• 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 I July 11, 2024 I 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.       

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

SOURCE: Ipsen