- BioNTech receives exclusive licenses from DualityBio for two
investigational antibody-drug conjugate assets (DB-1303 and
DB-1311) directed against targets expressed in a broad range of
human cancers
- Collaboration will add a new class of precision medicine
therapeutics to BioNTech’s clinical-stage oncology portfolio,
expanding the breadth of its immunotherapy toolkit with synergistic
potential
- DualityBio receives upfront payments totaling $170 million, and
will be eligible to receive development, regulatory and commercial
milestone payments potentially totaling over $1.5 billion as well
as single-digit to double-digit tiered royalties on potential
future product sales
MAINZ, Germany and SHANGHAI, China,
April 3, 2023 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and
Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”), a
clinical-stage biotech company focusing on the discovery and
development of next generation antibody-drug conjugate (“ADC”)
therapeutics to treat patients with cancer and autoimmune diseases,
today announced that the companies have entered into exclusive
license and collaboration agreements for two ADC assets to develop,
manufacture and commercialize the two assets globally, excluding
Mainland China, Hong Kong Special Administrative Region and Macau
Special Administrative Region. With this collaboration, ADCs will
become an additional drug class in BioNTech’s oncology portfolio
with the aim to further support BioNTech’s mission of developing
highly efficacious therapies for cancer patients at every stage of
disease.
ADCs are a class of potent cancer therapies
combining the selectivity of antibodies with the potent
cell-killing properties of chemotherapy or other anti-cancer
agents.
As part of the collaboration, BioNTech will gain
access to DualityBio’s lead candidate, DB-1303, which is a
topoisomerase-1 inhibitor-based ADC directed against Human
Epidermal Growth Factor Receptor 2 (HER2), a target that is
overexpressed in a variety of cancers, which contributes to the
aggressive growth and spread of cancer cells. Antibody therapy
targeting HER2 has been shown to be an effective treatment strategy
for HER2-expressing cancers. The DB-1303 program received the Fast
Track designation from the U.S. Food and Drug Administration
(“FDA”) and is currently in a Phase 2 clinical trial (NCT05150691)
for HER2-expressing advanced solid tumors.
BioNTech will also gain access to a second
topoisomerase-1 inhibitor-based ADC candidate, DB-1311.
“Over the last years, the ADC field has made
significant progress, overcoming several limitations and
demonstrating its potential as a broadly applicable precision
medicine drug class that might be an alternative to standard
chemotherapy,” said Prof. Ugur Sahin, M.D., Chief Executive
Officer and Co-Founder of BioNTech. “The addition of these
two ADCs to our portfolio strengthens our pipeline of
immunotherapies and expands our capabilities with the aim to
provide therapeutic benefits for patients with a range of solid
tumors, along the entire patient journey.”
“We are delighted to partner with BioNTech, a
leading company which brings transformational medicine to patients
through innovation,” said John Zhu, Ph.D., Founder and CEO
of DualityBio. “This is a recognition of
not only DualityBio’s next-generation ADC platform, but also its
internal discovery and development capabilities. With this
strategic partnership, we are committed to working together to
advance the development of innovative therapies for the benefit of
patients worldwide.”
Under the terms of the agreements, DualityBio
will receive upfront payments for both asset licenses totaling $170
million, and additional development, regulatory and commercial
milestone payments for both assets, potentially totaling over $1.5
billion. DualityBio will be eligible to receive single-digit to
double-digit tiered royalties on net sales for both ADC assets.
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. As
part of the agreement for DB-1311, DualityBio has the right to
exercise a co-development cost and profit/loss sharing option for
DB-1311 for the U.S. market, as well as a co-promotion option for
the U.S. market.
About DB-1303DB-1303, a third
generation HER2 ADC molecule built from DualityBio’s proprietary
Duality Immune Toxin Antibody Conjugates (DITAC) platform,
exhibited potent antitumor activity in both HER2 positive and HER2
low tumor models with a favorable safety profile and a potentially
expanded therapeutic window. Both preclinical data and preliminary
clinical data from DB-1303 suggest the potential of DB-1303 to
address unmet medical needs in various HER2 expressing cancers.
About DB-1311DB-1311 is an ADC
comprised of a humanized antibody and DualityBio’s proprietary
DITAC linker-payload. It has exhibited potent antitumor activity in
a range of tumor models representing multiple cancer types and has
been well tolerated in preclinical studies, with a good
pharmacokinetics profile. The wide therapeutic window demonstrated
by preclinical antitumor activity and its safety profile support
the potential of DB-1311 to address unmet medical needs across a
broad range of cancers.
About BioNTechBiopharmaceutical
New Technologies 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 T cells,
bi-specific checkpoint immuno-modulators, targeted cancer
antibodies and 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 Genmab, Sanofi, Genentech, a member of the Roche Group,
Regeneron, Genevant, Fosun Pharma, and Pfizer.
For more information, please visit
www.BioNTech.com.
BioNTech Forward-Looking
StatementsThis press release contains “forward-looking
statements” of BioNTech within the meaning of the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements may include, but may not be limited to, statements
concerning: BioNTech’s collaboration with Duality Biologics
(Suzhou) Co. Ltd.; the ability of DualityBio’s antibody-drug
conjugates (ADCs) to widen the therapeutic window of conjugated
drugs and enhance anti-tumor activity in various cancer
indications; DualityBio’s eligibility to receive development,
regulatory and commercial milestone payments as well as tiered
royalties; and the ability of BioNTech to develop and commercialize
these immunotherapies, if successfully developed and approved. 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.
For a discussion of these and other risks and
uncertainties, see BioNTech’s Annual Report on Form 20-F for the
year ended December 31, 2022, filed with the SEC on March 27, 2023,
which is available on the SEC’s website at www.sec.gov. All
information in this press release is as of the date of the release,
and BioNTech undertakes no duty to update this information unless
required by law.
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.
CONTACTS
BioNTechInvestor
RelationsMichael Horowicz+1 617 955 7420Investors@biontech.de
Media RelationsJasmina Alatovic+49 (0)6131 9084
1513Media@biontech.de
DualityBioBusiness
Developmentbd@dualitybiologics.com
BioNTech (NASDAQ:BNTX)
Gráfico Histórico do Ativo
De Mar 2024 até Abr 2024
BioNTech (NASDAQ:BNTX)
Gráfico Histórico do Ativo
De Abr 2023 até Abr 2024