other factors, overall vaccine efficacy has ranged from 10% to 60% in recent years, according to the CDC. Cell-based vaccines are quicker to manufacture, while a universal shot would ideally protect against all strains over multiple years.
Besides BiondVax, large pharma companies such as Sanofi and Johnson & Johnson are working to improve flu vaccines. Smaller biotechs FluGen, Vaccitech and others are also involved in the work.
For the BiondVax study, investigators will set up a call center to ask participants about flu symptoms on a twice-weekly basis throughout two flu seasons. If the participants think they might have the flu, they'll either visit a testing center or have a nurse visit them to confirm an infection. Babecoff said the flu virus sheds for 4 to 5 days, so investigators will need to keep in touch with the participants on an ongoing basis.
The trial data wouldn't support a U.S. approval, but Babecoff said a "bridging study" at a later time could support a potential FDA nod.
While the study plays out for the next two years, BiondVax is building a midsize manufacturing plant and working to complete required audits before a potential launch. The company received a €20 million loan from the European Investment Bank in July and raised $10 million through a secondary offering in September to support its efforts. As the biotech presses ahead, it'll hire modestly but not increase its staff size much above the 15 employees already on payroll.
"Small forces you to be efficient," Babecoff said. "This is what I want to continue."
In the long run, Babecoff said his company is doing everything necessary for an independent launch, but he didn't rule out partnerships as another path to growth.