* 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
(mailto: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 13611776259
Email: kerry.wang@foreseenbio.com (mailto:kerry.wang@foreseenbio.com)
Ipsen Disclaimers and/or Forward-Looking Statements
The 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
(https://www.globenewswire.com/Tracker?data=cRbeTYiLm_i554EQ7ITgGkjFSkEO7CuADsdG
INJYRhuLZP1b2RRGQKaNMQhqDBefwdyOcUcRf2VYKHI9RWUEWA==).
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
Â