Data supporting the selection will be presented in an oral session at the 29th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).
CB-012 is a novel conjugate of a highly potent antiviral agent linked to a human antibody fragment.
Applying the principles of oncology immunotherapy, Cidara's Cloudbreak AVCs attack influenza through a dual mechanism: The antiviral agent neutralizes the influenza virus directly, while the human antibody fragment engages a patient's immune system to accelerate elimination of the pathogen.
The approach is designed to improve on, and combine, the preventive effects of vaccination with an antiviral drug's capability to treat flu illness.
Cidara's vision is that a single dose of an AVC could prevent influenza for an entire flu season, with or without concurrent vaccine administration, cover strains that are missed by vaccines in any given year, and be effective even in people with decreased immune function.
The ECCMID presentation describes results from nonclinical studies, which evaluated the potential of CB-012 for the treatment and prevention of seasonal and pandemic influenza A as well as influenza B infections. Key findings suggest CB-012 offers:
Superior in vitro activity compared to standard-of-care antivirals and coverage of both influenza A and B viruses
Full protection from, or treatment of, H1N1, H3N2, and Tamiflu- (oseltamivir) resistant H1N1-related infections with a single dose of CB-012 in preclinical efficacy models
Long half-life in multiple preclinical species
Efficacy in multiple dosing formulations including intravenous, subcutaneous and intramuscular
Expanded treatment window in preclinical models to 72 hours post-infection versus Tamiflu (oseltamivir), which loses its ability to protect when administered beyond 24 hours post-infection
Influenza, or flu, is a respiratory infection caused by influenza viruses. The flu virus can cause mild to severe illness and, at times, can lead to death.
Young children, the elderly (people aged 65 years and older), pregnant women and immunocompromised patients are more prone to infection, but even healthy people are at risk of infection with seasonal flu.
While influenza vaccines are critical to global health, they have limited efficacy and must be redesigned every year as scientists attempt to predict the next season's dominant circulating strains.
On average, vaccines are only 40% effective, with lower rates in young children and the elderly. The US Centers for Disease Control and Prevention estimates that as many as 646,000 people may die from influenza each year worldwide.
According to CDC estimates for the United States, approximately 50 m people became ill from the flu and almost 80,000 people died in the 2017-18 season alone.
Cidara is a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives that have the potential to transform the standard of care and save or improve patients' lives.
Cidara is currently advancing its novel echinocandin antifungal, rezafungin acetate, in a Phase 3 clinical trial for the treatment of candidemia and invasive candidiasis, and continues to discuss with regulatory authorities its plans for the design and the initiation of a second Phase 3 trial in the prophylaxis of invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation.
According to the company, Rezafungin is the only once-weekly product candidate in development for the treatment and prevention of life-threatening invasive fungal infections.
Cidara also is leveraging its proprietary Cloudbreak platform to develop antiviral conjugates for serious infections, including further investigation of the high potency and long half-life observed in its AVCs for influenza.
The Cloudbreak platform is designed to discover compounds that both directly kill pathogens and direct a patient's immune system to attack and eliminate pathogens. Cidara is headquartered in San Diego, California.
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