Amplia Therapeutics allocated FDA fast-tracking for pancreatic cancer drug narmafotinib

Melbourne-based Amplia Therapeutics (ASX: ATX) has been granted Fast Track Designation for its narmafotinib advanced pancreatic cancer treatment candidate by the US Food and Drug Administration (FDA).

Narmafotinib is the company’s best-in-class inhibitor of the focal adhesion kinase protein (FAK), which is over-expressed in pancreatic and other cancers and a drug target gaining increasing attention for its role in studies of solid tumours.

The drug has shown promising data in a range of preclinical cancer studies and has been identified as a highly potent and selective inhibitor of FAK.

Healthy volunteer study

To date, Narmafotinib has been successfully assessed in a healthy volunteer study and is currently in an open-label Phase 2a trial in pancreatic cancer, where a combination of narmafotinib and the chemotherapies gemcitabine and Abraxane is being assessed for safety, tolerability and efficacy.

Pancreatic cancer is the eighth most commonly diagnosed cancer in Australia and it is estimated that one in 70 people will be diagnosed by the time they are 85.

Current treatment for pancreatic cancer may include surgery, endoscopic treatment, chemotherapy, radiation therapy or a combination thereof.

Major breakthrough

Amplia chief executive officer and managing director Dr Chris Burns said the FDA designation is a major breakthrough.

“With this designation, we can work more closely with the FDA to accelerate our clinical program and gather the most compelling evidence for regulatory approval in this devastating disease,” he said.

The Fast Track Designation is applicable to drugs which may provide an advantage over current therapies in the treatment of serious conditions.

It is designed to speed the development of these drugs to enable patients to receive them sooner.

Increased FDA access

The new designation will grant Amplia increased access to the FDA and the company is hopeful it may lead to narmafotinib being eligible for accelerated approval and priority review with the administration.

The company has previously received Orphan Drug Designation from the FDA for narmafotinib and earlier this year obtained FDA clearance for use of its IND application in a pancreatic cancer trial of narmafotinib in the US.

That trial is in advanced planning stages.

Amplia is also currently running the ACCENT clinical trial for advanced pancreatic cancer in Australia and South Korea.