Amplia Therapeutics Provides Clinical Trial Updates
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
22 OCTOBER 2026
ASX RELEASE
AMPLIA THERAPEUTICS PROVIDES CLINICAL TRIAL UPDATES
HIGHLIGHTS
• One patient remains on the ACCENT trial, with 2 patients completing 24 months on study
• One patient remains on the AMPLICITY trial with 1 confirmed and 1 unconfirmed partial
response (PR) recorded to date
• Pre-trial activities well advanced for ACCENT-Mini trial, with ethics approval expected
imminently
• Ethics approval has been submitted for the ovarian cancer PRROSE study
Melbourne, Australia: Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), (“Amplia” or the
“Company”), is pleased to provide an update on progress in the clinical development of its lead
drug narmafotinib. There are currently two ongoing studies underway, along with three clinical
trials in late-stage start up.
ACCENT Trial: The ACCENT trial is investigating the combination of narmafotinib with gemcitabine
and nab-paclitaxel (Abraxane®
) chemotherapy in newly diagnosed metastatic pancreatic cancer
patients. Mature data from this study – demonstrating promising efficacy, an unprecedented level
of confirmed complete responses, and good tolerability – has been reported previously. One
patient remains on study (currently at 19 months), while two patients have completed 2 years on
study. Analysis of the tumours’ genetic features for a subset of patients suggests that responses
to treatment do not appear to depend on commonly assessed tumour characteristics, including
mutations in the KRAS gene1
. Additional biomarker studies are underway and a scientific paper
describing the trial and data is currently being drafted.
AMPLICITY Trial: The AMPLICITY trial is investigating the combination of narmafotinib with
modified FOLFIRINOX chemotherapy in newly diagnosed metastatic pancreatic cancer patients.
Recruitment into the trial was halted after three dose-limiting toxicities – attributed to the
chemotherapy – were observed2
. One confirmed partial response and one unconfirmed partial
response have been recorded in this trial, and one patient remains on study.
1
KRAS (Kirsten rat sarcoma viral oncogene homolog) is a gene mutated in ~85% pancreatic cancer patients
2
ASX Announcement, 7 April 2026
ACCENT-MINI Trial: The ACCENT trial is investigating the combination of daily narmafotinib with
gemcitabine and Abraxane chemotherapy3
. Three (3) clinical trial sites in Australia have been
selected, and trial start up activities are underway. Ethics approval for this study has been
submitted and is expected imminently.
Safety and pharmacokinetic data from ACCENT-Mini will be available late Q1/early Q2 2027 and
will be included in our protocol submission to the FDA for the registrational study of narmafotinib
plus gemcitabine and Abraxane in pancreatic cancer.
PRROSE Study: The trial will investigate narmafotinib in combination with the chemotherapy
carboplatin and paclitaxel in ovarian cancer patients who have had limited or no response to
chemotherapy in the initial treatment setting4. The clinical trial is being run as a sponsored study
by ANZGOG at sites in Australia and New Zealand. The clinical trial protocol has now been finalised
and ethics approval for the study has been submitted.
Amplia Therapeutics Chief Medical Officer Dr Jason Lickliter commented: “It is exciting to be
moving forward with these trials as the Company builds on the positive clinical data from the
ACCENT trial and the promising preclinical data underpinning the PRROSE and Lilly combination
studies.”
A separate announcement regarding progress with the trial investigating the combination of
narmafotinib with Lilly’s investigational kRAS G12C inhibitor olomorasib in patients with advanced
non-small cell lung cancer5
will be released to the market separately.
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:
Hannah Howlett, Titch Comms
Hannah@titchcomms.com.au
+61 450 648 064
U.S. Media:
media@ampliatx.com
3
ASX Announcement, 19 May 2026
4
ASX Announcement, 8 May 2026
5
ASX Announcement, 4 August 2026. Video description here
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 first-line
patients with advanced pancreatic cancer.
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