The FDA has cleared BlueWillow Biologics’ IND for its BW-1010 intranasal anthrax vaccine, and a Phase 1 trial of the vaccine is planned for later this year, the company said. Earlier this year, BlueWillow (formerly NanoBio) announced that it had received a patent for the anthrax vaccine, which is formulated with the company’s NanoVax adjuvant.
BW-1010 is in development under contract with Porton Biopharma Limited (PBL) and with funding from the National Institute of Allergy and Infectious Diseases (NIAID. PBL said that it has signed a $4.5 million modification to the contract to advance the vaccine into clinical development following clearance of the IND. According to both companies, the full value of the contract if all options are exercised is $24 million.
BlueWillow CEO Dave Peralta said, “The BlueWillow/PBL anthrax vaccine has the potential to provide significant advantages over the current injectable vaccine. Animal studies have demonstrated BW-1010 is safe and elicits protection against anthrax after just one or two vaccinations. In addition, informal stability studies have shown that our vaccine has a shelf life of over five years, compared to three years for the current injectable vaccine. The improved stability of BW-1010 would allow for longer-term storage, potentially saving the U.S. government over $100 million annually.”
PBL Managing Director Roger Hinton commented, “We are delighted that we are able to progress into the clinical phase of the contract and this latest award is a recognition of all the hard work of staff at PBL and its partner Blue Willow, especially in writing, reviewing and gaining approval for the IND from the FDA. This is a pivotal study that builds on the research and development that has been used to progress this novel product to date by PBL and its partners in collaboration with NIAID’s technical team. It is a recognition of the knowledge and expertise within the company and demonstrates the ability of PBL to further deliver on our track record of developing and manufacturing life-saving products for world-wide markets.”
Read the BlueWillow Biologics press release.
Read the Porton Biopharma press release.
