- Designation is based on preliminary safety and efficacy data
from an ongoing Phase 1/2 trial in patients with platinum-resistant
ovarian epithelial cancer, fallopian tube, or primary peritoneal
cancer1
- Fast Track designation can facilitate the development and
expedite the regulatory review of BNT325/DB-1305
- Ovarian cancer is the fourth most common gynecological tumor
type2 with over 300,000 cases diagnosed globally each year3; over
90% of ovarian tumors arise from epithelial cells, including the
epithelial tissue of the ovary, the lining of a fallopian tube or
the peritoneum4
MAINZ, Germany and SHANGHAI, China, January
31, 2024 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and
Duality Biologics (Suzhou) Co., Ltd. (“DualityBio”) today announced
that the U.S. Food and Drug Administration (“FDA”) granted Fast
Track designation for BNT325/DB-1305 for the treatment of patients
with platinum-resistant ovarian epithelial cancer, fallopian tube
cancer, or primary peritoneal cancer who have received one to three
prior systemic treatment regimens. BNT325/DB-1305 is a
next-generation antibody-drug conjugate (“ADC”) candidate targeting
the trophoblast cell-surface antigen 2 (“TROP2”), a protein which
is overexpressed on a range of tumor types. The candidate is
currently being evaluated in an ongoing Phase 1/2 study
(NCT05438329) in patients with TROP2-expressing advanced solid
tumors.
Ovarian cancer is the fourth most common
gynecological tumor type, with over 300,000 cases diagnosed
globally each year.3 Over 90% of ovarian tumors arise from
epithelial cells including the epithelial tissue of the ovary, the
lining of a fallopian tube or the peritoneum.4 Ovarian epithelial
cancer is often diagnosed at advanced disease stages, leading to a
poor prognosis for patients. This makes it one of the most frequent
causes of cancer death in women.3 The 5-year survival rate ranges
from 26% to 42%, depending on the initial disease stage.3
“The FDA’s decision is an important recognition
of the potential of our TROP2-targeting ADC candidate.
Platinum-based chemotherapy is the backbone of treatment for
ovarian epithelial cancer and related subtypes that form in the
epithelial tissue. Patients with platinum resistance who relapse
within under six months have a poor prognosis, and effective and
well-tolerated treatment options remain a substantial unmet medical
need,” said Prof. Özlem Türeci, M.D., Chief Medical Officer and
Co-Founder at BioNTech. “Recent studies have indicated the role
of TROP2 in aggressive tumor growth and progression in patients
with chemotherapy-resistant ovarian tumors. We are committed to
further advancing BNT325/DB-1305 and believe that a TROP2-targeted
treatment approach has the potential to overcome current
limitations in the treatment of advanced ovarian cancers.”
“BNT325/DB-1305 is the second investigational
asset in our strategic collaboration which has received FDA Fast
Track designation highlighting the potential of the candidate to
fill an unmet medical need,” said Vivian Gu, M.D., Chief Medical
Officer at DualityBio. “Data from the Phase 1/2 clinical trial
with BNT325/DB-1305 have demonstrated encouraging anti-tumor
signals in heavily pretreated patients with TROP2-expressing solid
tumors who had failed standard therapy with an objective response
rate of 30.4% and a disease control rate of 87.0%.5 We look forward
to progressing the further development of BNT325/DB-1305 within the
fast track framework, and hope to be one step closer to potentially
improving outcomes for a range of patients.”
Fast Track is a process designed to facilitate
the development and expedite the review, of new drugs and vaccines
that are intended to treat or prevent serious conditions that have
the potential to address an unmet medical need. The designation is
based on preliminary data from an ongoing Phase 1/2 study with
BNT325/DB-1305 in patients with platinum-resistant ovarian
epithelial cancer, fallopian tube, or primary peritoneal cancer
patients.1 With the Fast Track designation, the development of
BNT325/DB-1305 can benefit from more frequent engagement with the
FDA, to support the development and expedite the review of
BNT325/DB-1305.
About BNT325/DB-1305BNT325/DB-1305 is a
third-generation topoisomerase-1 inhibitor-based ADC targeting
TROP2 which was built from DualityBio’s proprietary Duality Immune
Toxin Antibody Conjugates (“DITAC”) platform. TROP2 is a cell
surface protein which is expressed in many normal tissues but is
overexpressed in a variety of tumors. TROP2 plays an important role
in tumor cell proliferation, apoptosis, and invasion, thereby
impacting the prognosis and treatment of cancer patients.6,7
BNT325/DB-1305 has exhibited antitumor activity in tumor models as
well as in several advanced solid tumor indications, including
non-small cell lung cancer (”NSCLC“) and ovarian epithelial
cancer.8 Preclinical data and preliminary clinical data for
BNT325/DB-1305 indicate its potential to target TROP2 receptors on
solid tumors irrespective of expression level with a manageable
safety profile and a potentially expanded therapeutic window.5
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
BNT325/DB-1305; the registrational potential of any trial we may
initiate for BNT325/DB-1305; 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 Relations Victoria Meissner, M.D.
+1 617 528 8293 Investors@biontech.de
Media Relations Jasmina Alatovic +49 (0)6131 9084 1513
Media@biontech.de
DualityBio Business Development
bd@dualitybiologics.com
1 Data on file. Based on October 30, 2023, data cut-off from the
Phase 1/2 trial.2 Cabasag CT, Fagan PJ, et al. Int J Cancer. 2022
Nov 1;151(9):1535-1541.3 Havasi A et al. Medicina (Kaunas). 2023
Mar; 59(3): 544.4 Sankaranarayanan R., Ferlay J. Best Pract Res
Clin Obstet Gynaecol. 2006 Apr;20(2):207-25.5 Marathe O. et al.
Annals of Oncology (2023) 34 (suppl_2): S458-S497.
10.1016/annonc/annonc13246 Wen Y, Ouyang D et al. Ann Transl Med.
2022 Dec; 10(24): 1403.7 Wu B, Yu C et al. Exp Ther Med. 2017
Sep;14(3):1947-1952.8 Data on file:
https://investors.biontech.de/static-files/bf304f1c-3c61-47bf-b3b3-2efb5373a3b9
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