Formosa Pharmaceuticals and Almac Discovery License ALM-401 Bispecific ADC for Solid Tumor Treatment

Formosa Pharmaceuticals, a Taiwan-based biotechnology company, has announced a significant collaboration with Almac Discovery, a research-driven drug discovery company from Northern Ireland. The partnership grants Formosa exclusive rights to commercialize ALM-401, a pioneering bispecific antibody drug conjugate (ADC) aimed at treating solid tumors that exhibit the dual expression of EGFR and ROR1 proteins.

Almac Discovery specializes in protein homeostasis and the development of next-generation ADCs. Their diverse portfolio consists of both small and large molecule drug candidates, which are in various stages of preclinical and clinical development. The company has established numerous collaboration and licensing partnerships with global biotech and pharmaceutical organizations focused on research and development.

The exclusive licensing agreement between Formosa and Almac Discovery includes an upfront payment and development milestones. Additionally, there are considerations tied to the approval and post-commercialization phases of ALM-401’s development.

ALM-401 is distinguished by its novel bispecific antibody structure, which is engineered to be smaller through a single-chain architecture. This design potentially enhances the drug’s ability to engage with epitopes and penetrate tumors, while also simplifying the manufacturing process. The ADC has shown promising results in preclinical studies, demonstrating sustained tumor regressions in various solid tumor models, including non-small cell lung cancer (NSCLC). Moreover, ALM-401 induces a significant bystander effect, which enhances its overall therapeutic efficacy.

Dr. Erick Co, President and CEO of Formosa Pharmaceuticals, expressed enthusiasm about the collaboration, stating that ALM-401 aligns with the company’s strategic objectives and resources. Dr. Co emphasized the potential of this next-generation ADC to provide a unique treatment option for cancer patients globally. He also highlighted the importance of working closely with Almac Discovery to advance ALM-401 through clinical trials and commercialization.

Dr. Stephen Barr, President and Managing Director of Almac Discovery, also shared his thoughts on the partnership, noting that Almac Discovery is pleased to have met Formosa’s stringent criteria for next-generation ADC candidates. He expressed confidence that the collaboration would facilitate the smooth transition of ALM-401 into clinical evaluation under Formosa’s guidance.

Formosa Pharmaceuticals is a clinical-stage biotechnology company that primarily focuses on ophthalmology and oncology. The company’s leading program, APP13007, is a novel topical formulation of clobetasol propionate, a potent corticosteroid. Approved by the US FDA in 2024, APP13007 is used for treating post-operative inflammation and pain following ocular surgery. The company has several regional licensing partners worldwide. Formosa is known for its proprietary nanoparticle formulation technology (APNT®), which enhances the dissolution and bioavailability of active pharmaceutical ingredients for various routes of administration.

Almac Discovery operates drug discovery facilities in Belfast, Edinburgh, and Manchester. The company is led by an experienced team skilled in delivering successful preclinical programs. Their internal capabilities include discovery biology, bioinformatics, protein engineering, medicinal chemistry, and translational sciences. Almac Discovery leverages its expertise in protein engineering and small molecule development to create first-in-class and best-in-class new chemical entities. Once these entities reach the preclinical candidate or IND-ready stage, Almac seeks collaboration with partners to expedite further development.

The partnership between Formosa Pharmaceuticals and Almac Discovery marks an important step forward in the advancement of innovative cancer therapies. With ALM-401, the two companies aim to deliver a novel therapeutic option for patients with solid tumors, potentially making a significant impact in the field of oncology.