French biopharmaceutical company Ipsen has signed a licensing agreement worth up to $1.03bn with Foreseen Biotechnology, for the latter’s antibody-drug conjugate (ADC) candidate, FS001.

FS001 is a potential first-in-class ADC with demonstrated preclinical efficacy in multiple solid tumours as well as a favourable safety profile with a wide therapeutic window in animal studies.

The drug candidate works by targeting a novel tumour-associated antigen that is overexpressed in several solid tumours and has a key role in tumour proliferation and metastasis.

Under the terms of the agreement, Ipsen obtains exclusive rights to develop, manufacture, and commercialise FS001 worldwide.

Foreseen will receive upfront and milestone payments and is eligible to receive tiered royalties on global sales, after successful development and regulatory approvals.

Ipsen will be responsible for Phase 1 preparation, including submission of the investigational new drug (IND) application, and all other clinical-development, manufacturing, and marketing activities.

Ipsen senior vice president and early development head Mary Jane Hinrichs said: “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 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 identified the novel tumour antigen using high throughput, integrated translational proteomics, and artificial intelligence (AI) powered screening platforms.

The company is said to have analysed a large collection of well-characterised clinical tumour samples.

FS001 comprises Foreseen’s in-house antibody that specifically binds to a novel target identified using the company’s high throughput integrated translational proteomics platform.

The drug candidate uses an innovative, stable, and cleavable linker, coupled to a potent topoisomerase I inhibitor. Its preclinical efficacy was shown in multi-drug resistant cancer models.

The ADC therapy candidate, currently in the final stages of pre-clinical development, also features a linker payload developed by Shanghai Escugen Biotechnology.

Foreseen founder and chairman Catherine Wong said: “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.”