Biopharmaceutical company BlueWillow Biologics said on Wednesday that the US Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for BW-1010, the company's next-generation anthrax vaccine candidate.

With funding from the National Institute of Allergy and Infectious Diseases (NIAID), an institute within the National Institutes of Health (NIH), the company now plans to begin enrolment for a Phase 1 clinical study this year.

Development of an intranasal anthrax vaccine is ongoing through BlueWillow's eight-year partnership with Porton Biopharma Limited (PBL) under NIAID contract #HHSN272201600045C.

The vaccine combines BlueWillow's novel intranasal NanoVax system with recombinant protective antigen (rPA) for anthrax from PBL. The NanoVax platform employs a proprietary oil-in-water nanoemulsion adjuvant that elicits both systemic and mucosal immunity, uniquely enabling protection against challenging respiratory infections such as anthrax, the company said.

Anthrax is listed as a Category A priority pathogen by NIAID, indicating the biological agent poses the highest possible risk to national security and public health. Anthrax-causing bacteria can cause severe illness and death and pose a massive threat in bioterrorism.