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.
|BiondVax CEO Ron Babecoff|
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.
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