Cidara Therapeutics Announces FDA Acceptance of its Investigational New Drug Application for CD388 for Universal Prevention & Treatment of Influenza

Cidara Therapeutics, Inc. recently announced the US FDA has accepted its Investigational New Drug (IND) application for its lead flu drug-Fc conjugate (DFC), CD388 – a highly potent, long-acting antiviral immunotherapy designed to deliver universal prevention and treatment of seasonal and pandemic influenza. Cidara intends to initiate a Phase 1 study in healthy volunteers before the end of the current quarter.

In April 2021, Cidara announced an exclusive worldwide license and collaboration agreement with Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to develop and commercialize Cidara’s Cloudbreak DFCs for the prevention and treatment of seasonal and pandemic influenza. Under the collaboration, Cidara is responsible for the development and manufacturing of CD388 into the clinic and through Phase 2a clinical development, and Janssen is responsible for late-stage development, manufacturing, registration and global commercialization. Janssen will fund the Phase 1 trial-related development costs and all future research, development, manufacturing and commercialization for CD388.

“Receiving this clearance to advance CD388 into the clinic represents an important milestone for Cidara and our Cloudbreak platform. This marks the first opportunity to explore the clinical safety and pharmacokinetics of one of our novel long-acting DFCs,” said Jeffrey Stein, PhD, President and Chief Executive Officer of Cidara. “There is a significant unmet need for true universal prevention and treatment of seasonal and pandemic influenza, especially for those who are immunocompromised or at high risk for severe complications. We look forward to advancing CD388 and our Cloudbreak influenza program through the clinic with our collaborator, Janssen. Later this year, we expect the availability of new preclinical data for our other antiviral DFCs, including RSV and SARS, as well as preclinical data for our oncology DFCs directed against solid tumors.”

Cidara’s Cloudbreak platform is a fundamentally new approach to treat and prevent serious viral infections and solid tumors. Cloudbreak DFCs stably couple a highly potent small molecule or peptide to a proprietary variant of a human antibody fragment (Fc). These long-acting, bispecific DFCs are designed to directly inhibit viral proliferation. In influenza, the CD388 targeting domain is an antiviral that binds to a conserved target on the influenza virus’s surface, conferring universal antiviral activity, thereby suggesting its use in prevention and treatment.

Cidara is developing a new generation of immunotherapeutic antivirals from its Cloudbreak platform that couple potent antivirals to a human antibody fragment (Fc). These highly potent, long-acting drug-Fc conjugates (DFCs) directly inhibit viral proliferation while simultaneously engaging the immune system. DFCs being studied for the prevention and treatment of seasonal and pandemic influenza have the potential to deliver universal protection for an entire flu season. Cidara is also advancing preclinical and discovery DFC programs to target other life-threatening viruses, such as RSV, HIV, and SARS-CoV-2 strains causing COVID-19, as well as oncology diseases.

Influenza (the flu) is a contagious viral infection that can cause mild to severe illness, sometimes resulting in death. It’s caused by influenza viruses that infect the nose, throat and lungs, and can put people, such as older people, children, and people with certain health conditions, at higher risk for complications. While today’s flu vaccines are credited with significant public health benefits and currently offer the best defense against infection, only about 48% of US adults received a vaccine during the 2019-2020 influenza season. Every year, there are an estimated 1 billion cases of influenza, resulting in 290,000 to 650,000 influenza-related respiratory deaths.

Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The company’s portfolio is composed of new approaches aimed at transforming existing prevention and treatment paradigms, first with its lead Phase 3 antifungal candidate, rezafungin, in addition to drug-Fc conjugates (DFCs) targeting viral and oncology diseases from Cidara’s proprietary Cloudbreak platform. Cidara is headquartered in San Diego, CA. For more information, visit www.cidara.com.