- BioNTech SE (NASDAQ: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.
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