Porton Biopharma Ltd (PBL) has today announced that it has signed a modification to its contract (HHSN272201600045C) with the US National Institute of Health’s National Institute of Allergy and Infectious Diseases (NIAID) to advance a next-generation intra-nasal anthrax vaccine into the clinical-trial phase. The contract modification is worth $4.5 million and follows approval by the US Food and Drug Administration (FDA) of the investigational new drug (IND) application.

PBL is working with US clinical-stage company Blue Willow (Ann Arbor Michigan) who will be responsible for the execution of the clinical study.  The phase 1 clinical study is expected to begin enrolment this year and combines Blue Willow’s novel intra-nasal NanoVax^® system with PBL’s recombinant protective antigen for anthrax.  The combination of technologies produces 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

PBL’s contract supports the advanced development of candidate vaccine components and technologies that accelerate the immune responses for use in post-event settings following the intentional release of the Category A priority pathogen Bacillus anthracis, the bacterium that causes the disease anthrax, or in response to naturally occurring outbreaks of the disease.

The total costs of the work being performed under contract HHSN272201600045C is 100% financed by NIAID.  The total value of the contract could be worth up to $24 million over its eight-year term if all options are exercised.

Commenting on the award, Dr Roger Hinton Managing Director of PBL said: “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 worldwide markets.”