- The pivotal Phase 3 trial with
BNT323/DB-1303 follows positive Phase 1/2 safety and efficacy data
in patients with Human Epidermal Growth Factor Receptor 2
(“HER2”)-expressing advanced solid tumors with early signs of
anti-tumor activity in heavily pretreated patients with HER2-low
and HER2-positive breast cancer
- The trial is expected to enroll 532
patients with Hormone Receptor-positive (“HR+”) and HER2-low
metastatic breast cancer progressing on hormone therapy at clinical
trial sites worldwide, initially in China, followed by sites in the
United States, Europe, and additional regions
- The clinical milestone is in
furtherance of BioNTech’s and DualityBio’s strategic objective to
advance BNT323/DB-1303 into late-stage development in multiple high
unmet medical need cancer indications
MAINZ, Germany and SHANGHAI, China,
January 22, 2024 – BioNTech SE (Nasdaq:
BNTX, “BioNTech”) and Duality Biologics (Suzhou) Co., Ltd.
(“DualityBio”) today announced that the first patient with
metastatic breast cancer has been treated in a pivotal Phase 3
trial evaluating the efficacy and safety of the next-generation
antibody-drug conjugate (“ADC”) candidate BNT323/DB-1303 targeting
the Human Epidermal Growth Factor Receptor 2 (“HER2”), a cancer
cell surface protein.
Breast cancer is the most commonly diagnosed
cancer worldwide and the leading cause of death from malignant
tumors in women globally.1,2 The breast cancer subtype, which is
defined by the expression of hormone receptors ("hormone
receptor-positive”, "HR+") and a low expression level of the HER2
protein ("HER2-low") on the cancer cell surface, accounts for
approximately 40 % to 45 % of patients in advanced, metastatic
disease stage.3 HER2 has been shown to be a suitable target
structure for the treatment of breast cancers with intermediate and
high HER2 expression.4 HER2-directed therapies have been
ineffective in the past in patients with tumors with low expression
levels of the protein.5 Recent studies have indicated that
next-generation ADCs may have the potential to transfer the impact
of HER2-directed therapies to HER2-low tumors.6
The global, multi-center, open-label, randomized
Phase 3 trial (NCT06018337) will assess the efficacy and safety of
BNT323/DB-1303 compared to standard-of-care single-agent
chemotherapy in chemotherapy-naïve patients with HR+ and HER2-low
metastatic breast cancer that have progressed on hormone therapy.
The trial is expected to enroll 532 patients at more than 223
clinical sites worldwide, initially in China, followed by sites in
the United States, Europe, and additional regions. The study’s
primary endpoint is progression-free survival. Secondary endpoints
include overall survival, objective response rate, duration of
response, and safety.
“For patients with advanced HR+/HER2-low breast
cancers who progressed after primary therapy, single-agent
palliative chemotherapy is the most common regimen to control the
disease and reduce mortality. BNT323/DB-1303 has been designed with
the aim to combine the selectivity of antibodies with the cancer
cell-killing properties of chemotherapy, thereby aiming to minimize
the toxicity of the chemotherapeutic agents for patients,” said
Prof. Özlem Türeci, M.D., Chief Medical Officer and
Co-Founder at BioNTech. “Our objective is to further
expand the impact of HER2-targeted ADC therapies to chemotherapy
naïve patients in metastatic disease stage who express HER2 at low
levels at earliest possible treatment lines, seeking to extend the
therapeutic window and improve outcomes for these patients.”
“The initiation of the Phase 3 trial marks an
important step in the development of our next-generation ADC
candidate with the first indication progressing into pivotal
evaluation,” said Vivian Gu, M.D., Chief Medical Officer at
DualityBio. “Results from our Phase 1/2 clinical study
indicate a robust mechanism of action of BNT323/DB-1303 and have
demonstrated preliminary efficacy and a manageable safety profile.
We look forward to further advancing this differentiated ADC
candidate.”
The Phase 3 trial is based on positive safety
and efficacy data from a Phase 1/2 study (NCT05150691) with
BNT323/DB-1303 in patients with advanced/metastatic solid tumors.
Data presented at ASCO 2023 demonstrated encouraging anti-tumor
activity in heavily pretreated patients with HER2-low breast cancer
with an objective response rate of 38.5% and a disease control rate
of 84.6%. BNT323/DB-1303 was well tolerated with a manageable
safety profile across all evaluated patients with
advanced/metastatic solid tumors.
The milestone is in furtherance of BioNTech and
DualityBio’s strategic objective to advance the product candidate
into late-stage development in multiple high unmet medical need
cancer indications. The Phase 3 trial initiation marks a major
landmark in BioNTech’s and DualityBio’s strategic collaboration
initiated in April 2023. The collaboration aims to accelerate the
development of differentiated antibody-drug conjugate therapeutics
for solid tumors. BioNTech will hold commercial rights globally
(excluding Mainland China, Hong Kong Special Administrative Region,
and Macau Special Administrative Region), while DualityBio will
retain commercial rights for Mainland China, Hong Kong Special
Administrative Region, and Macau Special Administrative Region.
Further information for media:
Fact Sheet about BNT323/DB-1303
About
BNT323/DB-1303BNT323/DB-1303 is a third-generation
topoisomerase-1 inhibitor-based ADC targeting HER2 which was built
from DualityBio’s proprietary Duality Immune Toxin Antibody
Conjugates (“DITAC”) platform. HER2 is a surface-expressed protein
on solid tumors and has been linked to the aggressive growth and
spread of cancer cells, making it a potential target for innovative
cancer therapeutics. The candidate has exhibited antitumor activity
in both HER2-positive and HER2-low tumor models as well as in
several solid tumor indications, including patients with breast,
gastric, endometrial, biliary tract cancers, and other advanced
solid tumors. Preclinical data and preliminary clinical data for
BNT323/DB-1303 indicate its potential to target HER2 receptors on
solid tumors irrespective of expression level with a manageable
safety profile and a potentially expanded therapeutic window.
BNT323/DB-1303 is currently being evaluated in an ongoing Phase 1/2
study (NCT05150691) in patients with advanced/metastatic solid
tumors and in a pivotal Phase 3 study (NCT06018337) in patients
with Hormone Receptor-positive (“HR+”) and Human Epidermal Growth
Factor Receptor 2 (“HER2”)-low, metastatic breast cancer that have
progressed on hormone and/or cyclin-dependent kinase 4/6 (“CDK4/6”)
therapy. The BNT323/DB-1303 program received the Fast Track
designation and Breakthrough Therapy designation from the U.S. Food
and Drug Administration (“FDA”) for the treatment of endometrial
cancer in 2023.
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
Duality Biologics, Fosun Pharma, Genentech, a member of the Roche
Group, Genevant, Genmab, OncoC4, Regeneron and Pfizer.
For more information, please
visit www.BioNTech.com.
About DualityBioDualityBio is a
clinical-stage company focusing on the discovery and development of
the next generation ADC therapeutics for patients with cancer and
autoimmune diseases. DualityBio has successfully established a
number of next generation Antibody-Drug Conjugate (ADC) technology
platforms with global intellectual property rights. Building upon
deep understanding of disease biology and translational capability,
DualityBio has advanced 4 assets into global clinical studies, and
developed more than 10 innovative product candidates which are
currently in preclinical stage. Additionally, DualityBio is
continuing evolving its novel protein engineering and ADC
technology platforms for the next wave of “super ADC” molecules
including diverse payload classes, bispecific ADCs and dual payload
ADCs.
For more information, please
visit www.dualitybiologics.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: the collaboration between BioNTech and
DualityBio to jointly clinical develop antibody-drug conjugates
(ADCs) including BNT323/DB-1303; timing of the pivotal Phase 3
trial as well as any subsequent data readouts; the registrational
potential of any trial we may initiate for BNT323/DB-1303; the
nature and characterization of and timing for release of clinical
data across BioNTech’s platforms, which is subject to peer review,
regulatory review and market interpretation; the planned next steps
in BioNTech’s pipeline programs, including, but not limited to,
statements regarding timing or plans for initiation or enrollment
of clinical trials, or submission for and receipt of product
approvals with respect to BioNTech’s product candidates; the
ability of BioNTech’s mRNA technology to demonstrate clinical
efficacy outside of BioNTech’s infectious disease platform; the
potential safety and efficacy of BioNTech’s other product
candidates; and BioNTech’s anticipated market opportunity and size
for its product candidates. 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. These risks and uncertainties include
but are not limited to discussions with regulatory agencies
regarding timing and requirements for additional clinical trials;
and the ability to produce comparable clinical results in future
clinical trials. 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, including the data discussed in this release, 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 the clinical data, which is
subject to ongoing peer review, regulatory review and market
interpretation; the timing of and BioNTech's ability to obtain and
maintain regulatory approval for BioNTech's product candidates;
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, if approved, its product candidates;
BioNTech's ability to manage its development and expansion;
regulatory developments in the United States and other countries;
BioNTech's ability to effectively scale BioNTech's production
capabilities and manufacture BioNTech's products and BioNTech's
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, 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.
CONTACTS
BioNTechInvestor
RelationsVictoria Meissner, M.D.+1 617 528
8293Investors@biontech.de
Media RelationsJasmina Alatovic+49 (0)6131 9084
1513Media@biontech.de
DualityBioBusiness
Developmentbd@dualitybiologics.com
1 Arnold M, Morgan E, Rumgay H et al. Breast. 2022 Dec; 66:
15–23.2 Smolarz B, Nowak AZ, Romanowicz H. Breast
Cancer—Epidemiology, Classification, Pathogenesis and Treatment
(Review of Literature). Cancers. 2022; 14(10):2569. 3 Harbeck N, et
al. Nat Rev Dis Primers. 2019 Sep 23;5(1):66.4 Tarantino P,
Hamilton E, Tolaney SM, et al. J Clin Oncol. 2020 Jun
10;38(17):1951-1962.5 Modi S, Jacot W, Yamashita T, et al. N Engl J
Med. 2022 Jul 7;387(1):9-20.6 Mark C, Lee JS, Cui X, Yuan Y. Int J
Mol Sci. 2023 Sep 6;24(18):13726.
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