The U.S. government has continued to seek out new, better anthrax vaccines despite the availability of Emergent BioSolutions’ Biothrax. Now, BlueWillow Biologics, working with Porton Biopharma, has delivered phase 1 data on a nasal vaccine it argues has advantages over other options.
The trial randomized 84 healthy volunteers to receive one of two doses of BW-1010 via a sprayer or pipette, a placebo or an active control. The study is looking at the frequency of solicited systemic and local reactions in the 39 days after dosing, adverse events out as far as Day 393 and changes in the levels of neutralizing antibodies at Day 57 and Day 85. Researchers will compare the two time points to “identify the optimum timing of peak immuneresponse following nasal vaccination.”
BlueWillow shared little information about how the vaccine performed in its interim analysis. Giving two intranasal doses four weeks apart was found to be safe and well tolerated, BlueWillow said, and “induced systemic and mucosal immunity as evidenced by levels of neutralizing systemic antibodies, nasal IgA/IgG and Th17 response in peripheral blood cells.”
The study is set to wrap up in the fall. BlueWillow plans to take the anthrax vaccine through further clinical trials after getting a look at phase 1 data, positioning it to find out whether BW-1010 has a future in a space targeted by multiple other companies.
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Biothrax is the only FDA-approved vaccine today, but, backed by the U.S. government, other companies are working to add to defenses against the biological weapon. Emergent has a prospect that combines Biothrax and an immunostimulatory compound in phase 2 and 3 clinical trials, while Altimmune has a single-dose nasal vaccine in earlier-phase development.
The Altimmune prospect, NasoShield, potentially offers the same nasal delivery benefits as BW-1010 does with a simpler dosing schedule. NasoShield, which recently completed phase 1b, is covered by a U.S. government contract that could be worth up to $133.7 million.