Almac Group Awarded U.S. Patents for Ground-breaking “DDRD” Assay
13 June 2017
Craigavon, N.I., 13 June 2017 – Almac Group’s Diagnostics business unit announced today it has been granted U.S. patent protection for its DNA Damage Response Deficiency (DDRD) assay. The U.S. Patent and Trademark Office (USPTO) issued U.S. Patent Numbers 9,670,547 & 9,677,140, each entitled, “Molecular Diagnostic Test for Cancer”, effective until 2031. This adds to the patent protection already granted in China, Singapore, Australia, New Zealand and South Africa for this assay.
Almac’s molecular assay detects a subgroup of patients with a defective FA/BRCA pathway, who are more susceptible to DNA damage and therefore likely beneficiaries of DNA-damage therapeutic agents such as anthracyclines and PARP inhibitors. Furthermore, DNA damage leads to the activation of a specific innate immune response pathway (cGAS/STING/TBK1/IRF3) and activation of immune checkpoint targets (such as PDL1 and IDO1), hence confirming the assay may be used to predict response to immune checkpoint inhibitors. Almac documented these findings in a study entitled “Activation of STING-Dependent Innate Immune Signaling By S-Phase-Specific DNA Damage in Breast Cancer” published by the Journal of National Cancer Institute (JNCI) last year.
“Almac has been at the forefront of RNA based genomic innovation for over 10 years and this patent is expected to be the first of many in the US and EU to protect our innovative pipeline of predictive tests,” said Professor Paul Harkin, President and Managing Director, Almac Diagnostic Services. “The biology behind the DDRD assay is now well established with the first clinical validation for predicting response to DNA damaging agents in breast cancer published in JNCI back in 2014. Further validation is planned to ensure all applications are made commercially available and the significant benefits are realized by patients in the near future.”
About Almac Diagnostic Services
Almac Diagnostic Services is a global personalized medicine company focused on the discovery, development and commercialization of diagnostic tests including companion diagnostics. Our approach to personalized medicine is poised to change the way that medicines are developed, regulated and prescribed. We partner with biopharma companies to provide solutions ranging from pre-clinical biomarker discovery to companion diagnostic development including regulatory submissions and commercialization. We also facilitate biomarker clinical trial management and clinical test delivery from our CLIA-accredited lab. The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilized in phase I to phase III registrational clinical trials.
An emphasis on scientific and technological excellence combined with a committed and passionate multi-functional team, puts Almac Diagnostic Services in a leadership position to take companion and other diagnostic tests all the way through development and to commercialization.
About Almac Group
‘Partnering to Advance Human Health’
The Almac Group is an established contract development and manufacturing organization that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery development and commercialization, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately owned organization that has organically grown almost 50 years and now employs in 5600 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).