BioNTech doses first patient in Phase 1 clinical research study with BNT163

BioNTech announced that the first subject was dosed in a first-in-human Phase 1 clinical research study with BNT163, a herpes simplex virus, or HSV, vaccine candidate for the prevention of genital lesions caused by HSV-2 and potentially HSV-1. The trial will evaluate the safety, tolerability, and immunogenicity of BNT163. The mRNA vaccine encodes three HSV-2 glycoproteins with the aim of helping to prevent HSV cellular entry and spread, as well as counteract the immunosuppressive properties of HSVs. BioNTech’s placebo-controlled, observer blinded, dose-escalation Phase 1 trial is expected to enroll around 100 healthy volunteers aged 18 to 55 years without current or history of symptomatic genital herpes infections in the U.S. The study consists of a first dose escalation part that will focus on safety evaluations and assess the optimal dose-response in various dose levels. The second part of the trial is designed to expand the safety characterization for the selected dosing of BNT163 for a more comprehensive assessment of the impact of pre-existing immunity to HSV-1 and -2 on the safety and BNT163-induced immune responses.