- BNT327, BioNTech’s PD-L1xVEGF-A bispecific antibody, is a
clinically advanced investigational immunotherapy candidate with
the potential to surpass current checkpoint inhibitor outcomes and
set a new standard of care in multiple tumor types
- The co-development and co-commercialization collaboration with
a 50/50 profit/loss split will leverage both partners’ expertise,
resources and global footprint to accelerate BNT327’s path towards
potential regulatory approvals and market launches
- BioNTech and Bristol Myers Squibb will jointly execute a broad
clinical development program to evaluate and advance BNT327 across
numerous solid tumor types
BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Bristol Myers Squibb
(NYSE: BMY, “BMS”) today announced that the companies have entered
into an agreement for the global co-development and
co-commercialization of BioNTech’s investigational bispecific
antibody BNT327 across numerous solid tumor types. Under the
agreement, BioNTech and BMS will work jointly to broaden and
accelerate the development of this clinical candidate.
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BioNTech’s BNT327, a next-generation bispecific antibody
candidate targeting PD-L1 and VEGF-A, is currently being evaluated
in multiple ongoing trials with more than 1,000 patients treated to
date, including global Phase 3 trials with registrational potential
evaluating BNT327 as first-line treatment in extensive stage small
cell lung cancer (“ES-SCLC”) and non-small cell lung cancer
(“NSCLC”). A global Phase 3 trial evaluating the candidate in
triple negative breast cancer (“TNBC”) is planned to start by the
end of 2025. Preliminary data from ongoing trials underscore the
potential for combining anti-PD-L1 and anti-VEGF-A – two
well-established therapeutic targets – into a single molecule to
deliver synergistic clinical benefits for patients across multiple
tumor types.
Under the terms of the agreement, the companies will jointly
develop and commercialize BNT327, including the development of
BNT327 as monotherapy and in combination with other products. Both
companies have the right to independently develop BNT327 in further
indications and combinations, including combinations of BNT327 with
proprietary pipeline assets.
"We believe BNT327 has the potential to become a foundational
immuno-oncology backbone, moving beyond single-mechanism checkpoint
inhibitors and expanding into multiple solid-tumor indications. Our
collaboration with BMS, a pioneering leader in immuno-oncology,
aims to accelerate and broadly expand BNT327’s development to fully
realize its potential,” said Prof. Ugur Sahin, M.D., CEO and
Co-Founder of BioNTech. “Our focus remains on advancing
high-impact, pan-tumor programs and combination strategies in
oncology, with BNT327 complementing our antibody-drug conjugate
programs and mRNA-based immunotherapies. We are dedicated to
delivering truly transformative options for patients in need."
“Our deep experience and expertise in advancing and delivering
groundbreaking immuno-oncology medicines positions BMS well to
collaboratively realize the potential of BNT327, an asset with
significant potential for transforming the standard of care for
patients with solid tumors,” said Christopher Boerner, Ph.D., Board
Chair and CEO of Bristol Myers Squibb. “The science behind BNT327
and its leading clinical position in multiple hard-to-treat tumor
types, further bolsters our pursuit of novel mechanisms and
multiple modalities in oncology, and enhances our growth
trajectory. We are impressed by the innovation that BioNTech has
achieved to date, and we look forward to partnering to accelerate
existing clinical trials and time to market, while expanding the
number of potential indications.”
BMS will pay BioNTech $1.5 billion in an upfront payment and $2
billion total in non-contingent anniversary payments through 2028.
These tax-deductible charges will be recorded as Acquired IPR&D
Expense when incurred, with the $1.5 billion being incurred in Q2.
In addition, BioNTech will be eligible to receive up to $7.6
billion in additional development, regulatory and commercial
milestones. BioNTech and BMS will share joint development and
manufacturing costs on a 50:50 basis, subject to certain
exceptions. Global profits/losses will be equally shared between
BioNTech and BMS.
About BNT327
BNT327 is a novel investigational bispecific antibody combining
two complementary, validated mechanisms in oncology into one single
molecule. BNT327 combines PD-L1 checkpoint inhibition aimed at
restoring T cells’ ability to recognize and destroy tumor cells
with the neutralization of VEGF-A. The blocking of VEGF-A is aimed
at reversing the tumor’s immuno-suppressive effect in its
microenvironment and cutting off the blood and oxygen supply that
feeds tumor cells (anti-angiogenesis effect), with the intention of
preventing the tumor from growing and proliferating. BNT327 may be
differentiated via its mechanism of action of targeting PD-L1 on
tumor cells to localize anti-VEGF activity within the tumor
microenvironment, aiming to enhance therapeutic precision and
minimize systemic exposure. A treatment with BNT327 is intended to
help normalize blood vessels at the tumor site, improving delivery
and potential effectiveness of combination therapies. This targeted
vascular remodeling positions BNT327 as a potential backbone
therapy across a wide range of solid tumors.1,2
More than 1,000 patients have been treated with BNT327 in
clinical trials to date. More than 20 clinical trials are currently
ongoing or planned to evaluate BNT327 either as a monotherapy or in
combination with other treatment modalities targeting different
oncogenic pathways in more than 10 solid tumor indications.
Multiple global trials are ongoing or planned to start in 2025,
including three global clinical trials with registrational
potential in first-line small cell lung cancer (“SCLC”), first-line
non-small cell lung cancer (“NSCLC”) and first-line triple-negative
breast cancer (“TNBC”). Additional trials will explore combining
BNT327 and BioNTech’s proprietary antibody-drug conjugate
candidates (“ADCs”). If successfully developed and approved,
BioNTech aims to use this bispecific antibody candidate as a
next-generation immuno-oncology (“IO”) backbone in combination with
other treatment modalities targeting a broad range of cancer
indications.
About BioNTech
Biopharmaceutical New Technologies (BioNTech) is a global next
generation immunotherapy company pioneering novel investigative
therapies for cancer and other serious diseases. BioNTech exploits
a wide array of computational discovery and therapeutic modalities
with the intent of rapid development of novel biopharmaceuticals.
Its diversified portfolio of oncology product candidates aiming to
address the full continuum of cancer includes mRNA cancer
immunotherapies, next-generation immunomodulators and targeted
therapies such as antibody-drug conjugates (ADCs) and innovative
chimeric antigen receptor (CAR) T cell therapies. Based on its deep
expertise in mRNA development and in-house manufacturing
capabilities, BioNTech and its collaborators are researching and
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
Bristol Myers Squibb, Duality Biologics, 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 the collaboration
with Bristol Myers Squibb (BMS) on BioNTech’s business; the
creation of long-term value for BioNTech; the ability of BioNTech
and BMS to successfully co-develop and co-commercialize BNT327, if
approved; BioNTech’s eligibility to receive development,
regulatory, and commercial milestone payments; the rate and degree
of market acceptance of BioNTech’s investigational medicines, if
approved; 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; the impact of BioNTech’s collaboration and licensing
agreements; the development, nature and feasibility of sustainable
drug production and supply solutions; and BioNTech’s estimates of
revenues, research and development expenses, selling, general and
administrative expenses, and capital expenditures for operating
activities. 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 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, and including the possibility
of unfavorable new preclinical, clinical or safety data and further
analyses of existing preclinical, clinical or safety data; the
nature of clinical data, which is subject to ongoing peer review,
regulatory review and market interpretation; pricing and coverage
negotiations with governmental authorities, private health insurers
and other third-party payors; the impact of tariffs and escalations
in trade policy; competition related to BioNTech’s product
candidates, 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 timing of and BioNTech’s ability
to obtain and maintain regulatory approval for its product
candidates; discussions with regulatory agencies regarding timing
and requirements for additional clinical trials; BioNTech’s 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; unforeseen
safety issues and potential claims that are alleged to arise from
the use of products and product candidates developed or
manufactured by BioNTech; BioNTech’s and its collaborators’ ability
to commercialize and market its product candidates, if approved;
BioNTech’s ability to manage its development and related expenses;
regulatory and political 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 March 31, 2025 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 Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol Myers Squibb, visit us at BMS.com or
follow us on LinkedIn, X, YouTube, Facebook and Instagram.
Bristol Myers Squibb Cautionary Statement Regarding
Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding, among other things, the research, development and
commercialization of pharmaceutical products and the collaboration
with BioNTech. All statements that are not statements of historical
facts are, or may be deemed to be, forward-looking statements. Such
forward-looking statements are based on current expectations and
projections about Bristol Myers Squibb’s future financial results,
goals, plans and objectives and involve inherent risks, assumptions
and uncertainties, including internal or external factors that
could delay, divert or change any of them in the next several
years, that are difficult to predict, may be beyond Bristol Myers
Squibb’s control and could cause its future financial results,
goals, plans and objectives to differ materially from those
expressed in, or implied by, the statements. These risks,
assumptions, uncertainties and other factors include, among others,
that the expected benefits of, and opportunities related to the
collaboration with BioNTech may not be consistent with the realized
by Bristol Myers Squibb or may take longer to realize than
anticipated, that the therapeutic potential of BNT327 may change,
that Bristol Myers Squibb may fail to discover and develop any
commercially successful product candidates through the
collaboration with BioNTech, that such product candidates may not
receive regulatory approval for the indications described in this
release and, if approved, whether such product candidates will be
commercially successful. No forward-looking statement can be
guaranteed. Forward-looking statements in this press release should
be evaluated together with the many risks and uncertainties that
affect Bristol Myers Squibb’s business and market, particularly
those identified in the cautionary statement and risk factors
discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for
the year ended December 31, 2024, as updated by Bristol Myers
Squibb’s subsequent Quarterly Reports on Form 10-Q, Current Reports
on Form 8-K and other filings with the Securities and Exchange
Commission. The forward-looking statements included in this
document are made only as of the date of this document and except
as otherwise required by applicable law, Bristol Myers Squibb
undertakes no obligation to publicly update or revise any
forward-looking statement, whether as a result of new information,
future events, changed circumstances or otherwise.
________________________________ 1 Tzuri N, et al. Sci Rep.
2023;13(1):11923. 2 Kim HJ, et al. Arch Pharm Res.
2022;45(6):401-416.
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BioNTech
Media Relations Jasmina Alatovic Media@biontech.de
Investor Relations Douglas Maffei, PhD
Investors@biontech.de
Bristol Myers Squibb
Media Relations: media@bms.com Investor Relations:
investor.relations@bms.com
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