BioNTech to Acquire Biotheus to Boost Oncology Strategy
- 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/PM8002
BNT327/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 BioNTech
Biopharmaceutical 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
Statements
This 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 Biotheus
Biotheus 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 Guo
guo.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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