Interim Data from Accent Pancreatic Cancer Trial Supports Continuation of Trial

Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is pleased to report the interim data analysis from the Company’s Phase 2a clinical trial investigating narmafotinib in the treatment of advanced pancreatic cancer (the ACCENT trial). The trial is investigating the combination of the Company’s best-in-class FAK inhibitor narmafotinib with the standard-of-care chemotherapy regimen of gemcitabine and Abraxane®. Data cut-off for the interim analysis is 27 September 2024.

HIGHLIGHTS

• Data analysis up to 27 September 2024 from the ongoing ACCENT trial of narmafotinib in combination with chemotherapy has been undertaken
• Fifteen patients of the 26 enrolled in the study remain on trial with six (6) confirmed PRs having been recorded along with four (4) unconfirmed PRs and five (5) SDs
• The median duration on trial is longer than for comparative trials of chemotherapy alone
• The ACCENT trial has resumed recruitment for the final cohort of 24 patients and as of 24 October 2024, 3 patients have been recruited

As previously reported by the Company, narmafotinib continues to be generally well tolerated by patients with no dose reductions. In addition, six (6) patients recorded confirmed partial responses (PRs), meaning in these patients there is at least a 30% decrease in the overall size of tumour lesions, with no new tumour lesions, sustained for two or more months.

Further details regarding the responses observed by trial participants are summarised below and presented in the attached slides:

• 6 patients have recorded unconfirmed PRs, 4 of which are awaiting confirmation whilst 2 have subsequently recorded progressive disease (PD)
• 8 patients recorded sustained stable disease (SD), with 5 of these patients remaining on study
• 3 patients recorded PD as best response, while 3 other participants were considered ineligible or withdrew from the trial
• Of the 24 evaluable patients, 19 have recorded a decrease in tumour size as best response at any scan
• Median duration on trial at data cut-off is 136 days, which compares favourably with historical data for chemotherapy alone of 117 days
• Preliminary analysis indicates patients have a faster response to therapy in terms of tumour reduction, compared to historical data for chemotherapy alone

A total of 50 patients are planned for the Phase 2a ACCENT trial. With the six (6) confirmed PRs obtained, recruitment of the remaining 24 patients has begun. Recruitment of the second cohort of patients is expected to be completed by end of Q1 2025 and three patients have already been enrolled as of 24 October 2024.

Amplia CEO and MD Dr Chris Burns commented: “We continue to be excited by the data coming from the clinical study of narmafotinib in this challenging disease. We thank the patients and their loved ones for their involvement in the study. Further trial updates will be provided to the market in due course."

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