Cidara Secures $339M BARDA Funding for Non-Vaccine Flu Preventative as U.S. Shifts Away from mRNA

Cidara Therapeutics has landed a substantial federal contract to develop and manufacture its innovative non-vaccine flu preventative, CD388, in the United States. The deal comes as the U.S. government reevaluates its approach to influenza protection, moving away from mRNA-based technologies.

BARDA Awards Cidara Up to $339M for CD388 Development

The Biomedical Advanced Research and Development Authority (BARDA) has granted Cidara Therapeutics an award worth up to $339 million to support the development and domestic production of CD388, the company's non-vaccine flu preventative candidate. The initial $58 million, to be disbursed over two years, will primarily fund the establishment of U.S.-based manufacturing capabilities and help Cidara set up its initial commercial supply chain.

Jeffrey Stein, Ph.D., Cidara's chief executive, emphasized the potential of CD388, stating, "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." He added that the BARDA partnership would "both expand our commercial supply capacity, as well as ensure U.S. supply of CD388 in the event of an influenza pandemic."

The remaining $281 million in potential funding is earmarked for additional studies of CD388 in specific populations, complementing Cidara's plans for an FDA approval application.

CD388: A Novel Approach to Flu Prevention

CD388 represents a departure from traditional vaccine and monoclonal antibody approaches to flu prevention. As a drug-Fc conjugate, it combines multiple copies of a potent small molecule neuraminidase inhibitor with a custom Fc fragment of a human antibody. This low molecular weight biologic is designed to function as a long-acting small molecule inhibitor, potentially offering protection against all known strains of seasonal and pandemic influenza.

Crucially, as CD388 is not a vaccine, it is expected to be effective regardless of a patient's immune status. This characteristic could make it a valuable tool in protecting vulnerable populations who may not respond well to traditional flu vaccines.

Recent clinical data has bolstered confidence in CD388's potential. In the phase 2b Navigate study, the highest 450 mg dose of CD388 demonstrated 76% protection against seasonal influenza in unvaccinated adults compared to placebo. Lower doses of 300 mg and 150 mg showed 61% and 58% protection, respectively.

Building on these promising results, Cidara has initiated an accelerated development plan, including a single phase 3 study aiming to enroll 6,000 subjects. The company has already dosed the first participants in this pivotal trial.

Shifting Landscape of U.S. Influenza Prevention Strategy

The substantial BARDA investment in Cidara's non-vaccine approach comes amid a significant shift in U.S. health policy. Earlier this year, the Department of Health and Human Services (HHS) under Robert F. Kennedy Jr.'s leadership announced the termination of 22 mRNA vaccine development investments previously funded by BARDA.

Kennedy explained the decision, stating, "BARDA is terminating 22 mRNA vaccine development investments because the data show these vaccines fail to protect effectively against upper respiratory infections like COVID and flu. We're shifting that funding toward safer, broader vaccine platforms that remain effective even as viruses mutate."

This policy change reflects a broader reevaluation of the nation's approach to influenza prevention, with increased interest in alternatives to traditional vaccine technologies. Cidara's CD388, as a non-vaccine preventative, aligns with this new direction, potentially offering a more adaptable solution to the challenge of influenza protection.