BioNTech and CEPI Announce Partnership to Advance mRNA Mpox Vaccine
Development and Support CEPI’s 100 Days Mission
- BioNTech is initiating a Phase 1/2 clinical trial of the
mRNA-based mpox vaccine program, BNT166
- The Coalition for Epidemic Preparedness Innovations (CEPI)
commits funding of up to $90 million for the development of vaccine
candidates
- Data generated by this partnership will contribute to CEPI’s
100 Days Mission, a global effort to accelerate the development of
well-tolerated and effective vaccines against future viral threats
with pandemic potential
- The partnership is part of BioNTech’s strategy to develop novel
prophylactic vaccines for the prevention of high-medical-need
infectious diseases, including diseases that disproportionally
affect lower-income countries
MAINZ, Germany, and OSLO, Norway, September
18, 2023 — BioNTech SE (Nasdaq: BNTX, “BioNTech”, "the
Company") and the Coalition for Epidemic Preparedness
Innovations (CEPI) today announced a strategic partnership to
advance mRNA-based vaccine candidates with the development of
BNT166 for the prevention of mpox (formerly monkeypox, caused by a
member of the Orthopoxvirus viral family), an infectious disease
that can lead to severe, life-threatening complications. Mpox
gained global attention in May 2022 with an increasing number of
cases that then developed into an international outbreak.1,2 CEPI
will provide funding of up to $90 million to support the
development of mRNA-based vaccine candidates.
The mpox vaccine program BNT166 is part of
BioNTech’s efforts to develop novel prophylactic vaccines for a
range of infectious diseases with a high medical need, including
indications that are disproportionally prevalent in lower-income
countries. Since the eradication of smallpox in 1980, the global
population-level immunity against the Orthopoxvirus viral family,
including mpox, has been waning3. BioNTech is aiming to develop a
prophylactic mRNA-based mpox vaccine with a favorable safety
profile that can be manufactured at scale.
The strategic partnership between BioNTech and
CEPI is aiming to contribute to CEPI’s 100 Days Mission, a global
goal to accelerate development of well-tolerated and effective
vaccines against a potential future pandemic virus so that a
vaccine can be ready for regulatory authorization and manufacturing
at scale within 100 days of recognition of a pandemic pathogen.
This mission is spearheaded by CEPI and embraced by the G7, G20,
and industry leaders. The partnership between BioNTech and CEPI
could help accelerate responses to future outbreaks caused by
viruses of the Orthopoxvirus viral family in several ways. For
example, advancing the development of an mRNA-based mpox vaccine
candidate, if successfully approved and authorized, could help
provide larger supplies of vaccines for use against future mpox
outbreaks. In addition, the data generated could contribute to the
rapid development of mRNA-based vaccines against future outbreaks
caused by Orthopoxviruses.
“Mpox can cause severe complications,
particularly in children and pregnant women as well as in
immunocompromised individuals. The global outbreak, which was
declared a public health emergency of international concern,
underlines the need for a highly effective, well-tolerated, and
accessible mpox vaccine. We initiated our BNT166 program in May
2022 to help address this need,” said Prof. Ugur Sahin, M.D.,
CEO and Co-founder of BioNTech. “We believe our scientific
approach as well as our mRNA technology have the potential to
significantly contribute to deliver on CEPI’s 100 Days
Mission.”
“The 100 Days Mission aims to accelerate the
development of a vaccine against a novel virus with pandemic
potential to just 100 days, and BioNTech’s world-class scientists,
technology and facilities can make a vital contribution. Achieving
this mission, and potentially preventing the next pandemic, will
require gathering a wealth of knowledge and data about the
performance of the latest vaccine platforms, like mRNA, which can
enable rapid responses to emerging infectious threats across a
broad range of viruses. Our work on mpox could broaden the
portfolio of vaccines available against this potentially deadly
disease, while building our understanding of how mRNA technology
performs against Orthopoxviruses, a family of viruses that have
long afflicted humankind and remain an ongoing threat today,” said
Richard Hatchett, M.D., Chief Executive Officer of CEPI.
The BNT166 vaccine candidates encode surface
antigens that are expressed in the two infectious forms of the
monkeypox virus (MPXV) to efficiently fight virus replication and
infectivity. The clinical trial (NCT05988203) will evaluate the
safety, tolerability, reactogenicity and immunogenicity of two
mRNA-based multivalent vaccine candidates for active immunization
against mpox. The Phase 1/2 trial aims to enroll 196 healthy
participants with and without prior history of known or suspected
smallpox vaccination (vaccinia-naive participants).
BNT166 is part of BioNTech’s infectious disease
programs aiming to provide equitable access to effective and
well-tolerated vaccines for high medical need indications. This
includes BioNTech’s Malaria and Tuberculosis programs, BNT165 and
BNT164, respectively, which are both currently in Phase 1 clinical
trials. BioNTech’s efforts also include the establishment of a
decentralized and robust end-to-end manufacturing network in Africa
aiming to enable scalable production of mRNA-based medicines. The
first manufacturing site based on the Company’s state-of-the-art,
scalable BioNTainer solution is currently being built in Kigali,
Rwanda.
BioNTech and CEPI are committed to enabling
equitable access to the outputs of this partnership. Any licensed
vaccines developed as a result of this strategic partnership are
expected to be made available at affordable prices in low- and
middle-income countries.
About mpoxMpox (formerly monkeypox) is a
zoonotic infectious disease caused by the monkeypox virus (MPXV), a
member in the genus Orthopoxvirus that also comprises the
smallpox-causing variola virus. Typical symptoms include skin rash
and mucosal lesions, fever, swollen lymph nodes, head-/muscle ache
and sore throat. Severe forms of the disease can occur particularly
in children and immunocompromised individuals as well as during
pregnancy, with complications including superinfections of the rash
and lesions, pneumonia, sepsis, encephalitis, stillbirth and loss
of vision following corneal infection. Human-to-human transmission
can occur through physical contact, contaminated objects, or body
fluids, including sexual contact. Although vaccines against
members of the Orthopoxvirus family are currently available, there
is a high need for an mpox vaccine broadly available especially in
endemic regions. BioNTech and CEPI aim to address this need with
this strategic partnership by potentially broadening the portfolio
of vaccines available against this virus.
About BioNTechBiopharmaceutical New
Technologies (BioNTech) 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 (CAR) T cells,
several protein-based therapeutics, including bispecific immune
checkpoint modulators, targeted cancer antibodies and antibody-drug
conjugate (ADC) therapeutics, as well as 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 DualityBio, Fosun
Pharma, Genentech, a member of the Roche Group, Genevant, Genmab,
OncoC4, Regeneron, Sanofi and Pfizer.
For more information, please visit
www.BioNTech.com.
BioNTech Forward-looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, as
amended, including, but not be limited to, statements concerning:
BioNTech’s efforts to develop novel prophylactic vaccines for a
range of infectious diseases with high medical need; BioNTech’s
partnership with CEPI and BioNTech’s ability to receive up to $90
million in funding; the potential ability of BNT166 to provide
protection against mpox; the timing and success of a Phase 1/2
dose-escalation trial of BNT166a and BNT166c for active
immunization against mpox; qualitative assessments of available
data and expectations of potential benefits; and BioNTech’s ability
to develop and, if successfully developed and approved,
commercialize its vaccine candidates, including BNT166. In some
cases, forward-looking statements can be identified by terminology
such as “will,” “may,” “should,” “expects,” “intends,” “plans,”
“aims,” “anticipates,” “believes,” “estimates,” “predicts,”
“potential,” “continue,” or the negative of these terms or other
comparable terminology, although not all forward-looking statements
contain these words. The forward-looking statements in this press
release are neither promises nor guarantees, and you should not
place undue reliance on these forward-looking statements because
they involve known and unknown risks, uncertainties, and other
factors, many of which are beyond BioNTech’s control, and which
could cause actual results to differ materially from those
expressed or implied by these forward-looking statements. These
risks and uncertainties include, but are not limited to: the
uncertainties inherent in research and development, including the
ability to meet anticipated clinical endpoints, commencement and/or
completion dates for clinical trials, regulatory submission dates,
regulatory approval dates and/or launch dates, as well as risks
associated with preclinical and clinical data; the nature of the
clinical data, which is subject to ongoing peer review, regulatory
review and market interpretation; the future commercial demand and
medical need for an mRNA-based mpox vaccine; the availability of
raw materials to manufacture a vaccine; competition from other mpox
vaccines, including those with different mechanisms of action and
different manufacturing and distribution constraints, on the basis
of, among other things, efficacy, cost, convenience of storage and
distribution, breadth of approved use, side-effect profile and
durability of immune response; the ability to obtain
recommendations from vaccine advisory or technical committees and
other public health authorities and uncertainties regarding the
commercial impact of any such recommendations; the timing of and
BioNTech's ability to obtain and maintain regulatory approval for
BioNTech's product candidates; and other factors not known to
BioNTech at this time.You should review the risks and uncertainties
described under the heading “Risk Factors” in BioNTech’s Report on
Form 6-K for the period ended June 30, 2023, and in subsequent
filings made by BioNTech with the U.S. Securities and Exchange
Commission (“SEC”), which are available on the SEC’s website at
www.sec.gov. Except as required by law, BioNTech disclaims any
intention or responsibility for updating or revising any
forward-looking statements contained in this press release in the
event of new information, future developments or otherwise. These
forward-looking statements are based on BioNTech’s current
expectations and speak only as of the date hereof.
About CEPI CEPI is an
innovative partnership between public, private, philanthropic, and
civil organisations, launched at Davos in 2017, to develop vaccines
against future epidemics. Prior to COVID-19, CEPI’s work focused on
developing vaccines against the Ebola Virus Disease, Lassa virus,
Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift
Valley Fever virus and Chikungunya virus. It has over 20 vaccine
candidates against these pathogens in development. CEPI has also
invested in new platform technologies for rapid vaccine development
against unknown pathogens (Disease X).During the COVID-19 pandemic,
CEPI initiated multiple programs to develop vaccines against
SARS-CoV-2 and its variants with a focus on speed, scale and
access. These programs leverage the rapid response platforms
developed by CEPI’s partners prior to the emergence of COVID-19, as
well as new collaborations. The aim is to advance clinical
development of a diverse portfolio of safe and effective COVID-19
candidates and to enable fair allocation of these vaccines
worldwide through COVAX.
CEPI’s 5-year plan lays out a $3.5 billion
roadmap to compress vaccine development timelines to 100 days,
develop a broadly protective vaccine against COVID-19 and other
Betacoronaviruses, and create a “library” of vaccine candidates for
use against known and unknown pathogens. The plan is available at
https://endpandemics.cepi.net.
Follow CEPI’s news page for the latest updates.
Follow CEPI via @CEPIvaccines, @DrRHatchett, and on LinkedIn.
To read more about how the world can work
together to #endpandemics, check out DISEASE X – The 100 Days
Mission to End Pandemics, by CEPI’s Chief Scientific Writer Kate
Kelland, available here at Bookshop.org. All author proceeds go to
the World Health Organization Foundation’s COVID-19 Response.
CEPI and mpoxIn response to the public
health emergency of international concern (PHEIC) declared in July
2022, CEPI provided funding of up to $375,000 to the UK Medicines
and Healthcare products Regulatory Agency (MHRA) and the UK Health
Security Agency (UKHSA) to advance development of a mpox antibody
standard and assays, to provide a standardized approach to test the
performance of vaccines being used or in development against
mpox.
CONTACTS
BioNTech Media Relations Jasmina Alatovic +49 (0)6131
9084 1513 Media@biontech.de
Investor RelationsVictoria Meissner, M.D.+1 617 528
8293Investors@biontech.de CEPI+44 7387 055214press@cepi.net
-----1
https://www.who.int/emergencies/situations/monkeypox-oubreak-20222
https://www.who.int/europe/news/item/23-07-2022-who-director-general-declares-the-ongoing-monkeypox-outbreak-a-public-health-event-of-international-concern
3 Simpson K, Heymann D, Brown CS et al. Human monkeypox -
After 40 years, an unintended consequence of smallpox
eradication. Vaccine. 2020 Jul 14;38(33):5077-5081. doi:
10.1016/j.vaccine.2020.04.062. Epub 2020 May 13. PMID: 32417140;
PMCID: PMC9533855.
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