Tumour Response in Sixth Patient Triggers Additional Recruitment in Pancreatic Cancer Trial

Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is pleased to announce that the Company’s Phase 2a clinical trial investigating narmafotinib in the treatment of advanced pancreatic cancer (the ACCENT trial) has achieved the required response rate to support continued enrolment in the study. Six (6) patients have now recorded confirmed partial responses (PRs) out of 16 assessed at the four-month timepoint, indicating that the combination of narmafotinib with the chemotherapies gemcitabine and Abraxane® is sufficiently active to support continuation of the trial.

HIGHLIGHTS

Six (6) patients in the Company’s ACCENT trial in pancreatic cancer have now achieved the required reduction in tumour size with no detection of new lesionsThe ACCENT trial can now proceed to recruit the next cohort of 24 patients, giving a total of 50 patients on studyThe ACCENT trial explores the activity of narmafotinib, in combination with standard-of-care chemotherapy, in advanced pancreatic cancer patients

A total of 50 patients are planned for the Phase 2a ACCENT trial. With the six (6) confirmed PRs now obtained, recruitment of the remaining 24 patients in the trial will begin at the existing open trial sites in Australia and South Korea. Recruitment of the second cohort of patients is expected to be completed by end of Q1 2025.

A detailed interim analysis of the Phase 2a trial data obtained to date will be reported in the coming weeks; however, key points are noted below:

Narmafotinib continues to be generally well tolerated by patients with no safety trends identified or dose reductions recorded to dateIn addition to 6 confirmed PRs, there have been 7 patients who have recorded stable disease over 2 or more months, including one patient whose stable disease has improved to achieve a partial response at their 4-month assessment

Amplia CEO and MD Dr Chris Burns commented: “Having now confirmed our sixth PR, we will move forward with recruiting the remaining 24 patients for the trial. We are actively working with our clinical sites to ensure seamless reopening of enrolment with the goal of completing recruitment by the end of March 2025. As always, we thank the patients and their loved ones for being involved with this trial’

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

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