Herpes Vaccine Candidate Advances in 2023

When BioNTech SE announced that the first person was dosed in a first-in-human Phase 1 clinical trial with BNT163, a herpes simplex virus (HSV) vaccine candidate for the prevention of genital lesions caused by HSV-2 and potentially HSV-1, there was much enthusiasm generated by millions of people.

BioNTech's placebo-controlled, observer-blinded, two-dose-escalation study was launched on December 8, 2022, and is expected to enroll around 108 healthy adult volunteers.

This first-in-human HSV vaccine study was last updated on January 5, 2023.

However, it is scheduled for a June 2025 completion date.

BNT163 is not the only herpes vaccine candidate conducting early-stage research.

Still, it is the only mRNA vaccine that encodes three HSV-2 glycoproteins to help to prevent HSV cellular entry and spread, as well as counteract the immunosuppressive properties of HSVs.

"My colleagues and I are proud to have contributed to the early development and preclinical testing of this exciting new mRNA vaccine candidate that may have the potential to prevent people from contracting the virus," commented Prof. Harvey M. Friedman, M.D., Professor of Infectious Diseases at the University of Pennsylvania's Perelman School of Medicine, in a press release.

Dr. Friedman conducted preclinical and discovery science work on HSV and is the University's principal investigator for the preclinical discovery and enabling studies.

The U.S. Centers for Disease Control and Prevention (CDC) recently estimated that there were 572,000 new genital herpes infections in a year.

Throughout the U.S., about 12% of persons aged 14 to 49 have an HSV-2 infection.

From a herpes treatment perspective, research recently indicated about 15 vendors were participating in the herpes treatment market, which is valued at over three billion dollars annually.

Acyclovir and Valtrex® have significant shares in the pharmacy segment.

And United BioPharma is developing UB-621 as a first-in-class anti-gD monoclonal antibody candidate with demonstrated viral suppression of transmission and recurrence of HSV-1 and HSV-2. 

This HSV antibody candidate's phase 2 study was last updated on May 18, 2022.

Updated herpes vaccine candidates and treatment news are posted at PrecisionVaccinations.com/Herpes.