On May 6, 2025 Formosa Pharmaceuticals, Inc. ("Formosa"; 6838.TW ticker-symbol on the Taiwan Stock Exchange) and Almac Discovery reported a global licensing agreement for development and commercialisation of ALM-401, a first-in-class engineered bispecific Antibody-Drug Conjugate (ADC), addressing the high unmet needs of cancer patients worldwide suffering with intractable and aggressive solid tumours (Press release, Almac, MAY 6, 2025, View Source [SID1234652564]).
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The agreement facilitates the next phases of CMC and drug development by Formosa, including IND submission and early clinical proof-of-concept in international clinical trials.
ALM-401 has been the culmination of a multi-year R&D programme at Almac Discovery deploying their proprietary OmniaScape informatics platform, protein engineering and medicinal chemistry capabilities.
The design of ALM-401 has built upon the recent clinical successes within the ADC field, including selection of a linker-payload matched to potential clinical cancer indications, and the molecule also benefits from being approximately half the size of conventional ADCs, thereby facilitating enhanced solid tumour penetration. The main features of ALM-401 include:
Innovative bi-specific target-pairing based on co-expression and functional analysis of specific, aggressive solid tumours
Sustained high-efficacy in vivo in PDX models; as presented at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) (AACR; Chicago) annual meeting
Half-the-size of conventional ADCs for enhanced solid tumour penetration and optimised manufacturing.
Formosa Pharmaceuticals, Inc. (6838.TW) is a clinical stage biotechnology company with primary focus in the areas of ophthalmology and oncology, with particular CMC and manufacturing expertise for specialist ADC therapeutics. "Formosa Pharma is pleased to have this opportunity to bring ALM-401 into our development pipeline. 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." said Dr. Erick Co, President and CEO of Formosa Pharmaceuticals.
"We are pleased to have met Formosa’s exacting selection requirements for Next Generation ADC candidates," said Dr Stephen Barr, President and Managing Director of Almac Discovery. "This agreement allows the seamless progression of the molecule into clinical evaluation, driven by Formosa."
"In addition to an excellent preclinical efficacy profile, high-quality, robust and scalable CMC and manufacturing is a key competitive advantage for ADCs in the fast-moving race for effective cancer therapeutics" commented Dr Graham Cotton, Vice-President of Protein Therapeutics, Almac Discovery.