Cidara Therapeutics to Present on CD388 Drug-Fc Conjugate at IDWeek 2024

SAN DIEGO, Oct. 16, 2024 – Cidara Therapeutics, Inc., a biotechnology firm listed on Nasdaq under CDTX, is set to present pivotal clinical data at IDWeek 2024, which is scheduled to take place from October 16 to October 19 in Los Angeles, California. The key focus will be on their clinical-stage influenza drug-Fc conjugate (DFC) asset, CD388, noted for its promising safety and preventive efficacy against influenza.

Jeffrey Stein, Ph.D., the president and CEO of Cidara, expressed optimism about presenting the clinical data. "We are excited to showcase these clinical findings which highlight the potential of CD388 as an effective DFC for season-long influenza prevention with a single dose," he stated. Stein also indicated plans to share further results from the ongoing NAVIGATE Phase 2b trial of CD388 at future events.

The first significant presentation entitled “CD388, a Novel Drug-Fc Conjugate (DFC), Demonstrates Prophylactic Activity in an Influenza Human Challenge Model,” will be delivered by Dr. Taylor Sandison of Cidara Therapeutics. This presentation is part of the "Inhaling Insight: Advancements in Respiratory Viral Infections" session, scheduled for October 19, from 2:21 to 2:39 PM Pacific Time. The analysis in this study shows that a single subcutaneous dose of CD388, given five days before exposure to influenza, effectively prevented symptomatic illness in participants who developed antibodies following the influenza challenge.

Additionally, another presentation will cover the “Single-Dose and Repeat Single-Dose Ascending Dose Study Evaluating Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Intramuscular CD388.” Presented by Shawn Flanagan, Ph.D., this will take place on October 18, from 12:15 to 1:30 PM Pacific Time. This study assessed the safety, tolerability, and pharmacokinetics of CD388 when administered either subcutaneously or intramuscularly at varying doses in healthy subjects. Results showed that the drug was rapidly absorbed via both methods, with slow elimination, suggesting a single seasonal dose may suffice for influenza prevention. Additionally, the lack of anti-drug antibody formation with repeat doses supports the drug's potential for annual use without significant safety concerns.

CD388 stands out as an investigational DFC designed to provide universal protection against all known strains of both seasonal and pandemic influenza. Unlike traditional vaccines, CD388 operates independently of the immune response, making it potentially effective regardless of an individual’s immune status. It incorporates multiple copies of a potent neuraminidase inhibitor conjugated to a proprietary Fc fragment of a human antibody, functioning as a long-acting small molecule inhibitor.

Cidara Therapeutics, based in San Diego, California, is leveraging its Cloudbreak® platform to develop innovative DFCs that target small molecules or peptides to a proprietary human antibody fragment (Fc). CD388, their lead DFC candidate, aims to provide universal, single-dose prevention of seasonal and pandemic influenza by directly inhibiting viral proliferation. CD388 received Fast Track Designation from the U.S. Food and Drug Administration (FDA) in June 2023, and a Phase 2b trial commenced in September 2024. Cidara is also expanding its DFC portfolio to oncology, with CBO421 targeting CD73 in solid tumors, which received IND clearance in July 2024.