Amplia Therapeutics reports encouraging interim results for narmafotinib in metastatic pancreatic cancer, alongside a successful capital raise and key patent allowance.
- Narmafotinib shows 7.6 months median progression-free survival, outperforming chemotherapy alone
- New trial combining narmafotinib with FOLFIRINOX chemotherapy begins dosing patients
- US Patent Office grants key patent securing drug protection until at least 2040
- A$27.5 million capital raise completed, funding operations through 2027
- Operating cash outflows steady, primarily supporting ongoing clinical trials
Clinical Progress in Pancreatic Cancer Treatment
Amplia Therapeutics Limited (ASX, ATX) has delivered a promising update on its lead drug candidate, narmafotinib, a focal adhesion kinase (FAK) inhibitor targeting metastatic pancreatic cancer. The company’s ongoing ACCENT trial has reported an interim median progression-free survival (PFS) of 7.6 months, a notable improvement over the 5.5 months typically seen with chemotherapy alone. This two-month gain is significant in a cancer type known for its aggressive progression and limited treatment options.
Moreover, the objective response rate (ORR) in the trial has increased to 33%, surpassing historical chemotherapy response rates of around 23%. The trial has also recorded rare complete responses, including one pathological complete response following surgery, underscoring narmafotinib’s potential to improve patient outcomes.
Expansion into Combination Therapy with FOLFIRINOX
Amplia has initiated a new Phase 1b/2a clinical trial investigating narmafotinib in combination with FOLFIRINOX, a more aggressive chemotherapy regimen widely used in the US and Western Europe. Following ethics approvals in Australia and the US, patient dosing has commenced at multiple sites, including Melbourne and Sydney. This trial aims to establish the optimal dosing of narmafotinib alongside FOLFIRINOX, potentially broadening the drug’s applicability and enhancing therapeutic efficacy.
Intellectual Property and Regulatory Milestones
On the regulatory front, Amplia secured approval of the generic drug name “narmafotinib” by the US Adopted Names Council, complementing prior World Health Organization recognition. Critically, the US Patent and Trademark Office has allowed a key patent covering the specific salt and crystal form of narmafotinib used in clinical trials. This patent protection extends until at least 2040 across multiple jurisdictions, including Australia, Japan, Europe, and the US, safeguarding Amplia’s commercial interests and enhancing its attractiveness to potential partners.
Financial Position and Capital Raising
Amplia strengthened its financial position during the quarter by completing a capital raise of A$27.5 million before costs, comprising a well-supported institutional placement and a Share Purchase Plan. This funding boost has increased the company’s cash reserves to approximately A$29.2 million at quarter-end, providing runway into 2027 to support ongoing and planned clinical activities. Operating cash outflows remained consistent at around A$3.8 million for the quarter, primarily directed towards clinical trial costs and corporate expenses.
Payments to related parties, including directors’ fees and salaries, were disclosed in line with governance standards, amounting to A$172,500 for the quarter.
Looking Ahead
As Amplia advances its clinical programs, the company is actively engaging with potential partners and collaborators interested in its developing dataset. The combination of encouraging clinical efficacy, robust patent protection, and a solid financial foundation positions Amplia well in the competitive oncology landscape. Investors and analysts will be watching closely for further trial data, particularly from the FOLFIRINOX combination study, and any announcements regarding commercial partnerships.
Bottom Line?
Amplia’s progress with narmafotinib marks a meaningful step forward in pancreatic cancer treatment, but upcoming trial results and partnership deals will be critical to sustaining momentum.
Questions in the middle?
- Will the FOLFIRINOX combination trial confirm enhanced efficacy and manageable safety?
- How soon might Amplia secure commercial partnerships to accelerate narmafotinib’s market entry?
- What are the long-term survival outcomes beyond the interim progression-free survival data?