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; 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.

ENDS

About Formosa Pharmaceuticals, Inc.

Formosa Pharmaceuticals, Inc. (6838.TW) is a clinical stage biotechnology company with primary focus in the areas of ophthalmology and oncology.  The company’s flagship program, APP13007, is a novel topical formulation of the potent corticosteroid, clobetasol propionate, and was approved by the US FDA in 2024 for the treatment of post-operative inflammation and pain following ocular surgery, with multiple regional licensing partners worldwide.  The company’s proprietary nanoparticle formulation technology (APNT^®), through which APP13007 was developed, improves the dissolution and bioavailability of APIs for topical, oral, and inhaler administration.  For more details please visit www.formosapharma.com

Contact:

Mr Wayne Wei, MPH, CLP, RAC

Chief Strategy & Business Officer

E: waynewei@formosapharma.com

About Almac Discovery Limited

Almac Discovery has drug discovery facilities in Belfast, Edinburgh and Manchester. It is led by an experienced team with a track record in delivering successful pre-clinical programmes. Internal capabilities include discovery biology and bioinformatics, protein engineering, medicinal chemistry and translational sciences. Almac Discovery utilises its unique blend of protein engineering and small molecule capabilities to create and develop First in Class and Best in Class NCEs through to the pre-clinical candidate/IND-ready stages, after which it seeks to collaborate with partners to accelerate their development.

The Discovery business benefits from collaboration and licensing partnerships with global R&D-focused biotech and pharmaceutical organisations.

Contact:

Dr Enda Gribbon

Business Development and Licensing

E: enda.gribbon@almacgroup.com

The post Almac Discovery and Formosa Pharmaceuticals announce global licensing agreement for development and commercialisation of ALM-401, a first-in-class EGFRxROR1 Bispecific Antibody-Drug Conjugate appeared first on Almac.

This £55 million industry-led collaborative initiative, backed by a consortium of leading companies in Precision Medicine is also supported by leading academics from Queen’s University Belfast and Ulster University. 

Almac’s significant involvement in the new Institute, for Almac Discovery and Almac Diagnostic Services in particular, is a further demonstration of our commitment to the Life and Health Sciences Sector locally.

The FMI will also focus on skills development, leveraging the local universities and colleges to address talent gaps in the sector, foster spinouts, and drive job creation to support the broader Northern Ireland economy.  This will further help to build on Almac’s existing track record of investing in the area of skills, whether through STEM engagement, apprenticeships, placements and work experience.

Alan Armstrong, Chair and CEO of Almac Group said: “Congratulations to colleagues in Almac Discovery, Almac Diagnostic Services and Group for the central role they have played in today’s announcement of the £55m Future Medicines Institute. We look forward to working with our other industrial partners and the two universities to deliver on the potential for the life and health sciences sector that the Strength in Places project and the FMI represent for NI.” 

The industry-led consortium has been offered £35m from the Northern Ireland Executive towards FMI, with the consortium members contributing an additional £20m. This will fund a wide range of collaborative R&D activities between the companies and universities. It will also create a shared lab within Queen’s University Belfast, where industry and academics can come together to collaborate and access leading edge technologies.  

The post Almac announces key partnership with Future Medicines Institute appeared first on Almac.

ALM-401 has demonstrated an excellent preclinical efficacy profile in a range of models when benchmarked against clinical stage ROR1 targeting ADCs, as well as strong preclinical development potential.

The bispecific nature of ALM-401 enhances both the activity and selectivity of the product relative to monospecific drug conjugates, delivering sustained regressions in a series of NSCLC PDX models, and with a consistently improved efficacy profile relative to a clinical stage monospecific ROR1 targeting ADC. ALM-401 has a pleiotropic mechanism of action: in addition to direct tumour cell-killing, it blocks EGFR-mediated signalling and induces bystander killing for increased therapeutic activity. The architecture of ALM-401 has been designed to be half the size of a conventional ADC to promote improved tumour penetration and ease of manufacture.

Dr Graham Cotton, Vice President Protein Therapeutics at Almac Discovery, said: “The nomination of this candidate drug represents a significant value inflection point in the development of our ADC portfolio and an important step forward in our search for new treatments for solid tumours.  This molecule has arisen from our strategic collaboration with Elasmogen Ltd, and we are confident that ALM-401 has the potential to progress to a First-in-Class drug which exploits the co-localisation of these clinically validated targets.”

Prof. Tim Harrison, VP Drug Discovery at Almac Discovery, added: “We see the emergence of new ADC formats including bispecific and biparatopic pairings as an important stepping stone in the evolution of ADCs, and are excited about the potential of ALM-401. We are now seeking to identify a partner to accelerate the clinical development of this molecule.”

For further details contact Enda Gribbon (enda.gribbon@almacgroup.com)

Connect with Enda Gribbon to arrange a meeting at Bio 2024, San Diego to discuss the potential of ALM401 for the treatment of refractory lung cancer.

The post Almac Discovery nominates ALM-401 as a First in Class Bispecific Next Generation ADC targeting EGFR/ROR1 to progress into pre-clinical development appeared first on Almac.

The multi-million-pound facility, which is jointly funded by Almac Discovery and a BBSRC Prosperity Partnership award, is a first of its kind in Northern Ireland and will be located at Queen’s.

The project combines and harnesses the experience of industrial and academic experts to shine a new light on the way drug molecules could be used to treat disease, by using advanced mass spectrometry techniques to examine their effects on thousands of potential drug targets simultaneously, in disease relevant systems.

This latest collaboration builds on a long-established relationship between Almac Discovery and Queen’s in biological research and early-stage drug discovery.  It will leverage the capabilities and state-of-the-art expertise of Queen’s researchers in mass spectrometry and biological research across three Queen’s University research centres.

Securing a Prosperity Partnership award for this project highlights the importance of advanced proteomics in addressing drug discovery challenges which will ultimately make a difference to people’s lives.

Professor Tim Harrison, Vice President of Almac Discovery said: “Creating this industry-facing, university-based facility represents a unique opportunity to provide a step-change in proteomics-based experimental capabilities in Northern Ireland.

“Our vision is to build an internationally recognised resource comprising chemical probes, experimental capabilities, and proteomics expertise which will accelerate the research and development programmes of regional, national and international industrial and academic partners.”

Professor Christopher Scott, Dean of Research, Faculty of Medicine, Health and Life Sciences, Queen’s, said: “We are delighted to see this new exciting initiative which will drive the research capabilities of both Queen’s and Almac. Our vision is that this Centre of Excellence will become a national asset that can help support broader research and education pipelines nationally”.

The Centre of Excellence will also enhance Northern Ireland’s drug discovery research capabilities, providing skills training for apprenticeships through to doctoral researchers.

The post Almac Discovery and Queen’s University launch state-of-the-art Chemoproteomics facility in Belfast appeared first on Almac.

Almac Discovery, the drug discovery biotech operating within the Almac Group of companies, has announced that the highly selective WEE1 inhibitor which it licensed to Debiopharm (Switzerland) and now known as Debio 0123, has been progressed into further clinical studies.  The first patients have now received treatment in two separate clinical studies involving glioblastoma (GBM) and small cell lung cancer (SCLC). 

In both studies, Debiopharm has combined Debio 0123 with standard of care therapy in patients with either GBM, one of the most aggressive and common lethal tumours of the central nervous system, or SCLC, a highly aggressive, hard-to-treat cancer with poor prognosis.   

The Debio 0123 programme offers the potential to improve clinical outcomes and quality of life for patients suffering from GBM or SCLC. In cancer cells, DDR pathways are often upregulated due to genomic instability, providing potential resistance pathways to DNA-damaging therapies. Therefore, blocking kinases such as WEE1 which play essential roles in DNA repair is likely to increase the cancer’s vulnerability to SOC therapies. Preclinical results have shown that Debio 0123 successfully crosses the blood brain barrier and inhibits tumour growth.  

Dr Stephen Barr, Managing Director and President, Almac Discovery said: “Since the discovery of our highly selective WEE1 inhibitor, we have looked forward to understanding its potential therapeutic benefit for cancer patients across the globe. We are delighted that it has progressed into further clinical development in these two cancer indication studies with high unmet medical need and look forward to seeing further progress from this ongoing clinical research.” 

“The Debio 0123 program originates from a growing awareness of DDR inhibition in fighting life-threatening cancers. Optimizing efficacy, while preserving safety are key elements that Debiopharm is eager to assess throughout the clinical development of Debio 0123. With the fruition of these factors, Debio 0123 could become the first choice WEE1 inhibitor.” Angela Zubel, Chief Development Officer, Debiopharm. 

The post WEE1 Inhibitor discovered by Almac Discovery advanced into two clinical studies addressing the treatment of advanced solid tumours  appeared first on Almac.