Exclusive worldwide rights to develop, manufacture and commercialize FS001 have been secured and the final stages of preclinical development have been completed with the potential to be first-in-class. FS001 targets a novel tumor-associated antigen highly expressed in a range of solid tumors, identified through the application of Foreseen’s proprietary proteomics platform. FS001 has demonstrated robust preclinical efficacy in multiple tumor models and has a favorable preclinical safety profile.
Paris, France, July 11, 2024 – Ipsen (Euronext: IPN, ADR: IPSEY) and Foreseen Biotechnology (Foreseen) today announced an exclusive global license agreement for FS001, a potentially first-in-class antibody-drug conjugate (ADC). FS001 targets a novel tumor-associated antigen that is overexpressed in many solid tumors and plays a key role in tumor growth and metastasis. The novel tumor antigen was identified by analyzing a vast collection of well-characterized clinical tumor samples using Foreseen’s high-throughput, integrated translational proteomics and artificial intelligence (AI)-powered screening platform. FS001 utilizes an innovative, stable, cleavable linker coupled to a potent topoisomerase I inhibitor. Preclinical efficacy of FS001 has been demonstrated in multi-drug 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 that Ipsen has licensed in this year, to our growing pipeline. Using cutting-edge proteomics technology and an AI-powered screening platform, the Foreseen team has discovered a clinically significant new target that could unlock the potential of ADCs for even more people living with hard-to-treat cancers,” said Mary Jane Hinrichs, SVP and head of early development at Ipsen. “As we prepare to initiate a Phase I clinical trial, we will evaluate FS001 in certain solid tumor types, which we hope will provide an important new treatment for people living with cancer around the world.”
“Our strategic collaboration with Ipsen is a strong endorsement of our high-throughput integrated translational proteomics platform approach to discovering and developing innovative therapeutics with first-in-class potential,” said Catherine Wong, founder and chairperson of Forscene. “We are excited to collaborate with Ipsen to advance FS001 globally and leverage Ipsen’s strong track record of 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.”
Subject to successful development and regulatory approval, Foreceen Biotechnology is eligible to receive up to $1.03 billion, consisting of an upfront payment, development, regulatory and commercial milestone payments, and tiered royalties on global sales. Under the terms of the agreement, Ipsen will assume responsibility for Phase I preparatory activities, including the submission of an Investigational New Drug (IND) application, and all subsequent clinical development, manufacturing, and global commercialization activities.
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About Ibsen
We are a global biopharmaceutical company focused on delivering innovative medicines to patients across three therapeutic areas: oncology, rare diseases and neuroscience.
Our pipeline is driven 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 over 40 countries and 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 program (ADR: IPSEY). For more information, please visit ipsen.com.
About Foreseen Biotechnology
We are an emerging biotechnology company that has developed an integrated high-throughput translational proteomics platform powered by an AI-based data analytics system to accelerate the discovery of new targets for clinically relevant therapeutics and diagnostics. We are building a pipeline of novel product candidates for the diagnosis and treatment of cancer, inflammatory/autoimmune and neurological diseases. Foreseen Biotechnology is incubated by Nest.Bio Ventures.
About Antibody-Drug Conjugates (ADCs)
ADCs consist of three main components: the antibody, the payload, and a linker. The antibody selectively targets a identified tumor antigen. The payload is a pharmacologically active moiety for treating cancer that is attached to the antibody via a chemical linker. The linker connects the antibody and the payload and reduces the amount of payload that reaches tissues other than the tumor.1
About FS001
FS001 is a potential first-in-class ADC with demonstrated preclinical activity in multiple solid tumors and a favorable safety profile across a wide therapeutic window in animal studies. FS001 consists of (i) the Company’s proprietary antibody that specifically binds to a novel target identified using Foreseen’s high-throughput integrated translational proteomics platform and (ii) an innovative linker-payload with excellent pharmaceutical properties developed by Shanghai Eskugen Biotechnology Co., Ltd. FS001 is in the final stages of preclinical development.
Ibsen’s contact details
Email: corporate.communications@ipsen.com
Investor
Craig Marks | + 44 7584 349 193
Nikolas Vogler | +33 (0) 6 52 19 98 92
media
Amy Wolf | +41 7 95 76 07 23
Jess Smith | + 44 7557 267 634
Biotech Contacts
Kelly Wang | +86 13611776259
Email: kerry.wang@foreseenbio.com
Ipsen Disclaimer and/or Forward-Looking Statements
The forward-looking statements, objectives and targets contained in this document are based on Ipsen’s management strategies, current views and assumptions. These statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those projected herein. All of the above risks may affect Ipsen’s future ability to achieve its financial targets, which are set assuming reasonable macroeconomic conditions based on currently available information. The use of words such as “believes,” “expects,” “anticipates” and similar expressions is intended to identify forward-looking statements, including Ipsen’s expectations regarding future events, including regulatory filings and decisions. Furthermore, the targets set out in this document have been made without taking into account any external growth assumptions or possible future acquisitions that may change these parameters. These targets are based on data and assumptions that Ipsen considers reasonable. These targets depend on circumstances and facts that may occur in the future and not solely on historical data. Actual results may deviate materially from these targets given the occurrence of certain risks and uncertainties, in particular the fact that promising drugs in early development or clinical trials may not be brought to market and reach their commercial targets due to regulatory or competitive reasons.Ipsen will have to or may face competition from generic drugs that could result in a loss of market share. Furthermore, the research and development process involves multiple stages, each of which involves significant risks that Ipsen will not achieve its goals and will be forced to abandon efforts with respect to pharmaceutical products in which it has invested heavily. Accordingly, Ipsen cannot be sure that favorable results obtained in preclinical trials will be confirmed in subsequent clinical trials or that the results of clinical trials will be sufficient to prove the safety and effectiveness of such pharmaceutical products. There can be no assurance that pharmaceutical products will receive necessary regulatory approvals or that they will be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those described 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 exchange rate fluctuations, the impact of pharmaceutical industry regulation and health care legislation, the global trend toward health care cost containment, technological advances acquired by competitors, the challenges inherent in new drug development, including obtaining new drugs, patents and regulatory approvals, Ipsen’s ability to accurately predict future market conditions, manufacturing difficulties or delays, financial instability and sovereign risk in the international economy, Ipsen’s reliance on the effectiveness of Ipsen’s patents and other protections for innovative medicines, and exposure to litigation and regulatory actions, including patent litigation. Ipsen also depends on third parties to develop and market some of its medicines, which may generate significant royalties. These partners may take actions that could harm Ipsen’s activities or financial results. Ipsen cannot be certain that its partners will meet their obligations. Ipsen may not be able to realize the benefits from these agreements. If any of Ipsen’s partners default on their obligations, Ipsen may experience lower revenues than expected. Such conditions could have an adverse effect on Ipsen’s business, financial condition or results of operations. Except as required by applicable law, Ipsen expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, objectives or estimates contained in this press release to reflect changes in events, conditions, assumptions or circumstances on which such statements are based. Ipsen’s business is subject to risk factors set out in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and readers are advised to consult Ipsen’s most recent universal registration documents available at ipsen.com.
References
1 E. Jabbour, S. Paul, H. Kantarjian. Clinical development of antibody-drug conjugates – lessons from leukemia. Nature Reviews Clinical Onocology. 2021. 18: 418-433. Available at: https://www.nature.com/articles/s41571-021-00484-2
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