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Porton Biopharma signs potential $24m deal to push its intranasal anthrax vaccine into Phase 1 trials

pharmafile | October 22, 2019 | News story | Manufacturing and Production, Research and Development FDA, Porton Biopharma, anthrax, pharma 

Porton Biopharma has signed a modification to its existing agreement with the US National Institute of Health’s National Institute of Allergy and Infectious Diseases (NIAID) worth $4.5 million to take its intranasal anthrax vaccine into Phase 1 clinical trials.

The news follows acceptance by the FDA of the investigational new drug application submitted by the company. The trial is set to bring together Porton Biopharma’s recombinant protective anthrax antigen and clinical-stage firm Blue Willow’s novel intranasal NanoVax system, delivering “a more effective product than currently licensed vaccines by enabling immunity to be achieved in fewer doses and via intra-nasal delivery, instead of injection”. Blue Willow will also handle the execution of the study.

The trial, which under the contract will be entirely financed from NIAID, is potentially worth up to $24 million if all options are exercised over its eight-year duration.  

“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,” commented Dr Roger Hinton Managing Director of Porton Biopharma. “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.”  

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