Amplia Therapeutics Ltd (ASX:ATX) has received a Certificate of Grant from the United States Patent and Trademark Office (USPTO) for a key patent covering its focal adhesion kinase (FAK) inhibitor, narmafotinib.
The granted patent, titled A salt and crystal form of a FAK inhibitor, protects the specific form of narmafotinib being advanced through the company’s clinical development programs.
The patent has already been granted in several major jurisdictions, including Europe, Japan, India, Korea and Australia. In these regions, the grant extends protection for narmafotinib to at least 2040, while applications in other territories remain under review by the respective patent offices.
Amplia is advancing a pipeline of focal adhesion kinase (FAK) inhibitors for cancer and fibrosis. FAK is an increasingly important target in oncology, and Amplia has a particular development focus on fibrotic cancers such as pancreatic and ovarian cancer. FAK is also implicated in several chronic diseases, including idiopathic pulmonary fibrosis (IPF).
“With the granting of this patent in the US and other key pharmaceutical markets, we are strengthening narmafotinib’s patent portfolio to protect and maximise the company’s intellectual property for the long term,” Amplia CEO Dr Chris Burns said.
About narmafotinib
Narmafotinib (AMP945) is the company’s best-in-class inhibitor of FAK, a protein that is overexpressed in pancreatic cancer and is an emerging target in solid tumours. The drug is a highly potent and selective FAK inhibitor and has demonstrated promising activity in a range of preclinical cancer studies.
Narmafotinib is currently being evaluated in the ACCENT clinical trial, in which it is dosed in combination with gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer. The trial has met its primary endpoint with a confirmed response rate of 33%, compared with 23% reported in the benchmark MPACT study for gemcitabine and Abraxane alone. An interim median progression-free survival (PFS) of 7.6 months has also been reported.
A second trial, AMPLICITY, has recently opened under an IND at sites in Australia and the US, investigating narmafotinib in combination with the chemotherapy regimen FOLFIRINOX in patients with advanced pancreatic cancer.