NARMAFOTINIB ADOPTED AS NONPROPRIETARY DRUG NAME IN USA
Released
Released
Announcement PDF
ABN 16 165 160 841
ASX RELEASE
2 SEPTEMBER 2025
NARMAFOTINIB ADOPTED AS NONPROPRIETARY DRUG NAME IN USA
HIGHLIGHTS
•
The United States Adopted Names (USAN) Council has approved the name narmafotinib as the
nonproprietary drug name for Amplia Therapeutics' lead FAK inhibitor
•
The timing coincides with the imminent initiation of a clinical trial in pancreatic cancer of
narmafotinib combined with the chemotherapy FOLFIRINOX to be conducted in Australia and
the USA
Melbourne, Australia: Amplia Therapeutics Limited (ASX: ATX) (“Amplia” or the “Company”) is pleased
to announce that the United States Adopted Names (USAN) Council has adopted the name
narmafotinib as the generic drug name for the Company’s lead FAK inhibitor currently undergoing
clinical studies in pancreatic cancer.
Amplia has previously reported that the World Health Organization (WHO) approved narmafotinib as
the International Non-Proprietary Name (INN) for global use 1. The USAN council’s adoption of the
name narmafotinib is a separate process that formalises the nonproprietary name for the molecule in
the United States.
Dr Chris Burns, Amplia’s CEO and Managing Director commented: “We are delighted that the USAN
council have adopted the name narmafotinib. Obtaining a USAN is an essential step for any drug
molecule intended for the US market, and it represents an important step in the drug’s commercial
development as we begin our trial of narmafotinib in the USA.”
This ASX announcement was approved and authorised for release by the CEO of Amplia Therapeutics.
1
ASX Announcement 21 June 2023.
Level 5, 90 William Street, Melbourne VIC 3000
Email info@ampliatx.com
www.ampliatx.com
About Narmafotinib
Narmafotinib (AMP945) is the company’s best-in-class inhibitor of the protein FAK, a protein overexpressed in pancreatic cancer and a drug target gaining increasing attention for its role in solid
tumours. The drug, which is a highly potent and selective inhibitor of FAK, has shown promising data
in a range of preclinical cancer studies. Narmafotinib is currently undergoing a clinical trial (the ACCENT
trial) where it is dosed in combination with the chemotherapies gemcitabine and Abraxane in first-line
patients with advanced pancreatic cancer. The trial has already achieved its desired outcome in
achieving a response rate of 31%, superior to chemotherapy alone. In particular, one (1) complete
response and one (1) pathological complete response have been recorded in this study.
About the FOLFIRINOX Trial
Narmafotinib, in combination with the modified FOLFIRINOX chemotherapy regimen, will explore the
safety, tolerability, efficacy and pharmacokinetics of the combination in newly-diagnosed patients
with advanced (metastatic) pancreatic cancer. The trial is entitled ‘A Phase 1b/2a, Multicenter, Open
Label Study of the Safety, Efficacy and Pharmacokinetics of narmafotinib in Combination with
modified FOLFIRINOX in Pancreatic Cancer Patients’ and is being conducted under an open IND from
the US FDA.
Designed as a single-arm, open-label study, the trial will proceed in two parts, incorporating the
principles of the FDA's Project Optimus guidance for developing new oncology therapies 2. Part A will
explore a range of oral daily doses of narmafotinib (AMP945) in combination with modified
FOLFIRINOX (administered every 14 days), for safety, tolerability, and pharmacokinetics.
Part B of the trial is designed to identify the optimal daily dose of narmafotinib for future studies, by
comparing two (2) doses identified from Part A, for safety, tolerability and efficacy.
The trial is being conducted initially at sites in Australia and the US. More information about the trial
can be found at the Amplia Therapeutics website and at ClinicalTrials.gov under the identifier
NCT07026279.
The Company has previously presented data from preclinical studies demonstrating that the addition
of narmafotinib to FOLFIRINOX improves survival in animal models of pancreatic cancer compared to
animals treated with FOLFIRINOX alone.
The Company will provide further updates on the trial as activity progresses.
Investor Contact:
Dr Chris Burns
Chief Executive Officer
chris@ampliatx.com
Media Contact:
H^CK Director, Haley Chartres
haley@hck.digital
+61 423 139 163
About Amplia Therapeutics Limited
Amplia Therapeutics Limited is an Australian pharmaceutical company advancing a pipeline of Focal
Adhesion Kinase (FAK) inhibitors for cancer and fibrosis. FAK is an increasingly important target in the
field of cancer and Amplia has a particular development focus in fibrotic cancers such as pancreatic
and ovarian cancer. FAK also plays a significant role in a number of chronic diseases, such as idiopathic
pulmonary fibrosis (IPF). For more information visit www.ampliatx.com and follow Amplia on Twitter
(@ampliatx) and LinkedIn.
2
https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus
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