- Designation is based on
pre-clinical data and data from an ongoing Phase 1/2 trial for
BNT324/DB-1311, with antitumor activity and a manageable safety
profile demonstrated by preliminary Phase 1/2 clinical data from
patients with advanced or metastatic solid tumors1,2
- With the Fast Track designation,
the development of BNT324/DB-1311 can benefit from more frequent
engagement with the U.S. Food and Drug Administration (“FDA”) to
support development and expedite regulatory review
- Prostate cancer is the second
leading cause of cancer-related deaths among men worldwide3 often
diagnosed at advanced disease stages; patients with metastatic
castration–resistant prostate cancer (“mCRPC”), an advanced form of
prostate cancer, have a 5-year survival rate of around 36%4
- All three clinical stage
antibody-drug conjugate (“ADC”) candidates in BioNTech’s and
DualityBio’s strategic collaboration have received FDA Fast Track
designation supporting the potential of the companies’ ADC
technology
MAINZ, Germany and SHANGHAI, China, June 24,
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 BNT324/DB-1311 for the treatment
of patients with advanced/unresectable, or metastatic
castration-resistant prostate cancer (“CRPC”) who have progressed
on or after standard systemic regimens. BNT324/DB-1311 is a
next-generation antibody-drug conjugate (“ADC”) candidate targeting
the transmembrane glycoprotein B7-H3, an immune checkpoint protein
which is overexpressed in a range of tumor types and has been
associated with disease progression and poor prognosis for
patients. The candidate is currently being evaluated in an ongoing
Phase 1/2 study (NCT05914116) in patients with advanced solid
tumors.
“The FDA’s decision is a recognition of the
potential of our B7-H3-targeting ADC candidate for the treatment of
advanced CRPC. While patients with metastatic prostate cancer
initially respond to hormone therapy, most patients progress after
18-24 months and develop CRPC, an advanced form of prostate cancer,
leading to a poor prognosis for these patients. The 5-year survival
rate for patients with metastatic CRPC is only around 36%,” said
Prof. Özlem Türeci, M.D., Chief Medical Officer and Co-Founder
at BioNTech. “We are committed to further advancing
BNT324/DB-1311 with our partner DualityBio and believe that a
targeted ADC immunotherapy approach has the potential to improve
outcomes for patients at advanced stages of the disease.”
“BNT324/DB-1311 is the third asset in our
strategic collaboration which has received FDA Fast Track
designation, highlighting the potential of the candidate to fill an
unmet medical need for novel treatment options for B7-H3 expressing
cancers,” said Vivian Gu, M.D., Chief Medical Officer at
DualityBio. “Preliminary data from our ongoing Phase 1/2 trial
has demonstrated antitumor activity and a manageable safety profile
of BNT324/DB-1311 in patients with advanced solid tumors. With the
designation and support by the FDA, we seek to expedite further
development of BNT324/DB-1311.”
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 and have
the potential to address an unmet medical need. The designation is
based on preliminary safety and efficacy data from an ongoing Phase
1/2 trial with BNT324/DB-1311 in patients advanced or metastatic
solid tumors. With the Fast Track designation, the development of
BNT324/DB-1311 can benefit from more frequent engagement with the
FDA, to support the development and expedite the regulatory review
of BNT324/DB-1311.
All three clinical stage ADC candidates in
BioNTech’s and DualityBio’s global strategic partnership have
received FDA Fast Track designation. The lead candidate in the
collaboration, BNT323/DB-1303, a next-ADC candidate targeting the
Human Epidermal Growth Factor Receptor 2 (“HER2”), is being
evaluated in a Phase 1/2 trial in patients with advanced
solid tumors and a global Phase 3 clinical trial in patients with
metastatic breast cancer. The BNT323/DB-1303 program received the
Fast Track designation and Breakthrough Therapy designation from
the FDA for the treatment of endometrial cancer in 2023. In January
2024, the companies’ ADC candidate targeting the trophoblast
cell-surface antigen 2 (“TROP2”), BNT325/DB-1305, received FDA Fast
Track designation for the treatment of patients with
platinum-resistant ovarian epithelial cancer.
About BNT324/DB-1311BNT324/DB-1311 is a
next-generation topoisomerase-I-inhibitor-based ADC candidate
targeting the immune checkpoint protein B7-H3. The transmembrane
glycoprotein B7-H3 plays a critical role in the anti-tumor immune
response and the shaping of the tumor microenvironment. It is
overexpressed in a range of solid tumors, with limited expression
in healthy tissues, and has been associated with disease
progression and very poor prognosis.5 Preclinical studies have
shown that BNT324/DB-1311 exhibits antitumor activity in various
solid tumor models.2 Preliminary data from the ongoing Phase 1/2
trial has demonstrated antitumor activity and a manageable safety
profile for BNT324/DB-1311 in patients with advanced solid tumors.1
BNT324/DB-1311 is currently being evaluated in a Phase 1/2 clinical
trial (NCT05914116) in patients with advanced or metastatic solid
tumors.
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 Biotheus, 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.
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 four 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 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
clinically develop antibody-drug conjugates (ADCs), including
BNT324/DB-1311; the registrational potential of any trial we may
initiate for BNT324/DB-1311; 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 and potential
commercialization 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; and the
potential safety and efficacy of BioNTech’s product candidates. 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, 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 clinical data, which is
subject to ongoing peer review, regulatory review and market
interpretation; 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 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, 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 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, 2024, 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.
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
Developmentbd@dualitybiologics.com
1 Data on file.2 Li C, Yao J, et al. Cancer Res (2023) 83
(7_Supplement): 2967.3 Cancer TODAY. Global Cancer Statistics 2020:
GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36
Cancers in 185 Countries. Available at: https://gco.iarc.who.int
(last access: 20.06.2024).4 SEER*Explorer: An interactive
website for SEER cancer statistics. Cancer Stat Facts: Prostate
Cancer. 2024 Apr 17.Available at:
https://seer.cancer.gov/statfacts/html/prost.html (last access:
20.06.2024).5 Ranjana K. Kanchan, et al. Biochim Biophys Acta Rev
Cancer. 2022 Sep;1877(5):188783.
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