Cidara Therapeutics has selected the antiviral conjugate (AVC) CB-012 as its first clinical development candidate from the company’s Cloudbreak influenza antiviral program.
Data supporting the selection will be presented on April 15 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.
“The data clearly demonstrate the potential for CB-012 as either a long-acting preventative or fast-acting therapy with potent activity against seasonal and pandemic strains of influenza. A single molecule which links a potent antiviral drug with a long-acting immune system engager has the potential for important advantages over traditional vaccines and therapies,” said Jeffrey Stein, PhD, president and chief executive officer of Cidara. “We are committed to advancing our portfolio of promising development candidates, including CB-012, and are progressing IND-enabling studies this year.”
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.
Today’s 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
“The data being presented today at ECCMID suggest CB-012 could provide longer, effective protection for patients from the influenza virus as compared to current standards of care,” said Les Tari, PhD, senior vice president of research for Cidara, and presenter of the CB-012 data at ECCMID. “We believe Cloudbreak AVCs offer an exciting new approach in the global fight against seasonal and pandemic influenza.”