BioNTech and DualityBio Receive FDA Fast Track Designation for
Next-Generation Antibody-Drug Conjugate Candidate BNT325/DB-1305
- 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-1305
BNT325/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 BioNTech
Biopharmaceutical 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 DualityBio
DualityBio 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 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 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
BioNTech
Investor 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/annonc1324
6 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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