Problems with seasonal flu shots have been well documented, and now U.K. biotech Imutex believes it has the next big advance for flu vaccine technology. The company this week reported phase 2b data showing that its universal flu shot, FLU-v, boosted immune responses and lowered infection rates.
Imutex is a joint venture between clinical research specialist hVIVO and drug development organization SEEK Group; the team has been working on its universal flu vaccine candidate for 14 years, SEEK CEO Gregory Stoloff told FiercePharma. He said that with the results, the team is ready to head into phase 3 testing and is in discussions with Big Pharma players for a potential partnership.
While the group could take its shot to late-stage testing itself through grants, Stoloff said a pharma partnership makes more sense because a large drugmaker would already have late-stage testing capabilities established.
In phase 2b results released Monday, FLU-v met its primary endpoint of boosting T-cell responses at both 42 days and 180 days after vaccination. The vaccine also lowered infection rates and symptom severity, the biotech reported, and met a secondary endpoint of boosting antibodies in 100% of vaccinated subjects. With the results and data from earlier studies, investigators determined that a single adjuvanted dose is the "most immunological and efficient."
Authorities in the U.S. and Europe have helped fund the biotech's phase 2 work, Stoloff said. Citing the urgency for better flu shots, he believes the vaccine could be available in two years.
In each of the studies for the vaccine so far, investigators administered the same vaccine against a range of influenza viruses. Stoloff said FLU-v is a true "universal" shot designed to protect against all influenza A and influenza B strains in humans and animals. Others in development provide partial protection, he said.
Such a product would create quite a market, according to the helmsman. Stoloff believes FLU-v could generate $10 billion to $20 billion annually over 20 years because it would be a global vaccine for a target population of 7 billion people. Currently, seasonal flu shots generate about $4 billion per year on about 350 million doses, he said.
Negotiations with big pharma companies are ongoing. The SEEK CEO said his team has been speaking with potential pharma partners for years, and that they had been waiting to continue the talks until the new test results. hVIVO share prices have doubled since the company reported the phase 2b results.
The results come right after BiondVax, another biotech working to advance its own universal flu vaccine, pushed its candidate into phase 3 in Europe. The company has additionally partnered with the U.S. National Institute for Allergy and Infectious Diseases for a phase 2 test in the U.S.
Other companies, including global giants Sanofi and Johnson & Johnson, are also working on advancing flu vaccine technology. FluGen and Vaccitech are among the biotechs with universal flu programs.