Nine Partial Responses Recorded in Amplia’s Phase 2a Pancreatic Cancer Study

Clinical Progress in Pancreatic Cancer Trial

Amplia Therapeutics Limited (ASX: ATX) has reported significant advancements in its Phase 2a ACCENT trial, targeting pancreatic cancer with its focal adhesion kinase (FAK) inhibitor, narmafotinib. The trial combines narmafotinib with established chemotherapy agents gemcitabine and Abraxane® in first-line treatment for advanced pancreatic cancer patients.

As of mid-December 2024, the company has recruited 12 patients into the second and final cohort of the trial, which requires a total of 24 patients. This follows the initial cohort of 26 patients, from which nine confirmed partial responses (PRs) have now been recorded. This represents an objective response rate of approximately 35%, notably higher than the 23% benchmark from historical data.

In addition, the median duration patients remained on the trial was 172 days, a 47% improvement over historical comparators, indicating a potentially meaningful extension in disease control. These results underscore the promise of narmafotinib in combination therapy for a notoriously difficult-to-treat cancer.

Strategic Collaboration and Research Expansion

Amplia has also initiated a preclinical research collaboration with Next&Bio, a Korean biotechnology company specializing in drug screening using patient-derived cancer cells. This partnership aims to evaluate the efficacy of Amplia’s FAK inhibitors combined with emerging kRas inhibitors, which could broaden therapeutic options not only for pancreatic cancer but also for other malignancies such as lung and colorectal cancers.

Financial Strength and Capital Raising

Financially, Amplia closed the December quarter with a robust cash balance of $13.7 million, a substantial increase from $4.6 million in the previous quarter. This was largely driven by a successful capital raise of $13 million before costs, comprising a $7.8 million placement and a pro-rata accelerated non-renounceable entitlement offer raising approximately $5.2 million.

The capital injection is earmarked to support the completion of the ACCENT Phase 2a trial and to advance a US-based trial combining narmafotinib with the FOLFIRINOX chemotherapy regimen. Operating cash outflows for the quarter were $3 million, primarily related to clinical trial costs, contract research organisation fees, and manufacturing expenses.

Looking Ahead

Amplia’s immediate focus remains on completing enrolment for the remaining patients in the ACCENT trial and progressing regulatory and ethical approvals for the US trial. The company is also actively exploring additional clinical opportunities for narmafotinib, including novel combination therapies, which could further enhance its pipeline and market potential.

With encouraging clinical signals and strengthened financial resources, Amplia Therapeutics is positioning itself as a notable player in the oncology space, particularly in addressing fibrotic cancers like pancreatic cancer where unmet medical needs remain high.