- Acquisition to support the global execution of BioNTech’s
oncology strategy and provide full global rights to BNT327/PM8002,
an investigational PD-L1 x VEGF-A bispecific antibody, with
potential to replace current checkpoint inhibitor standard of care
treatments for solid tumors
- With the acquisition of Biotheus, BioNTech aims to further
strengthen its capabilities to develop, manufacture and
commercialize next-generation bispecific antibodies and novel
treatment combinations
- BioNTech and Biotheus plan to initiate multiple registrational
trials with BNT327/PM8002 in late 2024 and 2025; further clinical
trials evaluating BNT327/PM8002 as combination therapies are
planned to start in 2024 and 2025
- BioNTech to pay $800 million to acquire 100 percent of the
issued share capital and up to $150 million in potential milestone
payments
- Additional details will be shared at BioNTech’s Innovation
Series R&D Day event on 14 November 2024
MAINZ, Germany, November 13, 2024 (GLOBE
NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX,
“BioNTech”) and Biotheus (“Biotheus”) today announced the signing
of a definitive agreement for the acquisition of Biotheus, a
clinical-stage biotechnology company dedicated to the discovery and
development of novel antibodies to address unmet medical needs of
patients with oncological or inflammatory diseases.
With the acquisition, BioNTech will obtain full
global rights to the late-stage clinical asset BNT327/PM8002, an
investigational bispecific antibody targeting PD-L1 and VEGF-A. The
transaction is part of BioNTech’s oncology strategy, aimed at
enhancing the company’s capabilities to research, develop and
commercialize combination therapies using BNT327/PM8002. Clinical
trials with BNT327/PM8002 and the PD-(L)1 x VEGF bispecific class
of drugs have demonstrated encouraging clinical activity in various
tumor types including in patients with PD-L1-low and -negative
tumors who have typically been less responsive to current
checkpoint inhibitor treatments.
“The acquisition of Biotheus builds on our
successful ongoing collaboration on BNT327/PM8002 and other
investigational bispecific antibodies,” said Prof. Ugur
Sahin, M.D., Ph.D., CEO and co-founder of BioNTech. "We
believe that BNT327/PM8002 has the potential to set a new standard
of care in multiple oncology indications, surpassing traditional
checkpoint inhibitors. We are committed to advancing its research
and development in combination with our investigational mRNA
vaccines, targeted therapies, and immunomodulators with the aim of
enhancing outcomes for patients with solid tumors."
“We are thrilled to deepen our bond with
BioNTech. We share the goal of advancing the development of
BNT327/PM8002 for future combination therapies in the fight against
cancer,” said Xiaolin Liu, President, CEO, and Co-Founder
of Biotheus. “We believe that BNT327/PM8002 holds
significant potential across various tumor indications, and we have
an exciting pipeline of innovative investigational assets under
development including an antibody discovery and development
platform. As we move forward, we are committed to leveraging our
strengths with the aim of advancing transformative cancer
treatments and enhance our ability to develop treatments for
patients in need.”
BNT327/PM8002 has shown encouraging efficacy and
tolerability in patients across various tumor types, with more than
700 patients treated in clinical trials to date. Multiple
registrational trials are planned to start in 2024 and 2025,
evaluating BNT327/PM8002 plus chemotherapy in various solid tumor
indications including in patients with small cell lung cancer,
non-small cell lung cancer and triple-negative breast cancer.
Additional trials will explore combining BNT327/PM8002 and
BioNTech’s proprietary antibody-drug conjugates (“ADCs”). In June
2024, the evaluation of BNT327/PM8002 in combination with
BNT325/DB-1305, a Trophoblast Cell-Surface Antigen 2
(“TROP2”)-targeted ADC candidate developed by BioNTech in
collaboration with Duality Biologics (Suzhou) Co., Ltd.
(“DualityBio”), was initiated as part of an ongoing Phase 1/2
clinical trial (NCT05438329).
Under the terms of the agreement, BioNTech will
pay Biotheus shareholders an upfront consideration of $800 million,
predominantly in cash, with a small portion in American depositary
shares (“ADS”), to acquire 100 percent of the issued share capital,
subject to customary purchase price adjustments, plus additional
performance-based contingent payments of up to $150 million if
certain milestones are met. The transaction is expected to close in
the first quarter of 2025, subject to the satisfaction of customary
closing conditions, including regulatory approvals. The acquisition
follows an initial exclusive global license and collaboration
agreement between BioNTech and Biotheus, which closed in November
2023, granting BioNTech the rights to develop, manufacture and
commercialize BNT327/PM8002 globally ex-Greater China.
Upon closing, BioNTech will gain full rights to
Biotheus’ pipeline candidates and its in-house bispecific antibody
drug conjugate capability. The acquisition will expand BioNTech’s
footprint in China, adding a local research and development hub to
conduct clinical trials. In addition, BioNTech will gain a
state-of-the-art biologics manufacturing facility to contribute to
its future global manufacturing and supply, and more than 300
Biotheus employees in R&D, manufacturing and enabling functions
are expected to join the BioNTech workforce.
BioNTech’s Innovation Series R&D
Day BioNTech leadership will present additional details on
the Biotheus transaction, as well as updates on the corporate
strategy, commercial strategy and clinical progress across its
pipeline during an edition of the company’s Innovation Series
R&D Day on 14 November. The live webcast of the event will be
available via this link and will begin at 4:30 pm CET (3:30 pm GMT,
10:30 am EST). A replay of the webcast will be available shortly
after the event’s conclusion and archived on BioNTech’s website for
one year.
About
BNT327/PM8002BNT327/PM8002 is an investigational
bispecific antibody combining PD-L1 checkpoint inhibition with
VEGF-A neutralization. The checkpoint inhibition is aimed at
restoring T cells’ ability to recognize and destroy tumor cells
while targeting VEGF-A is aimed at inhibiting tumor angiogenesis,
which cuts off the blood and oxygen supply that feeds tumor cells
and thus prevents the tumor from growing and proliferating. The
combined blockade of the PD-(L)1 pathway and the VEGF-A driven
angiogenesis has been shown to deliver synergistically enhanced
anti-tumor immune responses in several solid tumor types.i,ii If
successfully developed and approved, BioNTech aims to use this
bispecific antibody candidate as a new therapeutic backbone in
combination with other treatment modalities targeting different
oncogenic pathways.
About BioNTechBiopharmaceutical
New Technologies (BioNTech) is a global next generation
immunotherapy company pioneering novel therapies for cancer and
other serious diseases. BioNTech 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 and specialized pharmaceutical collaborators,
including Biotheus, DualityBio, Fosun Pharma, Genentech, a member
of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and
Regeneron.
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 limited to,
statements concerning expectations regarding the impact of this
proposed acquisition on BioNTech’s and Biotheus’ business; the
timing of the closing of the proposed acquisition; the creation of
long-term value for BioNTech and Biotheus shareholders; potential
synergies between BioNTech and Biotheus and their businesses;
BioNTech’s ability to research, develop and potentially
commercialize BNT327/PM8002 and potentially other assets in
Biotheus’ pipeline; the expansion of BioNTech’s operations in
China; the initiation, timing, progress, results, and cost of
BioNTech’s research and development programs, including BioNTech’s
current and future preclinical studies and clinical trials,
including statements regarding the expected timing of initiation,
enrollment, and completion of studies or trials and related
preparatory work and the availability of results, and the timing
and outcome of applications for regulatory approvals and marketing
authorizations; BioNTech’s expectations regarding potential future
commercialization in oncology, including goals regarding timing and
indications; the targeted timing and number of additional
potentially registrational trials, and the registrational potential
of any trial BioNTech may initiate; discussions with regulatory
agencies; BioNTech’s expectations with respect to intellectual
property; and the impact of BioNTech’s collaboration and licensing
agreements. 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 based on BioNTech’s current
expectations and beliefs of future events, and are neither promises
nor guarantees. 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 and adversely from those expressed or implied by these
forward-looking statements. These risks and uncertainties include,
but are not limited to: the possibility that the proposed
transaction may not close; the reaction of BioNTech and Biotheus’
competitors and business partners to the proposed transaction; the
retention of Biotheus employees; BioNTech’s plans for Biotheus; the
future development of BioNTech’s and Biotheus’ business and the
possibility that integration following the proposed transaction may
be more difficult than expected; the risk that Biotheus’
collaborations will not continue or will not be successful; risks
related to Biotheus’ ability to protect and maintain its
intellectual property position; risks related to Biotheus’ capital
requirements, use of capital and unexpected expenditures, including
Biotheus’ ability to manage operating expenses or obtain funding to
support planned business activities or to explore and establish
strategic alternative transactions; risks related to Biotheus’
ability to attract and retain personnel; the uncertainties inherent
in research and development; competition from other product
candidates Biotheus’ and its counterparties’ ability to manage
and source necessary energy resources; BioNTech’s ability to
identify research opportunities and discover and develop
investigational medicines; the ability and willingness of
BioNTech’s third-party collaborators to continue research and
development activities relating to BioNTech's development
candidates and investigational medicines; BioNTech’s ability to
manage its development; regulatory developments in the United
States and other countries; BioNTech’s ability to effectively scale
its production capabilities and manufacture its products and
product candidates; risks relating to the global financial system
and markets; 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 September 30, 2024 and in
subsequent filings made by BioNTech with the SEC, which are
available on the SEC’s website at www.sec.gov. These
forward-looking statements speak only as of the date hereof. 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.
About BiotheusBiotheus is a
clinical-stage biotech company dedicated to the discovery,
development, and delivery of novel antibodies to address the unmet
medical needs of patients with oncology or inflammatory diseases
worldwide. Since its inception, Biotheus has established several
innovative platforms for antibody discovery. With an experienced
development team, Biotheus has built a robust pipeline of ten
programs at various stages of clinical development.
For more information about Biotheus, please
visit www.biotheus.com.
CONTACTS
BioNTech:
Investor Relations Michael Horowicz
Investors@biontech.de
Media Relations Jasmina Alatovic
Media@biontech.de
Biotheus:
Media Relations Yinyin
Guoguo.yy@biotheus.com
i Tzuri N, et al. Sci Rep. 2023;13(1):11923.ii Kim HJ, et al.
Arch Pharm Res. 2022;45(6):401-416.
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