The first-in-man Phase I clinical trial of the EpCAM-targeting immunotoxin MOC31PE
Yvonne Andersson and colleagues at the Department of Tumor Biology and Department of Oncology at OUS have performed the first-in-man Phase I clinical trial of the EpCAM-targeting immunotoxin (IT) MOC31PE.
The work - entitled “Phase I trial of EpCAM-targeting immunotoxin MOC31PE, alone and in combination with cyclosporin” - is published in British Journal of Cancer.
There is a long history of in-house production of ITs at the Tumor Biology Department, and many in vitro and in vivo studies on mechanisms of action and anti-cancer effects of ITs have been undertaken under the supervision of Professor Fodstad.
In the present clinical study, the authors (Andersson, Engebraaten, Juell, Aamdal, Brunsvig, Fodstad and Dueland) demonstrate that MOC31PE can safely be administered intravenously to the patients, and the data suggests a new strategy in combining IT treatment with cyclosporin (CsA, Sandimmune®). CsA efficiently delayed the anti-IT antibody response when the IT was administered repeatedly, implying that CsA may be useful in the clinic to prevent a humoral immune response against this and similar types of therapeutics.
The combination allows repeated administration of MOC31PE, which is considered to be a necessity for significant anti-cancer effects in non-hematological cancer.
The successful phase I trial warrants a phase II study to further examine the potential of MOC31PE as a new EpCAM-targeting anti-cancer drug.
Links:
Andersson Y, Engebraaten O, Juell S, Aamdal S, Brunsvig P, Fodstad Ø, Dueland S (2015)
Phase I trial of EpCAM-targeting immunotoxin MOC31PE, alone and in combination with cyclosporin
Br J Cancer (in press)
PubMed 26554649 PDF