Ipsen and Foreseen Biotechnology Announce Exclusive Worldwide License Agreement for Antibody-Drug Conjugate with First-in-Class Potential
Friday, July 12, 2024
Ipsen (Euronext: IPN; ADR: IPSEY) and Foreseen Biotechnology (Foreseen) today announced the signing of an exclusive worldwide license agreement for FS001, a potentially first-in-class antibody-drug conjugate (ADC). FS001 targets a novel tumor-associated antigen, overexpressed in many solid tumors, that plays a critical role in tumor proliferation and metastasis. This novel tumor antigen was identified using Foreseen’s high-throughput screening platforms, combining integrated translational proteomics and artificial intelligence (AI) to analyze a broad range of well-characterized clinical tumor samples. FS001 utilizes a novel, stable, cleavable linker molecule coupled to a potent topoisomerase I inhibitor. FS001 has demonstrated preclinical efficacy in multidrug-resistant cancer models. The agreement provides Ipsen with exclusive worldwide rights to develop, manufacture and commercialize FS001.
“We are pleased to add FS001, the second ADC to be licensed to Ipsen this year, to our growing pipeline of R&D products. Using cutting-edge proteomics and AI-based screening platforms , the Foreseen team has discovered a new clinically relevant target that could enable ADCs to be used in more people with difficult-to-treat forms of cancer, ” said Mary Jane Hinrichs, Senior Vice President and Global Head of Preclinical Development at Ipsen. “We are preparing to initiate a Phase I clinical trial evaluating FS001 in select solid tumor types, which we hope will enable us to bring critical new treatments to people with cancer around the world.”
“Our strategic partnership with Ipsen strongly supports our integrated, high-throughput translational proteomics platform approach to the discovery and development of innovative therapeutic solutions with first-in-class potential,” said Catherine Wong, Founder and President of Foreseen. “We are excited to collaborate with Ipsen to advance FS001 globally and leverage Ipsen’s historical expertise in accelerating the clinical development and commercialization of innovative therapeutics. We believe FS001 has the potential to treat multiple cancers as a monotherapy or in combination with standard-of-care therapy.”
Foreseen will receive up to $1.03 billion, including an upfront payment and development payments contingent upon the achievement of regulatory and commercial milestones. Foreseen will also be entitled to receive tiered royalties on global sales, contingent upon the successful completion of development and regulatory activities.
Under the terms of the agreement, Ipsen will assume responsibility for Phase I preparation activities, including the filing of the Investigational New Drug (IND) application, as well as all subsequent clinical development, manufacturing and global commercialization activities.
About Ipsen
We are a global biopharmaceutical group focused on developing innovative medicines for patients in three therapeutic areas: Oncology, Rare Diseases and Neuroscience.
Our R&D portfolio is built on external innovation and nearly 100 years of development experience across global hubs in the United States, France and the United Kingdom. Our teams in over 40 countries and our partnerships around the world enable us to bring our medicines to patients in over 80 countries.
Ipsen is listed in Paris (Euronext: IPN) and in the United States through a sponsored Level I American Depositary Receipt ( ADR: IPSEY) program. For more information, visit ipsen.com.
About Foreseen Biotechnology
Foreseen Technologies is an emerging biotechnology company that has pioneered the development of an integrated, high-throughput translational proteomics platform, powered by AI-driven data analytics, to accelerate the discovery of novel, clinically relevant therapeutic and diagnostic targets. Our teams are focused on developing 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 consist of three main components: the antibody carrier, the payload, and the linker molecule. The antibody selectively targets an identified tumor antigen. Payloads are the active component that treats the cancer, attached to the antibody via a linker molecule. The linker molecule connects the antibody to the payload and decreases the amount of payload that reaches non-tumor tissues 1 .
About FS001
FS001 is a potential first-in-class ADC that has demonstrated preclinical efficacy in multiple solid tumors and a favorable safety profile with a broad therapeutic window in animal studies. FS001 comprises (i) Foreseen’s proprietary antibody targeting a novel tumor-associated antigen identified using the Company’s integrated high-throughput translational proteomics platform and (ii) a novel linker and payload compound with excellent pharmaceutical characteristics, developed by Shanghai Escugen Biotechnology Co. Ltd. FS001 is currently advancing into the final stages of preclinical development.
Contacts Ipsen
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
Contacts Foreseen Biotechnology
Kerry Wang | +86 13611776259
Email: kerry.wang@foreseenbio.com
Warnings and/or forward-looking statements
The forward-looking statements and targets contained in this press release are based on the current strategy and assumptions of Ipsen's management. These statements and targets involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated in this press release. Such risks and unforeseen events could affect Ipsen's ability to achieve its financial targets, which are based on reasonable assumptions about future macroeconomic conditions based on information currently available. The use of the words "believes", "plans" and "expects" or similar expressions is intended to identify forward-looking statements, including Ipsen's expectations regarding future events such as regulatory filings and decisions. In addition, the targets mentioned in this document are established without taking into account possible future external growth operations that could change all of these parameters. These forecasts are based on data and assumptions considered reasonable by Ipsen, and depend on circumstances or facts likely to occur in the future, some of which are beyond the Group's control, and not exclusively on historical data. Actual results could prove to be substantially different from these objectives given the materialization of certain risks or uncertainties, and in particular that a new drug may appear promising during a preparatory phase of development or after clinical trials, but never be marketed or fail to achieve its commercial objectives, in particular for regulatory or competitive reasons. Ipsen must or may have to face competition from generic products, which could result in loss of market share. In addition, the research and development process comprises several stages and, at each stage, there is a significant risk that Ipsen may not be able to achieve its objectives and that it may be forced to abandon its efforts on a drug in which it has invested significant sums. Also, Ipsen cannot be certain that favorable results obtained in preclinical trials will be confirmed subsequently in clinical trials or that the results of clinical trials will be sufficient to demonstrate the safety and efficacy of the drug concerned. There can be no assurance that a drug will receive the necessary regulatory approvals or that it will achieve its commercial objectives. Actual results could differ materially from those anticipated in the forward-looking statements if underlying assumptions prove inaccurate or if certain risks or uncertainties materialize. Other risks and uncertainties include,but 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 greater cost containment; technological advances, new drugs and patents obtained by competitors; problems inherent in the development of new drugs, including obtaining approval; Ipsen's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability in the international economy and sovereign risk; dependence on the effectiveness of Ipsen's patents and other protections for innovative drugs; and the risk of litigation, including patent litigation or regulatory actions. Ipsen also depends on third parties for the development and commercialization of its drugs, which may give rise to substantial royalties; In addition, these partners could act in a way that could harm Ipsen's activities and financial results. Ipsen cannot be certain that its partners will meet their commitments. As such, the Group may not be able to benefit from these agreements. A failure by one of its partners could result in an unexpected drop in revenue for Ipsen. Such situations could have a negative impact on Ipsen's activity, financial position or results. Except as required by applicable law, Ipsen undertakes no obligation to update or revise the forward-looking statements or objectives referred to in this press release in order to reflect changes that would affect the events, situations, assumptions or circumstances on which these statements are based. Ipsen's business is subject to risk factors that are described in its information documents registered with the Autorité des Marchés Financiers. The risks and uncertainties presented are not the only ones that the Group must face and the reader is invited to read the latest edition of the Ipsen Universal Registration Document, available onincluding obtaining approval; Ipsen’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability in the international economy and sovereign risk; dependence on the effectiveness of Ipsen’s patents and other protections for innovative medicines; and the risk of litigation, including patent litigation or regulatory proceedings. Ipsen also depends on third parties for the development and commercialization of its medicines, which may give rise to substantial royalties; in addition, these partners could act in a manner that harms Ipsen’s business and financial results. Ipsen cannot be certain that its partners will meet their commitments. As such, the Group may not be able to benefit from these agreements. A failure by one of its partners could result in an unexpected decline in revenues for Ipsen. Such situations could have a negative impact on Ipsen’s business, financial condition or results. Except as required by applicable law, Ipsen undertakes no obligation to update or revise any forward-looking statements or objectives contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which these statements are based. Ipsen's business is subject to risk factors that are described in its information documents filed with the Autorité des Marchés Financiers. The risks and uncertainties presented are not the only ones that the Group must face and the reader is invited to read the latest edition of Ipsen's Universal Registration Document, available atincluding obtaining approval; Ipsen’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability in the international economy and sovereign risk; dependence on the effectiveness of Ipsen’s patents and other protections for innovative medicines; and the risk of litigation, including patent litigation or regulatory proceedings. Ipsen also depends on third parties for the development and commercialization of its medicines, which may give rise to substantial royalties; in addition, these partners could act in a manner that harms Ipsen’s business and financial results. Ipsen cannot be certain that its partners will meet their commitments. As such, the Group may not be able to benefit from these agreements. A failure by one of its partners could result in an unexpected decline in revenues for Ipsen. Such situations could have a negative impact on Ipsen’s business, financial condition or results. Except as required by applicable law, Ipsen undertakes no obligation to update or revise any forward-looking statements or objectives contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which these statements are based. Ipsen's business is subject to risk factors that are described in its information documents filed with the Autorité des Marchés Financiers. The risks and uncertainties presented are not the only ones that the Group must face and the reader is invited to read the latest edition of Ipsen's Universal Registration Document, available atits financial position or results. Subject to applicable legal provisions, Ipsen undertakes no obligation to update or revise the forward-looking statements or objectives referred to in this press release in order to reflect changes that may affect events, situations, assumptions or circumstances on which these statements are based. Ipsen's business is subject to risk factors that are described in its information documents registered with the Autorité des Marchés Financiers. The risks and uncertainties presented are not the only ones that the Group must face and the reader is invited to read the latest edition of Ipsen's Universal Registration Document, available onits financial position or results. Subject to applicable legal provisions, Ipsen undertakes no obligation to update or revise the forward-looking statements or objectives referred to in this press release in order to reflect changes that may affect events, situations, assumptions or circumstances on which these statements are based. Ipsen's business is subject to risk factors that are described in its information documents registered with the Autorité des Marchés Financiers. The risks and uncertainties presented are not the only ones that the Group must face and the reader is invited to read the latest edition of Ipsen's Universal Registration Document, available onipsen.com.
Source: globenewswire.com
