Amplia Therapeutics Accelerates Pancreatic Cancer Trials with Promising Interim Data

Accelerated Recruitment and Early Efficacy Signals

Amplia Therapeutics Limited (ASX: ATX) has reported a significant milestone in its pancreatic cancer program, completing recruitment for its Phase 2a ACCENT trial two months ahead of schedule. The trial, which investigates the efficacy of Amplia’s focal adhesion kinase (FAK) inhibitor narmafotinib in combination with standard chemotherapy, enrolled 55 patients with advanced pancreatic cancer. This accelerated recruitment pace underscores strong patient and investigator engagement in what remains a challenging therapeutic area.

Interim data from the ACCENT trial revealed that 13 patients have achieved confirmed partial responses, defined as sustained tumour shrinkage exceeding 30% without new lesions for at least two months. This figure approaches the pre-specified threshold of 15 partial responses that would suggest the narmafotinib combination outperforms chemotherapy alone. With 29 patients still under observation and many yet to reach the four-month assessment, the data trajectory remains promising but incomplete.

Advancing a Second Trial with FDA Endorsement

Building on the ACCENT trial momentum, Amplia is progressing a second clinical study combining narmafotinib with FOLFIRINOX, the preferred first-line chemotherapy regimen for advanced pancreatic cancer in the United States. This trial will be conducted across sites in the US and Australia under an Investigational New Drug (IND) application previously cleared by the FDA.

Importantly, the FDA has provided positive feedback on proposed protocol modifications, describing them as “reasonable” and effectively greenlighting the finalisation of the study design. This regulatory endorsement is a critical step towards formal trial initiation, with Amplia targeting dosing of the first patient before the end of the current quarter.

Financial Position and Operational Efficiency

Amplia closed the March 2025 quarter with a robust cash balance of $10.9 million, down from $13.7 million at the end of December 2024. The $2.7 million net operating cash outflow primarily reflects ongoing research and development expenditures, including clinical trial costs, contract research organisation fees, and manufacturing expenses related to narmafotinib.

Staff and corporate administration costs accounted for $0.7 million of outflows, while $2.3 million was directed towards R&D activities. Payments to related parties, including directors’ fees and salaries, totaled $147,500 for the quarter, consistent with prior disclosures.

Scientific Recognition and Next Steps

Amplia’s interim ACCENT trial data has garnered scientific interest, with additional results selected for presentation at the prestigious American Association of Cancer Research (AACR) annual meeting. This exposure not only elevates Amplia’s profile within the oncology research community but also signals the potential clinical relevance of narmafotinib in a notoriously difficult-to-treat cancer.

Looking ahead, the company remains focused on completing the Phase 2a ACCENT trial and advancing the FOLFIRINOX combination study. Investors will be keenly awaiting further efficacy data and updates on patient dosing timelines, which will be pivotal in validating narmafotinib’s therapeutic promise.