reports
- Dr Jonas Peciulis
- Positive Phase IIb, preparing for pivotal Phase III
Following the positive Phase IIb trial results with universal flu vaccine, M-001, BiondVax is now preparing to initiate a Phase III study, which will likely evaluate M-001 as a universal, standalone vaccine – another major strategic decision by BiondVax – as opposed to a stepwise approach to develop M-001 as a primer and then as a standalone vaccine. A universal, standalone flu vaccine indication is the most lucrative and the pivotal trial could start in 2018. We increase our valuation of BiondV...
- Dr Jonas Peciulis
- New funds to support M-001’s Phase III initiation
The €20m loan agreement with the European Investment Bank (EIB) is a game changing event for BiondVax, we believe. The agreement was signed on 19 June 2017 and over the next three years the company will be able to drawdown all the money presuming the development milestones related to the lead universal flu vaccine candidate M-001 are met. BiondVax now aims to initiate Phase III activities and also invest in a new manufacturing facility securing the supply of M-001 for the remaining development a...
- Dr Jonas Peciulis
- Phase IIb with universal flu vaccine readout close
BiondVax’s FY16 business update reiterated that the company and its partners are on track to deliver full results from the ongoing Phase IIb trial with multimeric vaccine candidate M-001 by end Q217. According to plans, the US National Institutes of Health (NIH) will initiate the last Phase II study with M-001 in 2017, which will pave the way for partnering and the Phase III programme. Currently BiondVax is a leader in the development of a universal influenza vaccine. Our valuation is increased ...
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