Amplia Therapeutics Starts Phase 2b Trial of Narmafotinib for Pancreatic Cancer

Amplia Therapeutics has launched a Phase 2b registration-enabling trial of narmafotinib in pancreatic cancer. The study will test continuous daily dosing at two potency levels combined with gemcitabine and Abraxane. The trial will enroll 12 newly diagnosed patients split into two cohorts of six.

Patient recruitment is scheduled to begin by Q4 2026 at three to four clinical sites in Australia, with safety and pharmacokinetic data expected in Q2 2027.

Narmafotinib targets Focal Adhesion Kinase (FAK), a protein that pancreatic cancer cells use to build protective scar tissue around tumors. The drug is intended to reduce this barrier so chemotherapy and the immune system can reach the cancer more effectively. The company previously reported final results from its 64-patient ACCENT trial in March. 1 months.

Therapeutics was founded in 2000 as Innate Immunotherapeutics and shifted focus to cancer drugs in 2018. It acquired narmafotinib through the purchase of Amplia Therapeutics that year and later changed its name and ASX ticker to ATX. The company has also begun a separate study with the Australia New Zealand Gynaecological Oncology Group to test narmafotinib with paclitaxel in 15 to 20 patients with advanced recurrent ovarian cancer.

Amplia is exploring combinations with KRAS inhibitors, which are under development for pancreatic cancer. Laboratory data presented in March showed narmafotinib blocked emergency survival pathways in pancreatic, lung, and ovarian cancer cells.