Ipsen has entered an exclusive global licensing agreement with Foreseen Biotechnology for FS001, a potentially first-in-class antibody-drug conjugate (ADC).

This partnership grants Ipsen worldwide rights to develop, manufacture and commercialise FS001, which is in the final stages of its pre-clinical phase. FS001 targets a novel tumour-associated antigen prevalent in many solid tumours, critical for their growth and spread.

FS001 incorporates a stable and cleavable linker with a potent topoisomerase I inhibitor.

Preclinical studies have shown FS001 to be effective in multi-drug-resistant cancer models.

Foreseen Biotechnology is eligible to receive $1.03bn in payments, including upfront, development, regulatory and commercial milestones, as well as tiered royalties on global sales, based upon successful development and regulatory approvals.

Ipsen senior vice-president and head of early development Mary Jane Hinrichs stated: “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.

 “As we prepare for the initiation of a Phase I clinical trial, we will evaluate FS001 in selected solid tumour types, which we hope will deliver critical new treatments for people living with cancer around the world.”

Foreseen chairman and founder Catherine Wong stated: “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.

“We are pleased to be collaborating with Ipsen to advance FS001 globally, harnessing Ipsen’s robust track record in accelerating the clinical development and commercialisation of innovative therapeutics. We believe FS001 has the potential to treat multiple cancers as a single agent or in combination with standard of care.”

Ipsen will also be responsible for Phase I preparation activities, which include the investigational new drug application submission and all further clinical development, manufacture and commercialisation aspects.