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CAL02 is a first-in-class, clinical-stage broad-spectrum anti-toxin therapy that acts as a decoy to neutralize damaging toxins, to treat severe infections and fight antibiotic resistance or improve antibiotic efficacy.

CAL02 is a novel drug consisting of empty liposomes that neutralize a broad variety of bacterial toxins, with the potential to combat bacterial infections in a large spectrum of infectious diseases such as pneumonia, nosocomial infections, meningitis, and sepsis, including those caused by the most frequent and clinically-relevant bacterial strains, including Gram-positive and Gram-negative bacteria regardless of their antibiotic resistance profile. This broad-spectrum activity allows the drug to overcome the hurdles caused by the heterogeneity in bacterial virulence factors.

The drug effectively neutralizes virulence factors produced by Staphylococcus aureus, Streptococcus pneumoniae, Pseudomonas aeruginosa and various other streptococcal or clostridium strains. It is therefore active against the most frequent bacteria - including antibiotic-resistant pathogens (e.g. MRSA) - that cause severe infections such as community- and hospital-acquired pneumonia, ventilator-associated pneumonia, other nosocomial infections and meningitis.

Furthermore, CAL02 does not display any direct bactericidal activity and therefore does not impose any selective pressure on bacterial growth, conferring the key advantage of steering clear of the emergence of bacterial resistance.

CAL02 is currently being tested in Europe in a randomised, multicentre, multinational, double-blind, placebo-controlled, Phase I/IIa study aiming at assessing the safety, tolerability, and efficacy of CAL02 as adjunctive therapy to standard of care in ICU patients with severe pneumonia caused by Streptococcus pneumoniae.



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Henry BD et al. Engineered liposomes sequester bacterial exotoxins and protect from severe invasive infections in mice. Nature Biotechnology, 2015 Jan; 33(1):81-8, doi:10.1038/nbt.3037.