BioNTech Starts Dosing In Herpes Vaccine Candidate Study

BioNTech SE BNTX has dosed in a first-in-human Phase 1 clinical research study with BNT163, a herpes simplex virus (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.
According to the World Health Organization, approximately 500 million people globally are estimated to be affected by genital infections caused by HSV-2.
No vaccine has been approved for the prevention of genital lesions caused by HSV to date. Currently, available HSV therapies only reduce the severity and frequency of symptoms.
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 a current or history of symptomatic genital herpes infections in the U.S.
In 2018, the University of Pennsylvania and BioNTech entered a research collaboration and license agreement to develop novel mRNA vaccine candidates for the prevention and treatment of various infectious diseases.
Under the terms of the agreement, BioNTech can obtain an exclusive worldwide license to further develop and commercialize product candidates arising from the research collaboration.
After completing all IND-enabling studies, BNT163 is the first candidate from this collaboration to enter the clinic.
Price Action: BNTX shares are up 1.68% at $175.60 on the last check Wednesday.