Taiwan-based Formosa Pharmaceuticals has secured exclusive global commercialization rights to ALM-401, a first-in-class bispecific antibody drug conjugate (ADC) developed by Northern Ireland's Almac Discovery. The licensing agreement, announced on May 6, 2025, focuses on treating solid tumors characterized by dual expression of EGFR and ROR1.
The financial terms include an upfront payment, development milestones, and additional considerations through approval and post-commercialization phases, though specific amounts remain undisclosed.
Novel Bispecific ADC Technology
ALM-401 represents a significant advancement in ADC technology, featuring a novel bispecific antibody engineered with a single-chain architecture that results in a smaller molecular size. This structural innovation potentially enhances epitope engagement and tumor penetration while simplifying manufacturing processes.
Preclinical studies have shown promising results, with ALM-401 demonstrating durable and sustained tumor regressions across multiple solid tumor models, particularly in non-small cell lung cancer (NSCLC). Notably, the therapeutic induces a pronounced bystander effect, which amplifies its overall efficacy by affecting nearby cancer cells not directly targeted by the antibody.
Dr. Erick Co, President and CEO of Formosa Pharmaceuticals, emphasized the strategic importance of the acquisition: "This novel, next-generation ADC complements our corporate strategy and resources and promises to deliver a differentiated therapy to cancer patients worldwide. We look forward to collaborating closely with Almac Discovery in advancing this exciting program through clinical trials, commercialization, and beyond."
Addressing Unmet Needs in Solid Tumors
The dual targeting of EGFR and ROR1 represents a novel approach in oncology. EGFR (Epidermal Growth Factor Receptor) is a well-established target in cancer therapy, with overexpression observed in various solid tumors. ROR1 (Receptor Tyrosine Kinase-like Orphan Receptor 1) is an emerging target that shows elevated expression in multiple cancer types with limited expression in normal adult tissues, potentially offering improved therapeutic selectivity.
This bispecific approach may address resistance mechanisms that have limited the efficacy of single-target EGFR therapies, particularly in lung cancer where resistance frequently develops.
Strategic Expansion for Formosa Pharmaceuticals
For Formosa Pharmaceuticals (6838.TW), this agreement marks a significant expansion of their oncology portfolio. The company recently achieved FDA approval in 2024 for APP13007, a novel topical formulation of clobetasol propionate for post-operative inflammation and pain following ocular surgery.
Dr. Stephen Barr, President and Managing Director of Almac Discovery, noted: "We are pleased to have met Formosa's exacting selection requirements for Next Generation ADC candidates. This agreement allows the seamless progression of the molecule into clinical evaluation, driven by Formosa."
About the Companies
Formosa Pharmaceuticals is a clinical-stage biotechnology company focused on ophthalmology and oncology. The company leverages its proprietary nanoparticle formulation technology (APNT®) to improve the dissolution and bioavailability of active pharmaceutical ingredients for various administration routes.
Almac Discovery operates drug discovery facilities in Belfast, Edinburgh, and Manchester, specializing in protein homeostasis and next-generation antibody drug conjugates. The company's portfolio includes both small and large molecule modalities at preclinical and clinical stages, with multiple global partnerships supporting their development pipeline.
The companies have not disclosed a timeline for initiating clinical trials of ALM-401, but the agreement positions the novel ADC to advance toward human studies under Formosa's direction.
