Cidara Therapeutics Announces Publication of CD388 Preclinical Data in Nature Microbiology
Data highlights potential of CD388 as a potent, universal antiviral for influenza prevention regardless of immune status
SAN DIEGO, March 17, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies, today announced the publication of preclinical data assessing CD388, the company's influenza DFC, in the peer-reviewed scientific journal Nature Microbiology. The article, entitled "Drug-Fc Conjugate CD388 targets influenza virus neuraminidase and is broadly protective in mice," highlights the potential of CD388 as a potent, universal preventative for influenza A and B in healthy and high-risk populations.
"This publication, combined with the promising clinical data we've generated to date, further validates our Cloudbreak DFC platform and the potential of CD388 to offer universal protection against both seasonal and pandemic influenza strains," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "While vaccines play a vital role in flu prevention, they do not offer sufficient protection, particularly for immune-compromised individuals, underscoring the critical need for a durable, broadly acting antiviral like CD388. We look forward to the results of our ~5,000 subject Phase 2b NAVIGATE study that is evaluating CD388 during the particularly severe 2024-2025 flu season."
Les Tari, Ph.D., chief scientific officer of Cidara added, "DFCs are a unique drug modality with the potential to enhance the efficacy and safety of targeted small molecules, while combining them with the long half-lives of monoclonal antibodies. These preclinical data indicate that CD388's efficacy is driven by the intrinsic antiviral activity of the drug, potentially enabling it to work as a long-term preventative against influenza regardless of immune status."
Key Findings
- The publication describes CD388 and its potential for universal activity across influenza A and B viruses in cellular and animal models.
- Administration of CD388 resulted in the following:
- Potent, universal activity against all influenza A and B virus strains, including high pathogenicity strains like H5N1, also known as avian influenza or bird flu, and strains that are resistant to approved neuraminidase inhibitors
- Low potential for resistance development
- Efficacy at similar exposures in immune-competent and immune-compromised lethal challenge models in mice demonstrating that efficacy is driven predominantly by the intrinsic antiviral activity of CD388
- Administration of CD388 resulted in the following:
CD388 is currently under clinical evaluation in the ~5000 patient Phase 2b NAVIGATE trial, evaluating CD388 for the single-dose prevention of seasonal influenza in healthy unvaccinated adult subjects.
About CD388
CD388 is an investigational drug-Fc conjugate (DFC) comprising multiple copies of a potent small molecule neuraminidase inhibitor stably conjugated to a proprietary Fc fragment of a human antibody. DFCs are not vaccines or monoclonal antibodies but are low molecular weight biologics which are designed to function as long-acting small molecule inhibitors. CD388 was designed to provide universal protection against all known strains of seasonal and pandemic influenza with the potential to provide season-long protection with a single subcutaneous or intramuscular administration. Importantly, because CD388 is not a vaccine, its activity is not reliant on an immune response and thereby is expected to be efficacious in individuals regardless of immune status. More information can be found at: https://www.cidara.com/cloudbreak/influenza/
About Cidara Therapeutics
Cidara Therapeutics is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs) comprising targeted small molecules or peptides coupled to a proprietary human antibody fragment (Fc). Cidara's lead DFC candidate, CD388, is a long-acting antiviral designed to achieve universal prevention of seasonal and pandemic influenza with a single dose by directly inhibiting viral proliferation. In June 2023, CD388 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA), and the Company announced completion of Phase 2b enrollment in December 2024. Additional DFCs have been developed for oncology and in July 2024 Cidara received IND clearance for CBO421 which is intended to target CD73 in solid tumors. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.
Forward-Looking Statements
This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "anticipates," "expect," "intends," "believes," "may," "plan" or "will". Forward-looking statements in this release include, but are not limited to, statements related to the potential of and future plans for CD388, whether and when we will complete our Phase 2b NAVIGATE trial, and whether animal data will be predictive of safety or effectiveness of CD388 in prevention of influenza infection in humans. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara's clinical trials and other risks related to clinical development, delays in action by regulatory authorities, other obstacles on the enrollment of patients or other aspects of CD388 or other DFC development, the impacts of the realignment and restructuring being different than expected and other risks and uncertainties associated with Cidara's business in general. These and other risks are identified under the caption "Risk Factors" in Cidara's most recent Quarterly Report on Form 10-Q and other filings subsequently made with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.
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