Cidara wins BARDA award worth $339M to onshore flu therapeutic manufacturing

Cidara Therapeutics, a biotechnology company headquartered in San Diego, said it has secured an award valued up to $339 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services.

The multi-year contract includes base funding of $58 million over 24 months to onshore manufacturing of CD388, the company’s lead drug-Fc conjugate candidate for influenza prevention. Cidara said the funding will also support a clinical trial to demonstrate comparability of a higher-concentration formulation and additional presentations of CD388, as well as studies to further characterize its activity against pandemic influenza strains and begin development of trial protocols for expanded populations.

The U.S. government could exercise option periods valued at up to $281 million to fund additional clinical and non-clinical studies in specific populations. Cidara said these activities would complement its plans for a potential Biologics License Application submission to the U.S. Food and Drug Administration.

“Clinical and non-clinical data generated to date suggest that CD388 has the potential to be an effective non-vaccine preventative for both pandemic and seasonal influenza,” Cidara CEO Jeffrey Stein said in a statement. “We welcome BARDA’s partnership that will enable us to accelerate domestic supply options for CD388 production. This will both expand our commercial supply capacity, as well as ensure U.S. supply of CD388 in the event of an influenza pandemic.”