Universities of Erlangen, Würzburg & Regensburg

4-Antibody’s most advanced antibody development program is in the area of viral diseases. This program started in 2006 as an R&D collaboration with expert immunologists and virologists of the University of Erlangen and resulted in the generation of a best-in-class, fully human antibody product targeting the human Cytomegalovirus (hCMV).

hCMV is an opportunistic viral pathogen that leads to a life-long latent infection in 50-80% of the human population, depending on geographic location and socio-economic background. The infection with hCMV usually occurs early in life and remains asymptomatic in individuals with a normal and functional immune system. However, the virus is never cleared by infected individuals.

hCMV leads to major, and sometimes life-threatening infections in patients with a compromised immune system, for example, in patients undergoing organ or bone marrow/stem cell transplantations under immunosuppressive treatments designed to prevent graft rejection. In such patients hCMV infection is a major cause of morbidity and mortality.

Lastly, hCMV infection is a major medical problem in women who become infected with hCMV for the first time during pregnancy. In such cases, hCMV infection can have detrimental effects on the unborn child and this can lead to a whole spectrum of severe disabilities in newborns ranging from deafness, blindness, to mental retardation, and can even lead to loss of the foetus. Despite the fact that according to statistics published by the U.S. Centers of Disease Control (CDC) in Atlanta, hCMV infections are the major cause of child disabilities (even topping Down’s syndrome and fetal alcohol syndrome), there is no treatment option available for this patient group, and prophylactic vaccines are not yet available against hCMV.

Together with expert immunologists and virologists at the University of Erlangen, 4-Antibody has developed highly potent, and, we believe, ‘best-in class’ hCMV neutralizing fully human antibodies that recognize a novel, functional epitope on one of the major envelope proteins of hCMV, (the gB protein).

The most potent lead antibody, 4Ab-028, is currently entering IND-enabling preclinical and clinical development for the indication of bone-marrow and stem cell patients with high risk of hCMV infection. This clinical development program is being planned as a collaborative effort with expert clinical hematologists and transplant centers at the German universities of Erlangen, Würzburg and Regensburg.

Intellectual Property and commercialization rights for the lead compound are fully owned by 4-Antibody.