Less than a month after pairing with the NIAID on a Phase II trial of its universal flu vaccine in the U.S., BiondVax ($BVXV) is looking to Hungary for its next trial, this time in conjunction with an overseas public health authority.
The Israeli biotech said on Wednesday that it received regulatory approval to proceed with a Phase IIb trial of its candidate, Multimeric-001 (M-001), in partnership with the EU-funded UNISEC project. Recruitment for the 222-patient study–which will test the safety and immunogenicity of the candidate as a primer to the H5N1 flu vaccine–has begun and results are expected in the second half of next year.
Comprising three university partners, 5 national health institutions, and others, UNISEC brings expertise together for work on recently developed universal flu vaccine concepts.
In early September, BiondVax announced that the NIAID would begin a Phase II trial of M-001 as a primer to be administered several weeks before a pandemic vaccine against the H7N9 avian strain. If the candidate proves useful as a primer, it could strengthen BiondVax’s argument that the shot be included in national stockpiles. The approach, BiondVax says, enables public authorities to be proactive during a pandemic flu outbreak, rather than waiting approximately 6 months to manufacture a traditional strain-specific vaccine.
To date, BiondVax has completed 5 M-001 clinical trials. It raised $9.5 million to fund the candidate’s development through a Nasdaq IPO in June.
The race to develop a universal flu shot, which has been called the “holy grail” in the field, isn’t without attention, leaving BiondVax far from alone in the contest. In August, three organizations–large and small–announced steps forward in developing their candidates. On Aug. 25, Wisconsin-based FluGen said it had raised $12 million to fund an early-stage trial of Redee Flu, just one day after Johnson & Johnson ($JNJ) and The Scripps Research Institute said their most advanced candidate fully protected mice in a lethal challenge.