How Amplia’s Narmafotinib Is Shaping the Future of Pancreatic Cancer Treatment
Amplia Therapeutics reports strong progress in its pancreatic cancer drug development, completing the ACCENT trial recruitment ahead of schedule and initiating a new US trial, while managing a $6.57 million loss for FY25.
- ACCENT Phase 2a trial fully enrolled two months early with 55 patients
- 15 confirmed partial responses demonstrating promising efficacy
- Initiation of US-based FOLFIRINOX combination trial underway
- FDA Fast Track Designation granted for narmafotinib
- FY25 net loss of $6.57 million with $10.86 million cash reserves
Clinical Momentum in Pancreatic Cancer
Amplia Therapeutics Limited (ASX: ATX) has marked a significant milestone in its clinical development program with the completion of recruitment for its ACCENT Phase 2a trial in advanced pancreatic cancer two months ahead of schedule. The trial enrolled 55 patients across Australia and South Korea, testing the company’s lead FAK inhibitor, narmafotinib, in combination with standard chemotherapy.
Interim data from the trial are encouraging, with 15 confirmed partial responses recorded, surpassing the threshold that suggests the combination therapy outperforms chemotherapy alone. Importantly, narmafotinib has demonstrated a favorable safety profile, with no patients withdrawing due to drug-related adverse effects, underscoring its tolerability in a patient population already burdened by aggressive disease and chemotherapy side effects.
Expanding Clinical Footprint in the US
Building on this momentum, Amplia has initiated a second pivotal clinical trial in the United States, combining narmafotinib with the FOLFIRINOX chemotherapy regimen, which is the preferred first-line treatment for advanced pancreatic cancer in the US and parts of Europe. This dual-track approach strategically positions narmafotinib to complement the two main chemotherapy standards globally, potentially broadening its commercial appeal and patient impact.
The US Food and Drug Administration (FDA) has granted Fast Track Designation to narmafotinib, facilitating more frequent regulatory interactions and opening pathways for accelerated approval. Amplia recently completed a Type D meeting with the FDA, receiving positive feedback on trial protocol modifications, clearing the way for trial initiation activities in mid-2025.
Strengthening Intellectual Property and Collaborations
Amplia has fortified its intellectual property position with key patents granted in Europe and Japan for the chemical form of narmafotinib used in clinical trials. The company also expanded its research collaborations, notably with Korean biotech Next&Bio, to explore combining FAK inhibitors with emerging kRas inhibitors, potentially extending therapeutic applications beyond pancreatic cancer to other solid tumors.
Financial Overview and Outlook
Financially, Amplia reported a net loss after tax of $6.57 million for the year ended 31 March 2025, reflecting increased investment in clinical development and manufacturing scale-up. The company successfully raised $17.48 million in capital during the year, bolstering its cash reserves to $10.86 million at year-end and eliminating borrowings. Amplia also received a $3.77 million R&D tax incentive refund, further strengthening its balance sheet.
Looking ahead, Amplia is focused on delivering topline data from the ACCENT trial in mid-2025 and advancing the US FOLFIRINOX trial. The company’s dual-track clinical strategy, combined with regulatory progress and strategic partnerships, positions it well to unlock value and potentially transform treatment outcomes for patients with pancreatic cancer, a disease with historically poor prognosis and limited therapeutic options.
Bottom Line?
Amplia’s clinical and regulatory strides in pancreatic cancer set the stage for critical data readouts that could redefine treatment paradigms and shareholder value.
Questions in the middle?
- Will the upcoming ACCENT trial topline data confirm the early promising response rates?
- How will the US FOLFIRINOX trial impact narmafotinib’s commercial positioning globally?
- What are the prospects for narmafotinib’s application beyond pancreatic cancer, especially in combination with kRas inhibitors?
