Amplia Therapeutics Announces Opening of US Sites for Amplicity Pancreatic Cancer Trial

Melbourne, Australia, Feb. 11, 2026 (GLOBE NEWSWIRE) -- HIGHLIGHTS

• Two US-based sites have completed trial initiation activities for the AMPLICITY trial in pancreatic cancer

• These sites join the two Australian sites already open and recruiting patients

• Three additional US sites are expected to be open in the coming weeks

Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), (“Amplia” or the “Company”), announces that two (2) sites in the US have been initiated and will shortly be commencing recruitment activities for the AMPLICITY trial.

The two sites – University of California, Irvine (Irvine, Calif.) and The Cleveland Clinic (Cleveland, Oh.) – join the two (2) sites already open in Australia as part of the Company’s AMPLICITY trial, which is investigating Amplia’s lead drug, narmafotinib, in advanced pancreatic cancer patients. An additional three (3) sites in the US will be initiated in the near future as recruitment to the trial continues.

Dr Chris Burns, CEO of Amplia, commented, “These two excellent clinical trial sites in the US help to significantly expand our potential patient base for the AMPLICITY trial, while also contributing to enhancing our presence in the United States both from a clinical and investor perspective. With these two sites, and shortly an additional three sites, we expect to be able to enroll the ongoing study as efficiently as possible. We thank the trial sites and clinical teams for their diligent efforts in completing the pre-trial activities.”

The AMPLICITY trial is investigating narmafotinib, the Company’s best-in-class FAK inhibitor, in combination with the chemotherapy FOLFIRINOX in advanced pancreatic cancer. The trial is already open at two sites in Australia, at the Epworth Hospital (Melbourne) and Genesis Care (Sydney). Further information regarding the AMPLICITY trial can be found at the trial website amplicitytrial.com.

This ASX announcement was approved and authorized for release by the Board of Amplia Therapeutics.

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

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 being investigated in two clinical trials in pancreatic cancer. The most advanced clinical trial (ACCENT) investigates a 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 7.7 months has also been reported.

About AMPLICITY

The AMPLICITY trial explores the safety, tolerability, efficacy and pharmacokinetics of the combination of narmafotinib with the chemotherapy regimen known as modified FOLFIRINOX in newly-diagnosed patients with advanced 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. Part A will explore a range of oral daily doses of narmafotinib 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; ClinicalTrials.gov under the identifier NCT07026279; and at amplicitytrial.com.

The Company has previously presented data from preclinical studies demonstrating that the addition of narmafotinib to FOLFIRINOX significantly improves survival in animal models of pancreatic cancer compared to animals treated with FOLFIRINOX alone.

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