Amplia Launches First Stage of Pivotal Narmafotinib Trial
Released
Released
Announcement PDF
ABN 16 165 160 841
+61 (0) 3 9123 1140 | info@ampliatx.com
Level 5, 90 William Street, Melbourne VIC 3000 Australia
www.ampliatx.com
19 MAY 2026
ASX RELEASE
AMPLIA THERAPEUTICS LAUNCHES FIRST STAGE OF REGISTRATION-ENABLING TRIAL OF
NARMAFOTINIB
HIGHLIGHTS
• New Phase 2b study builds on compelling Phase 1b/2a ACCENT study data to lay foundation for
Phase 3 registrational study
• Focus on investigating new, daily dosing of narmafotinib in combination with standard regimen of
gemcitabine and Abraxane in patients with advanced pancreatic cancer
• Accelerated initiation made possible by clinic-ready drug product and resources transitioned from
AMPLICITY study
• Patient enrolment planned to begin by Q4 2026
Melbourne, Australia: Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), (“Amplia” or the
“Company”), announces that it is initiating a Phase 2b study of narmafotinib in pancreatic cancer
exploring a new dosing regimen. Designed in alignment with FDA feedback, the study will form the basis –
and first stage – of a registrational study in this indication given the high existing unmet need for innovative
treatments. Narmafotinib is a best-in-class FAK inhibitor that has received orphan drug designation and
fast track designation from the U.S. FDA as a potential treatment in pancreatic cancer.
“To-date narmafotinibhas shownno significant tolerabilityburden over chemotherapy alone,and wehave
observed a range of compelling efficacy signals across responses and survival. This has been achieved
with only an intermittent dosing schedule, giving us confidence that moving into daily dosing may further
enhance the therapeutic potential of narmafotinib”, said Dr Chris Burns, CEO and Managing Director of
Amplia. “We have been able to accelerate this phase of the narmafotinib program with redeployed
resources, including drug product, following the wind-down of recruitment in the AMPLICITY trial. We
believe our registrational study submission to the FDA will be stronger for the inclusion of this portion of
the Phase 2b study and we look forward to further engagement with regulators.”
The study will investigate, for the first time, a daily dosing schedule for narmafotinib, at two dosing levels,
with the chemotherapies gemcitabine and Abraxane® in newly diagnosed advanced pancreatic cancer
patients. In this first stage, each dosing cohort will have 6 patients (12 patients in total), which will be
combined with gemcitabine and Abraxane given on their conventional schedule. In addition to safety and
tolerability, pharmacokinetics (PK) and efficacy will be assessed. Exploratory endpoints will include
effects on disease biomarkers as well as effects on fibrosis, a key indicator of FAK activity. The study will
enrol patients across 3-4 sites in Australia. The Company anticipates patient enrolment will begin by the
fourth quarter of this year with the safety, tolerability and PK assessment for the 12 patients completed in
the second quarter of 2027.
This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.
Investor Contact:
Dr Chris Burns
Chief Executive Officer
chris@ampliatx.com
U.S. Contact:
Robert Giordano
rjgiordano@ggrouplifesciences.com
+1 917 327 3938
Media Contact:
Tom Trezona, H^CK Acting MD
tom@hck.digital
+61 411 235 692
U.S. Media:
media@ampliatx.com
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 X
(@ampliatx) and LinkedIn.
About Narmafotinib
Narmafotinib (AMP945) is the company’s best-in-class inhibitor of the protein FAK, a protein over-
expressed 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 achieved its desired outcome in achieving a response rate of
36%, superior to chemotherapy alone, and a mOS of 11.1 months has been reported. A second trial –
AMPLICITY – is being run at sites in Australia investigating the combination of narmafotinib with the
chemotherapy FOLFIRINOX in advanced pancreatic cancer patients.
Share your feedback
Discover