BioNTech and DualityBio Receive FDA Breakthrough Therapy
Designation for Antibody-Drug Conjugate Candidate BNT323/DB-1303 in
Endometrial Cancer
- Designation is based on Phase 1/2 safety and efficacy data in
patients with Human Epidermal Growth Factor Receptor 2
(“HER2”)-expressing advanced endometrial cancer with encouraging
early signs of anti-tumor activity
- Breakthrough Therapy designation will allow for an expedited
development and regulatory review of BNT323/DB-1303
- Endometrial or uterine cancer is the second most common
gynecologic cancer globally with over 400,000 cases occurring each
year
MAINZ, Germany and SHANGHAI, China, December
21, 2023 – BioNTech SE (Nasdaq: BNTX,
“BioNTech”) and Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”)
today announced that the U.S. Food and Drug Administration (“FDA”)
granted Breakthrough Therapy designation for BNT323/DB-1303 for the
treatment of advanced endometrial cancer in patients who progressed
on or after treatment with immune checkpoint inhibitors.
BNT323/DB-1303 is a next-generation antibody-drug conjugate (“ADC”)
candidate targeting the Human Epidermal Growth Factor Receptor 2
(“HER2”), a cell surface protein which is expressed in a range of
tumor types. The designation is based on encouraging topline data
from a Phase 1/2 study (NCT05150691) with BNT323/DB-1303 in
patients with HER2-expressing advanced endometrial cancer.
Endometrial or uterine cancer is the second most
common gynecologic cancer globally, with over 400,000 cases
occurring each year1,2 and both incidence and mortality are
increasing3,4. While localized, early disease stages can be cured
via surgery, the five-year survival rate for patients with
advanced, metastatic or recurrent disease is only 18.4%5.
“The Breakthrough Therapy designation for
BNT323/DB-1303 shows the potential of our ADC candidate to address
current treatment challenges for patients with advanced
HER2-expressing endometrial cancer who progressed under several
lines of systemic therapy. For these patients the survival rates
are still low and the medical need for new and more effective
treatments remains high,” said Prof. Özlem Türeci, M.D., Chief
Medical Officer and Co-Founder at BioNTech. “With the
designation and support by the FDA, we seek to expedite further
development of BNT323/DB-1303.”
“The FDA's decision is an important milestone in
the development of our novel differentiated ADC candidate directed
at HER2. The HER2 protein overexpression and/or gene amplification
is present in approximately 17% to 38%6 of patients with
endometrial cancer and more than 50%7 of patients in late disease
stage exhibit HER2 overexpression. We believe BNT323/DB-1303 has
the potential to serve as a new therapeutic option for patients
with HER2 expressing advanced endometrial carcinoma including both
patients with high and low expression levels of HER2,” said
Vivian Gu, M.D., Chief Medical Officer at DualityBio. “We
are committed to advancing BNT323/DB-1303 with the aim to improve
outcomes for patients in late disease stages.”
Breakthrough Therapy designation is an FDA
program designed to expedite the development and regulatory review
of investigational therapies that are designed to address serious
or life-threatening conditions. To receive the designation, the
candidate needs to demonstrate preliminary clinical evidence that
indicates that it may offer substantial improvement over existing
therapies on one or more clinically significant endpoints. With the
Breakthrough Therapy designation, the development of BNT323/DB-1303
may benefit from more frequent engagement with the FDA, which will
support the collection of appropriate data needed to accelerate
development and may also allow for priority review if the relevant
criteria are met.
Data presented from the ongoing Phase 1/2 study
at ASCO 2023 and ESGO 2023 demonstrated encouraging anti-tumor
activity in heavily pretreated patients with advanced endometrial
cancer with an unconfirmed objective response rate of 58.8% and an
unconfirmed disease control rate of 94.1%. BNT323/DB-1303 was well
tolerated with a manageable safety profile across all evaluated
patients with advanced/metastatic solid tumors.
The BNT323/DB-1303 program received FDA Fast
Track designation for the treatment of endometrial cancer in
January 2023.
About BNT323/DB-1303
BNT323/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 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 HER2-low metastatic
breast cancer that have progressed on hormone and/or
cyclin-dependent kinase 4/6 (“CDK4/6”) therapy.
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, Sanofi 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 to evolve
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 the antibody-drug conjugate
(ADC) candidate BNT323/DB-1303; 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 for
BNT323/DB-1303, which is subject to peer review, regulatory review
and market interpretation; planned next steps in BioNTech’s
pipeline programs, including, but not limited to, statements
regarding timing or plans for initiation of clinical trials,
enrolment 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 our 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: 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; discussions
with regulatory agencies regarding timing and requirements for
additional clinical trials; the ability to produce comparable
clinical results in future clinical trials; 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 Sung H, Ferlay J, Siegel RL et al. CA Cancer J Clin. 2021
May;71(3):209-249.2 World Cancer Research Fund International.
Endometrial cancer statistics, 2020. Available under:
https://www.wcrf.org/cancer-trends/endometrial-cancer-statistics/
(Last access: 19.12.2023)3 Lortet-Tieulent J, Ferlay J, Bray F,
Jemal A. J Natl Cancer Inst. 2018 Apr 1;110(4):354-3614 Rahib L,
Smith BD, Aizenberg R et al. Cancer Res. 2014 Jun 1;74(11):2913-215
National Cancer Institute. Surveillance, Epidemiology, and End
Results Program (SEER). Cancer Stat Facts: Uterine Cancer.
Available under: https://seer.cancer.gov/statfacts/html/corp.html
(Last access: 19.12.2023)6 Livasy C A, et al. Gynecol Oncol. 2005;
100 (2006):101-106.7 Grushko TA. Gynecol Oncol. 2008
Jan;108(1):3-9.
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