Can Amplia Sustain Momentum After Rare Complete Responses in Tough Cancer?
Amplia Therapeutics reports encouraging ACCENT trial results for its FAK inhibitor narmafotinib, including rare complete responses in pancreatic cancer, alongside a $27.5 million capital raise to fund ongoing clinical development.
- ACCENT trial shows 31% response rate with 17 partial responses
- Two patients achieved rare complete responses, including metastatic pancreatic cancer
- Ethics approvals secured for second narmafotinib trial with FOLFIRINOX chemotherapy
- Appointment of Dr Jason Lickliter as Chief Medical Officer
- $27.5 million capital raise funds operations into 2027
Clinical Progress in Pancreatic Cancer
Amplia Therapeutics Limited (ASX – ATX) has reported promising developments in its ongoing clinical program targeting fibrotic cancers, particularly pancreatic cancer. The company’s lead candidate, narmafotinib, a focal adhesion kinase (FAK) inhibitor, demonstrated a 31% response rate in the ACCENT Phase 2 trial when combined with chemotherapy, surpassing the 23% response rate typically seen with chemotherapy alone. This milestone was marked by 17 confirmed partial responses among trial participants.
Notably, two patients achieved complete responses, a rare and encouraging outcome in metastatic pancreatic cancer. One patient’s cancer lesions became undetectable for over two months, while another exhibited a pathological complete response confirmed by surgical pathology. These results have attracted significant media attention and underscore the potential of narmafotinib to improve outcomes in a notoriously difficult-to-treat cancer.
Expanding Clinical Trials and Leadership
Building on this momentum, Amplia has secured ethics approvals in both the USA and Australia to initiate a second trial combining narmafotinib with the FOLFIRINOX chemotherapy regimen. This trial aims to explore whether narmafotinib can similarly enhance responses to this more intensive chemotherapy protocol. The first stage, involving dose escalation studies, is set to commence imminently.
Amplia also strengthened its clinical leadership by appointing Dr Jason Lickliter as Chief Medical Officer. Dr Lickliter brings extensive oncology and clinical trial expertise, having advised the company since 2021. His appointment signals Amplia’s commitment to advancing its clinical programs with experienced guidance.
Financial Position and Outlook
To support its expanding clinical activities, Amplia successfully raised $27.5 million in July 2025 through an institutional placement and a Share Purchase Plan. This capital injection is expected to fund operations through to 2027, providing a solid runway for ongoing trials and regulatory interactions, including planned engagements with the US Food and Drug Administration.
Despite operating cash outflows of $3.8 million during the quarter, primarily related to trial costs and manufacturing, the company ended June 2025 with $7.0 million in cash. Amplia also anticipates a $3.8 million Research and Development tax incentive refund in the coming quarter, further bolstering its financial position.
Looking Ahead
Amplia’s near-term focus will be on data collection and analysis from the ACCENT trial, progressing the FOLFIRINOX combination study, and advancing regulatory discussions. The company’s clinical and financial progress positions it well to continue its pursuit of novel treatments for fibrotic cancers, with pancreatic cancer remaining a critical area of unmet medical need.
Bottom Line?
Amplia’s clinical advances and fresh capital set the stage for pivotal trial milestones and regulatory engagement ahead.
Questions in the middle?
- Will the pathological complete responses translate into durable long-term survival benefits?
- How quickly can Amplia progress through the FOLFIRINOX combination trial phases?
- What feedback will Amplia receive from the US FDA regarding its clinical development plans?
