Cidara Therapeutics has announced it will receive federal backing to advance its influenza preventive CD388, following the reacquisition of rights to the asset last year. The U.S. Department of Health and Human Services’ (HHS) Biomedical Advanced Research and Development Authority (BARDA) has awarded the company up to $339 million to support development and domestic production.
According to Cidara, the multi-year arrangement consists of a base contract with additional option periods. The base period provides $58 million in confirmed funding over 24 months. These funds will be directed toward establishing U.S.-based manufacturing for CD388 as part of the company’s initial commercial supply chain.
The award will also finance a clinical trial comparing a higher-concentration formulation and multiple presentations of CD388, further research into the drug’s activity against pandemic influenza strains in nonclinical models, and the creation of protocols for trials in broader patient populations.
The remaining $281 million in option funding, if exercised by the U.S. government, could support additional studies of CD388 in defined groups of patients. This funding would complement Cidara’s plans for a potential biologics license application (BLA) submission to the U.S. Food and Drug Administration (FDA).
Cidara’s chief executive, Jeffrey Stein, Ph.D., said, “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 BARDA’s involvement would help expand supply capacity and ensure U.S. availability of CD388 in the event of an influenza pandemic.
CD388 is a drug-Fc conjugate (DFC) therapeutic developed as a non-vaccine alternative for flu prevention. Cidara has emphasized that DFCs are not vaccines or monoclonal antibodies. Instead, they are low molecular weight biologics designed to act as long-acting small molecule inhibitors.
CD388 is being developed to protect against all known strains of seasonal and pandemic influenza. Because the therapy does not rely on stimulating an immune response, Cidara has stated that it is expected to be effective regardless of patient immune status.
Cidara reacquired CD388 from Janssen in April of last year after the Johnson & Johnson subsidiary exited infectious disease and vaccine research. At that time, the biotech company paid Janssen $85 million upfront to regain the rights, in addition to potential future payments tied to development, regulatory, and commercial milestones.
The return of the program left Cidara without a major pharmaceutical partner, though it has since taken steps to secure additional funding. Alongside the BARDA contract, the company has drawn support from a private stock placement led by RA Capital Management and other financing initiatives.
CD388 has recently progressed through several stages of clinical development. In June, Cidara reported results from its phase 2b Navigate trial. In that study, the highest tested dose of 450 mg provided 76% protection against seasonal influenza in unvaccinated adults compared to placebo. Lower doses of 300 mg and 150 mg showed protection rates of 61% and 58%, respectively.
The company has since announced plans for a single phase 3 trial intended to support FDA approval. Cidara aims to enroll 6,000 participants, who will receive either the 450-mg dose or a placebo. While the company initially anticipated beginning the study next spring, it later disclosed that the first participants had already been dosed, just one day after confirming its phase 3 strategy.
BARDA’s award to Cidara arrives at a time when the agency is adjusting its portfolio of medical countermeasures. Earlier this year, HHS announced the end of 22 BARDA-funded mRNA vaccine development projects. At the time, HHS Secretary Robert F. Kennedy Jr. said the decision reflected data indicating that mRNA vaccines did not provide effective protection against upper respiratory infections such as COVID-19 and influenza. He stated that funding would be redirected toward platforms with broader and more durable effectiveness.
