Innovative Immune Approach To Microbial Diseases
Alopexx is a clinical stage biotechnology company developing novel, broad-spectrum immune therapeutics for the prevention, treatment, and mitigation of bacterial, fungal, and parasitic infections. Unlike all current immune therapeutics encompassing vaccines and monoclonal antibodies that are only effective against a narrow range of microbes expressing the therapeutic’s specific antigenic target, Alopexx’s technology is directed towards the highly conserved surface polysaccharide, poly N-acetyl glucosamine (PNAG), found on over 75 distinct pathogens.
Our fully human monoclonal antibody, F598, targets PNAG, and has been shown to be well tolerated. No serious adverse events were noted in phase 1 and pilot phase 2 trials. We believe it can provide immediate protection lasting 2-3 months. We seek to establish F598 as the standard of care for preventing and ameliorating Gram-negative and Gram-positive bacterial infections along with fungal infections by organisms that express PNAG in patients admitted to intensive care units (ICU).
In a first-in-man trial, our vaccine candidate, AV0328, has been shown to be well tolerated with no serious adverse events observed. It was noted to induce protective antibodies against all PNAG-expressing pathogens tested. We believe our vaccine’s broad-spectrum potential will allow it to be used for the long-term prevention of a wide range of infections, including pneumococcal pneumonia, methicillin-resistant Staphylococcus aureus (MRSA), meningitis, and sexually transmitted diseases.
Utilization of these therapeutics also has potential applicability beyond infectious diseases, including treatment of neurological conditions and cognitive decline due to inflammation.
While the ultimate decision on the safety and efficacy of our therapeutics will be determined by the FDA and other health authorities, it is our management’s assessment that the broad-spectrum potential of our therapeutics will allow them to be used for the prevention, treatment, and mitigation of a wide range of infections.