Pharma Focus Europe

BioNTech Starts Phase 1 Clinical Trial for Prophylactic Herpes Simplex Virus-2 Vaccine Candidate BNT163

Thursday, December 22, 2022

BioNTech SE announced that the first subject was 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 (NCT05432583) 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.

According to the World Health Organization (“WHO”), approximately 500 million people globally are estimated to be affected by genital infections caused by HSV-2,1 with painful genital lesions, an increased risk for meningitis and high levels of emotional distress. Once acquired, HSV persists lifelong in the body with reoccurring symptomatic outbreaks. Moreover, HSV-2 infection increases the risk of acquiring HIV infections by approximately three-fold, and co-infections with both HIV and HSV-2 increase the likelihood of transmitting HIV to others according to the WHO.2 No vaccine has been approved for 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 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.

“This program is part of our strategy to help address diseases with a high unmet medical need and of global health relevance by combining our new technologies such as mRNA and our expertise in immune engineering,” said Prof. Özlem Türeci, M.D., Chief Medical Officer and Co-Founder of BioNTech. “BNT163 is based on three non-infectious mRNA-encoded HSV-2 glycoproteins. We aim to induce a broad immune response which is directed against multiple antigens of the virus and mobilizes various immune effectors to support virus neutralization and clearance.”

“HSV-2 is a very challenging and life-altering disease which can only be partially prevented. 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,” said Prof. Harvey M. Friedman, M.D., Professor of Infectious Diseases at the University of Pennsylvania’s Perelman School of Medicine, who conducted preclinical and discovery science work on HSV and is the University of Pennsylvania’s principal investigator for the preclinical discovery and IND-enabling studies.

In 2018, Penn 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 completion of all IND-enabling studies, BNT163 is the first candidate from this collaboration to enter the clinic.

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