Amplia Therapeutics Provides Clinical Trial Updates

On October 22, 2026 Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), ("Amplia" or the "Company"), reported 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.

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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.

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.

(Press release, Amplia Therapeutics, OCT 22, 2026, View Source [SID1234673650])