Amplia Therapeutics reports encouraging clinical progress for its pancreatic cancer drug narmafotinib, with a 35% confirmed response rate in the ACCENT trial and FDA support for dose optimisation. The company also uplisted to the US OTCQB market and secured a key patent extending protection to 2040.
- 35% confirmed partial response rate in ACCENT trial surpasses chemotherapy alone
- Phase 1b/2a AMPLICITY trial combining narmafotinib with FOLFIRINOX underway
- Positive FDA feedback supports dose optimisation without delaying development
- Key patent granted extending narmafotinib protection to 2040
- Strong cash position of $31.5 million with positive operating cash flow
Clinical Progress Accelerates
Amplia Therapeutics has delivered a promising update on its lead drug candidate, narmafotinib, targeting metastatic pancreatic cancer. The ACCENT trial, which combines narmafotinib with standard chemotherapies gemcitabine and Abraxane®, reported a confirmed partial response rate of 35% among 55 patients. This marks a significant improvement over the 23% response rate typically seen with chemotherapy alone, suggesting narmafotinib’s potential to enhance treatment efficacy.
Moreover, the trial’s mean duration on treatment reached 219 days, with some patients remaining on therapy for over a year, indicating durable disease control. Importantly, narmafotinib’s safety profile remains favourable, with adverse events mirroring those expected from chemotherapy alone.
Expanding Clinical Horizons
Building on this momentum, Amplia has initiated the AMPLICITY Phase 1b/2a trial, exploring narmafotinib in combination with the more aggressive FOLFIRINOX chemotherapy regimen. Recruitment is underway in Melbourne and Sydney, with US sites expected to open shortly. This trial aims to establish the optimal daily dose of narmafotinib alongside FOLFIRINOX, potentially broadening its applicability in advanced pancreatic cancer treatment.
Regulatory and Intellectual Property Milestones
Amplia’s regulatory pathway received a boost with positive feedback from the US Food and Drug Administration (FDA) endorsing the company’s dose optimisation strategy for upcoming pivotal trials. This endorsement is critical as it supports trial design amendments without impacting the overall development timeline.
Additionally, Amplia secured a key patent covering the specific salt and crystal form of narmafotinib used in clinical studies. This patent extends exclusivity in major markets, including the US, Europe, Japan, India, and Australia, until at least 2040, providing a strong intellectual property foundation for future commercialisation.
Market Access and Financial Health
Amplia’s uplisting to the US OTCQB Venture Market enhances its visibility and accessibility to American investors, complementing its primary ASX listing. Financially, the company ended the December quarter with a robust cash balance of $31.5 million, supported by positive operating cash flow of $2.4 million. Government grants and tax incentives contributed significantly, while research and development expenses remained controlled.
Ongoing Preclinical Research
On the research front, Amplia advanced to the second phase of a collaboration with Korean biotech Next & Bio. This program evaluates narmafotinib’s activity against patient-derived pancreatic cancer cells with specific genetic mutations prevalent in over 90% of cases. These studies may unlock further therapeutic opportunities beyond current clinical trials.
Looking ahead, Amplia plans to release mature data from the ACCENT trial and updates from the AMPLICITY trial, alongside additional preclinical findings. These developments will be closely watched by investors and the oncology community alike.
Bottom Line?
Amplia’s clinical and regulatory strides position narmafotinib as a compelling candidate in pancreatic cancer, but upcoming trial data will be pivotal for its commercial trajectory.
Questions in the middle?
- Will the AMPLICITY trial confirm the optimal dose and safety profile for combination with FOLFIRINOX?
- How will mature survival and progression data from ACCENT influence regulatory approvals?
- What commercial partnerships or licensing deals might Amplia pursue to maximise narmafotinib’s market potential?