Date: 2015-11-23
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Arsanis Biosciences (Austria)
Product: ASN100
Action
mechanism: monoclonal antibody. ASN100 was discovered in collaboration with Arsanis’ strategic partner Adimab, using its industry-leading antibody discovery platform. The program has been supported by the Austrian Research Promotion Agency (FFG) from conception to clinical testing. ASN100 is a combination of two monoclonal antibodies, ASN-1 and ASN-2, that together neutralize six clinically important Staphylococcus aureus cytotoxins, including toxins that inflict damage to lung epithelial cells and inhibit an effective immune response. ASN-1 neutralizes alpha-hemolysin (Hla) and four of the five leukocidins, HlgAB, HlgCB, LukSF (also known as Panton-Valentine leukocidin or PVL), and LukED. ASN-2 neutralizes the fifth leukocidin, LukGH (also known as LukAB).
Disease: hospital associated S. aureus infections
Therapeutic area: Infectious diseases
Country: Austria
Trial details:
Latest
news: * On November 23, 2015, Arsanis announced that the first cohort has been initiated in its Phase 1 clinical trial of ASN100, a novel combination of two monoclonal antibodies that target the pathogen Staphylococcus aureus. The study is being conducted in Vienna, Austria, and will examine the safety, tolerability, and pharmacokinetics of ASN100 in healthy volunteers. * On May 23, 2013, Arsanis Biosciences announced that the company has nominated the preclinical development candidates for its lead program, a monoclonal antibody cocktail to prevent and treat severe hospital associated S. aureus infections.
* On January 15, 2015, Arsanis scientists and their collaborators at Adimab have described a unique monoclonal antibody with the potential to treat Staphylococcus aureus infections through the simultaneous neutralization of multiple key toxins produced by S. aureus, including alpha-hemolysin and four additional leukocidins. The findings are published online in the journal mAbs and demonstrate superior in vitro potency compared to antibodies targeting alpha-hemolysin alone (Five birds, one stone: neutralization of alpha-hemolysin and 4 bi-component leukocidins of Staphylococcus aureus with a single human monoclonal antibody.MAbs. 2015;7(1):243-54. doi: 10.4161/19420862.2014.985132). The mAb also shows high protective efficacy from lethal S. aureus infections in several animal models. Arsanis also noted the recent online publication in the American Journal of Respiratory and Critical Care Medicine describing alpha-hemolysin expression as a novel predictive biomarker for S. aureus ventilator-associated pneumonia (VAP) enabling the possibility to identify at risk patients and use prophylactic approaches to prevent the disease. Efforts by others have focused on neutralizing alpha-hemolysin, a major virulence factor that damages several types of human cells. However, recent findings suggest that the concerted actions of several cytotoxins, including the bi-component leukocidins, also play important roles in staphylococcal pathogenesis. Arsanis’ research team has drawn on its extensive infectious disease experience and the company’s partnership with Adimab to develop this unique cross reactive antibody which is incorporated in Arsanis’ lead product candidate, ASN100. ASN100 is currently in preclinical development for GMP manufacture with a leading contract research organization, and Arsanis expects to begin human clinical trials with ASN100 in 2015. Further preclinical programs in Arsanis’ pipeline target MDR (Multi-Drug Resistant) Gram-negative nosocomial infections and severe community acquired infections.
