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Additional Confirmed Response Reported as Part of Amplia Investor Presentation

HIGHLIGHTS

  • An additional confirmed partial response has been recorded in the ongoing ACCENT trial

  • This brings the confirmed Objective Response Rate to 35%

  • Updated data to be presented at the Life Sciences Virtual Investor Forum

Melbourne, Australia, Dec. 12, 2025 (GLOBE NEWSWIRE) -- Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), (“Amplia” or the “Company”), is pleased to announce that an additional confirmed partial response (PR) has been recorded in the ongoing ACCENT trial in metastatic pancreatic cancer. The trial investigates the combination of the Company’s best-in-class FAK inhibitor narmafotinib in combination with the chemotherapies gemcitabine and nab-paclitaxel (Abraxane®).

The additional PR brings the confirmed objective response rate (ORR) to 35% (19/55) which compares favourably to the ORR of 23% recorded for gemcitabine and nab-paclitaxel alone in the benchmark MPACT trial upon which ACCENT is based.

A presentation outlining the data from the ACCENT trial was presented by Amplia CEO Dr Chris Burns at the Life Sciences Virtual Investor Forum on Thursday December 11 at 3pm US ET (Friday December 12 7am AEDT).

This ASX announcement was approved and authorised for release by the CEO of Amplia Therapeutics.

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 tumors. 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 primary endpoint in achieving a confirmed response rate of 35%, superior to 23% reported in the benchmark MPACT study for gemcitabine and Abraxane alone. An interim median PFS of 7.6 months has also been reported. A second trial – AMPLICITY – has recently opened and is being run under an IND at sites in Australia and the US, investigating the combination of narmafotinib with the chemotherapy FOLFIRINOX in advanced pancreatic cancer patients.

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:
H^CK Director, Haley Chartres
haley@hck.digital 
+61 423 139 163

U.S. Media:
media@ampliatx.com


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