- Exclusive global
rights secured for development, manufacture and commercialization
of FS001, completing final stages of pre-clinical development with
first-in-class potential
- FS001 targets a novel tumor associated
antigen, highly expressed across a range of solid tumors,
identified through the application of Foreseen’s proprietary
proteomic platforms
- FS001 has demonstrated robust
preclinical efficacy in multiple tumor models and exhibits a
favorable preclinical safety profile
PARIS, FRANCE, 11 July 2024 -
Ipsen (Euronext: IPN; ADR: IPSEY) and Foreseen Biotechnology
(Foreseen) today announced an exclusive global licensing agreement
for FS001, an antibody-drug conjugate (ADC) with first-in-class
potential. FS001 targets a novel tumor-associated antigen that is
overexpressed in many solid tumors and plays a critical role in
tumor proliferation and metastasis. This novel tumor antigen was
identified using Foreseen’s high throughput, integrated
translational proteomics, and artificial intelligence (AI)-powered
screening platforms, to analyze their vast collection of
well-characterized clinical tumor samples. FS001 utilized an
innovative, stable and cleavable linker coupled to a potent
topoisomerase I inhibitor. Preclinical efficacy of FS001 was
demonstrated in multi-drug resistant cancer models. The agreement
gives Ipsen exclusive worldwide rights to develop, manufacture and
commercialize FS001.
“We are excited to add FS001, the second ADC
Ipsen has in-licensed this year, to our growing pipeline. Using
cutting-edge proteomics technology and AI-powered screening
platforms the Foreseen team has uncovered a novel and clinically
relevant target which could unlock the potential of ADCs for even
more people living with hard-to-treat forms of cancer,” said Mary
Jane Hinrichs, SVP and Head of Early Development at Ipsen. “As we
prepare for the initiation of a Phase I clinical trial, we will
evaluate FS001 in selected solid tumor types, which we hope will
deliver critical new treatments for people living with cancer
around the world.”
“Our strategic partnership with Ipsen provides a
strong endorsement to our high throughput integrated translational
proteomics platform approach to discover and develop innovative
therapeutic products with first-in-class potential”, said Catherine
Wong, Founder and Chairman of Foreseen. “We are pleased to be
collaborating with Ipsen to advance FS001 globally, harnessing
Ipsen’s robust track record in accelerating the clinical
development and commercialization of innovative therapeutics. We
believe FS001 has the potential to treat multiple cancers as a
single agent or in combination with standard of care.”
Foreseen Biotechnology is eligible to receive up
to $1.03bn comprising upfront, development, regulatory and
commercial milestone payments, and tiered royalties on global
sales, contingent upon successful development and regulatory
approvals. Under the terms of the agreement, Ipsen will assume
responsibility for Phase I preparation activities, including
submission of the Investigational New Drug (IND) application, and
all subsequent clinical-development, manufacturing, and global
commercialization activities.
ENDS
About Ipsen
We are a global biopharmaceutical company with a
focus on bringing transformative medicines to patients in three
therapeutic areas: Oncology, Rare Disease and Neuroscience.
Our pipeline is fueled by external innovation
and supported by nearly 100 years of development experience and
global hubs in the U.S., France and the U.K. Our teams in more than
40 countries and our partnerships around the world enable us to
bring medicines to patients in more than 80 countries.
Ipsen is listed in Paris (Euronext: IPN) and in
the U.S. through a Sponsored Level I American Depositary Receipt
program (ADR: IPSEY). For more information, visit ipsen.com.
About Foreseen
Biotechnology
We are an emerging biotechnology company that
pioneered a high throughput integrated translational proteomics
platform powered by AI-based data analytical system to accelerate
discovery of novel targets for therapeutics and diagnostics that
are clinically relevant. We are building a pipeline of novel
product candidates for the diagnosis and treatment of cancer,
inflammatory/autoimmune diseases and neurological disorders.
Foreseen Biotechnology is incubated by Nest.Bio Ventures.
About Antibody-Drug Conjugates
(ADCs)
ADCs are comprised of three main components: the
antibody, a payload and a linker. The antibody selectively targets
an identified tumor antigen. Payloads are the pharmaceutically
active component to treat the cancer, attached to the antibody via
a chemical linker. The linker connects the antibody and the payload
and reduces the amount of payload that reaches non-tumor
tissue.1
About FS001
FS001 is a potential first-in-class ADC with
demonstrated preclinical efficacy in multiple solid tumors as well
as a favorable safety profile with wide therapeutic window in
animal studies. FS001 is comprised of (i) Foreseen’s proprietary
antibody that specifically binds to a novel target identified using
the company’s high throughput integrated translational proteomics
platform and (ii) an innovative linker-payload with excellent
pharmaceutical features developed by Shanghai Escugen Biotechnology
Co. Ltd. FS001 is in the final stages of pre-clinical
development.
Ipsen contacts
Email:
corporate.communications@ipsen.com
Investors
Craig Marks | + 44 7584 349
193
Nicolas Bogler | +33 (0) 6 52
19 98 92
Media
Amy Wolf | +41 7 95 76 07
23
Jess Smith | + 44 7557 267
634
Foreseen Biotechnology
contacts
Kerry Wang | +86
13611776259Email: kerry.wang@foreseenbio.com
Ipsen Disclaimers and/or Forward-Looking
StatementsThe forward-looking statements, objectives and
targets contained herein are based on Ipsen’s management strategy,
current views and assumptions. Such statements involve known and
unknown risks and uncertainties that may cause actual results,
performance or events to differ materially from those anticipated
herein. All of the above risks could affect Ipsen’s future ability
to achieve its financial targets, which were set assuming
reasonable macroeconomic conditions based on the information
available today. Use of the words ‘believes’, ‘anticipates’ and
‘expects’ and similar expressions are intended to identify
forward-looking statements, including Ipsen’s expectations
regarding future events, including regulatory filings and
determinations. Moreover, the targets described in this document
were prepared without taking into account external-growth
assumptions and potential future acquisitions, which may alter
these parameters. These objectives are based on data and
assumptions regarded as reasonable by Ipsen. These targets depend
on conditions or facts likely to happen in the future, and not
exclusively on historical data. Actual results may depart
significantly from these targets given the occurrence of certain
risks and uncertainties, notably the fact that a promising medicine
in early development phase or clinical trial may end up never being
launched on the market or reaching its commercial targets, notably
for regulatory or competition reasons. Ipsen must face or might
face competition from generic medicine that might translate into a
loss of market share. Furthermore, the research and development
process involves several stages each of which involves the
substantial risk that Ipsen may fail to achieve its objectives and
be forced to abandon its efforts with regards to a medicine in
which it has invested significant sums. Therefore, Ipsen cannot be
certain that favorable results obtained during preclinical trials
will be confirmed subsequently during clinical trials, or that the
results of clinical trials will be sufficient to demonstrate the
safe and effective nature of the medicine concerned. There can be
no guarantees a medicine will receive the necessary regulatory
approvals or that the medicine will prove to be commercially
successful. If underlying assumptions prove inaccurate or risks or
uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements. Other risks
and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including
interest rate and currency exchange rate fluctuations; the impact
of pharmaceutical industry regulation and healthcare legislation;
global trends toward healthcare cost containment; technological
advances, new medicine and patents attained by competitors;
challenges inherent in new-medicine development, including
obtaining regulatory approval; Ipsen’s ability to accurately
predict future market conditions; manufacturing difficulties or
delays; financial instability of international economies and
sovereign risk; dependence on the effectiveness of Ipsen’s patents
and other protections for innovative medicines; and the exposure to
litigation, including patent litigation, and/or regulatory actions.
Ipsen also depends on third parties to develop and market some of
its medicines which could potentially generate substantial
royalties; these partners could behave in such ways which could
cause damage to Ipsen’s activities and financial results. Ipsen
cannot be certain that its partners will fulfil their obligations.
It might be unable to obtain any benefit from those agreements. A
default by any of Ipsen’s partners could generate lower revenues
than expected. Such situations could have a negative impact on
Ipsen’s business, financial position or performance. Ipsen
expressly disclaims any obligation or undertaking to update or
revise any forward-looking statements, targets or estimates
contained in this press release to reflect any change in events,
conditions, assumptions or circumstances on which any such
statements are based, unless so required by applicable law. Ipsen’s
business is subject to the risk factors outlined in its
registration documents filed with the French Autorité des
Marchés Financiers. The risks and uncertainties set out are not
exhaustive and the reader is advised to refer to Ipsen’s latest
Universal Registration Document, available on ipsen.com.
References
1 E. Jabbour, S. Paul, H. Kantarjian. The
clinical development of antibody-drug conjugates – lessons from
leukemia. Nature Reviews Clinical Onoclogy. 2021. 18: 418-433.
Available here:
https://www.nature.com/articles/s41571-021-00484-2
- Ipsen PR_Foreseen_11072024
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