BioNTech Starts Phase 1 Clinical Trial for Prophylactic Herpes Simplex Virus-2 Vaccine Candidate BNT163
December 21 2022 - 6:45AM
- First-in-human study aims to evaluate the safety and
immunogenicity of prophylactic herpes virus vaccine candidate
BNT163
- BNT163 is the first candidate from BioNTech’s infectious
disease mRNA vaccine collaboration with the University of
Pennsylvania to enter the clinic
- The program is part of BioNTech’s strategy to address diseases
with high unmet medical need, as no vaccine has been approved for
prevention of genital lesions caused by HSV
MAINZ, Germany, December 21, 2022 –
BioNTech SE (Nasdaq: BNTX, “BioNTech” or the "Company”) today
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.
Editor’s Note: The University of
Pennsylvania has licensed some intellectual property related to the
BNT163 vaccine candidate to BioNTech. The University of
Pennsylvania receives sponsored research funding from BioNTech
related to preclinical development of the BNT163 vaccine candidate.
As inventors of certain intellectual property related to the BNT163
vaccine candidate, some of the scientists involved in the
preclinical development of the candidate along with Penn, may
receive additional financial benefits under the BioNTech license in
the future.
About Herpes Simplex VirusHerpes Simplex
Virus-1 (HSV-1) and Herpes Simplex Virus-2 (HSV-2) cause two highly
prevalent viral infections globally. Up to 95% of the global
population are estimated to be infected by herpes with most of the
infections remaining asymptomatic, but symptoms of herpes include
painful blisters or ulcers that can recur over time.3 HSV-1 is
mainly transmitted by oral contact and causes lesions around the
mouth but in some cases can also lead to genital infections and
respective lesions. HSV-2 is a sexually transmitted disease that
causes genital herpes. Both viruses are highly contagious and can
also be transmitted during childbirth. Infections with HSV-2
further increase the risk of acquiring and transmitting HIV
infections. As neurotropic and neuroinvasive viruses, HSV-1 and -2
persist in the body by hiding from the immune system in the cell
bodies of neurons where they reside lifelong, and thus cannot be
eradicated with current treatments.
About BioNTechBiopharmaceutical New
Technologies is a next generation immunotherapy company pioneering
novel therapies for cancer and other serious diseases. The Company
exploits a wide array of computational discovery and therapeutic
drug platforms for the rapid development of novel
biopharmaceuticals. Its broad portfolio of oncology product
candidates includes individualized and off-the-shelf mRNA-based
therapies, innovative chimeric antigen receptor T cells, bispecific
immune checkpoint modulators, targeted cancer antibodies and small
molecules. Based on its deep expertise in mRNA vaccine development
and in-house manufacturing capabilities, BioNTech and its
collaborators are developing multiple mRNA vaccine candidates for a
range of infectious diseases alongside its diverse oncology
pipeline. BioNTech has established a broad set of relationships
with multiple global pharmaceutical collaborators, including
Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron,
Genevant, Fosun Pharma, and Pfizer. For more information, please
visit www.BioNTech.com.
BioNTech Forward-Looking StatementsThis
press release contains “forward-looking statements” of BioNTech
within the meaning of the Private Securities Litigation Reform Act
of 1995. These forward-looking statements may include, but may not
be limited to: the collaboration and license agreement with the
University of Pennsylvania; the investigational program candidate
BNT163; the timing, for any data readouts of the BNT163 phase 1
trial; the registrational potential of BNT163; ability of BioNTech
to further develop and commercialize a vaccine for the Herpes
Simplex Virus (HSV); the ability of BioNTech’s mRNA technology to
demonstrate clinical efficacy outside of BioNTech’s infectious
disease platform; the potential safety and efficacy of our other
product candidates; and BioNTech’s anticipated market opportunity
and size for its product candidates, the rate and degree of market
acceptance of BioNTech’s investigational medicines, if approved.
Any forward-looking statements in this press release are based on
BioNTech’s current expectations and beliefs of future events and
are subject to a number of risks and uncertainties that could cause
actual results to differ materially and adversely from those set
forth in or implied by such forward-looking statements.
For a discussion of these and other risks and
uncertainties, see BioNTech’s Quarterly Report as Form 6-K for the
quarter ended September 30, 2022, filed with the SEC on November 7,
2022, which is available on the SEC’s website at www.sec.gov. All
information in this press release is as of the date of the release,
and BioNTech undertakes no duty to update this information unless
required by law.
CONTACTS
Media RelationsJasmina Alatovic+49 (0)6131 9084
1513Media@biontech.de
Investor RelationsSylke Maas, Ph.D.+49 (0)6131
9084 1074Investors@biontech.de
-----------------------------
1
https://www.who.int/news/item/01-05-2020-massive-proportion-world-population-living-with-herpes-infection2
https://www.nih.gov/news-events/nih-research-matters/why-genital-herpes-boosts-risk-hiv-infection3
Chayavichitsilp, Pamela et al. “Herpes simplex.” Pediatrics in
review 30 4 (2009): 119-29; quiz 130.
BioNTech (NASDAQ:BNTX)
Historical Stock Chart
From Mar 2024 to Apr 2024
BioNTech (NASDAQ:BNTX)
Historical Stock Chart
From Apr 2023 to Apr 2024