Almac Discovery Initiates Phase 1 Study of ALM201 for the Treatment of Patients with Advanced Ovarian Cancer and other Solid Tumours

ALM201 represents the first clinical stage programme for Almac Discovery

Craigavon, N.I., UK, – Almac Discovery, a biopharmaceutical company focused on discovering and identifying innovative therapeutics for the treatment of cancer, today announced that it has received approval to dose the first patient with ALM201 in an open label, Phase 1 dose escalation study to investigate subcutaneous ALM201 in advanced ovarian cancer and other solid tumours. ALM201 is a therapeutic peptide derived from FKBPL, a natural protein that binds CD44. ALM201 has multiple modes of action including anti-angiogenesis, a mechanism that is particularly relevant in ovarian cancer.

Epithelial ovarian cancer (EOC) ranks among the top ten diagnosed cancers, the most common type being high-grade serous ovarian cancer (HGSOC) which accounts for at least 70% of cases. HGSOC represents an area of clear unmet medical need.  Over the past 20 years treatment has progressed very little, with five-year survival figures remaining unchanged for advanced disease.

Stephen Barr, President of Almac Discovery commented, "I am particularly pleased by the progress of our novel drug candidate ALM201 into clinical development. The drug is the culmination of significant effort by the Almac team over the past years and we believe that it will prove to be an essential complement to the oncologist's armamentarium."

About the Study

The Phase 1 dose-escalation study is designed to assess the safety and tolerability of ALM201 in patients with advanced ovarian cancer or other solid tumours. The study is being led from Queen's University Belfast and also involves two further sites at Newcastle and Manchester. Prof. Richard Wilson of Queen's University is the lead investigator. In addition to the primary safety endpoint, secondary endpoints of pharmacokinetics and activity will be evaluated, as well as assessment of a number of tumour biomarkers and markers of ALM201 activity.

Prof. Wilson remarked "ALM201 appears to have a novel mode of action and, should it be found to have significant anti-cancer activity with limited side-effects it has the potential to strengthen existing drug regimens and provide a new option for patients where resistance to therapy has become a problem."

About ALM201

ALM201 is a peptide fragment derived from the naturally occurring protein FK506 binding protein-like (FKBP-L). The development of ALM201 builds upon extensive work by Prof. Tracy Robson from the School of Pharmacy, Queen's University Belfast, who has shown that FKBPL is a naturally secreted anti-angiogenic protein which inhibits blood vessel development by targeting the cell surface receptor CD44. As well as exhibiting anti-angiogenic activity, Prof. Robson has also demonstrated that ALM201 targets cancer stem cells, providing duel anti-tumour activity to this therapeutic peptide.

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About Almac Discovery

Almac Discovery is an independent member of the Almac Group. The company is focused on the discovery and development of novel and innovative approaches to the treatment of cancer and associated conditions, with the goal of developing biomarkers or diagnostic tools in parallel with each potential new therapeutic. Founded in 2008, Almac Discovery is located in Craigavon, Northern Ireland.

For more information, please visit www.almacgroup.com/discovery or e-mail [email protected].

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