Amplia Advances Narmafotinib Trials and Board with $24M Cash Position

ACCENT Trial Data Highlights Narmafotinib Potential

Amplia Therapeutics (ASX:ATX) showcased mature data from its ACCENT trial at the American Association for Cancer Research meeting, revealing narmafotinib’s promising profile in metastatic pancreatic cancer. The drug, a focal adhesion kinase (FAK) inhibitor, demonstrated an 8% complete response rate compared to just 0.2% with chemotherapy alone, alongside a 36% overall response rate and a disease control rate of 70% versus 50% for chemotherapy. Median overall survival extended to 11.1 months, with progression-free survival at 7.7 months, both improvements over chemotherapy alone. Notably, narmafotinib was administered only 12 days per 28-day cycle, with plans to explore daily dosing to potentially boost outcomes.

Phase 2b Pancreatic Cancer Study Initiated Following FDA Feedback

Building on these results, Amplia launched a Phase 2b study to evaluate daily dosing of narmafotinib combined with gemcitabine and Abraxane® in advanced pancreatic cancer. This trial, set to begin enrolment in Q4 2026 across three to four Australian sites, will recruit 12 newly diagnosed patients in two dose cohorts. It aims to assess safety, tolerability, pharmacokinetics, efficacy, biomarkers, and fibrosis, with critical safety data expected by mid-2027. The study replaces the halted AMPLICITY trial, redirecting resources to accelerate the planned registrational submission to the FDA in Q2 2027.

Expanding FAK Inhibitor Program into Ovarian Cancer

Amplia also partnered with the Australia New Zealand Gynaecological Oncology Group (ANZGOG) to launch the PRROSE trial targeting high-grade serous ovarian cancer patients who respond poorly to initial chemotherapy. Led by Dr Gwo Yaw Ho, the investigator-initiated study will enrol around 20 patients across Australia and New Zealand, combining narmafotinib with standard chemotherapy. The trial focuses on safety and exploring whether the addition of narmafotinib can improve response rates and increase eligibility for life-extending surgery. Extensive biomarker analyses will probe narmafotinib’s mechanism, broadening the company’s clinical footprint beyond pancreatic cancer.

Board Renewal with Experienced Leadership Appointments

In governance moves, Amplia implemented Board succession plans with Ms Jane Bell AM appointed Chair from 30 June 2026, succeeding Dr Warwick Tong who retired as Chair but remains a Non-Executive Director. Bell brings life sciences expertise and strategic insight at a pivotal time for Amplia’s clinical progress. Further strengthening the Board, Brett Carter joined as a Non-Executive Director in July. Carter’s 25-plus years in oncology drug development and corporate strategy, including senior roles at GSK and as CEO of the Cancer Therapeutics CRC where Amplia’s assets originated, add significant depth to the leadership team.

Intellectual Property Expansion and Financial Position

Amplia published a new patent application covering chemically novel FAK inhibitors, potentially extending intellectual property protection through to 2046. This broadens the company’s pipeline beyond narmafotinib and its preclinical candidate AMP886, enhancing long-term commercial opportunities across multiple disease indications. Financially, Amplia closed the quarter with A$24 million in cash, down from A$27.9 million in March, reflecting net operating outflows of A$3.9 million primarily due to clinical trial costs and research and development activities. Payments to related parties amounted to A$112,500, covering directors’ fees and CEO remuneration.