Amplia Therapeutics (ASX: ATX) — Momentum Builds with Complete Responses in Pancreatic Cancer Trial
- Noel Ong
- Jul 17
- 7 min read
Announcement
Amplia Therapeutics Limited (ASX: ATX) is entering a compelling phase in its clinical journey, as recent announcements reinforce the growing potential of its lead compound, narmafotinib (AMP945), in the fight against advanced pancreatic cancer (Figure 1). With news of two rare and confirmed complete responses emerging from the ongoing ACCENT trial, investors have reason to take notice. These outcomes are not only clinically remarkable—they may signal a turning point in one of oncology’s most difficult indications.
Narmafotinib blocks the activity of the FAK protein.
Figure 1: Narmafotinib blocks critical pathways supporting tumour growth (source: ATX)
Narmafotinib (AMP945) is the company’s best-in-class inhibitor of the protein FAK (Focal Adhesion Kinase). FAK, a protein—an enzyme that plays a critical role in cancer growth, disease spread, and the formation of fibrotic (scar) tissue. FAK is frequently over-expressed and hyperactive in solid tumours, and elevated levels are strongly associated with poorer patient outcomes. By targeting and blocking FAK activity, narmafotinib reduces cancer progression both within cancer cells and across the tumour microenvironment.
ACCENT Trial Delivers Rare Complete Responses
The ACCENT clinical trial is a Phase 1b/2a multicentre, open-label study evaluating narmafotinib in combination with gemcitabine and Abraxane® in first-line patients with advanced pancreatic cancer (Figure 2). Initially focused on dose safety and optimisation, the study has progressed into Phase 2a, where efficacy is the key focus. The trial is being conducted at seven sites in Australia and five sites in South Korea.
Figure 2: Narmafotinib in combination with standard of care gemcitabine and Abraxane® (source: ATX)
On 16 June 2025, Amplia announced that a patient in the trial had achieved a pathological complete response (pCR)—meaning no live tumour tissue was detected following surgical resection of both the primary pancreatic tumour and liver metastases. Just days later, on 19 June, a second patient recorded a confirmed complete response (CR), defined as the total disappearance of all tumour lesions sustained for more than two months.
A pathological complete response (pCR) is very rarely reported in patients with advanced pancreatic cancer, where the disease has spread to other organs in the body. In patients with locally advanced (i.e. non-metastatic) pancreatic cancer, however, around 5% of patients do record a pCR in response to treatment with neoadjuvant chemotherapy (chemotherapy before surgery). In these earlier-stage patients, a pCR is associated with improvements in overall survival.
These results are statistically rare in metastatic pancreatic cancer. For context, the pivotal MPACT study (NEJM 2013) reported only one CR among 431 patients treated with gemcitabine and Abraxane alone. Amplia’s achievement of two such responses among just 55 trial participants suggests a strong signal of efficacy that warrants continued clinical attention.
Regulatory and Clinical Expansion into the US
In a parallel development, Amplia has secured Institutional Review Board (IRB) approval in the US to initiate a new Phase 2 clinical trial exploring narmafotinib in combination with FOLFIRINOX. This alternative chemotherapy regimen is the preferred first-line therapy in the United States. This marks a strategic broadening of the company’s development footprint and a critical step in establishing narmafotinib as a globally viable oncology asset.
FOLFIRINOX is a chemotherapy cocktail of four drugs used in the treatment of advanced pancreatic cancer, and in the US is the preferred treatment for newly diagnosed patients.
The trial is structured as a two-part study and will adhere to the FDA’s Project Optimus framework. Part A will determine the optimal dose of narmafotinib when used with FOLFIRINOX, and Part B will assess safety and efficacy at the recommended dose. Amplia expects to recruit 60–70 patients across up to six US sites and two Australian locations.
Dr Chris Burns, Amplia’s CEO and Managing Director, commented:
“Receiving the protocol approval from the IRB is a critical step in initiating the US trial of narmafotinib in combination with FOLFIRINOX.
Importantly, results from this trial will complement the existing positive data emerging from our current ACCENT trial, aiming to establish narmafotinib as the optimal combination partner for chemotherapy in this challenging disease.”
Capital Raising Supports Clinical Acceleration for a Solution to Pancreatic Cancer
To fund this expanded pipeline, Amplia launched a capital raising in October 2024 of up to A$13 million. The offer included a pro-rata entitlement offer and institutional placement priced at A$0.115 per share, with attaching options exercisable at $0.1725. Funds raised are being directed toward:
Completion of the ACCENT Phase 2a trial
Launch and progression of the US-based FOLFIRINOX trial
Preclinical R&D and drug manufacturing
General working capital and operational support
As of 30 September 2024, Amplia had $4.6 million in cash and anticipated an additional $4.0 million in R&D rebates, placing it in a relatively stable position to deliver key trial milestones in 2025.
Samso Concluding Comments
At Samso, we often talk about the importance of clinical signals that challenge the norms, and Amplia Therapeutics may have just delivered one. In the complex and unforgiving landscape of advanced pancreatic cancer, recording two confirmed complete responses in a small patient cohort is not business as usual. These results, drawn from a well-structured trial using narmafotinib in combination with standard chemotherapy, are giving early shape to what could become a pivotal story in oncology drug development.
What makes this even more compelling is the scientific backbone supporting the results. Narmafotinib targets Focal Adhesion Kinase (FAK), a protein increasingly recognised for its role in cancer progression and treatment resistance. By inhibiting FAK, narmafotinib appears to disrupt both the cancer cell’s internal survival mechanisms and the broader tumour microenvironment—an approach that may be enabling chemotherapy to work better, faster, and more durably. This isn’t just another combination trial; it’s a strategic layering of mechanisms backed by translational logic.
Amplia’s concurrent move into the US clinical landscape, with FOLFIRINOX as the backbone chemotherapy, is a smart step. It shows not just confidence in the science but also a clear understanding of clinical positioning and market expectations. Layer in their recent capital raise—timed to support both the completion of the ACCENT trial and the launch of the FOLFIRINOX study—and the strategy becomes one of focused execution, not speculative ambition.
The additional response to the pancreatic cancer trials is another positive for the company's case for discovery. The additional response brings the objective response rate to 29%. The response data is made up of 6 out of 55 patients enrolled in the trial, with 20 patients still enrolled in the trial.
The market is obviously loving the results (Figure 3), and with a market capitalisation of AUD $132M, I would think that there is still plenty of room for expansion. The steep rise in valuation since mid-June is a clear indication that shareholders are excited.
Figure 3: Amplia Therapeutics Limited share price chart as of 9th July 2025. (source: commsec)
As always, the data will speak for itself in time, but the early indicators are strong. Amplia appear to be staying in their lane and pursuing a high-value therapeutic niche with a well-differentiated molecule. It feels that in the case of looking for a really important topic, such as pancreatic cancer, diversification from this path, for me, would be a sign that they are not focused enough.
For clinicians, these complete responses offer hope. And for Samso, this is precisely the kind of story we’re here to track: grounded in science, validated by data, and delivered with clarity.
The Samso Way – Seek the Research
At Samso, we believe that true insights emerge when you look beyond the headlines and into the data that drives conviction. Amplia Therapeutics (ASX: ATX) exemplifies this approach. Their focused pursuit of FAK inhibition in hard-to-treat cancers is backed by rigorous science, translational depth, and early clinical results that are breaking through expectations. The company’s recent clinical milestones in pancreatic cancer are not just updates—they are signals worth dissecting. This is why we say: Seek the Research. Because it’s in the fine print of well-run trials and the clarity of execution where the most compelling stories often begin.
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