BioNTech Starts Dosing In Herpes Vaccine Candidate Study

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  • 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.
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