Foreseen Biotech Strikes $1.03B Deal with Ipsen for First-in-Class ADC

Foreseen Biotechnology Co. Ltd., secured a global licensing deal worth up to $1.03 billion with Ipsen SA of Paris. This agreement focuses on the antibody-drug conjugate FS-001, which holds first-in-class potential. The drug targets a novel tumor-associated antigen over-expressed in many solid tumors. It plays a crucial role in tumor proliferation and metastasis, according to the companies.

Under the licensing agreement, Ipsen will now handle Phase I preparation activities, including the Investigational New Drug (IND) application submission. They will also manage all clinical development, manufacturing, and commercialization efforts.

FS001, A Stable, Cleavable Linker with Potent Topo-I Inhibitor Targeting Difficult-to-Treat Cancers

Ipsen (Euronext: IPN; ADR: IPSEY) is expanding its cancer pipeline by licensing another antibody-drug conjugate (ADC). Foreseen Biotechnology announced that it will grant Ipsen global rights to develop, manufacture, and commercialize a potentially first-in-class preclinical asset. This exclusive agreement is valued at over $1 billion.

Foreseen’s FS001 is an ADC targeting a novel antigen over-expressed in many solid tumors. As a promising therapeutic candidate for various difficult-to-treat cancers, FS001 directly acts on the antigen that plays a crucial role in tumor proliferation and metastasis. The company identified this antigen through proprietary proteomic and AI-powered platforms. Specifically, Foreseen identified the novel tumor antigen using high-throughput, integrated translational proteomics and AI-powered screening platforms to analyze their extensive collection of well-characterized clinical tumor samples. FS001 uses an innovative, stable, and cleavable linker paired with a potent topoisomerase I inhibitor. Foreseen’s preclinical work on FS001 showed efficacy in multi-drug resistant cancer models. 

Mary Jan Hinrichs, Ipsen’s senior vice president of early development, said in a statement, “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.”

Exclusive Global Licensing Agreement Balances Financial Gains and Clinical Developments

Under the agreement, Foreseen Biotechnology stands to earn up to $1.03 billion, including upfront payments, development milestones, regulatory milestones, and commercial milestone payments, as well as tiered royalties on global sales, subject to successful development and regulatory approvals. Meanwhile, Ipsen takes charge of Phase I preparation activities, including the submission of the IND application. Additionally, Ipsen will manage all subsequent clinical development, manufacturing, and commercialization efforts.

Catherine Wong, Founder and Chairman of Foreseen, stated, “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.” The company has maintained a low profile, with its website undergoing maintenance. Foreseen positions itself as an emerging biotechnology company that has pioneered a high-throughput integrated translational proteomics platform powered by an artificial intelligence-based data analytical system to develop diagnostics and pharmaceuticals.

Recently, Ipsen has been active in securing new assets. In early April, the company acquired exclusive global rights to a preclinical ROR1-targeting candidate from Sutro Biopharma Inc., valued at up to $900 million. STRO-003, Ipsen’s first ADC, utilizes Sutro’s site-specific technology to develop a stable conjugate with exatecan payloads, showing promising preclinical efficacy in solid tumors and hematological malignancies and potentially offering a unique safety profile. Additionally, Ipsen expanded its partnership with Marengo Therapeutics Inc. by $1.2 billion, adding two assets that target “cold” tumors to its portfolio.

ADC Market Surge: Biopharma’s Billion-Dollar Bet on Future Growth

ADCs remain a highly sought-after area in biopharma investment, with the global market exceeding $10 billion last year for the first time. According to the market intelligence firm Evaluate, the market is set to approach nearly $30 billion by 2028. This expansion is expected at a compound annual growth rate (CAGR) of 9.2% from 2024 to 2030. Strong R&D pipelines and rising cancer rates, coupled with increasing demand for safe and potent drugs with low toxicity levels, drive this growth, prompting companies to heavily invest in entering this field.

Author

Bernice Lottering